The efficacy and safety of biologic or targeted synthetic DMARDs in rheumatoid arthritis treatment: one year of review 2024
Main Article Content
Keywords
b/ts DMARDs, JAK, IL-6, rheumatoid arthritis, TNF-α
Abstract
Background: Both articular and extra-articular structures are affected by rheumatoid arthritis (RA), a chronic inflammatory rheumatic illness that results in severe joint destruction, disability, and death. To increase the response rate and provide RA patients more options, there is an unmet need for the development of innovative treatment drugs. Evaluation of cellular, cytokine, genomic, and transcriptome profiles that would predict therapeutic response to biologic or targeted disease-modifying anti-rheumatic drugs (DMARDs) with various action modes is necessary for a customized therapy plan in RA. Owing to the development of new biologic medicines that target distinct mechanisms of action, the treatment algorithm for RA has undergone significant modification during the last one to two decades. More patients are now able to undergo biologic therapy early in the progression of their illness, thanks to the availability of less expensive biosimilars.
Objective: To summarize the efficacy and safety of biologic or targeted syntheticb/ts DMARDs in RA treatment based on the publications in the past year.
Material and Methods: We compiled the most recent findings from original research publications of 2024 about the effects of b/tsDMARDs on the treatment of RA. In addition, this review article also concluded the recent findings from original research publications of the year 2024 about the effects of b/tsDMARDs biosimilars for treating RA.
Conclusion: This article summarizes the evidence and safety of biologic DMARDs (bDMARDs) or targeted synthetic DMARDs (tsDMARDs) in the management of RA, including those that target tumor necrosis factor alpha, interleukin (IL)-6, B cells, T-cell co-stimulation, and Janus kinase (JAK) from original research articles published in 2024.
References
1 Figus FA, Piga M, Azzolin I, McConnell R, Iagnocco A. Rheumatoid arthritis: Extra-articular manifestations and comorbidities. Autoimmun Rev. 2021;20(4):102776. 10.1016/j.autrev.2021.102776
2 Fu J, Nogueira SV, Drongelen VV, Coit P, Ling S, Rosloniec EF, et al. Shared epitope-aryl hydrocarbon receptor crosstalk underlies the mechanism of gene-environment interaction in autoimmune arthritis. Proc Natl Acad Sci USA. 2018;115(18):4755–60. 10.1073/pnas.1722124115
3 Safiri S, Kolahi AA, Hoy D, Smith E, Bettampadi D, Mansournia MA, et al. Global, regional and national burden of rheumatoid arthritis 1990–2017: A systematic analysis of the Global Burden of Disease study 2017. Ann Rheum Dis. 2019;78(11):1463–71. 10.1136/annrheumdis-2019-215920
4 Carmona L, Cross M, Williams B, Lassere M, March L. Rheumatoid arthritis. Best Pract Res Clin Rheumatol. 2010;24(6):733–45. 10.1016/j.berh.2010.10.001
5 Mok CC, Kwok CL, Ho LY, Chan PT, Yip SF. Life expectancy, standardized mortality ratios, and causes of death in six rheumatic diseases in Hong Kong, China. Arthritis Rheum. 2011;63(5):1182–9. 10.1002/art.30277
6 Cush JJ. Rheumatoid arthritis: Early diagnosis and treatment. Med Clin North Am. 2021;105(2):355–65. 10.1016/j.mcna.2020.10.006
7 Fraenkel L, Bathon JM, England BR, St Clair EW, Arayssi T, Carandang K, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2021;73(7):924–39. 10.1002/acr.24596
8 Smolen JS, Landewé RBM, Bergstra SA, Kerschbaumer A, Sepriano A, Aletaha D, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis. 2023;82(1):3–18. 10.1136/ard-2022-223356
9 Kim H, Alten R, Avedano L, Dignass A, Gomollón F, Greveson K, et al. The future of biosimilars: Maximizing benefits across immune-mediated inflammatory diseases. Drugs. 2020;80(2):99–113. 10.1007/s40265-020-01256-5
10 Kvien TK, Patel K, Strand V. The cost savings of biosimilars can help increase patient access and lift the financial burden of health care systems. Semin Arthritis Rheum. 2022;52:151939. 10.1016/j.semarthrit.2021.11.009
11 Chingcuanco F, Segal JB, Kim SC, Alexander GC. Bioequivalence of biosimilar tumor necrosis factor-α inhibitors compared with their reference biologics: A systematic review. Ann Intern Med. 2016;165(8):565–74. 10.7326/M16-0428
12 Ascef BdO, Almeida MO, Medeiros-Ribeiro ACd, Oliveira de Andrade DC, Oliveira Junior HAd, de Soárez PC. Therapeutic equivalence of biosimilar and reference biologic drugs in rheumatoid arthritis: A systematic review and meta-analysis. JAMA Network Open. 2023;6(5):e2315872-e. 10.1001/jamanetworkopen.2023.15872
13 Fraenkel L, Bathon JM, England BR, St Clair EW, Arayssi T, Carandang K, et al. American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Rheumatol. 2021;73(7):1108–23. 10.1002/art.41752
14 Ho CTK, Mok CC, Cheung TT, Kwok KY, Yip RML. Management of rheumatoid arthritis: 2019 updated consensus recommendations from the Hong Kong Society of Rheumatology. Clin Rheumatol. 2019;38(12):3331–50. 10.1007/s10067-019-04761-5
15 Parisi S, Bortoluzzi A, Sebastiani GD, Conti F, Caporali R, Ughi N, et al. The Italian Society for Rheumatology clinical practice guidelines for rheumatoid arthritis. Reumatismo. 2019;71(S1):22–49. 10.4081/reumatismo.2019.1202
16 Kawahito Y, Morinobu A, Kaneko Y, Kohno M, Hirata S, Kishimoto M, et al. Drug treatment algorithm and recommendations from the 2020 update of the Japan College of Rheumatology clinical practice guidelines for the management of rheumatoid arthritis-secondary publication. Mod Rheumatol. 2023;33(1):21–35. 10.1093/mr/roac017
17 Petrović-Rackov L. Evaluation of the degree of clinical rheumatoid arthritis activity based on the concentrations of cytokines TNF-alpha, IL-12, IL-15, and IL-18 in serum and synovial fluid. Vojnosanit Pregl. 2006;63(1):21–6. 10.2298/VSP0601021P
18 Visvanathan S, Rahman MU, Keystone E, Genovese M, Klareskog L, Hsia E, et al. Association of serum markers with improvement in clinical response measures after treatment with golimumab in patients with active rheumatoid arthritis despite receiving methotrexate: Results from the GO-FORWARD study. Arthritis Res Ther. 2010;12(6):R211. 10.1186/ar3188
19 Emery P, Breedveld F, van der Heijde D, Ferraccioli G, Dougados M, Robertson D, et al. Two-year clinical and radiographic results with combination etanercept-methotrexate therapy versus monotherapy in early rheumatoid arthritis: A two-year, double-blind, randomized study. Arthritis Rheum. 2010;62(3):674–82. 10.1002/art.27268
20 Ruderman EM. Overview of safety of non-biologic and biologic DMARDs. Rheumatology (Oxford). 2012;51(Suppl 6):vi37–43. 10.1093/rheumatology/kes283
21 Garza-Elizondo AK, Oscherwitz M, Cervantes-Ramirez V, Salazar-Marentes E, Galarza-Delgado DA, Cardenas-de la Garza JA. Case report: Latrogenic Kaposi sarcoma secondary to Janus kinase and tumor necrosis factor-alpha inhibitors in rheumatoid arthritis. Int J Rheum Dis. 2024;27(10):e15365. 10.1111/1756-185X.15365
22 Oliveira D, Martins A, Martins F, Gomes C, Pimenta S, Vaz C, et al. Systemic lupus erythematosus induced by anti-tumor necrosis factor α therapy in inflammatory rheumatic diseases: A case series. Reumatismo. 2024;76(4):286-90. 10.4081/reumatismo.2024.1658
23 Zheng B, Liu M, Dai D, Shang Y, Dou X, Liu B, et al. Safety of TNF-α inhibitors: A real-world study based on the US FDA Adverse Event Reporting System database. Medicine (Baltimore). 2024;103(29):e39012. 10.1097/MD.0000000000039012
24 Almashali M, Alotaibi MA, Shadid A. Merkel cell carcinoma associated with TNF inhibitor therapy: A systematic review of case reports. Dermatol Online J. 2024;30(2). 10.5070/D330263575
25 Pelechas E, Voulgari PV, Drosos AA. Preclinical discovery and development of adalimumab for the treatment of rheumatoid arthritis. Expert Opin Drug Discov. 2021;16(3):227–34. 10.1080/17460441.2021.1846516
26 Tamai H, Ikeda K, Miyamoto T, Taguchi H, Kuo CF, Shin K, et al. Reduced versus maximum tolerated methotrexate dose concomitant with adalimumab in patients with rheumatoid arthritis (MIRACLE): A randomised, open-label, non-inferiority trial. Lancet Rheumatol. 2023;5(4):e215–24. 10.1016/S2665-9913(23)00070-X
27 Machado MA, Maciel AA, de Lemos LL, Costa JO, Kakehasi AM, Andrade EI, et al. Adalimumab in rheumatoid arthritis treatment: A systematic review and meta-analysis of randomized clinical trials. Rev Bras Reumatol. 2013;53(5):419–30. 10.1016/S2255-5021(13)70113-5
28 Li JB, Liu PC, Chen L, Wu R. Infiltrations of plasma cells in synovium predict inadequate response to adalimumab in rheumatoid arthritis patients. Arthritis Res Ther. 2024;26(1):186. 10.1186/s13075-024-03426-2
29 Yu Z, Gao L, Zang Y, Cheng L, Gao W, Xu Y. Adalimumab exhibits superiority over etanercept in terms of a numerically higher response rate and equivalent adverse events: A real-world finding. Immun Inflamm Dis. 2024;12(2):e1166. 10.1002/iid3.1166
30 Luo F, Gau SY, Wu YX, Liao HL, Tang F, Zhong Q, et al. Efficacy of adalimumab combined with tripterygium wilfordii Hook F in the treatment of patient with rheumatoid arthritis: A multicenter, open-label, randomized-controlled trial. Int J Rheum Dis. 2024;27(1):e15031. 10.1111/1756-185X.15031
31 Jeries H, Daood R, Hijazi B, Golan-Cohen A, Green I, Merzon E, et al. Drug survival on first biologic therapy among late-onset rheumatoid arthritis patients compared to early-onset patients: A population-based cohort study. Musculoskeletal Care. 2024;22(3):e1928. 10.1002/msc.1928
32 Ma XN, Shi MF, Wang SI, Feng W, Chen SL, Zhong XQ, et al. Risk of dyslipidemia and major adverse cardiac events with tofacitinib versus adalimumab in rheumatoid arthritis: A real-world cohort study from 7580 patients. Front Pharmacol. 2024;15:1370661. 10.3389/fphar.2024.1370661
33 Khosravi S, Zamani B, Motamed MR, Akhoundi FH. Adalimumab-induced CNS demyelination in a patient with multiple pre-existing autoimmune diseases; treatment contemplation. Mod Rheumatol Case Rep. 2024;9(1):75-8. 10.1093/mrcr/rxae069
34 Shirah B, Altwirgi S, Faridoon I, Alghamdi S. Adalimumab-induced central nervous system demyelination in a patient with rheumatoid arthritis. Neuroradiol J. 2024;37(2):234–6. 10.1177/19714009231173102
35 Weinblatt ME, Baranauskaite A, Niebrzydowski J, Dokoupilova E, Zielinska A, Jaworski J, et al. Phase III randomized study of SB5, an adalimumab biosimilar, versus reference adalimumab in patients with moderate-to-severe rheumatoid arthritis. Arthritis Rheumatol. 2018;70(1):40–8. 10.1002/art.40336
36 Fautrel B, Bouhnik Y, Salliot C, Carbonnel F, Fumery M, Bernardeau C, et al. Real-world evidence of clinical outcomes of the use of the adalimumab biosimilar SB5 in rheumatic and gastrointestinal immune-mediated inflammatory diseases: 12-Month data from the PERFUSE study. Drugs Real World Outcomes. 2024;11(4):573-91. 10.1007/s40801-024-00459-6
37 García Miguel J, Yankova Komsalova L, Mata Arnaiz C, Alegre-Sancho JJ, González Polo J, Torrente-Segarra V, et al. Clinical outcomes of switching to adalimumab biosimilar (MSB11022) in patients with rheumatoid arthritis: RESTART Spanish Registry. Curr Med Res Opin. 2024:40(8):1431–1438. 10.1080/03007995.2024.2372295
38 Colina M, Khodeir M, Rimondini R, Valentini M, Campomori F, Corvaglia S, et al. Forty-Eight-month monitoring of disease activity in patients with long-standing rheumatoid arthritis treated with TNF-α inhibitors: Time for clinical outcome prediction and biosimilar vs biologic originator performance. Clin Drug Investig. 2024;44(3):141-8. 10.1007/s40261-024-01341-7
39 Hassett B, Singh E, Mahgoub E, O’Brien J, Vicik SM, Fitzpatrick B. Manufacturing history of etanercept (Enbrel®): Consistency of product quality through major process revisions. MAbs. 2018;10(1):159–65. 10.1080/19420862.2017.1388483
40 Tichý Š, Nekvindová L, Baranová J, Vencovský J, Pavelka K, Horák P, et al. Drug survival analysis of etanercept compared with monoclonal antibody tumour necrosis factor-α inhibitors in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: A propensity score-matched analysis from the Czech ATTRA registry. Scand J Rheumatol. 2024:1–8. 10.1080/03009742.2024.2381746. Epub ahead of print.
41 Bertrand D, Joly J, Neerinckx B, Durez P, Lenaerts J, Joos R, et al. Effectiveness of methotrexate and bridging glucocorticoids with or without early introduction of a 6-month course of etanercept in early RA: Results of the 2-year, pragmatic, randomised CareRA2020 trial. RMD Open. 2024;10(3):e004535. 10.1136/rmdopen-2024-004535
42 Kassabian B, Facco M, Miscioscia A, Carraro S, Rinaldi F, Gallo P, et al. Case report: Breaking CNS immuno-privilege: TNFα-inhibitor triggers aseptic meningitis in a patient with rheumatoid arthritis. Front Immunol. 2024;15:1432360. 10.3389/fimmu.2024.1432360
43 Hosseinpour A, Haj Mohamad Ebrahim Ketabforoush A, Daneshzad E, Babanezhad Gajouti A, Hajimollarabi S. Unexpected multiple sclerosis-like symptoms in a rheumatoid arthritis patient treated with etanercept: A case report. Clin Case Rep. 2024;12(11):e9486. 10.1002/ccr3.9486
44 Robinson SE, Varman R. Ramsay Hunt syndrome associated with etanercept treatment for rheumatoid arthritis: A case report and a review of literature. Cureus. 2024;16(8):e66531. 10.7759/cureus.66531
45 Roy M, Rathore H, Roy AK. Pulmonary embolism in a patient with rheumatoid arthritis on etanercept therapy. J Community Hosp Intern Med Perspect. 2024;14(1):39–42. 10.55729/2000-9666.1294
46 Yu T, Yang C. Multifocal leukoencephalopathy in a patient medicated with etanercept and methotrexate for rheumatoid arthritis. Z Rheumatol. 2024;83(4):297–302. 10.1007/s00393-023-01430-6
47 Shih PC, Hung PC, Leong PY, Hsu JN, Yang CC, Wei JCC, et al. Incidence and risk factors of discontinuation of tofacitinib and biologic disease-modifying anti-rheumatic drugs among patients with rheumatoid arthritis: A population-based cohort study. Clin Rheumatol. 2024;43(12):3625-37. 10.1007/s10067-024-07161-6
48 Pekhenko V, Udovitskiy V, Barbukho O. Efficacy, safety and immunogenicity of the biosimilar etanercept compared to the reference formulation original etanercept in patients with rheumatoid arthritis: An open-label, randomized, comparative, multicenter study. Medicine (Baltimore). 2024;103(30):e39060. 10.1097/MD.0000000000039060
49 Sakane H, Yonemoto Y, Okamura K, Suto T, Inoue M, Mitomi H, et al. Efficacy of switching from originator etanercept to biosimilar YLB113 in real-world patients with rheumatoid arthritis: A retrospective 12 months follow-up study. J Orthop Surg (Hong Kong). 2024;32(2):10225536241265818. 10.1177/10225536241265818
50 Okazaki S, Shirai T, Sato H, Ishii T, Fujii H. Development of anti-MDA5 autoantibody-positive dermatomyositis following the use of etanercept biosimilar in rheumatoid arthritis. Mod Rheumatol Case Rep. 2024;8(2):296-301. 10.1093/mrcr/rxae013
51 Kawakami T, Masui S, Onishi A, Onizawa H, Fujii T, Murakami K, et al. Comparison of safety and effectiveness between etanercept biosimilar LBEC0101 and reference in patients with rheumatoid arthritis in real-world data using the KURAMA cohort. Mod Rheumatol. 2024;34(6):1135-41. 10.1093/mr/roae018
52 Deakin CT, Littlejohn GO, Griffiths H, Ciciriello S, O’Sullivan C, Smith T, et al. Comparative effectiveness of etanercept originator and biosimilar for treating rheumatoid arthritis: implications for cost-savings. Intern Med J. 2024;54(5):795-801. 10.1111/imj.16296
53 Deeks ED. GP2015: An etanercept biosimilar. BioDrugs. 2017;31(6):555–8. 10.1007/s40259-017-0246-1
54 Schmalzing M, Kellner H, Askari A, De Toro Santos J, Vazquez Perez-Coleman JC, Foti R, et al. Real-world effectiveness and safety of SDZ ETN, an etanercept biosimilar, in patients with rheumatic diseases: Final results from multi-country COMPACT study. Adv Ther. 2024;41(1):315-30. 10.1007/s12325-023-02706-8
55 Kearsley-Fleet L, Rokad A, Tsoi MF, Zhao SS, Lunt M, Watson KD, et al. Outcomes following switching from etanercept originator to etanercept biosimilar in 1024 patients with RA: A matched-analysis of the BSRBR-RA. Rheumatology (Oxford). 2024;63(8):2082–92. 10.1093/rheumatology/kead470
56 Matsubara T, Katayama K, Sagawa A, Yoshida M, Mitsuka T, Hashimoto K, et al. Investigation of treatment continuity, usefulness, and nocebo effect in switching from the original etanercept to its biosimilar in patients with rheumatoid arthritis: A JET observational study in Japanese clinical practice. Mod Rheumatol. 2024;34(2):307–12. 10.1093/mr/road027
57 Melo AT, Campanilho-Marques R, Fonseca JE. Golimumab (anti-TNF monoclonal antibody): Where we stand today. Hum Vaccin Immunother. 2021;17(6):1586–98. 10.1080/21645515.2020.1836919
58 Husni ME, Deodhar A, Schwartzman S, Chakravarty SD, Hsia EC, Leu JH, et al. Pooled safety results across phase 3 randomized trials of intravenous golimumab in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Arthritis Res Ther. 2022;24(1):73. 10.1186/s13075-022-02753-6
59 D’Angelo S, Tirri E, Giardino AM, De Rosa T, Matucci-Cerinic M, Dagna L, et al. Real-world effectiveness and persistence of golimumab as second-line anti-TNFα drug in rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis patients in Italy: GO-BEYOND, a 12-month prospective observational study. Int J Rheum Dis. 2024;27(3):e15091. 10.1111/1756-185X.15091
60 Govoni M, Batalov A, Boumpas DT, D’Angelo S, De Keyser F, Flipo RM, et al. Real-world effectiveness of golimumab in the treatment of patients with active rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis who failed initial TNF-α inhibitor therapy: A pooled analysis of European prospective observational study. Clin Exp Rheumatol. 2024;42(3):642–50. 10.55563/clinexprheumatol/7sr1ni
61 Asano T, Ishii Y, Tsuchiya H, Masuda J. Efficacy of golimumab in rheumatoid arthritis patients at high risk of a poor prognosis: Post hoc analysis of GO-FORTH study using cluster analysis. Mod Rheumatol. 2024;34(6):1125–34. 10.1093/mr/roae037
62 Xia W, Zhou L, Gao W, Zhang Y, Si F, Bai F, et al. Patient self-reported experience and satisfaction with golimumab and etanercept treatments for rheumatic diseases: A cohort study. Medicine (Baltimore). 2024;103(8):e36982. 10.1097/MD.0000000000036982
63 Yanagihara T, Oka Y, Moriwaki A, Moriuchi Y, Ogata H, Ishimatsu A, et al. A case of pneumocystis pneumonia developed during rheumatoid arthritis treatment with methotrexate and golimumab. Cureus. 2024;16(1):e52944. 10.7759/cureus.52944
64 Baker JF, Bakewell C, Dikranian A, Lam G, O’Brien J, Moore PC, et al. Characteristics and 6-month outcomes in patients with rheumatoid arthritis initiating infliximab biosimilar IFX-dyyb in a real-world setting. Rheumatol Ther. 2024;11(3):841-53. 10.1007/s40744-024-00653-6
65 Jourdain H, Hoisnard L, Sbidian E, Zureik M. Persistence and safety of anti-TNF biosimilars versus originators in immune-mediated inflammatory diseases: An observational study on the French National Health Data System. RMD Open. 2024;10(1):e003531. 10.1136/rmdopen-2023-003531
66 Gan H, Ren X, Zou Y, Li L, Ding J, Peng L, et al. Rheumatoid arthritis complicated with cervical actinomycosis and ureteral obstruction: A case report and literature review. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2024;49(5):818–24.
67 Nielly H, Bialé L, Gilardin L, Carmoi T, Éon A, Vanquaethem H, et al. Tocilizumab-induced psoriatic eruption : A case report and a case-based review. Rheumatol Int. 2024;44(10):2205–12. 10.1007/s00296-024-05663-9
68 Bouladi M, Ben Othmen A, Sawssen M, Kalou M, Laater A, El Fekih L. New onset of uveitis during infliximab treatment: A case report. Tunis Med. 2024;102(1):58–60. 10.62438/tunismed.v102i1.4564
69 Martinez Perez P, Hanna L, Jaynes E, Gwiggner M. Infliximab rescue therapy in a case of severe granulomatous colitis associated with rituximab use. BMJ Case Rep. 2024;17(2):e257729. 10.1136/bcr-2023-257729.
70 Fukumoto K, Watanabe R, Tsutsumi M, Takakuwa T, Miyamoto M, Hayashi N, et al. Lymphoproliferative disorder progressing after partial remission following immunosuppressive drugs withdrawal in a patient with rheumatoid arthritis. Mod Rheumatol Case Rep. 2024;8(2):243-8. 10.1093/mrcr/rxae007
71 Kameda H, Nishida K, Nanki T, Watanabe A, Oshima Y, Momohara S. Safety and effectiveness of certolizumab pegol in Japanese patients with rheumatoid arthritis: Up to 3-year results from a postmarketing surveillance study. Mod Rheumatol. 2024;34(6):1103-14. 10.1093/mr/roae019
72 Tanaka Y, Miyazaki Y, Kawanishi M, Yamasaki H, Takeuchi T. Long-term safety and efficacy of anti-TNF multivalent VHH antibodies ozoralizumab in patients with rheumatoid arthritis. RMD Open. 2024;10(3):e004480. 10.1136/rmdopen-2024-004480
73 Ito T, Miyoshi Y. Acute heart failure with reduced ejection fraction following ozoralizumab in a patient with rheumatoid arthritis: A case report. Mod Rheumatol Case Rep. 2024;9(1):1-5. 10.1093/mrcr/rxae053
74 Srivastava S, Rasool M. Underpinning IL-6 biology and emphasizing selective JAK blockade as the potential alternate therapeutic intervention for rheumatoid arthritis. Life Sci. 2022;298:120516. 10.1016/j.lfs.2022.120516
75 Favalli EG. Understanding the role of interleukin-6 (IL-6) in the joint and beyond: A comprehensive review of IL-6 inhibition for the management of rheumatoid arthritis. Rheumatol Ther. 2020;7(3):473–516. 10.1007/s40744-020-00219-2
76 Hennigan S, Kavanaugh A. Interleukin-6 inhibitors in the treatment of rheumatoid arthritis. Ther Clin Risk Manag. 2008;4(4):767–75. 10.2147/TCRM.S3470
77 Hsieh PH, Wu O, Geue C, McIntosh E, McInnes IB, Siebert S. Economic burden of rheumatoid arthritis: A systematic review of literature in biologic era. Ann Rheum Dis. 2020;79(6):771–7. 10.1136/annrheumdis-2019-216243
78 Jocić J, Lučić AT, Jovanović I, Jurišević M, Stanisavljević I, Stamenković B, et al. Interleukin 41 as a potential predictor of bio-therapy efficacy in patients with rheumatoid arthritis: A prospective observational study. Int J Med Sci. 2024;21(13):2518–24. 10.7150/ijms.98752
79 Albahdal AS, Alotaibi AM, Alanazi MA, Abanmy N, Alwhaibi M, AlRuthia Y. Cost-consequence analysis of tocilizumab versus adalimumab and etanercept among rheumatoid arthritis patients in Saudi Arabia: A single-center study. Cost Eff Resour Alloc. 2024;22(1):14. 10.1186/s12962-024-00522-7
80 Athanassiou P, Katsimbri P, Bounas A, Gazi S, Sarikoudis T, Syrigou V, et al. Persistence on subcutaneous tocilizumab as monotherapy or in combination with synthetic disease-modifying anti-rheumatic drugs in rheumatoid arthritis patients in Greece (EMBRACE study): A multicenter, post-marketing, non-interventional, observational trial. Clin Rheumatol. 2024;43(5):1469-78. 10.1007/s10067-024-06916-5
81 Karadag O, Farisogullari B, Yagiz B, Erden A, Ademoglu Z, Kimyon G, et al. Tocilizumab as a first line biologic agent in rheumatoid arthritis patients with inadequate response to disease-modifying anti-rheumatic drugs: Real life experience from the TReasure Registry. Clin Exp Rheumatol. 2024;42(1):130-7. 10.55563/clinexprheumatol/2h6ma1
82 Ho Lee Y, Gyu Song G. Comparison of the efficacy and safety of tocilizumab, sarilumab, and olokizumab in patients with active rheumatoid arthritis: A network meta-analysis of randomized controlled trials. Z Rheumatol. 2024;83(Suppl 1):97-106. 10.1007/s00393-022-01315-0
83 Kim JG, Koo BS, Lee JH, Yoon BY. Anemia as an indicator of a higher retention rate for tocilizumab versus tumor necrosis factor inhibitors in patients with rheumatoid arthritis from a Korean multi-center registry. J Rheum Dis. 2024;31(4):212–22. 10.4078/jrd.2024.0026
84 Harada M, Honma Y, Shiba E, Tomosugi N, Harada R. Tocilizumab, a humanized anti-interleukin-6 receptor antibody, induces hepatic iron overload in a susceptible patient. Intern Med. 2024. 10.2169/internalmedicine.4329-24
85 Seki K, Kobayashi A, Takahashi N, Kamimoto A. Medication-related osteonecrosis of the jaw in a patient with rheumatoid arthritis with suspected involvement of methotrexate and tocilizumab. J Dent Sci. 2024;19(4):2428–9. 10.1016/j.jds.2024.07.024
86 Fang YF, Chang SH, Kuo CF, See LC. Safety outcomes of tocilizumab and tofacitinib treatment for rheumatoid arthritis: Target trial emulation. Int J Rheum Dis. 2024;27(11):e15406. 10.1111/1756-185X.15406
87 Louters A, Van Oosterhout M, Burgemeister L, Jessurun NT, Van Lint JA. Prosthetic infections following tocilizumab treatment in patients with rheumatoid arthritis. Rheumatology (Oxford). 2024;63(10):e290-1. 10.1093/rheumatology/keae228
88 Westermann R, Cordtz RL, Duch K, Mellemkjaer L, Hetland ML, Magnussen B, et al. Cancer risk with tocilizumab/sarilumab, abatacept, and rituximab treatment in patients with rheumatoid arthritis: A Danish cohort study. Rheumatology (Oxford). 2024. 10.1093/rheumatology/keae140
89 Leng X, Leszczyński P, Jeka S, Liu S, Liu H, Miakisz M, et al. A phase 3, randomized, double-blind, active-controlled clinical trial to compare BAT1806/BIIB800, a tocilizumab biosimilar, with tocilizumab reference product in participants with moderate-to-severe rheumatoid arthritis with inadequate response to methotrexate: Treatment period 2 analysis (week 24 to week 48). Arthritis Res Ther. 2024;26(1):157. 10.1186/s13075-024-03375-w
90 Smolen JS, Trefler J, Racewicz A, Jaworski J, Zielińska A, Krogulec M, et al. Efficacy and safety of CT-P47 versus reference tocilizumab: 32-Week results of a randomised, active-controlled, double-blind, phase III study in patients with rheumatoid arthritis, including 8 weeks of switching data from reference tocilizumab to CT-P47. RMD Open. 2024;10(4):e004514. 10.1136/rmdopen-2024-004514
91 Zubrzycka-Sienkiewicz A, Klama K, Ullmann M, Petit-Frere C, Baker P, Monnet J, et al. Comparison of the efficacy and safety of a proposed biosimilar MSB11456 with tocilizumab reference product in subjects with moderate-to-severe rheumatoid arthritis: Results of a randomised double-blind study. RMD Open. 2024;10(1):e003596. 10.1136/rmdopen-2023-003596
92 Leng X, Leszczyński P, Jeka S, Liu SY, Liu H, Miakisz M, et al. Comparing tocilizumab biosimilar BAT1806/BIIB800 with reference tocilizumab in patients with moderate-to-severe rheumatoid arthritis with an inadequate response to methotrexate: A phase 3, randomised, multicentre, double-blind, active-controlled clinical trial. Lancet Rheumatol. 2024;6(1):e40–50. 10.1016/S2665-9913(23)00237-0
93 Salvarani C, Cantini F, Niccoli L, Macchioni P, Consonni D, Bajocchi G, et al. Acute-phase reactants and the risk of relapse/recurrence in polymyalgia rheumatica: A prospective followup study. Arthritis Rheum. 2005;53(1):33–8. 10.1002/art.20901
94 van der Geest KS, Abdulahad WH, Rutgers A, Horst G, Bijzet J, Arends S, et al. Serum markers associated with disease activity in giant cell arteritis and polymyalgia rheumatica. Rheumatology (Oxford). 2015;54(8):1397–402. 10.1093/rheumatology/keu526
95 Kivitz A, Gottenberg JE, Bergman M, Qiu C, van Hoogstraten H, de Nijs R, et al. Real-world effectiveness of sarilumab in RA: Results from the open-label, prospective, single-arm observational PROFILE study. Rheumatol Ther. 2024;11(6):1533-50. 10.1007/s40744-024-00715-9
96 Kameda H, Tasaka S, Takahashi T, Suzuki K, Soeda N, Tanaka Y. Safety and effectiveness of sarilumab in Japanese patients with rheumatoid arthritis refractory to previous treatments: An interim analysis of a post-marketing surveillance. Mod Rheumatol. 2024;34(3):444-52. 10.1093/mr/road055
97 Harada H, Kondo M, Maeyama A, Fukuda T, Ikemura S, Shono E, et al. Effectiveness and safety of sarilumab in patients with rheumatoid arthritis: A multicenter, retrospective, inverse probability of treatment-weighted analysis based on the FRAB-registry. Clin Rheumatol. 2024;43(5):1447-59. 10.1007/s10067-024-06907-6
98 Kameda H, Tasaka S, Takahashi T, Suzuki K, Soeda N, van Hoogstraten H, et al. Safety of sarilumab in a Japanese population with rheumatoid arthritis by age group: Data from an interim analysis of a post-marketing surveillance study. Mod Rheumatol. 2024;35(1):42-9. 10.1093/mr/roae051
99 Tada Y, Maeyama A, Hagio T, Sakai M, Maruyama A, Yamamoto T. Usefulness of sarilumab in patients with rheumatoid arthritis after regression of lymphoproliferative disorders. Case Rep Rheumatol. 2023;2023:5780733. 10.1155/2023/5780733
100 Smolen JS, Feist E, Fatenejad S, Grishin SA, Korneva EV, Nasonov EL, et al. Olokizumab versus placebo or adalimumab in rheumatoid arthritis. N Engl J Med. 2022;387(8):715–26. 10.1056/NEJMoa2201302
101 Nasonov EL, Lisitsyna TA, Zonova EV, Kuzkina S. The effect of olokizumab on rheumatoid arthritis patient’s reported outcomes: Results of a double-blind randomized placebo-controlled multicenter phase III trial (CREDO 1). Rheumatol Sci Pract. 2021. 10.47360/1995-4484-2021-62-69
102 Karateev A, Polishchuk EY, Filatova ES, Amirdzhanova VN, Khlaboshina VN, Lila A, et al. Olokizumab effect on chronic pain in rheumatoid arthritis: Results of the PROLOGUE observational study. Int J Rheum Dis. 2024;27(10):e15320. 10.1111/1756-185X.15320
103 Lee YH, Song GG. Comparison of the efficacy and safety of olokizumab at different dosages in patients with active rheumatoid arthritis: A network meta-analysis of randomized controlled trials. Z Rheumatol. 2024;83(Suppl 1):107–14. 10.1007/s00393-023-01367-w
104 Akimova AA, Banshchikova NE, Sizikov AE, Mullagaliev AA, Letyagina EA, Ilina NA, et al. Results of a 12-week open-label, non-interventional study of the efficacy and safety of olokizumab therapy in patients with rheumatoid arthritis after switching from anti-B-cell therapy during the SARS-CoV-2 pandemic. Dokl Biochem Biophys. 2024;518(1):291-9. 10.1134/S1607672924701060
105 Feist E, Fleischmann RM, Fatenejad S, Bukhanova D, Grishin S, Kuzkina S, et al. Olokizumab plus methotrexate: safety and efficacy over 106 weeks of treatment. Ann Rheum Dis. 2024;83(11):1454-64. 10.14412/1996-7012-2024-6-21-35
106 Ho Lee Y, Gyu Song G. Comparison of the efficacy and safety of tocilizumab, sarilumab, and olokizumab in patients with active rheumatoid arthritis: A network meta-analysis of randomized controlled trials. Z Rheumatol. 2024;83(Suppl 1):97–106. 10.1007/s00393-022-01315-0
107 Panayi GS. B cells: A fundamental role in the pathogenesis of rheumatoid arthritis? Rheumatology (Oxford). 2005; 44(Suppl 2):ii3–ii7. 10.1093/rheumatology/keh616
108 Marston B, Palanichamy A, Anolik JH. B cells in the pathogenesis and treatment of rheumatoid arthritis. Curr Opin Rheumatol. 2010;22(3):307–15. 10.1097/BOR.0b013e3283369cb8
109 Takemura S, Klimiuk PA, Braun A, Goronzy JJ, Weyand CM. T cell activation in rheumatoid synovium is B cell dependent. J Immunol. 2001;167(8):4710–8. 10.4049/jimmunol.167.8.4710
110 Mok CC. Rituximab for the treatment of rheumatoid arthritis: An update. Drug Des Devel Ther. 2013;8:87–100. 10.2147/DDDT.S41645
111 Cohen SB, Emery P, Greenwald MW, Dougados M, Furie RA, Genovese MC, et al. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthritis Rheum. 2006;54(9):2793–806. 10.1002/art.22025
112 Emery P, Fleischmann R, Filipowicz-Sosnowska A, Schechtman J, Szczepanski L, Kavanaugh A, et al. The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: Results of a phase IIB randomized, double-blind, placebo-controlled, dose-ranging trial. Arthritis Rheum. 2006;54(5):1390–400. 10.1002/art.21778
113 Rigby W, Ferraccioli G, Greenwald M, Zazueta-Montiel B, Fleischmann R, Wassenberg S, et al. Effect of rituximab on physical function and quality of life in patients with rheumatoid arthritis previously untreated with methotrexate. Arthritis Care Res (Hoboken). 2011;63(5):711–20. 10.1002/acr.20419
114 Tak PP, Rigby W, Rubbert-Roth A, Peterfy C, van Vollenhoven RF, Stohl W, et al. Sustained inhibition of progressive joint damage with rituximab plus methotrexate in early active rheumatoid arthritis: 2-Year results from the randomised controlled trial IMAGE. Ann Rheum Dis. 2012;71(3):351–7. 10.1136/annrheumdis-2011-200170
115 Gerlag DM, Safy M, Maijer KI, Tang MW, Tas SW, Starmans-Kool MJF, et al. Effects of B-cell directed therapy on the preclinical stage of rheumatoid arthritis: The PRAIRI study. Ann Rheum Dis. 2019;78(2):179–85. 10.1136/annrheumdis-2017-212763
116 Frazzei G, Cramer SHM, Landewé RBM, Maijer KI, Gerlag DM, Tak PP, et al. The effect of rituximab on patient reported outcomes in the preclinical phase of rheumatoid arthritis: 2 Year data from the PRAIRI study. RMD Open. 2024;10(4):e004622. 10.1136/rmdopen-2024-004622
117 De Meyst E, Bertrand D, Joly J, Doumen M, Marchal A, Thelissen M, et al. Treat-to-target fixed dose rituximab retreatment versus fixed interval retreatment with disease activity-guided rituximab dose optimisation for patients with rheumatoid arthritis: Study protocol for a multicentre randomised controlled superiority trial focusing on long-term disease impact (RITUXERA). Trials. 2024;25(1):681. 10.1186/s13063-024-08542-7
118 Novella-Navarro M, Ruiz-Esquide V, López-Juanes N, Chacur CA, Monjo-Henry I, Nuño L, et al. Subsequent biologic and targeted synthetic disease modifying anti rheumatic drugs after fulfilling difficult-to-treat rheumatoid arthritis criteria: A survival analysis. Clin Rheumatol. 2024;43(9):2817-23. 10.1007/s10067-024-07070-8
119 Choquette D, Haraoui B, Movahedi M, Bessette L, Sauvageau LC, Ferdinand I, et al. Which advanced treatment should be used following the failure of a first-line anti-TNF in patients with rheumatoid arthritis? 15 Years of evidence from the Quebec registry RHUMADATA. Rheumatology (Oxford). 2024. 10.1093/rheumatology/keae283
120 Wientjes MHM, van Huissteden J, van Herwaarden N, Verhoef LM, den Broeder AA. Dose reduction of rituximab in clinical practice: A retrospective cohort study of rheumatoid arthritis patients in low disease activity on rituximab. Clin Exp Rheumatol. 2024;42(11):2215-20. 10.55563/clinexprheumatol/lrctjp
121 Santos Faria M, Godinho I, Nogueira E, Tavares J, Carvalho D, Ponte C. Rheumatoid arthritis and ANCA-associated vasculitis–An unusual overlap successfully treated with rituximab. ARP Rheumatol. 2024;3(3):248–9. 10.63032/ZTDH8563
122 Janda P, Sączek A, Milan-Ciesielska K, Dolipska J, Kraśniak A, Krzanowski M. IgA vasculitis with Koebner’s phenomenon and renal involvement induced by anti-TNF-α therapy in the treatment of rheumatoid arthritis. Pol Arch Intern Med. 2025;135:16854. 10.20452/pamw.16854
123 Kumar S, Singh SK, Arora R, Kashif AW. Membranous nephropathy in a treatment naïve patient of rheumatoid arthritis. Indian J Nephrol. 2024;34(5):543–4. 10.25259/IJN_40_2024
124 Veeken LD, Opdam MAA, Verhoef LM, Popa C, van Crevel R, den Broeder AA. Infection incidence, timing and dose dependency in rheumatoid arthritis patients treated with rituximab: a retrospective cohort study. Rheumatology (Oxford). 2024;63(5):1246–50. 10.1093/rheumatology/kead328
125 den Broeder N, Verhoef L, de Man YA, Kok MR, Thurlings R, van der Weele W, et al. Long-term clinical and radiological effectiveness and safety of ultralow doses of rituximab in rheumatoid arthritis: observational extension of the REDO trial. RMD Open. 2024;10(2):e003659. 10.1136/rmdopen-2023-003659
126 Nahra V, Panning D, Anthony D, Mattar M. Implementation of an accelerated infusion protocol (90-minute infusion) of rituximab and its safety in patients with autoimmune rheumatic diseases at a tertiary veterans affairs center. Cureus. 2024;16(5):e60558. 10.7759/cureus.60558
127 Sendaydiego X, Gold LS, Dubreuil M, Andrews JS, Reid P, Liew DFL, et al. Use of biologic or targeted synthetic disease-modifying antirheumatic drugs and cancer risk. JAMA Netw Open. 2024;7(11):e2446336. 10.1001/jamanetworkopen.2024.46336
128 Weyand CM, Bryl E, Goronzy JJ. The role of T cells in rheumatoid arthritis. Arch Immunol Ther Exp (Warsz). 2000;48(5):429–35. PMid: 11140470
129 Bonelli M, Scheinecker C. How does abatacept really work in rheumatoid arthritis? Curr Opin Rheumatol. 2018;30(3):295–300. 10.1097/BOR.0000000000000491
130 Walker LS, Sansom DM. The emerging role of CTLA4 as a cell-extrinsic regulator of T cell responses. Nat Rev Immunol. 2011;11(12):852–63. 10.1038/nri3108
131 Jiang H, Tang S, Li Y, Wang J, Ying Z. Clinical efficacy study of abatacept in the treatment of rheumatoid arthritis patients in China. Int J Rheum Dis. 2024;27(10):e15300. 10.1111/1756-185X.15300
132 Asai S, Takahashi N, Terabe K, Yoshioka Y, Kojima T, Kobayakawa T, et al. Clinical effectiveness of baricitinib and abatacept in patients with rheumatoid arthritis. Int J Rheum Dis. 2024;27(11):e15414. 10.1111/1756-185X.15414
133 Balanean A, Brown-Bickerstaff C, Klink A, Patel V, Zheng H, N’Dri L, et al. Real-world clinical outcomes and rationale for initiating abatacept as a first-line biologic for patients with anticitrullinated protein antibody-and rheumatoid factor-positive rheumatoid arthritis. J Comp Eff Res. 2024:13(12):e230144. 10.57264/cer-2023-0144.
134 Harrold LR, Wittstock K, Kelly S, Han X, Zhuo J, Schrader A, et al. Comparative effectiveness of abatacept versus TNF inhibitors in rheumatoid arthritis patients who are ACPA and shared epitope positive. Adv Rheumatol. 2024;64(1):10. 10.1186/s42358-024-00352-4
135 Asif M, Asif A, Rahman UA, Haseeb A, Jafar U, Farooq H. Efficacy and safety of abatacept in preclinical rheumatoid arthritis: A systematic review and meta-analysis of randomized controlled trials. Semin Arthritis Rheum. 2024;69:152562. 10.1016/j.semarthrit.2024.152562
136 Misaki K, Tanaka E, Inoue E, Tamura N, Hirano F, Taniguchi Y, et al. Factors contributing to the improvement in J-HAQ after 3 years of treatment with abatacept in biologic-naïve rheumatoid arthritis patients: Interim results of a long-term, observational, multicentre study in Japan (ORIGAMI). Mod Rheumatol. 2024;35(1):17-26. 10.1093/mr/roae043
137 Chen KH, Li KJ, Fang YF, Hsieh SC, Chen YC, Lee CS, et al. Abatacept retention and clinical effectiveness in patients with rheumatoid arthritis in a real-world setting in Taiwan. Int J Rheum Dis. 2024;27(7):e15199. 10.1111/1756-185X.15199
138 Miyakawa N, Tsuritani K, Teixeira BC, Fujio K. Disease-modifying anti-rheumatic drug selection in Japanese patients with rheumatoid arthritis treated with biologics or JAK inhibitors without methotrexate: A retrospective hospital-based administrative claims database study. Mod Rheumatol. 2024;34(5):900-9. 10.1093/mr/roae021
139 Rech J, Tascilar K, Hagen M, Kleyer A, Manger B, Schoenau V, et al. Abatacept inhibits inflammation and onset of rheumatoid arthritis in individuals at high risk (ARIAA): A randomised, international, multicentre, double-blind, placebo-controlled trial. Lancet. 2024;403(10429):850-9. 10.1016/S0140-6736(23)02650-8
140 Cope AP, Jasenecova M, Vasconcelos JC, Filer A, Raza K, Qureshi S, et al. Abatacept in individuals at high risk of rheumatoid arthritis (APIPPRA): A randomised, double-blind, multicentre, parallel, placebo-controlled, phase 2B clinical trial. Lancet. 2024;403(10429):838-49. 10.1016/S0140-6736(23)02649-1
141 Sunaga A, Inoue T. Hypervirulent Klebsiella pneumoniae in rheumatoid arthritis on abatacept. J Clin Rheumatol. 2025;31(1):e4. 10.1097/RHU.0000000000002167
142 Hoshina D, Nagata Y. Mycosis fungoides-like eruptions associated with abatacept. Australas J Dermatol. 2024;65(3):e77-8. 10.1111/ajd.14249
143 Simon TA, Suissa S, Boers M, Hochberg MC, Skovron ML, Askling J, et al. Malignancy outcomes in patients with rheumatoid arthritis treated with abatacept and other disease-modifying antirheumatic drugs: Results from a 10-year international post-marketing study. Semin Arthritis Rheum. 2024:64:152240. 10.1016/j.semarthrit.2023.152240
144 Simon TA, Dong L, Suissa S, Michaud K, Pedro S, Hochberg M, et al. Abatacept and nonmelanoma skin cancer in patients with rheumatoid arthritis: A comprehensive evaluation of randomised controlled trials and observational studies. Ann Rheum Dis. 2024;83(2):177-83. 10.1136/ard-2023-224356
145 O’Shea J J. Targeting the Jak/STAT pathway for immunosuppression. Ann Rheum Dis. 2004;63(Suppl 2):ii67–ii71. 10.1136/ard.2004.028290
146 Fleischmann R. Novel small-molecular therapeutics for rheumatoid arthritis. Curr Opin Rheumatol. 2012;24(3):335–41. 10.1097/BOR.0b013e32835190ef
147 Winthrop KL. The emerging safety profile of JAK inhibitors in rheumatic disease. Nat Rev Rheumatol. 2017;13(4):234–43. 10.1038/nrrheum.2017.23
148 Pugliesi A, Oliveira DGC, Filho VAS, Machado JO, Pereira AG, Bichuette JCS, et al. Cardiovascular safety of the class of JAK inhibitors or tocilizumab compared with TNF inhibitors in patients with rheumatoid arthritis: Systematic review and a traditional and Bayesian network meta-analysis of randomized clinical trials. Semin Arthritis Rheum. 2024;69:152563. 10.1016/j.semarthrit.2024.152563
149 Ramirez Huaranga MA, Calvo Pascual LA, Velasco Sanchez D, Martin de la Sierra Lopez L, Jimenez Rodriguez L, Lopez Menchero Mora A, et al. Real-world experience with janus kinase inhibitors in immune-mediated diseases: Clinical experience of a university hospital. Cureus. 2024;16(8):e67729. 10.7759/cureus.67729
150 Huang YC, Lee NY, Weng MY. Increased risk of Pneumocystis jirovecii colonization in rheumatoid arthritis patients on biologics and Janus kinase inhibitor. J Microbiol Immunol Infect. 2025;58(1):112-9. 10.1016/j.jmii.2024.08.013
151 Hayashi S, Nakano N, Tsubosaka M, Kamenaga T, Kuroda Y, Matsumoto T, et al. Real-world study comparing the efficacy of Janus kinase inhibitors in patients with difficult-to-treat rheumatoid arthritis. Clin Rheumatol. 2024;43(11):3285-92. 10.1007/s10067-024-07117-w
152 Al Tabaa O, Hecquet S, Thomas M, Carvès S, Combier A, Miceli-Richard C, et al. Real-world assessment of the efficacy and tolerability profile of JAK inhibitors in difficult-to-treat rheumatoid arthritis. Semin Arthritis Rheum. 2024;69:152572. 10.1016/j.semarthrit.2024.152572
153 Tada M, Okano T, Mamaoto K, Yamada Y, Orita K, Mandai K, et al. Comparison of creatine kinase elevation caused by Janus kinase inhibitors and interleukin-6 inhibitors in patients with rheumatoid arthritis: A propensity score-matched study. Arch Rheumatol. 2024;39(3):350–7. 10.46497/ArchRheumatol.2024.10645
154 Lee YH, Song GG. Relative remission rates of Janus kinase inhibitors in comparison with adalimumab in patients with active rheumatoid arthritis: A network meta-analysis. Z Rheumatol. 2024;83(Suppl 1):88–96. 10.1007/s00393-022-01165-w
155 Genovese MC, van Vollenhoven RF, Wilkinson B, Wang L, Zwillich SH, Gruben D, et al. Switching from adalimumab to tofacitinib in the treatment of patients with rheumatoid arthritis. Arthritis Res Ther. 2016;18:145. 10.1186/s13075-016-1049-3
156 Papp KA, Krueger JG, Feldman SR, Langley RG, Thaci D, Torii H, et al. Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: Long-term efficacy and safety results from 2 randomized phase-III studies and 1 open-label long-term extension study. J Am Acad Dermatol. 2016;74(5):841–50. 10.1016/j.jaad.2016.01.013
157 Fournier J, Boussat B, Dervaux B, Gaudin P, Romand X. Cost-utility of tofacitinib in the treatment of moderate-to-severe rheumatoid arthritis in France: A multi-state Markov model analysis. Clin Exp Rheumatol. 2025;43(1):62-9. 10.55563/clinexprheumatol/3f60yv
158 Ekin A, Misirci S, İldemir S, Coskun BN, Yagiz B, Dalkilic E, et al. Efficacy and safety of tofacitinib in rheumatoid arthritis: Nine years of real-world data. Clin Transl Sci. 2024;17(11):e70084. 10.1111/cts.70084
159 Haraoui B, Khraishi M, Choquette D, Fortin I, Kinch CD, Galos C, et al. Tofacitinib safety and effectiveness in Canadian patients with rheumatoid arthritis by cardiovascular risk enrichment: Subanalysis of the CANTORAL study. Rheumatol Ther. 2024;11(6):1629-48. 10.1007/s40744-024-00719-5
160 Chang J, Wang G. A retrospective study of efficacy of tofacitinib combined with bDMARDs in the treatment of rheumatoid arthritis patients with inadequate response to bDMARDs. Int J Rheum Dis. 2024;27(9):e15311. 10.1111/1756-185X.15311
161 Pope J, Finckh A, Silva-Fernández L, Mandl P, Fan H, Rivas JL, et al. Tofacitinib monotherapy in rheumatoid arthritis: Clinical trials and real-world data contextualization of patients, efficacy, and treatment retention. Open Access Rheumatol. 2024;16:115–26. 10.2147/OARRR.S446431
162 D’Alessandro F, Cazzato M, Laurino E, Morganti R, Bardelli M, Frediani B, et al. ToRaRI (Tofacitinib in Rheumatoid Arthritis a Real-Life experience in Italy): Effectiveness, safety profile of tofacitinib and concordance between patient-reported outcomes and physician’s global assessment of disease activity in a retrospective study in central-Italy. Clin Rheumatol. 2024;43(2):657-65. 10.1007/s10067-023-06836-w
163 Kuwana M, Sugiyama N, Momohara S, Atsumi T, Takei S, Tamura N, et al. Six-month safety and effectiveness of tofacitinib in patients with rheumatoid arthritis in Japan: Interim analysis of post-marketing surveillance. Mod Rheumatol. 2024;34(2):272-86. 10.1093/mr/road063
164 Pappas DA, O’Brien J, Moore PC, Dodge R, Germino R, Masri KR, et al. Treatment patterns and effectiveness of tofacitinib in patients initiating therapy for rheumatoid arthritis: Results from the CorEvitas rheumatoid arthritis registry. J Rheumatol. 2024;51(5):452-61. 10.3899/jrheum.2023-0752
165 Cho SK, Song YJ, Kim HW, Nam E, Jeon JY, Yoo HJ, et al. Comparative effectiveness of tofacitinib and tumour necrosis factor inhibitors in patients with rheumatoid arthritis in real-world practice: A prospective observational study. Rheumatology (Oxford). 2025;64(2):541-7. 10.1093/rheumatology/keae109
166 Charles-Schoeman C, Fleischmann R, Mysler E, Greenwald M, Ytterberg SR, Koch GG, et al. Risk of venous thromboembolism with tofacitinib versus tumor necrosis factor inhibitors in cardiovascular risk-enriched rheumatoid arthritis patients. Arthritis Rheumatol. 2024;76(8):1218-29. 10.1002/art.42846
167 Opdam MAA, Broeder ND, van den Bemt BJF, Mulder K, van de Wiel KM, van Ballegooijen H, et al. Higher infection risk for JAK inhibitors tofacitinib and baricitinib compared to subcutaneous biological DMARDs. Clin Rheumatol. 2024;43(6):2133-8. 10.1007/s10067-024-06980-x
168 Buch MH, Bhatt DL, Charles-Schoeman C, Giles JT, Mikuls T, Koch GG, et al. Risk of extended major adverse cardiovascular event endpoints with tofacitinib versus TNF inhibitors in patients with rheumatoid arthritis: A post hoc analysis of a phase 3b/4 randomised safety study. RMD Open. 2024;10(2):e003912. 10.1136/rmdopen-2023-003912
169 Citera G, Mysler E, Kakehasi AM, Pascual-Ramos V, Masson W, Cadatal MJ, et al. Cardiovascular events, malignancies, and efficacy outcomes in Latin American patients with rheumatoid arthritis receiving tofacitinib or tumor necrosis factor inhibitors: A post hoc analysis of the ORAL Surveillance Study. J Clin Rheumatol. 2024;30(5):208-16. 10.1097/RHU.0000000000002106
170 Zhao J, Huang H, Wang Y, Deng X, Geng Y, Zhang X, et al. Real-world clinical equivalence of generic and branded tofacitinib: A prospective longitudinal cohort study in patients with rheumatoid arthritis. Mayo Clin Proc. 2024;99(1):26–38. 10.1016/j.mayocp.2023.08.029
171 Her M, Park J, Lee SG. A large pulmonary nodule in a rheumatoid arthritis patient treated with tofacitinib. Int J Rheum Dis. 2024;27(1):e15013. 10.1111/1756-185X.15013
172 Li Z, Shan Y, Dong J, Mei H, Kong Q, Li Y. Disseminated cryptococcosis presenting with generalized cutaneous involvement in a rheumatoid arthritis patient receiving tofacitinib: A case report. J Dermatol. 2024;51(2):e39-41. 10.1111/1346-8138.16960
173 Deng C, Chiu KH, Lou N, Xing F. Case report: Occult Listeria monocytogenes invasion leading to prosthetic hip joint infection in a patient with rheumatoid arthritis taking tofacitinib. Front Med (Lausanne). 2023;10:1322993. 10.3389/fmed.2023.1322993
174 Boussaa H, Hamdi O, Miladi S, Makhlouf Y, Abdelghani KB, Fazaa A, et al. Tofacitinib-induced acute pancreatitis in a patient with rheumatoid arthritis: A case report and review of the literature. Curr Drug Saf. 2024. 10.2174/0115748863300565240819114551
175 Sun YS, Huang DF, Chen WS, Liao HT, Chen MH, Tsai HC, et al. Real-world risk factors for herpes zoster in patients with rheumatoid arthritis undergoing tofacitinib treatment. J Chin Med Assoc. 2024;87(11):988-92. 10.1097/JCMA.0000000000001159
176 Keystone EC, Taylor PC, Tanaka Y, Gaich C, DeLozier AM, Dudek A, et al. Patient-reported outcomes from a phase 3 study of baricitinib versus placebo or adalimumab in rheumatoid arthritis: Secondary analyses from the RA-BEAM study. Ann Rheum Dis. 2017;76(11):1853–61. 10.1136/annrheumdis-2017-211259
177 Dougados M, van der Heijde D, Chen YC, Greenwald M, Drescher E, Liu J, et al. Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: Results from the RA-BUILD study. Ann Rheum Dis. 2017;76(1):88–95. 10.1136/annrheumdis-2016-210094
178 Mahmoud EM, Radwan A, Elsayed SA. A prospective randomized-controlled non-blinded comparative study of the JAK inhibitor (baricitinib) with TNF-α inhibitors and conventional DMARDs in a sample of Egyptian rheumatoid arthritis patients. Clin Rheumatol. 2024;43(12):3657-68. 10.1007/s10067-024-07194-x
179 Edwards CJ, Takeuchi T, Finckh A, Kleyer A, Haladyj E, Gerwien JG, et al. Baricitinib as monotherapy for treatment of rheumatoid arthritis: Analysis of real-world data. Curr Med Res Opin. 2024:40(11):1993–2002. 10.1080/03007995.2024.2416979
180 Caporali R, Taylor PC, Aletaha D, Sanmartí R, Takeuchi T, Mo D, et al. Efficacy of baricitinib in patients with moderate-to-severe rheumatoid arthritis up to 6.5 years of treatment: Results of a long-term study. Rheumatology (Oxford). 2024;63(10):2799-809. 10.1093/rheumatology/keae012
181 Ekin A, Misirci S, Görünen A, Coskun BN, Yagiz B, Dalkilic E, et al. Is baricitinib effective and safe for patients with difficult-to-treat rheumatoid arthritis? Comparative data with the RA group of rheumatoid arthritis not difficult to treat. Med Princ Pract. 2025;34(1):75–86. 10.1159/000541488
182 van de Laar CJ, Oude Voshaar MAH, Ten Klooster P, Tedjo DI, Bos R, Jansen T, et al. PERFECTRA: A pragmatic, multicentre, real-life study comparing treat-to-target strategies with baricitinib versus TNF inhibitors in patients with active rheumatoid arthritis after failure on csDMARDs. RMD Open. 2024;10(2):e004291. 10.1136/rmdopen-2024-004291
183 Gilbert BTP, Mongin D, Aymon R, Lauper K, Laedermann C, Perrier C, et al. Comparative effectiveness of baricitinib and alternative biological DMARDs in a Swiss cohort study of patients with RA. BMJ Open. 2024;14(3):e072300. 10.1136/bmjopen-2023-072300
184 Okamoto N, Atsumi T, Takagi M, Takahashi N, Takeuchi T, Tamura N, et al. Safety of baricitinib in Japanese patients with rheumatoid arthritis in clinical use: 3-Year data of all-case post-marketing surveillance study. Mod Rheumatol. 2024;35(2):215-24. 10.1093/mr/roae064
185 Calvo-Garcia A, Ramírez Herráiz E, Llorente Cubas IM, Varas De Dios B, Benedí González J, Morell Baladrón A, et al. The real-world effectiveness, persistence, adherence, and safety of Janus kinase inhibitor baricitinib in rheumatoid arthritis: A long-term study. J Clin Med. 2024;13(9):2517. 10.3390/jcm13092517
186 Mariani FM, Alunno A, Carubbi F, Ferri C. A rare case of symptomatic creatine kinase elevation in a patient with rheumatoid arthritis treated with baricitinib. Reumatismo. 2024;76(2). 10.4081/reumatismo.2024.1620
187 Genovese MC, Smolen JS, Weinblatt ME, Burmester GR, Meerwein S, Camp HS, et al. Efficacy and safety of ABT-494, a selective JAK-1 inhibitor, in a phase IIB study in patients with rheumatoid arthritis and an inadequate response to methotrexate. Arthritis Rheumatol. 2016;68(12):2857–66. 10.1002/art.39808
188 Kremer JM, Emery P, Camp HS, Friedman A, Wang L, Othman AA, et al. A phase IIB study of ABT-494, a selective JAK-1 inhibitor, in patients with rheumatoid arthritis and an inadequate response to anti-tumor necrosis factor therapy. Arthritis Rheumatol. 2016;68(12):2867–77. 10.1002/art.39801
189 Lo Gullo A, Parisi S, Becciolini A, Paroli M, Bravi E, Andracco R, et al. Multicenter observational study on the efficacy of selective Janus kinase-1 inhibitor upatacitinib in rheumatoid arthritis. Minerva Med. 2024;115(4):430–8. 10.23736/S0026-4806.24.09409-6
190 Barešić M, Kilić P, Balen Topić M, Anić B. Prolonged eosinophilia caused by strongyloidiasis in a patient with rheumatoid arthritis treated with upadacitinib. Mod Rheumatol Case Rep. 2025;9(1):6-9. 10.1093/mrcr/rxae061
191 So H, Cheng I, Chow E, Wu Q, Li M, Hung V, et al. Erosion regression in patients with rheumatoid arthritis after upadacitinib-a pilot study using high resolution peripheral quantitative computed tomography. Rheumatology (Oxford). 2024. 10.1142/S2661341724740286
192 Burmester GR, Van den Bosch F, Tesser J, Shmagel A, Liu Y, Khan N, et al. Upadacitinib in rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying antirheumatic drugs: Efficacy and safety through 5 years (SELECT-NEXT). J Rheumatol. 2024;51(7):663-72. 10.3899/jrheum.2023-1062
193 Bessette L, Chan J, Chow A, Lisnevskaia L, Richard N, Fournier PA, et al. Real-world effectiveness of upadacitinib for treatment of rheumatoid arthritis in Canadian patients: Interim results from the prospective observational Close-Up study. Rheumatol Ther. 2024;11(3):563-82. 10.1007/s40744-024-00651-8
194 Baker JF, Zueger P, Ali M, Bennett D, Yu M, Munoz Maldonado Y, et al. Real-world use and effectiveness outcomes in patients with rheumatoid arthritis treated with upadacitinib: An analysis from the CorEvitas registry. Rheumatol Ther. 2024;11(2):363-80. 10.1007/s40744-024-00639-4
195 Baldi C, Parisi S, Falsetti P, Sota J, Ditto MC, Capassoni M, et al. Efficacy and safety of upadacitinib in rheumatoid arthritis: Real-life experience from a prospective longitudinal multicentric study. J Clin Med. 2024;13(2):401. 10.3390/jcm13020401
196 Xu H, Su B, Li R, Wang L, Zhou J, Zhao L. Successful treatment of anti-PTX3 positive seronegative rheumatoid arthritis with upadacitinib. Int J Rheum Dis. 2024;27(1):e14899. 10.1111/1756-185X.14899
197 Omidi F, Delkash P, Nasiri MJ, Mirsaeidi M. Upadacitinib and cardiovascular adverse events in rheumatoid arthritis: A systematic review and meta-analysis. Curr Rheumatol Rev. 2024. 10.1101/2023.10.24.23297509
198 Charles-Schoeman C, Giles JT, Lane NE, Choy E, Furst DE, Vencovský J, et al. Impact of upadacitinib on laboratory parameters and related adverse events in patients with RA: Integrated data up to 6.5 years. Rheumatol Ther. 2024;11(1):157-75. 10.1007/s40744-023-00624-3
199 Fleischmann R, Meerwein S, Charles-Schoeman C, Combe B, Hall S, Khan N, et al. Efficacy and safety of upadacitinib in patients with rheumatoid arthritis and inadequate response or intolerance to biological treatments: Results through 5 years from the SELECT-BEYOND study. RMD Open. 2024;10(3):e003918. 10.1136/rmdopen-2023-003918
200 Fleischmann R, Swierkot J, Penn SK, Durez P, Bessette L, Bu X, et al. Long-term safety and efficacy of upadacitinib versus adalimumab in patients with rheumatoid arthritis: 5-Year data from the phase 3, randomised SELECT-COMPARE study. RMD Open. 2024;10(2):e004007. 10.1136/rmdopen-2023-004007
201 Fleischmann R, Blanco R, Van den Bosch F, Bessette L, Song Y, Penn SK, et al. Long-term efficacy and safety following switch between upadacitinib and adalimumab in patients with rheumatoid arthritis: 5-Year data from SELECT-COMPARE. Rheumatol Ther. 2024;11(3):599-615. 10.1007/s40744-024-00658-1
202 Caporali R, Kadakia A, Howell O, Patel J, Milligan J, Strengholt S, et al. A real-world comparison of clinical effectiveness in patients with rheumatoid arthritis treated with upadacitinib, tumor necrosis factor inhibitors, and other advanced therapies after switching from an initial tumor necrosis factor inhibitor. Adv Ther. 2024;41(9):3706-21. 10.1007/s12325-024-02948-0
203 van Vollenhoven R, Strand V, Takeuchi T, Chávez N, Walter PM, Singhal A, et al. Upadacitinib monotherapy versus methotrexate monotherapy in patients with rheumatoid arthritis: Efficacy and safety through 5 years in the SELECT-EARLY randomized controlled trial. Arthritis Res Ther. 2024;26(1):143. 10.1186/s13075-024-03358-x
204 van Vollenhoven RF, Hall S, Wells AF, Meerwein S, Song Y, Tanjinatus O, et al. Long-term sustainability of response to upadacitinib among patients with active rheumatoid arthritis refractory to biological treatments: Results up to 5 years from SELECT-BEYOND. RMD Open. 2024;10(3):e004037. 10.1136/rmdopen-2023-004037.
205 Rubbert-Roth A, Kato K, Haraoui B, Rischmueller M, Liu Y, Khan N, et al. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis refractory to biologic DMARDs: Results through week 216 from the SELECT-CHOICE Study. Rheumatol Ther. 2024;11(5):1197-215. 10.1007/s40744-024-00694-x
206 Picchianti Diamanti A, Cattaruzza MS, Salemi S, Di Rosa R, Sesti G, De Lorenzo C, et al. Clinical and ultrasonographic remission in bio-naïve and bio-failure patients with rheumatoid arthritis at 24 weeks of upadacitinib treatment: The UPARAREMUS real-life study. Rheumatol Ther. 2024;11(5):1347-61. 10.1007/s40744-024-00712-y
207 Namour F, Desrivot J, Van der Aa A, Harrison P, Tasset C, van’t Klooster G. Clinical confirmation that the selective JAK1 inhibitor filgotinib (GLPG0634) has a low liability for drug-drug interactions. Drug Metab Lett. 2016;10(1):38–48. 10.2174/1872312810666151223103353
208 Kavanaugh A, Kremer J, Ponce L, Cseuz R, Reshetko OV, Stanislavchuk M, et al. Filgotinib (GLPG0634/GS-6034), an oral selective JAK1 inhibitor, is effective as monotherapy in patients with active rheumatoid arthritis: Results from a randomised, dose-finding study (DARWIN 2). Ann Rheum Dis. 2017;76(6):1009–19. 10.1136/annrheumdis-2016-210105
209 Combe B, Kivitz A, Tanaka Y, van der Heijde D, Simon JA, Baraf HSB, et al. Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: A phase III randomised clinical trial. Ann Rheum Dis. 2021;80(7):848–58. 10.1136/annrheumdis-2020-219214
210 Westhovens R, Rigby WFC, van der Heijde D, Ching DWT, Stohl W, Kay J, et al. Filgotinib in combination with methotrexate or as monotherapy versus methotrexate monotherapy in patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate: The phase 3, randomised controlled FINCH 3 trial. Ann Rheum Dis. 2021;80(6):727–38. 10.1136/annrheumdis-2020-219213
211 Winthrop KL, Tanaka Y, Takeuchi T, Kivitz A, Matzkies F, Genovese MC, et al. Integrated safety analysis of filgotinib in patients with moderately to severely active rheumatoid arthritis receiving treatment over a median of 1.6 years. Ann Rheum Dis. 2022;81(2):184–92. 10.1136/annrheumdis-2021-221051
212 Buch MH, Aletaha D, Combe BG, Tanaka Y, Caporali R, Schulze-Koops H, et al. Efficacy and safety of filgotinib in patients with rheumatoid arthritis: Week 156 interim results from a long-term extension study. RMD Open. 2024;10(4): e004476. 10.1136/rmdopen-2024-004476.
213 Buch MH, Walker D, Edwards CJ, Barry J, Akroyd L, Omoruyi EVE, et al. Efficacy and safety of filgotinib in patients with moderately active rheumatoid arthritis and an inadequate response to methotrexate. Rheumatology (Oxford). 2024. 10.1093/rheumatology/keae486
214 Tanaka Y, Matsubara T, Atsumi T, Amano K, Ishiguro N, Hirata S, et al. Safety and efficacy of filgotinib in Japanese patients with rheumatoid arthritis: Week 156 interim results in FINCH 4. Mod Rheumatol. 2024. 10.1093/mr/roae099
215 Burmester GR, Gottenberg JE, Caporali R, Winthrop KL, Tanaka Y, Ekoka Omoruyi EV, et al. Integrated safety analysis of filgotinib in patients with moderate-to-severe rheumatoid arthritis over a treatment duration of up to 8.3 years. Ann Rheum Dis. 2024;83(9):1110-7. 10.1136/ard-2024-225759
216 Schultz O, Fiehn C, Kneitz C, Picker N, Kromer D, Zignani M, et al. Real-world experience with filgotinib for rheumatoid arthritis in Germany: A retrospective chart review. Z Rheumatol. 2024;84:39-47. 10.1007/s00393-024-01506-x
217 Fornaro M, Caporali R, Biggioggero M, Bugatti S, De Stefano L, Cauli A, et al. Effectiveness and safety of filgotinib in rheumatoid arthritis patients: Data from the GISEA registry. Clin Exp Rheumatol. 2024;42(5):1043-50. 10.55563/clinexprheumatol/b40rv4
218 La Barbera L, Rizzo C, Camarda F, Atzeni F, Miceli G, Molica Colella AB, et al. Effectiveness and safety of filgotinib in rheumatoid arthritis: A real-life multicentre experience. Clin Exp Rheumatol. 2024;42(5):991-8. 10.55563/clinexprheumatol/k78ug3
219 Gao X, He X, Oshima H, Miyatake D, Otsuka Y, Kato K, et al. Pharmacokinetics and safety of single and multiple doses of peficitinib (ASP015K) in healthy Chinese subjects. Drug Des Devel Ther. 2022;16:1365–81. 10.2147/DDDT.S359501
220 Tanaka Y, Izutsu H. Peficitinib for the treatment of rheumatoid arthritis: An overview from clinical trials. Expert Opin Pharmacother. 2020;21(9):1015–25. 10.1080/14656566.2020.1739649
221 Yang Y, Li J, Liu J, Liu L, Wang Y, Hu J, et al. Safety and efficacy of peficitinib in Asian patients with rheumatoid arthritis who had an inadequate response or intolerance to methotrexate: Results of a multicenter, randomized, double-blind, placebo-controlled phase 3 study. Lancet Reg Health West Pac. 2024;42:100925. 10.1016/j.lanwpc.2023.100925
222 Tanaka Y, Takeuchi T, Morita Y, Kaneko Y, Terada W. Safety and effectiveness of peficitinib 100 mg/day in patients achieving clinical remission from a long-term open-label extension study in Japan, Korea, and Taiwan (RAJ2). Mod Rheumatol. 2024;34(5):918-26. 10.1093/mr/road110
223 Tanaka Y, Takeuchi T, Morita Y, Kato D, Kaneko Y, Terada W. Post hoc analysis of patients with rheumatoid arthritis under clinical remission in two Japanese phase 3 trials of peficitinib treatment (RAJ3 and RAJ4). Mod Rheumatol. 2024;34(3):453–65. 10.1093/mr/road059
224 Prakken B, Albani S, Martini A. Juvenile idiopathic arthritis. Lancet. 2011;377(9783):2138–49. 10.1016/S0140-6736(11)60244-4
225 Petty RE, Southwood TR, Manners P, Baum J, Glass DN, Goldenberg J, et al. International League of Associations for Rheumatology classification of juvenile idiopathic arthritis: Second revision, Edmonton, 2001. J Rheumatol. 2004;31(2):390–2.
226 Srinivasalu H, Simpson J, Stoll ML. Drug therapy in juvenile spondyloarthritis. Curr Opin Rheumatol. 2024;36(4):295–301. 10.1097/BOR.0000000000001016
227 Poddighe D, Romano M, Gattinara M, Gerloni V. Biologics for the treatment of juvenile idiopathic arthritis. Curr Med Chem. 2018;25(42):5860–93. 10.2174/0929867325666180522085716
2 Fu J, Nogueira SV, Drongelen VV, Coit P, Ling S, Rosloniec EF, et al. Shared epitope-aryl hydrocarbon receptor crosstalk underlies the mechanism of gene-environment interaction in autoimmune arthritis. Proc Natl Acad Sci USA. 2018;115(18):4755–60. 10.1073/pnas.1722124115
3 Safiri S, Kolahi AA, Hoy D, Smith E, Bettampadi D, Mansournia MA, et al. Global, regional and national burden of rheumatoid arthritis 1990–2017: A systematic analysis of the Global Burden of Disease study 2017. Ann Rheum Dis. 2019;78(11):1463–71. 10.1136/annrheumdis-2019-215920
4 Carmona L, Cross M, Williams B, Lassere M, March L. Rheumatoid arthritis. Best Pract Res Clin Rheumatol. 2010;24(6):733–45. 10.1016/j.berh.2010.10.001
5 Mok CC, Kwok CL, Ho LY, Chan PT, Yip SF. Life expectancy, standardized mortality ratios, and causes of death in six rheumatic diseases in Hong Kong, China. Arthritis Rheum. 2011;63(5):1182–9. 10.1002/art.30277
6 Cush JJ. Rheumatoid arthritis: Early diagnosis and treatment. Med Clin North Am. 2021;105(2):355–65. 10.1016/j.mcna.2020.10.006
7 Fraenkel L, Bathon JM, England BR, St Clair EW, Arayssi T, Carandang K, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2021;73(7):924–39. 10.1002/acr.24596
8 Smolen JS, Landewé RBM, Bergstra SA, Kerschbaumer A, Sepriano A, Aletaha D, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis. 2023;82(1):3–18. 10.1136/ard-2022-223356
9 Kim H, Alten R, Avedano L, Dignass A, Gomollón F, Greveson K, et al. The future of biosimilars: Maximizing benefits across immune-mediated inflammatory diseases. Drugs. 2020;80(2):99–113. 10.1007/s40265-020-01256-5
10 Kvien TK, Patel K, Strand V. The cost savings of biosimilars can help increase patient access and lift the financial burden of health care systems. Semin Arthritis Rheum. 2022;52:151939. 10.1016/j.semarthrit.2021.11.009
11 Chingcuanco F, Segal JB, Kim SC, Alexander GC. Bioequivalence of biosimilar tumor necrosis factor-α inhibitors compared with their reference biologics: A systematic review. Ann Intern Med. 2016;165(8):565–74. 10.7326/M16-0428
12 Ascef BdO, Almeida MO, Medeiros-Ribeiro ACd, Oliveira de Andrade DC, Oliveira Junior HAd, de Soárez PC. Therapeutic equivalence of biosimilar and reference biologic drugs in rheumatoid arthritis: A systematic review and meta-analysis. JAMA Network Open. 2023;6(5):e2315872-e. 10.1001/jamanetworkopen.2023.15872
13 Fraenkel L, Bathon JM, England BR, St Clair EW, Arayssi T, Carandang K, et al. American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Rheumatol. 2021;73(7):1108–23. 10.1002/art.41752
14 Ho CTK, Mok CC, Cheung TT, Kwok KY, Yip RML. Management of rheumatoid arthritis: 2019 updated consensus recommendations from the Hong Kong Society of Rheumatology. Clin Rheumatol. 2019;38(12):3331–50. 10.1007/s10067-019-04761-5
15 Parisi S, Bortoluzzi A, Sebastiani GD, Conti F, Caporali R, Ughi N, et al. The Italian Society for Rheumatology clinical practice guidelines for rheumatoid arthritis. Reumatismo. 2019;71(S1):22–49. 10.4081/reumatismo.2019.1202
16 Kawahito Y, Morinobu A, Kaneko Y, Kohno M, Hirata S, Kishimoto M, et al. Drug treatment algorithm and recommendations from the 2020 update of the Japan College of Rheumatology clinical practice guidelines for the management of rheumatoid arthritis-secondary publication. Mod Rheumatol. 2023;33(1):21–35. 10.1093/mr/roac017
17 Petrović-Rackov L. Evaluation of the degree of clinical rheumatoid arthritis activity based on the concentrations of cytokines TNF-alpha, IL-12, IL-15, and IL-18 in serum and synovial fluid. Vojnosanit Pregl. 2006;63(1):21–6. 10.2298/VSP0601021P
18 Visvanathan S, Rahman MU, Keystone E, Genovese M, Klareskog L, Hsia E, et al. Association of serum markers with improvement in clinical response measures after treatment with golimumab in patients with active rheumatoid arthritis despite receiving methotrexate: Results from the GO-FORWARD study. Arthritis Res Ther. 2010;12(6):R211. 10.1186/ar3188
19 Emery P, Breedveld F, van der Heijde D, Ferraccioli G, Dougados M, Robertson D, et al. Two-year clinical and radiographic results with combination etanercept-methotrexate therapy versus monotherapy in early rheumatoid arthritis: A two-year, double-blind, randomized study. Arthritis Rheum. 2010;62(3):674–82. 10.1002/art.27268
20 Ruderman EM. Overview of safety of non-biologic and biologic DMARDs. Rheumatology (Oxford). 2012;51(Suppl 6):vi37–43. 10.1093/rheumatology/kes283
21 Garza-Elizondo AK, Oscherwitz M, Cervantes-Ramirez V, Salazar-Marentes E, Galarza-Delgado DA, Cardenas-de la Garza JA. Case report: Latrogenic Kaposi sarcoma secondary to Janus kinase and tumor necrosis factor-alpha inhibitors in rheumatoid arthritis. Int J Rheum Dis. 2024;27(10):e15365. 10.1111/1756-185X.15365
22 Oliveira D, Martins A, Martins F, Gomes C, Pimenta S, Vaz C, et al. Systemic lupus erythematosus induced by anti-tumor necrosis factor α therapy in inflammatory rheumatic diseases: A case series. Reumatismo. 2024;76(4):286-90. 10.4081/reumatismo.2024.1658
23 Zheng B, Liu M, Dai D, Shang Y, Dou X, Liu B, et al. Safety of TNF-α inhibitors: A real-world study based on the US FDA Adverse Event Reporting System database. Medicine (Baltimore). 2024;103(29):e39012. 10.1097/MD.0000000000039012
24 Almashali M, Alotaibi MA, Shadid A. Merkel cell carcinoma associated with TNF inhibitor therapy: A systematic review of case reports. Dermatol Online J. 2024;30(2). 10.5070/D330263575
25 Pelechas E, Voulgari PV, Drosos AA. Preclinical discovery and development of adalimumab for the treatment of rheumatoid arthritis. Expert Opin Drug Discov. 2021;16(3):227–34. 10.1080/17460441.2021.1846516
26 Tamai H, Ikeda K, Miyamoto T, Taguchi H, Kuo CF, Shin K, et al. Reduced versus maximum tolerated methotrexate dose concomitant with adalimumab in patients with rheumatoid arthritis (MIRACLE): A randomised, open-label, non-inferiority trial. Lancet Rheumatol. 2023;5(4):e215–24. 10.1016/S2665-9913(23)00070-X
27 Machado MA, Maciel AA, de Lemos LL, Costa JO, Kakehasi AM, Andrade EI, et al. Adalimumab in rheumatoid arthritis treatment: A systematic review and meta-analysis of randomized clinical trials. Rev Bras Reumatol. 2013;53(5):419–30. 10.1016/S2255-5021(13)70113-5
28 Li JB, Liu PC, Chen L, Wu R. Infiltrations of plasma cells in synovium predict inadequate response to adalimumab in rheumatoid arthritis patients. Arthritis Res Ther. 2024;26(1):186. 10.1186/s13075-024-03426-2
29 Yu Z, Gao L, Zang Y, Cheng L, Gao W, Xu Y. Adalimumab exhibits superiority over etanercept in terms of a numerically higher response rate and equivalent adverse events: A real-world finding. Immun Inflamm Dis. 2024;12(2):e1166. 10.1002/iid3.1166
30 Luo F, Gau SY, Wu YX, Liao HL, Tang F, Zhong Q, et al. Efficacy of adalimumab combined with tripterygium wilfordii Hook F in the treatment of patient with rheumatoid arthritis: A multicenter, open-label, randomized-controlled trial. Int J Rheum Dis. 2024;27(1):e15031. 10.1111/1756-185X.15031
31 Jeries H, Daood R, Hijazi B, Golan-Cohen A, Green I, Merzon E, et al. Drug survival on first biologic therapy among late-onset rheumatoid arthritis patients compared to early-onset patients: A population-based cohort study. Musculoskeletal Care. 2024;22(3):e1928. 10.1002/msc.1928
32 Ma XN, Shi MF, Wang SI, Feng W, Chen SL, Zhong XQ, et al. Risk of dyslipidemia and major adverse cardiac events with tofacitinib versus adalimumab in rheumatoid arthritis: A real-world cohort study from 7580 patients. Front Pharmacol. 2024;15:1370661. 10.3389/fphar.2024.1370661
33 Khosravi S, Zamani B, Motamed MR, Akhoundi FH. Adalimumab-induced CNS demyelination in a patient with multiple pre-existing autoimmune diseases; treatment contemplation. Mod Rheumatol Case Rep. 2024;9(1):75-8. 10.1093/mrcr/rxae069
34 Shirah B, Altwirgi S, Faridoon I, Alghamdi S. Adalimumab-induced central nervous system demyelination in a patient with rheumatoid arthritis. Neuroradiol J. 2024;37(2):234–6. 10.1177/19714009231173102
35 Weinblatt ME, Baranauskaite A, Niebrzydowski J, Dokoupilova E, Zielinska A, Jaworski J, et al. Phase III randomized study of SB5, an adalimumab biosimilar, versus reference adalimumab in patients with moderate-to-severe rheumatoid arthritis. Arthritis Rheumatol. 2018;70(1):40–8. 10.1002/art.40336
36 Fautrel B, Bouhnik Y, Salliot C, Carbonnel F, Fumery M, Bernardeau C, et al. Real-world evidence of clinical outcomes of the use of the adalimumab biosimilar SB5 in rheumatic and gastrointestinal immune-mediated inflammatory diseases: 12-Month data from the PERFUSE study. Drugs Real World Outcomes. 2024;11(4):573-91. 10.1007/s40801-024-00459-6
37 García Miguel J, Yankova Komsalova L, Mata Arnaiz C, Alegre-Sancho JJ, González Polo J, Torrente-Segarra V, et al. Clinical outcomes of switching to adalimumab biosimilar (MSB11022) in patients with rheumatoid arthritis: RESTART Spanish Registry. Curr Med Res Opin. 2024:40(8):1431–1438. 10.1080/03007995.2024.2372295
38 Colina M, Khodeir M, Rimondini R, Valentini M, Campomori F, Corvaglia S, et al. Forty-Eight-month monitoring of disease activity in patients with long-standing rheumatoid arthritis treated with TNF-α inhibitors: Time for clinical outcome prediction and biosimilar vs biologic originator performance. Clin Drug Investig. 2024;44(3):141-8. 10.1007/s40261-024-01341-7
39 Hassett B, Singh E, Mahgoub E, O’Brien J, Vicik SM, Fitzpatrick B. Manufacturing history of etanercept (Enbrel®): Consistency of product quality through major process revisions. MAbs. 2018;10(1):159–65. 10.1080/19420862.2017.1388483
40 Tichý Š, Nekvindová L, Baranová J, Vencovský J, Pavelka K, Horák P, et al. Drug survival analysis of etanercept compared with monoclonal antibody tumour necrosis factor-α inhibitors in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: A propensity score-matched analysis from the Czech ATTRA registry. Scand J Rheumatol. 2024:1–8. 10.1080/03009742.2024.2381746. Epub ahead of print.
41 Bertrand D, Joly J, Neerinckx B, Durez P, Lenaerts J, Joos R, et al. Effectiveness of methotrexate and bridging glucocorticoids with or without early introduction of a 6-month course of etanercept in early RA: Results of the 2-year, pragmatic, randomised CareRA2020 trial. RMD Open. 2024;10(3):e004535. 10.1136/rmdopen-2024-004535
42 Kassabian B, Facco M, Miscioscia A, Carraro S, Rinaldi F, Gallo P, et al. Case report: Breaking CNS immuno-privilege: TNFα-inhibitor triggers aseptic meningitis in a patient with rheumatoid arthritis. Front Immunol. 2024;15:1432360. 10.3389/fimmu.2024.1432360
43 Hosseinpour A, Haj Mohamad Ebrahim Ketabforoush A, Daneshzad E, Babanezhad Gajouti A, Hajimollarabi S. Unexpected multiple sclerosis-like symptoms in a rheumatoid arthritis patient treated with etanercept: A case report. Clin Case Rep. 2024;12(11):e9486. 10.1002/ccr3.9486
44 Robinson SE, Varman R. Ramsay Hunt syndrome associated with etanercept treatment for rheumatoid arthritis: A case report and a review of literature. Cureus. 2024;16(8):e66531. 10.7759/cureus.66531
45 Roy M, Rathore H, Roy AK. Pulmonary embolism in a patient with rheumatoid arthritis on etanercept therapy. J Community Hosp Intern Med Perspect. 2024;14(1):39–42. 10.55729/2000-9666.1294
46 Yu T, Yang C. Multifocal leukoencephalopathy in a patient medicated with etanercept and methotrexate for rheumatoid arthritis. Z Rheumatol. 2024;83(4):297–302. 10.1007/s00393-023-01430-6
47 Shih PC, Hung PC, Leong PY, Hsu JN, Yang CC, Wei JCC, et al. Incidence and risk factors of discontinuation of tofacitinib and biologic disease-modifying anti-rheumatic drugs among patients with rheumatoid arthritis: A population-based cohort study. Clin Rheumatol. 2024;43(12):3625-37. 10.1007/s10067-024-07161-6
48 Pekhenko V, Udovitskiy V, Barbukho O. Efficacy, safety and immunogenicity of the biosimilar etanercept compared to the reference formulation original etanercept in patients with rheumatoid arthritis: An open-label, randomized, comparative, multicenter study. Medicine (Baltimore). 2024;103(30):e39060. 10.1097/MD.0000000000039060
49 Sakane H, Yonemoto Y, Okamura K, Suto T, Inoue M, Mitomi H, et al. Efficacy of switching from originator etanercept to biosimilar YLB113 in real-world patients with rheumatoid arthritis: A retrospective 12 months follow-up study. J Orthop Surg (Hong Kong). 2024;32(2):10225536241265818. 10.1177/10225536241265818
50 Okazaki S, Shirai T, Sato H, Ishii T, Fujii H. Development of anti-MDA5 autoantibody-positive dermatomyositis following the use of etanercept biosimilar in rheumatoid arthritis. Mod Rheumatol Case Rep. 2024;8(2):296-301. 10.1093/mrcr/rxae013
51 Kawakami T, Masui S, Onishi A, Onizawa H, Fujii T, Murakami K, et al. Comparison of safety and effectiveness between etanercept biosimilar LBEC0101 and reference in patients with rheumatoid arthritis in real-world data using the KURAMA cohort. Mod Rheumatol. 2024;34(6):1135-41. 10.1093/mr/roae018
52 Deakin CT, Littlejohn GO, Griffiths H, Ciciriello S, O’Sullivan C, Smith T, et al. Comparative effectiveness of etanercept originator and biosimilar for treating rheumatoid arthritis: implications for cost-savings. Intern Med J. 2024;54(5):795-801. 10.1111/imj.16296
53 Deeks ED. GP2015: An etanercept biosimilar. BioDrugs. 2017;31(6):555–8. 10.1007/s40259-017-0246-1
54 Schmalzing M, Kellner H, Askari A, De Toro Santos J, Vazquez Perez-Coleman JC, Foti R, et al. Real-world effectiveness and safety of SDZ ETN, an etanercept biosimilar, in patients with rheumatic diseases: Final results from multi-country COMPACT study. Adv Ther. 2024;41(1):315-30. 10.1007/s12325-023-02706-8
55 Kearsley-Fleet L, Rokad A, Tsoi MF, Zhao SS, Lunt M, Watson KD, et al. Outcomes following switching from etanercept originator to etanercept biosimilar in 1024 patients with RA: A matched-analysis of the BSRBR-RA. Rheumatology (Oxford). 2024;63(8):2082–92. 10.1093/rheumatology/kead470
56 Matsubara T, Katayama K, Sagawa A, Yoshida M, Mitsuka T, Hashimoto K, et al. Investigation of treatment continuity, usefulness, and nocebo effect in switching from the original etanercept to its biosimilar in patients with rheumatoid arthritis: A JET observational study in Japanese clinical practice. Mod Rheumatol. 2024;34(2):307–12. 10.1093/mr/road027
57 Melo AT, Campanilho-Marques R, Fonseca JE. Golimumab (anti-TNF monoclonal antibody): Where we stand today. Hum Vaccin Immunother. 2021;17(6):1586–98. 10.1080/21645515.2020.1836919
58 Husni ME, Deodhar A, Schwartzman S, Chakravarty SD, Hsia EC, Leu JH, et al. Pooled safety results across phase 3 randomized trials of intravenous golimumab in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Arthritis Res Ther. 2022;24(1):73. 10.1186/s13075-022-02753-6
59 D’Angelo S, Tirri E, Giardino AM, De Rosa T, Matucci-Cerinic M, Dagna L, et al. Real-world effectiveness and persistence of golimumab as second-line anti-TNFα drug in rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis patients in Italy: GO-BEYOND, a 12-month prospective observational study. Int J Rheum Dis. 2024;27(3):e15091. 10.1111/1756-185X.15091
60 Govoni M, Batalov A, Boumpas DT, D’Angelo S, De Keyser F, Flipo RM, et al. Real-world effectiveness of golimumab in the treatment of patients with active rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis who failed initial TNF-α inhibitor therapy: A pooled analysis of European prospective observational study. Clin Exp Rheumatol. 2024;42(3):642–50. 10.55563/clinexprheumatol/7sr1ni
61 Asano T, Ishii Y, Tsuchiya H, Masuda J. Efficacy of golimumab in rheumatoid arthritis patients at high risk of a poor prognosis: Post hoc analysis of GO-FORTH study using cluster analysis. Mod Rheumatol. 2024;34(6):1125–34. 10.1093/mr/roae037
62 Xia W, Zhou L, Gao W, Zhang Y, Si F, Bai F, et al. Patient self-reported experience and satisfaction with golimumab and etanercept treatments for rheumatic diseases: A cohort study. Medicine (Baltimore). 2024;103(8):e36982. 10.1097/MD.0000000000036982
63 Yanagihara T, Oka Y, Moriwaki A, Moriuchi Y, Ogata H, Ishimatsu A, et al. A case of pneumocystis pneumonia developed during rheumatoid arthritis treatment with methotrexate and golimumab. Cureus. 2024;16(1):e52944. 10.7759/cureus.52944
64 Baker JF, Bakewell C, Dikranian A, Lam G, O’Brien J, Moore PC, et al. Characteristics and 6-month outcomes in patients with rheumatoid arthritis initiating infliximab biosimilar IFX-dyyb in a real-world setting. Rheumatol Ther. 2024;11(3):841-53. 10.1007/s40744-024-00653-6
65 Jourdain H, Hoisnard L, Sbidian E, Zureik M. Persistence and safety of anti-TNF biosimilars versus originators in immune-mediated inflammatory diseases: An observational study on the French National Health Data System. RMD Open. 2024;10(1):e003531. 10.1136/rmdopen-2023-003531
66 Gan H, Ren X, Zou Y, Li L, Ding J, Peng L, et al. Rheumatoid arthritis complicated with cervical actinomycosis and ureteral obstruction: A case report and literature review. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2024;49(5):818–24.
67 Nielly H, Bialé L, Gilardin L, Carmoi T, Éon A, Vanquaethem H, et al. Tocilizumab-induced psoriatic eruption : A case report and a case-based review. Rheumatol Int. 2024;44(10):2205–12. 10.1007/s00296-024-05663-9
68 Bouladi M, Ben Othmen A, Sawssen M, Kalou M, Laater A, El Fekih L. New onset of uveitis during infliximab treatment: A case report. Tunis Med. 2024;102(1):58–60. 10.62438/tunismed.v102i1.4564
69 Martinez Perez P, Hanna L, Jaynes E, Gwiggner M. Infliximab rescue therapy in a case of severe granulomatous colitis associated with rituximab use. BMJ Case Rep. 2024;17(2):e257729. 10.1136/bcr-2023-257729.
70 Fukumoto K, Watanabe R, Tsutsumi M, Takakuwa T, Miyamoto M, Hayashi N, et al. Lymphoproliferative disorder progressing after partial remission following immunosuppressive drugs withdrawal in a patient with rheumatoid arthritis. Mod Rheumatol Case Rep. 2024;8(2):243-8. 10.1093/mrcr/rxae007
71 Kameda H, Nishida K, Nanki T, Watanabe A, Oshima Y, Momohara S. Safety and effectiveness of certolizumab pegol in Japanese patients with rheumatoid arthritis: Up to 3-year results from a postmarketing surveillance study. Mod Rheumatol. 2024;34(6):1103-14. 10.1093/mr/roae019
72 Tanaka Y, Miyazaki Y, Kawanishi M, Yamasaki H, Takeuchi T. Long-term safety and efficacy of anti-TNF multivalent VHH antibodies ozoralizumab in patients with rheumatoid arthritis. RMD Open. 2024;10(3):e004480. 10.1136/rmdopen-2024-004480
73 Ito T, Miyoshi Y. Acute heart failure with reduced ejection fraction following ozoralizumab in a patient with rheumatoid arthritis: A case report. Mod Rheumatol Case Rep. 2024;9(1):1-5. 10.1093/mrcr/rxae053
74 Srivastava S, Rasool M. Underpinning IL-6 biology and emphasizing selective JAK blockade as the potential alternate therapeutic intervention for rheumatoid arthritis. Life Sci. 2022;298:120516. 10.1016/j.lfs.2022.120516
75 Favalli EG. Understanding the role of interleukin-6 (IL-6) in the joint and beyond: A comprehensive review of IL-6 inhibition for the management of rheumatoid arthritis. Rheumatol Ther. 2020;7(3):473–516. 10.1007/s40744-020-00219-2
76 Hennigan S, Kavanaugh A. Interleukin-6 inhibitors in the treatment of rheumatoid arthritis. Ther Clin Risk Manag. 2008;4(4):767–75. 10.2147/TCRM.S3470
77 Hsieh PH, Wu O, Geue C, McIntosh E, McInnes IB, Siebert S. Economic burden of rheumatoid arthritis: A systematic review of literature in biologic era. Ann Rheum Dis. 2020;79(6):771–7. 10.1136/annrheumdis-2019-216243
78 Jocić J, Lučić AT, Jovanović I, Jurišević M, Stanisavljević I, Stamenković B, et al. Interleukin 41 as a potential predictor of bio-therapy efficacy in patients with rheumatoid arthritis: A prospective observational study. Int J Med Sci. 2024;21(13):2518–24. 10.7150/ijms.98752
79 Albahdal AS, Alotaibi AM, Alanazi MA, Abanmy N, Alwhaibi M, AlRuthia Y. Cost-consequence analysis of tocilizumab versus adalimumab and etanercept among rheumatoid arthritis patients in Saudi Arabia: A single-center study. Cost Eff Resour Alloc. 2024;22(1):14. 10.1186/s12962-024-00522-7
80 Athanassiou P, Katsimbri P, Bounas A, Gazi S, Sarikoudis T, Syrigou V, et al. Persistence on subcutaneous tocilizumab as monotherapy or in combination with synthetic disease-modifying anti-rheumatic drugs in rheumatoid arthritis patients in Greece (EMBRACE study): A multicenter, post-marketing, non-interventional, observational trial. Clin Rheumatol. 2024;43(5):1469-78. 10.1007/s10067-024-06916-5
81 Karadag O, Farisogullari B, Yagiz B, Erden A, Ademoglu Z, Kimyon G, et al. Tocilizumab as a first line biologic agent in rheumatoid arthritis patients with inadequate response to disease-modifying anti-rheumatic drugs: Real life experience from the TReasure Registry. Clin Exp Rheumatol. 2024;42(1):130-7. 10.55563/clinexprheumatol/2h6ma1
82 Ho Lee Y, Gyu Song G. Comparison of the efficacy and safety of tocilizumab, sarilumab, and olokizumab in patients with active rheumatoid arthritis: A network meta-analysis of randomized controlled trials. Z Rheumatol. 2024;83(Suppl 1):97-106. 10.1007/s00393-022-01315-0
83 Kim JG, Koo BS, Lee JH, Yoon BY. Anemia as an indicator of a higher retention rate for tocilizumab versus tumor necrosis factor inhibitors in patients with rheumatoid arthritis from a Korean multi-center registry. J Rheum Dis. 2024;31(4):212–22. 10.4078/jrd.2024.0026
84 Harada M, Honma Y, Shiba E, Tomosugi N, Harada R. Tocilizumab, a humanized anti-interleukin-6 receptor antibody, induces hepatic iron overload in a susceptible patient. Intern Med. 2024. 10.2169/internalmedicine.4329-24
85 Seki K, Kobayashi A, Takahashi N, Kamimoto A. Medication-related osteonecrosis of the jaw in a patient with rheumatoid arthritis with suspected involvement of methotrexate and tocilizumab. J Dent Sci. 2024;19(4):2428–9. 10.1016/j.jds.2024.07.024
86 Fang YF, Chang SH, Kuo CF, See LC. Safety outcomes of tocilizumab and tofacitinib treatment for rheumatoid arthritis: Target trial emulation. Int J Rheum Dis. 2024;27(11):e15406. 10.1111/1756-185X.15406
87 Louters A, Van Oosterhout M, Burgemeister L, Jessurun NT, Van Lint JA. Prosthetic infections following tocilizumab treatment in patients with rheumatoid arthritis. Rheumatology (Oxford). 2024;63(10):e290-1. 10.1093/rheumatology/keae228
88 Westermann R, Cordtz RL, Duch K, Mellemkjaer L, Hetland ML, Magnussen B, et al. Cancer risk with tocilizumab/sarilumab, abatacept, and rituximab treatment in patients with rheumatoid arthritis: A Danish cohort study. Rheumatology (Oxford). 2024. 10.1093/rheumatology/keae140
89 Leng X, Leszczyński P, Jeka S, Liu S, Liu H, Miakisz M, et al. A phase 3, randomized, double-blind, active-controlled clinical trial to compare BAT1806/BIIB800, a tocilizumab biosimilar, with tocilizumab reference product in participants with moderate-to-severe rheumatoid arthritis with inadequate response to methotrexate: Treatment period 2 analysis (week 24 to week 48). Arthritis Res Ther. 2024;26(1):157. 10.1186/s13075-024-03375-w
90 Smolen JS, Trefler J, Racewicz A, Jaworski J, Zielińska A, Krogulec M, et al. Efficacy and safety of CT-P47 versus reference tocilizumab: 32-Week results of a randomised, active-controlled, double-blind, phase III study in patients with rheumatoid arthritis, including 8 weeks of switching data from reference tocilizumab to CT-P47. RMD Open. 2024;10(4):e004514. 10.1136/rmdopen-2024-004514
91 Zubrzycka-Sienkiewicz A, Klama K, Ullmann M, Petit-Frere C, Baker P, Monnet J, et al. Comparison of the efficacy and safety of a proposed biosimilar MSB11456 with tocilizumab reference product in subjects with moderate-to-severe rheumatoid arthritis: Results of a randomised double-blind study. RMD Open. 2024;10(1):e003596. 10.1136/rmdopen-2023-003596
92 Leng X, Leszczyński P, Jeka S, Liu SY, Liu H, Miakisz M, et al. Comparing tocilizumab biosimilar BAT1806/BIIB800 with reference tocilizumab in patients with moderate-to-severe rheumatoid arthritis with an inadequate response to methotrexate: A phase 3, randomised, multicentre, double-blind, active-controlled clinical trial. Lancet Rheumatol. 2024;6(1):e40–50. 10.1016/S2665-9913(23)00237-0
93 Salvarani C, Cantini F, Niccoli L, Macchioni P, Consonni D, Bajocchi G, et al. Acute-phase reactants and the risk of relapse/recurrence in polymyalgia rheumatica: A prospective followup study. Arthritis Rheum. 2005;53(1):33–8. 10.1002/art.20901
94 van der Geest KS, Abdulahad WH, Rutgers A, Horst G, Bijzet J, Arends S, et al. Serum markers associated with disease activity in giant cell arteritis and polymyalgia rheumatica. Rheumatology (Oxford). 2015;54(8):1397–402. 10.1093/rheumatology/keu526
95 Kivitz A, Gottenberg JE, Bergman M, Qiu C, van Hoogstraten H, de Nijs R, et al. Real-world effectiveness of sarilumab in RA: Results from the open-label, prospective, single-arm observational PROFILE study. Rheumatol Ther. 2024;11(6):1533-50. 10.1007/s40744-024-00715-9
96 Kameda H, Tasaka S, Takahashi T, Suzuki K, Soeda N, Tanaka Y. Safety and effectiveness of sarilumab in Japanese patients with rheumatoid arthritis refractory to previous treatments: An interim analysis of a post-marketing surveillance. Mod Rheumatol. 2024;34(3):444-52. 10.1093/mr/road055
97 Harada H, Kondo M, Maeyama A, Fukuda T, Ikemura S, Shono E, et al. Effectiveness and safety of sarilumab in patients with rheumatoid arthritis: A multicenter, retrospective, inverse probability of treatment-weighted analysis based on the FRAB-registry. Clin Rheumatol. 2024;43(5):1447-59. 10.1007/s10067-024-06907-6
98 Kameda H, Tasaka S, Takahashi T, Suzuki K, Soeda N, van Hoogstraten H, et al. Safety of sarilumab in a Japanese population with rheumatoid arthritis by age group: Data from an interim analysis of a post-marketing surveillance study. Mod Rheumatol. 2024;35(1):42-9. 10.1093/mr/roae051
99 Tada Y, Maeyama A, Hagio T, Sakai M, Maruyama A, Yamamoto T. Usefulness of sarilumab in patients with rheumatoid arthritis after regression of lymphoproliferative disorders. Case Rep Rheumatol. 2023;2023:5780733. 10.1155/2023/5780733
100 Smolen JS, Feist E, Fatenejad S, Grishin SA, Korneva EV, Nasonov EL, et al. Olokizumab versus placebo or adalimumab in rheumatoid arthritis. N Engl J Med. 2022;387(8):715–26. 10.1056/NEJMoa2201302
101 Nasonov EL, Lisitsyna TA, Zonova EV, Kuzkina S. The effect of olokizumab on rheumatoid arthritis patient’s reported outcomes: Results of a double-blind randomized placebo-controlled multicenter phase III trial (CREDO 1). Rheumatol Sci Pract. 2021. 10.47360/1995-4484-2021-62-69
102 Karateev A, Polishchuk EY, Filatova ES, Amirdzhanova VN, Khlaboshina VN, Lila A, et al. Olokizumab effect on chronic pain in rheumatoid arthritis: Results of the PROLOGUE observational study. Int J Rheum Dis. 2024;27(10):e15320. 10.1111/1756-185X.15320
103 Lee YH, Song GG. Comparison of the efficacy and safety of olokizumab at different dosages in patients with active rheumatoid arthritis: A network meta-analysis of randomized controlled trials. Z Rheumatol. 2024;83(Suppl 1):107–14. 10.1007/s00393-023-01367-w
104 Akimova AA, Banshchikova NE, Sizikov AE, Mullagaliev AA, Letyagina EA, Ilina NA, et al. Results of a 12-week open-label, non-interventional study of the efficacy and safety of olokizumab therapy in patients with rheumatoid arthritis after switching from anti-B-cell therapy during the SARS-CoV-2 pandemic. Dokl Biochem Biophys. 2024;518(1):291-9. 10.1134/S1607672924701060
105 Feist E, Fleischmann RM, Fatenejad S, Bukhanova D, Grishin S, Kuzkina S, et al. Olokizumab plus methotrexate: safety and efficacy over 106 weeks of treatment. Ann Rheum Dis. 2024;83(11):1454-64. 10.14412/1996-7012-2024-6-21-35
106 Ho Lee Y, Gyu Song G. Comparison of the efficacy and safety of tocilizumab, sarilumab, and olokizumab in patients with active rheumatoid arthritis: A network meta-analysis of randomized controlled trials. Z Rheumatol. 2024;83(Suppl 1):97–106. 10.1007/s00393-022-01315-0
107 Panayi GS. B cells: A fundamental role in the pathogenesis of rheumatoid arthritis? Rheumatology (Oxford). 2005; 44(Suppl 2):ii3–ii7. 10.1093/rheumatology/keh616
108 Marston B, Palanichamy A, Anolik JH. B cells in the pathogenesis and treatment of rheumatoid arthritis. Curr Opin Rheumatol. 2010;22(3):307–15. 10.1097/BOR.0b013e3283369cb8
109 Takemura S, Klimiuk PA, Braun A, Goronzy JJ, Weyand CM. T cell activation in rheumatoid synovium is B cell dependent. J Immunol. 2001;167(8):4710–8. 10.4049/jimmunol.167.8.4710
110 Mok CC. Rituximab for the treatment of rheumatoid arthritis: An update. Drug Des Devel Ther. 2013;8:87–100. 10.2147/DDDT.S41645
111 Cohen SB, Emery P, Greenwald MW, Dougados M, Furie RA, Genovese MC, et al. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthritis Rheum. 2006;54(9):2793–806. 10.1002/art.22025
112 Emery P, Fleischmann R, Filipowicz-Sosnowska A, Schechtman J, Szczepanski L, Kavanaugh A, et al. The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: Results of a phase IIB randomized, double-blind, placebo-controlled, dose-ranging trial. Arthritis Rheum. 2006;54(5):1390–400. 10.1002/art.21778
113 Rigby W, Ferraccioli G, Greenwald M, Zazueta-Montiel B, Fleischmann R, Wassenberg S, et al. Effect of rituximab on physical function and quality of life in patients with rheumatoid arthritis previously untreated with methotrexate. Arthritis Care Res (Hoboken). 2011;63(5):711–20. 10.1002/acr.20419
114 Tak PP, Rigby W, Rubbert-Roth A, Peterfy C, van Vollenhoven RF, Stohl W, et al. Sustained inhibition of progressive joint damage with rituximab plus methotrexate in early active rheumatoid arthritis: 2-Year results from the randomised controlled trial IMAGE. Ann Rheum Dis. 2012;71(3):351–7. 10.1136/annrheumdis-2011-200170
115 Gerlag DM, Safy M, Maijer KI, Tang MW, Tas SW, Starmans-Kool MJF, et al. Effects of B-cell directed therapy on the preclinical stage of rheumatoid arthritis: The PRAIRI study. Ann Rheum Dis. 2019;78(2):179–85. 10.1136/annrheumdis-2017-212763
116 Frazzei G, Cramer SHM, Landewé RBM, Maijer KI, Gerlag DM, Tak PP, et al. The effect of rituximab on patient reported outcomes in the preclinical phase of rheumatoid arthritis: 2 Year data from the PRAIRI study. RMD Open. 2024;10(4):e004622. 10.1136/rmdopen-2024-004622
117 De Meyst E, Bertrand D, Joly J, Doumen M, Marchal A, Thelissen M, et al. Treat-to-target fixed dose rituximab retreatment versus fixed interval retreatment with disease activity-guided rituximab dose optimisation for patients with rheumatoid arthritis: Study protocol for a multicentre randomised controlled superiority trial focusing on long-term disease impact (RITUXERA). Trials. 2024;25(1):681. 10.1186/s13063-024-08542-7
118 Novella-Navarro M, Ruiz-Esquide V, López-Juanes N, Chacur CA, Monjo-Henry I, Nuño L, et al. Subsequent biologic and targeted synthetic disease modifying anti rheumatic drugs after fulfilling difficult-to-treat rheumatoid arthritis criteria: A survival analysis. Clin Rheumatol. 2024;43(9):2817-23. 10.1007/s10067-024-07070-8
119 Choquette D, Haraoui B, Movahedi M, Bessette L, Sauvageau LC, Ferdinand I, et al. Which advanced treatment should be used following the failure of a first-line anti-TNF in patients with rheumatoid arthritis? 15 Years of evidence from the Quebec registry RHUMADATA. Rheumatology (Oxford). 2024. 10.1093/rheumatology/keae283
120 Wientjes MHM, van Huissteden J, van Herwaarden N, Verhoef LM, den Broeder AA. Dose reduction of rituximab in clinical practice: A retrospective cohort study of rheumatoid arthritis patients in low disease activity on rituximab. Clin Exp Rheumatol. 2024;42(11):2215-20. 10.55563/clinexprheumatol/lrctjp
121 Santos Faria M, Godinho I, Nogueira E, Tavares J, Carvalho D, Ponte C. Rheumatoid arthritis and ANCA-associated vasculitis–An unusual overlap successfully treated with rituximab. ARP Rheumatol. 2024;3(3):248–9. 10.63032/ZTDH8563
122 Janda P, Sączek A, Milan-Ciesielska K, Dolipska J, Kraśniak A, Krzanowski M. IgA vasculitis with Koebner’s phenomenon and renal involvement induced by anti-TNF-α therapy in the treatment of rheumatoid arthritis. Pol Arch Intern Med. 2025;135:16854. 10.20452/pamw.16854
123 Kumar S, Singh SK, Arora R, Kashif AW. Membranous nephropathy in a treatment naïve patient of rheumatoid arthritis. Indian J Nephrol. 2024;34(5):543–4. 10.25259/IJN_40_2024
124 Veeken LD, Opdam MAA, Verhoef LM, Popa C, van Crevel R, den Broeder AA. Infection incidence, timing and dose dependency in rheumatoid arthritis patients treated with rituximab: a retrospective cohort study. Rheumatology (Oxford). 2024;63(5):1246–50. 10.1093/rheumatology/kead328
125 den Broeder N, Verhoef L, de Man YA, Kok MR, Thurlings R, van der Weele W, et al. Long-term clinical and radiological effectiveness and safety of ultralow doses of rituximab in rheumatoid arthritis: observational extension of the REDO trial. RMD Open. 2024;10(2):e003659. 10.1136/rmdopen-2023-003659
126 Nahra V, Panning D, Anthony D, Mattar M. Implementation of an accelerated infusion protocol (90-minute infusion) of rituximab and its safety in patients with autoimmune rheumatic diseases at a tertiary veterans affairs center. Cureus. 2024;16(5):e60558. 10.7759/cureus.60558
127 Sendaydiego X, Gold LS, Dubreuil M, Andrews JS, Reid P, Liew DFL, et al. Use of biologic or targeted synthetic disease-modifying antirheumatic drugs and cancer risk. JAMA Netw Open. 2024;7(11):e2446336. 10.1001/jamanetworkopen.2024.46336
128 Weyand CM, Bryl E, Goronzy JJ. The role of T cells in rheumatoid arthritis. Arch Immunol Ther Exp (Warsz). 2000;48(5):429–35. PMid: 11140470
129 Bonelli M, Scheinecker C. How does abatacept really work in rheumatoid arthritis? Curr Opin Rheumatol. 2018;30(3):295–300. 10.1097/BOR.0000000000000491
130 Walker LS, Sansom DM. The emerging role of CTLA4 as a cell-extrinsic regulator of T cell responses. Nat Rev Immunol. 2011;11(12):852–63. 10.1038/nri3108
131 Jiang H, Tang S, Li Y, Wang J, Ying Z. Clinical efficacy study of abatacept in the treatment of rheumatoid arthritis patients in China. Int J Rheum Dis. 2024;27(10):e15300. 10.1111/1756-185X.15300
132 Asai S, Takahashi N, Terabe K, Yoshioka Y, Kojima T, Kobayakawa T, et al. Clinical effectiveness of baricitinib and abatacept in patients with rheumatoid arthritis. Int J Rheum Dis. 2024;27(11):e15414. 10.1111/1756-185X.15414
133 Balanean A, Brown-Bickerstaff C, Klink A, Patel V, Zheng H, N’Dri L, et al. Real-world clinical outcomes and rationale for initiating abatacept as a first-line biologic for patients with anticitrullinated protein antibody-and rheumatoid factor-positive rheumatoid arthritis. J Comp Eff Res. 2024:13(12):e230144. 10.57264/cer-2023-0144.
134 Harrold LR, Wittstock K, Kelly S, Han X, Zhuo J, Schrader A, et al. Comparative effectiveness of abatacept versus TNF inhibitors in rheumatoid arthritis patients who are ACPA and shared epitope positive. Adv Rheumatol. 2024;64(1):10. 10.1186/s42358-024-00352-4
135 Asif M, Asif A, Rahman UA, Haseeb A, Jafar U, Farooq H. Efficacy and safety of abatacept in preclinical rheumatoid arthritis: A systematic review and meta-analysis of randomized controlled trials. Semin Arthritis Rheum. 2024;69:152562. 10.1016/j.semarthrit.2024.152562
136 Misaki K, Tanaka E, Inoue E, Tamura N, Hirano F, Taniguchi Y, et al. Factors contributing to the improvement in J-HAQ after 3 years of treatment with abatacept in biologic-naïve rheumatoid arthritis patients: Interim results of a long-term, observational, multicentre study in Japan (ORIGAMI). Mod Rheumatol. 2024;35(1):17-26. 10.1093/mr/roae043
137 Chen KH, Li KJ, Fang YF, Hsieh SC, Chen YC, Lee CS, et al. Abatacept retention and clinical effectiveness in patients with rheumatoid arthritis in a real-world setting in Taiwan. Int J Rheum Dis. 2024;27(7):e15199. 10.1111/1756-185X.15199
138 Miyakawa N, Tsuritani K, Teixeira BC, Fujio K. Disease-modifying anti-rheumatic drug selection in Japanese patients with rheumatoid arthritis treated with biologics or JAK inhibitors without methotrexate: A retrospective hospital-based administrative claims database study. Mod Rheumatol. 2024;34(5):900-9. 10.1093/mr/roae021
139 Rech J, Tascilar K, Hagen M, Kleyer A, Manger B, Schoenau V, et al. Abatacept inhibits inflammation and onset of rheumatoid arthritis in individuals at high risk (ARIAA): A randomised, international, multicentre, double-blind, placebo-controlled trial. Lancet. 2024;403(10429):850-9. 10.1016/S0140-6736(23)02650-8
140 Cope AP, Jasenecova M, Vasconcelos JC, Filer A, Raza K, Qureshi S, et al. Abatacept in individuals at high risk of rheumatoid arthritis (APIPPRA): A randomised, double-blind, multicentre, parallel, placebo-controlled, phase 2B clinical trial. Lancet. 2024;403(10429):838-49. 10.1016/S0140-6736(23)02649-1
141 Sunaga A, Inoue T. Hypervirulent Klebsiella pneumoniae in rheumatoid arthritis on abatacept. J Clin Rheumatol. 2025;31(1):e4. 10.1097/RHU.0000000000002167
142 Hoshina D, Nagata Y. Mycosis fungoides-like eruptions associated with abatacept. Australas J Dermatol. 2024;65(3):e77-8. 10.1111/ajd.14249
143 Simon TA, Suissa S, Boers M, Hochberg MC, Skovron ML, Askling J, et al. Malignancy outcomes in patients with rheumatoid arthritis treated with abatacept and other disease-modifying antirheumatic drugs: Results from a 10-year international post-marketing study. Semin Arthritis Rheum. 2024:64:152240. 10.1016/j.semarthrit.2023.152240
144 Simon TA, Dong L, Suissa S, Michaud K, Pedro S, Hochberg M, et al. Abatacept and nonmelanoma skin cancer in patients with rheumatoid arthritis: A comprehensive evaluation of randomised controlled trials and observational studies. Ann Rheum Dis. 2024;83(2):177-83. 10.1136/ard-2023-224356
145 O’Shea J J. Targeting the Jak/STAT pathway for immunosuppression. Ann Rheum Dis. 2004;63(Suppl 2):ii67–ii71. 10.1136/ard.2004.028290
146 Fleischmann R. Novel small-molecular therapeutics for rheumatoid arthritis. Curr Opin Rheumatol. 2012;24(3):335–41. 10.1097/BOR.0b013e32835190ef
147 Winthrop KL. The emerging safety profile of JAK inhibitors in rheumatic disease. Nat Rev Rheumatol. 2017;13(4):234–43. 10.1038/nrrheum.2017.23
148 Pugliesi A, Oliveira DGC, Filho VAS, Machado JO, Pereira AG, Bichuette JCS, et al. Cardiovascular safety of the class of JAK inhibitors or tocilizumab compared with TNF inhibitors in patients with rheumatoid arthritis: Systematic review and a traditional and Bayesian network meta-analysis of randomized clinical trials. Semin Arthritis Rheum. 2024;69:152563. 10.1016/j.semarthrit.2024.152563
149 Ramirez Huaranga MA, Calvo Pascual LA, Velasco Sanchez D, Martin de la Sierra Lopez L, Jimenez Rodriguez L, Lopez Menchero Mora A, et al. Real-world experience with janus kinase inhibitors in immune-mediated diseases: Clinical experience of a university hospital. Cureus. 2024;16(8):e67729. 10.7759/cureus.67729
150 Huang YC, Lee NY, Weng MY. Increased risk of Pneumocystis jirovecii colonization in rheumatoid arthritis patients on biologics and Janus kinase inhibitor. J Microbiol Immunol Infect. 2025;58(1):112-9. 10.1016/j.jmii.2024.08.013
151 Hayashi S, Nakano N, Tsubosaka M, Kamenaga T, Kuroda Y, Matsumoto T, et al. Real-world study comparing the efficacy of Janus kinase inhibitors in patients with difficult-to-treat rheumatoid arthritis. Clin Rheumatol. 2024;43(11):3285-92. 10.1007/s10067-024-07117-w
152 Al Tabaa O, Hecquet S, Thomas M, Carvès S, Combier A, Miceli-Richard C, et al. Real-world assessment of the efficacy and tolerability profile of JAK inhibitors in difficult-to-treat rheumatoid arthritis. Semin Arthritis Rheum. 2024;69:152572. 10.1016/j.semarthrit.2024.152572
153 Tada M, Okano T, Mamaoto K, Yamada Y, Orita K, Mandai K, et al. Comparison of creatine kinase elevation caused by Janus kinase inhibitors and interleukin-6 inhibitors in patients with rheumatoid arthritis: A propensity score-matched study. Arch Rheumatol. 2024;39(3):350–7. 10.46497/ArchRheumatol.2024.10645
154 Lee YH, Song GG. Relative remission rates of Janus kinase inhibitors in comparison with adalimumab in patients with active rheumatoid arthritis: A network meta-analysis. Z Rheumatol. 2024;83(Suppl 1):88–96. 10.1007/s00393-022-01165-w
155 Genovese MC, van Vollenhoven RF, Wilkinson B, Wang L, Zwillich SH, Gruben D, et al. Switching from adalimumab to tofacitinib in the treatment of patients with rheumatoid arthritis. Arthritis Res Ther. 2016;18:145. 10.1186/s13075-016-1049-3
156 Papp KA, Krueger JG, Feldman SR, Langley RG, Thaci D, Torii H, et al. Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: Long-term efficacy and safety results from 2 randomized phase-III studies and 1 open-label long-term extension study. J Am Acad Dermatol. 2016;74(5):841–50. 10.1016/j.jaad.2016.01.013
157 Fournier J, Boussat B, Dervaux B, Gaudin P, Romand X. Cost-utility of tofacitinib in the treatment of moderate-to-severe rheumatoid arthritis in France: A multi-state Markov model analysis. Clin Exp Rheumatol. 2025;43(1):62-9. 10.55563/clinexprheumatol/3f60yv
158 Ekin A, Misirci S, İldemir S, Coskun BN, Yagiz B, Dalkilic E, et al. Efficacy and safety of tofacitinib in rheumatoid arthritis: Nine years of real-world data. Clin Transl Sci. 2024;17(11):e70084. 10.1111/cts.70084
159 Haraoui B, Khraishi M, Choquette D, Fortin I, Kinch CD, Galos C, et al. Tofacitinib safety and effectiveness in Canadian patients with rheumatoid arthritis by cardiovascular risk enrichment: Subanalysis of the CANTORAL study. Rheumatol Ther. 2024;11(6):1629-48. 10.1007/s40744-024-00719-5
160 Chang J, Wang G. A retrospective study of efficacy of tofacitinib combined with bDMARDs in the treatment of rheumatoid arthritis patients with inadequate response to bDMARDs. Int J Rheum Dis. 2024;27(9):e15311. 10.1111/1756-185X.15311
161 Pope J, Finckh A, Silva-Fernández L, Mandl P, Fan H, Rivas JL, et al. Tofacitinib monotherapy in rheumatoid arthritis: Clinical trials and real-world data contextualization of patients, efficacy, and treatment retention. Open Access Rheumatol. 2024;16:115–26. 10.2147/OARRR.S446431
162 D’Alessandro F, Cazzato M, Laurino E, Morganti R, Bardelli M, Frediani B, et al. ToRaRI (Tofacitinib in Rheumatoid Arthritis a Real-Life experience in Italy): Effectiveness, safety profile of tofacitinib and concordance between patient-reported outcomes and physician’s global assessment of disease activity in a retrospective study in central-Italy. Clin Rheumatol. 2024;43(2):657-65. 10.1007/s10067-023-06836-w
163 Kuwana M, Sugiyama N, Momohara S, Atsumi T, Takei S, Tamura N, et al. Six-month safety and effectiveness of tofacitinib in patients with rheumatoid arthritis in Japan: Interim analysis of post-marketing surveillance. Mod Rheumatol. 2024;34(2):272-86. 10.1093/mr/road063
164 Pappas DA, O’Brien J, Moore PC, Dodge R, Germino R, Masri KR, et al. Treatment patterns and effectiveness of tofacitinib in patients initiating therapy for rheumatoid arthritis: Results from the CorEvitas rheumatoid arthritis registry. J Rheumatol. 2024;51(5):452-61. 10.3899/jrheum.2023-0752
165 Cho SK, Song YJ, Kim HW, Nam E, Jeon JY, Yoo HJ, et al. Comparative effectiveness of tofacitinib and tumour necrosis factor inhibitors in patients with rheumatoid arthritis in real-world practice: A prospective observational study. Rheumatology (Oxford). 2025;64(2):541-7. 10.1093/rheumatology/keae109
166 Charles-Schoeman C, Fleischmann R, Mysler E, Greenwald M, Ytterberg SR, Koch GG, et al. Risk of venous thromboembolism with tofacitinib versus tumor necrosis factor inhibitors in cardiovascular risk-enriched rheumatoid arthritis patients. Arthritis Rheumatol. 2024;76(8):1218-29. 10.1002/art.42846
167 Opdam MAA, Broeder ND, van den Bemt BJF, Mulder K, van de Wiel KM, van Ballegooijen H, et al. Higher infection risk for JAK inhibitors tofacitinib and baricitinib compared to subcutaneous biological DMARDs. Clin Rheumatol. 2024;43(6):2133-8. 10.1007/s10067-024-06980-x
168 Buch MH, Bhatt DL, Charles-Schoeman C, Giles JT, Mikuls T, Koch GG, et al. Risk of extended major adverse cardiovascular event endpoints with tofacitinib versus TNF inhibitors in patients with rheumatoid arthritis: A post hoc analysis of a phase 3b/4 randomised safety study. RMD Open. 2024;10(2):e003912. 10.1136/rmdopen-2023-003912
169 Citera G, Mysler E, Kakehasi AM, Pascual-Ramos V, Masson W, Cadatal MJ, et al. Cardiovascular events, malignancies, and efficacy outcomes in Latin American patients with rheumatoid arthritis receiving tofacitinib or tumor necrosis factor inhibitors: A post hoc analysis of the ORAL Surveillance Study. J Clin Rheumatol. 2024;30(5):208-16. 10.1097/RHU.0000000000002106
170 Zhao J, Huang H, Wang Y, Deng X, Geng Y, Zhang X, et al. Real-world clinical equivalence of generic and branded tofacitinib: A prospective longitudinal cohort study in patients with rheumatoid arthritis. Mayo Clin Proc. 2024;99(1):26–38. 10.1016/j.mayocp.2023.08.029
171 Her M, Park J, Lee SG. A large pulmonary nodule in a rheumatoid arthritis patient treated with tofacitinib. Int J Rheum Dis. 2024;27(1):e15013. 10.1111/1756-185X.15013
172 Li Z, Shan Y, Dong J, Mei H, Kong Q, Li Y. Disseminated cryptococcosis presenting with generalized cutaneous involvement in a rheumatoid arthritis patient receiving tofacitinib: A case report. J Dermatol. 2024;51(2):e39-41. 10.1111/1346-8138.16960
173 Deng C, Chiu KH, Lou N, Xing F. Case report: Occult Listeria monocytogenes invasion leading to prosthetic hip joint infection in a patient with rheumatoid arthritis taking tofacitinib. Front Med (Lausanne). 2023;10:1322993. 10.3389/fmed.2023.1322993
174 Boussaa H, Hamdi O, Miladi S, Makhlouf Y, Abdelghani KB, Fazaa A, et al. Tofacitinib-induced acute pancreatitis in a patient with rheumatoid arthritis: A case report and review of the literature. Curr Drug Saf. 2024. 10.2174/0115748863300565240819114551
175 Sun YS, Huang DF, Chen WS, Liao HT, Chen MH, Tsai HC, et al. Real-world risk factors for herpes zoster in patients with rheumatoid arthritis undergoing tofacitinib treatment. J Chin Med Assoc. 2024;87(11):988-92. 10.1097/JCMA.0000000000001159
176 Keystone EC, Taylor PC, Tanaka Y, Gaich C, DeLozier AM, Dudek A, et al. Patient-reported outcomes from a phase 3 study of baricitinib versus placebo or adalimumab in rheumatoid arthritis: Secondary analyses from the RA-BEAM study. Ann Rheum Dis. 2017;76(11):1853–61. 10.1136/annrheumdis-2017-211259
177 Dougados M, van der Heijde D, Chen YC, Greenwald M, Drescher E, Liu J, et al. Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: Results from the RA-BUILD study. Ann Rheum Dis. 2017;76(1):88–95. 10.1136/annrheumdis-2016-210094
178 Mahmoud EM, Radwan A, Elsayed SA. A prospective randomized-controlled non-blinded comparative study of the JAK inhibitor (baricitinib) with TNF-α inhibitors and conventional DMARDs in a sample of Egyptian rheumatoid arthritis patients. Clin Rheumatol. 2024;43(12):3657-68. 10.1007/s10067-024-07194-x
179 Edwards CJ, Takeuchi T, Finckh A, Kleyer A, Haladyj E, Gerwien JG, et al. Baricitinib as monotherapy for treatment of rheumatoid arthritis: Analysis of real-world data. Curr Med Res Opin. 2024:40(11):1993–2002. 10.1080/03007995.2024.2416979
180 Caporali R, Taylor PC, Aletaha D, Sanmartí R, Takeuchi T, Mo D, et al. Efficacy of baricitinib in patients with moderate-to-severe rheumatoid arthritis up to 6.5 years of treatment: Results of a long-term study. Rheumatology (Oxford). 2024;63(10):2799-809. 10.1093/rheumatology/keae012
181 Ekin A, Misirci S, Görünen A, Coskun BN, Yagiz B, Dalkilic E, et al. Is baricitinib effective and safe for patients with difficult-to-treat rheumatoid arthritis? Comparative data with the RA group of rheumatoid arthritis not difficult to treat. Med Princ Pract. 2025;34(1):75–86. 10.1159/000541488
182 van de Laar CJ, Oude Voshaar MAH, Ten Klooster P, Tedjo DI, Bos R, Jansen T, et al. PERFECTRA: A pragmatic, multicentre, real-life study comparing treat-to-target strategies with baricitinib versus TNF inhibitors in patients with active rheumatoid arthritis after failure on csDMARDs. RMD Open. 2024;10(2):e004291. 10.1136/rmdopen-2024-004291
183 Gilbert BTP, Mongin D, Aymon R, Lauper K, Laedermann C, Perrier C, et al. Comparative effectiveness of baricitinib and alternative biological DMARDs in a Swiss cohort study of patients with RA. BMJ Open. 2024;14(3):e072300. 10.1136/bmjopen-2023-072300
184 Okamoto N, Atsumi T, Takagi M, Takahashi N, Takeuchi T, Tamura N, et al. Safety of baricitinib in Japanese patients with rheumatoid arthritis in clinical use: 3-Year data of all-case post-marketing surveillance study. Mod Rheumatol. 2024;35(2):215-24. 10.1093/mr/roae064
185 Calvo-Garcia A, Ramírez Herráiz E, Llorente Cubas IM, Varas De Dios B, Benedí González J, Morell Baladrón A, et al. The real-world effectiveness, persistence, adherence, and safety of Janus kinase inhibitor baricitinib in rheumatoid arthritis: A long-term study. J Clin Med. 2024;13(9):2517. 10.3390/jcm13092517
186 Mariani FM, Alunno A, Carubbi F, Ferri C. A rare case of symptomatic creatine kinase elevation in a patient with rheumatoid arthritis treated with baricitinib. Reumatismo. 2024;76(2). 10.4081/reumatismo.2024.1620
187 Genovese MC, Smolen JS, Weinblatt ME, Burmester GR, Meerwein S, Camp HS, et al. Efficacy and safety of ABT-494, a selective JAK-1 inhibitor, in a phase IIB study in patients with rheumatoid arthritis and an inadequate response to methotrexate. Arthritis Rheumatol. 2016;68(12):2857–66. 10.1002/art.39808
188 Kremer JM, Emery P, Camp HS, Friedman A, Wang L, Othman AA, et al. A phase IIB study of ABT-494, a selective JAK-1 inhibitor, in patients with rheumatoid arthritis and an inadequate response to anti-tumor necrosis factor therapy. Arthritis Rheumatol. 2016;68(12):2867–77. 10.1002/art.39801
189 Lo Gullo A, Parisi S, Becciolini A, Paroli M, Bravi E, Andracco R, et al. Multicenter observational study on the efficacy of selective Janus kinase-1 inhibitor upatacitinib in rheumatoid arthritis. Minerva Med. 2024;115(4):430–8. 10.23736/S0026-4806.24.09409-6
190 Barešić M, Kilić P, Balen Topić M, Anić B. Prolonged eosinophilia caused by strongyloidiasis in a patient with rheumatoid arthritis treated with upadacitinib. Mod Rheumatol Case Rep. 2025;9(1):6-9. 10.1093/mrcr/rxae061
191 So H, Cheng I, Chow E, Wu Q, Li M, Hung V, et al. Erosion regression in patients with rheumatoid arthritis after upadacitinib-a pilot study using high resolution peripheral quantitative computed tomography. Rheumatology (Oxford). 2024. 10.1142/S2661341724740286
192 Burmester GR, Van den Bosch F, Tesser J, Shmagel A, Liu Y, Khan N, et al. Upadacitinib in rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying antirheumatic drugs: Efficacy and safety through 5 years (SELECT-NEXT). J Rheumatol. 2024;51(7):663-72. 10.3899/jrheum.2023-1062
193 Bessette L, Chan J, Chow A, Lisnevskaia L, Richard N, Fournier PA, et al. Real-world effectiveness of upadacitinib for treatment of rheumatoid arthritis in Canadian patients: Interim results from the prospective observational Close-Up study. Rheumatol Ther. 2024;11(3):563-82. 10.1007/s40744-024-00651-8
194 Baker JF, Zueger P, Ali M, Bennett D, Yu M, Munoz Maldonado Y, et al. Real-world use and effectiveness outcomes in patients with rheumatoid arthritis treated with upadacitinib: An analysis from the CorEvitas registry. Rheumatol Ther. 2024;11(2):363-80. 10.1007/s40744-024-00639-4
195 Baldi C, Parisi S, Falsetti P, Sota J, Ditto MC, Capassoni M, et al. Efficacy and safety of upadacitinib in rheumatoid arthritis: Real-life experience from a prospective longitudinal multicentric study. J Clin Med. 2024;13(2):401. 10.3390/jcm13020401
196 Xu H, Su B, Li R, Wang L, Zhou J, Zhao L. Successful treatment of anti-PTX3 positive seronegative rheumatoid arthritis with upadacitinib. Int J Rheum Dis. 2024;27(1):e14899. 10.1111/1756-185X.14899
197 Omidi F, Delkash P, Nasiri MJ, Mirsaeidi M. Upadacitinib and cardiovascular adverse events in rheumatoid arthritis: A systematic review and meta-analysis. Curr Rheumatol Rev. 2024. 10.1101/2023.10.24.23297509
198 Charles-Schoeman C, Giles JT, Lane NE, Choy E, Furst DE, Vencovský J, et al. Impact of upadacitinib on laboratory parameters and related adverse events in patients with RA: Integrated data up to 6.5 years. Rheumatol Ther. 2024;11(1):157-75. 10.1007/s40744-023-00624-3
199 Fleischmann R, Meerwein S, Charles-Schoeman C, Combe B, Hall S, Khan N, et al. Efficacy and safety of upadacitinib in patients with rheumatoid arthritis and inadequate response or intolerance to biological treatments: Results through 5 years from the SELECT-BEYOND study. RMD Open. 2024;10(3):e003918. 10.1136/rmdopen-2023-003918
200 Fleischmann R, Swierkot J, Penn SK, Durez P, Bessette L, Bu X, et al. Long-term safety and efficacy of upadacitinib versus adalimumab in patients with rheumatoid arthritis: 5-Year data from the phase 3, randomised SELECT-COMPARE study. RMD Open. 2024;10(2):e004007. 10.1136/rmdopen-2023-004007
201 Fleischmann R, Blanco R, Van den Bosch F, Bessette L, Song Y, Penn SK, et al. Long-term efficacy and safety following switch between upadacitinib and adalimumab in patients with rheumatoid arthritis: 5-Year data from SELECT-COMPARE. Rheumatol Ther. 2024;11(3):599-615. 10.1007/s40744-024-00658-1
202 Caporali R, Kadakia A, Howell O, Patel J, Milligan J, Strengholt S, et al. A real-world comparison of clinical effectiveness in patients with rheumatoid arthritis treated with upadacitinib, tumor necrosis factor inhibitors, and other advanced therapies after switching from an initial tumor necrosis factor inhibitor. Adv Ther. 2024;41(9):3706-21. 10.1007/s12325-024-02948-0
203 van Vollenhoven R, Strand V, Takeuchi T, Chávez N, Walter PM, Singhal A, et al. Upadacitinib monotherapy versus methotrexate monotherapy in patients with rheumatoid arthritis: Efficacy and safety through 5 years in the SELECT-EARLY randomized controlled trial. Arthritis Res Ther. 2024;26(1):143. 10.1186/s13075-024-03358-x
204 van Vollenhoven RF, Hall S, Wells AF, Meerwein S, Song Y, Tanjinatus O, et al. Long-term sustainability of response to upadacitinib among patients with active rheumatoid arthritis refractory to biological treatments: Results up to 5 years from SELECT-BEYOND. RMD Open. 2024;10(3):e004037. 10.1136/rmdopen-2023-004037.
205 Rubbert-Roth A, Kato K, Haraoui B, Rischmueller M, Liu Y, Khan N, et al. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis refractory to biologic DMARDs: Results through week 216 from the SELECT-CHOICE Study. Rheumatol Ther. 2024;11(5):1197-215. 10.1007/s40744-024-00694-x
206 Picchianti Diamanti A, Cattaruzza MS, Salemi S, Di Rosa R, Sesti G, De Lorenzo C, et al. Clinical and ultrasonographic remission in bio-naïve and bio-failure patients with rheumatoid arthritis at 24 weeks of upadacitinib treatment: The UPARAREMUS real-life study. Rheumatol Ther. 2024;11(5):1347-61. 10.1007/s40744-024-00712-y
207 Namour F, Desrivot J, Van der Aa A, Harrison P, Tasset C, van’t Klooster G. Clinical confirmation that the selective JAK1 inhibitor filgotinib (GLPG0634) has a low liability for drug-drug interactions. Drug Metab Lett. 2016;10(1):38–48. 10.2174/1872312810666151223103353
208 Kavanaugh A, Kremer J, Ponce L, Cseuz R, Reshetko OV, Stanislavchuk M, et al. Filgotinib (GLPG0634/GS-6034), an oral selective JAK1 inhibitor, is effective as monotherapy in patients with active rheumatoid arthritis: Results from a randomised, dose-finding study (DARWIN 2). Ann Rheum Dis. 2017;76(6):1009–19. 10.1136/annrheumdis-2016-210105
209 Combe B, Kivitz A, Tanaka Y, van der Heijde D, Simon JA, Baraf HSB, et al. Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: A phase III randomised clinical trial. Ann Rheum Dis. 2021;80(7):848–58. 10.1136/annrheumdis-2020-219214
210 Westhovens R, Rigby WFC, van der Heijde D, Ching DWT, Stohl W, Kay J, et al. Filgotinib in combination with methotrexate or as monotherapy versus methotrexate monotherapy in patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate: The phase 3, randomised controlled FINCH 3 trial. Ann Rheum Dis. 2021;80(6):727–38. 10.1136/annrheumdis-2020-219213
211 Winthrop KL, Tanaka Y, Takeuchi T, Kivitz A, Matzkies F, Genovese MC, et al. Integrated safety analysis of filgotinib in patients with moderately to severely active rheumatoid arthritis receiving treatment over a median of 1.6 years. Ann Rheum Dis. 2022;81(2):184–92. 10.1136/annrheumdis-2021-221051
212 Buch MH, Aletaha D, Combe BG, Tanaka Y, Caporali R, Schulze-Koops H, et al. Efficacy and safety of filgotinib in patients with rheumatoid arthritis: Week 156 interim results from a long-term extension study. RMD Open. 2024;10(4): e004476. 10.1136/rmdopen-2024-004476.
213 Buch MH, Walker D, Edwards CJ, Barry J, Akroyd L, Omoruyi EVE, et al. Efficacy and safety of filgotinib in patients with moderately active rheumatoid arthritis and an inadequate response to methotrexate. Rheumatology (Oxford). 2024. 10.1093/rheumatology/keae486
214 Tanaka Y, Matsubara T, Atsumi T, Amano K, Ishiguro N, Hirata S, et al. Safety and efficacy of filgotinib in Japanese patients with rheumatoid arthritis: Week 156 interim results in FINCH 4. Mod Rheumatol. 2024. 10.1093/mr/roae099
215 Burmester GR, Gottenberg JE, Caporali R, Winthrop KL, Tanaka Y, Ekoka Omoruyi EV, et al. Integrated safety analysis of filgotinib in patients with moderate-to-severe rheumatoid arthritis over a treatment duration of up to 8.3 years. Ann Rheum Dis. 2024;83(9):1110-7. 10.1136/ard-2024-225759
216 Schultz O, Fiehn C, Kneitz C, Picker N, Kromer D, Zignani M, et al. Real-world experience with filgotinib for rheumatoid arthritis in Germany: A retrospective chart review. Z Rheumatol. 2024;84:39-47. 10.1007/s00393-024-01506-x
217 Fornaro M, Caporali R, Biggioggero M, Bugatti S, De Stefano L, Cauli A, et al. Effectiveness and safety of filgotinib in rheumatoid arthritis patients: Data from the GISEA registry. Clin Exp Rheumatol. 2024;42(5):1043-50. 10.55563/clinexprheumatol/b40rv4
218 La Barbera L, Rizzo C, Camarda F, Atzeni F, Miceli G, Molica Colella AB, et al. Effectiveness and safety of filgotinib in rheumatoid arthritis: A real-life multicentre experience. Clin Exp Rheumatol. 2024;42(5):991-8. 10.55563/clinexprheumatol/k78ug3
219 Gao X, He X, Oshima H, Miyatake D, Otsuka Y, Kato K, et al. Pharmacokinetics and safety of single and multiple doses of peficitinib (ASP015K) in healthy Chinese subjects. Drug Des Devel Ther. 2022;16:1365–81. 10.2147/DDDT.S359501
220 Tanaka Y, Izutsu H. Peficitinib for the treatment of rheumatoid arthritis: An overview from clinical trials. Expert Opin Pharmacother. 2020;21(9):1015–25. 10.1080/14656566.2020.1739649
221 Yang Y, Li J, Liu J, Liu L, Wang Y, Hu J, et al. Safety and efficacy of peficitinib in Asian patients with rheumatoid arthritis who had an inadequate response or intolerance to methotrexate: Results of a multicenter, randomized, double-blind, placebo-controlled phase 3 study. Lancet Reg Health West Pac. 2024;42:100925. 10.1016/j.lanwpc.2023.100925
222 Tanaka Y, Takeuchi T, Morita Y, Kaneko Y, Terada W. Safety and effectiveness of peficitinib 100 mg/day in patients achieving clinical remission from a long-term open-label extension study in Japan, Korea, and Taiwan (RAJ2). Mod Rheumatol. 2024;34(5):918-26. 10.1093/mr/road110
223 Tanaka Y, Takeuchi T, Morita Y, Kato D, Kaneko Y, Terada W. Post hoc analysis of patients with rheumatoid arthritis under clinical remission in two Japanese phase 3 trials of peficitinib treatment (RAJ3 and RAJ4). Mod Rheumatol. 2024;34(3):453–65. 10.1093/mr/road059
224 Prakken B, Albani S, Martini A. Juvenile idiopathic arthritis. Lancet. 2011;377(9783):2138–49. 10.1016/S0140-6736(11)60244-4
225 Petty RE, Southwood TR, Manners P, Baum J, Glass DN, Goldenberg J, et al. International League of Associations for Rheumatology classification of juvenile idiopathic arthritis: Second revision, Edmonton, 2001. J Rheumatol. 2004;31(2):390–2.
226 Srinivasalu H, Simpson J, Stoll ML. Drug therapy in juvenile spondyloarthritis. Curr Opin Rheumatol. 2024;36(4):295–301. 10.1097/BOR.0000000000001016
227 Poddighe D, Romano M, Gattinara M, Gerloni V. Biologics for the treatment of juvenile idiopathic arthritis. Curr Med Chem. 2018;25(42):5860–93. 10.2174/0929867325666180522085716
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May 1, 2025
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Liu, D., Yu, G., Yuan, N., & Nie, D. (2025). The efficacy and safety of biologic or targeted synthetic DMARDs in rheumatoid arthritis treatment: one year of review 2024. Allergologia Et Immunopathologia, 53(3), 140-162. https://doi.org/10.15586/aei.v53i3.1278
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Review Article
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Liu, D., Yu, G., Yuan, N., & Nie, D. (2025). The efficacy and safety of biologic or targeted synthetic DMARDs in rheumatoid arthritis treatment: one year of review 2024. Allergologia Et Immunopathologia, 53(3), 140-162. https://doi.org/10.15586/aei.v53i3.1278