Omalizumab treatment in adolescents with chronic spontaneous urticaria: Efficacy and safety
Main Article Content
Keywords
Adolescents, Chronic urticaria, Efficacy, Omalizumab, Safety
Abstract
Background: Omalizumab is useful as an add-on treatment in patients unresponsive to high doses of second-generation antihistamines. This study aimed to evaluate the efficacy and safety of omalizumab treatment in adolescents with refractory chronic spontaneous urticaria (CSU).
Methods: CSU patients aged 12---18 years old with the diagnosis of symptomatic CSU and unresponsive to classical treatment were included in the study. All patients had an urticaria activity-score (UAS7) of ≥16 or and were treated with 300 mg omalizumab every four weeks. The degree of response was classified into complete, partial and non-responders due to UAS7.
Results: A total of 29 patients were evaluated. The median age and symptom onset age of the patients was 15.2 (IQR, 12.8-16.5) years and 14.0 (IQR, 11.8-15.9) years, respectively. The median duration of urticaria was eight (IQR, 4-24) months at admission. Eleven (37.9%) patients had angioedema and ten (34.5%) patients had concomitant allergic diseases. The median age at the beginning of treatment with omalizumab was 15.4 (IQR, 12.9-16.9) years. The median symptom duration was 12 (IQR, 6.5-27.5) months before the omalizumab treatment. Twentyeight (96.5%) of the patients (89.6% complete, 6.9% partial) achieved response; however, one patient was a non-responder (3.5%). The adverse effect was observed in one (3.4%) patient as angioedema after the third dose. Twenty-three patients were followed up for a median of 18 (IQR, 13-27) months. Relapse was observed in three (13%) patients.
Conclusions: Omalizumab is considered as an effective and safe treatment for CSU in adolescents. Relapses mostly occur within the first year after the cessation of treatment.
References
2. Bernstein JA, Lang DM, Khan DA, Craig T, Dreyfus D, Hsieh F, et al. The diagnosis and management of acute and chronic urticaria: 2014 update. J Allergy Clin Immunol. 2014;133:1270-7.
3. Kaplan AP, Clinical practice. Chronic urticaria and angioedema. N Engl J Med. 2002;346:175-9.
4. Weller K, Viehmann K, Brautigam M, Krause K, Siebenhaar F, Zuberbier T, et al. Management of chronic spontaneous urticaria in real life-in accordance with the guidelines? A cross-sectional physician-based survey study. J Eur Acad Dermatol Venereol. 2013;27:43-50.
5. Doshi DR, Weinberger MM. Experience with cyclosporine in children with chronic idiopathic urticaria. Pediatr Dermatol. 2009;26:409-13.
6. Wright JD, Chu HM, Huang CH, Ma C, Chang TW, Lim C. Structural and physical basis for anti-IgE therapy. Sci Rep. 2015;5:11581.
7. Greiwe J, Bernstein JA. Therapy of antihistamine-resistant chronic spontaneous urticaria. Expert Rev Clin Immunol. 2017;13:311-8.
8. Nettis E, Cegolon L, Di Leo E, Canonica WG, Detoraki A. Omalizumab in elderly patients with chronic spontaneous urticaria: an Italian real-life experience. Ann Allergy Asthma Immunol. 2018;120:318-23.
9. Maurer M, Rosen K, Hsieh HJ, Saini S, Grattan C, Gimenez-Arnau A, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. N Engl J Med. 2013;368:924-35.
10. Saini SS, Bindslev-Jensen C, Maurer M, Grob JJ, Bulbul Baskan E, Bradley MS, et al. Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on h1 antihistamines: a randomized, placebo-controlled study. J Invest Dermatol. 2015;135:925.
11. Kaplan A, Ledford D, Ashby M, Canvin J, Zazzali JL, Conner E, et al. Omalizumab in patients with symptomatic chronic idiopathic/spontaneous urticaria despite standard combination therapy. J Allergy Clin Immunol. 2013;132:101-9.
12. Al-Shaikhly T, Rosenthal JA, Ayars AG, Petroni DH. Omalizumab for chronic urticaria in children less than 12 years of age: a systematic review. Ann Allergy Asthma Immunol. 2019.
13. Goldstein S, Gabriel S, Kianifard F, Ortiz B, Skoner DP. Clinical features of adolescents with chronic idiopathic or spontaneous urticaria: review of omalizumab clinical trials. Ann Allergy Asthma Immunol. 2017;118:500-4.
14. Zuberbier T, Aberer W, Asero R, Abdul Latiff AH, Baker D, Ballmer-Weber B, et al. The EAACI/GA(2)LEN/EDF/WAO guideline for the definition, classification, diagnosis and management of urticaria. Allergy. 2018;73:1393-414.
15. Kaplan A, Ferrer M, Bernstein JA, Antonova E, Trzaskoma B, Raimundo K, et al. Timing and duration of omalizumab response in patients with chronic idiopathic/spontaneous urticaria. J Allergy Clin Immunol. 2016;137:474-81.
16. Sackesen C, Sekerel BE, Orhan F, Kocabas CN, Tuncer A, Adalioglu G. The etiology of different forms of urticaria in childhood. Pediatr Dermatol. 2004;21:102-8.
17. Sahiner UM, Civelek E, Tuncer A, Yavuz ST, Karabulut E, Sackesen C, et al. Chronic urticaria: etiology and natural course in children. Int Arch Allergy Immunol. 2011;156:224-30.
18. Du Prel J-B, Röhrig B, Hommel G, Blettner M. Choosing statistical tests: part 12 of a series on evaluation of scientific publications. Deutsches Ärzteblatt Int. 2010;107:343.
19. Bernstein JA, Kavati A, Tharp MD, Ortiz B, MacDonald K, Denhaerynck K, et al. Effectiveness of omalizumab in adolescent and adult patients with chronic idiopathic/spontaneous urticaria: a systematic review of ‘real-world’ evidence. Expert Opin Biol Ther. 2018;18:425-48.
20. Gimenez-Arnau AM, Grattan C, Zuberbier T, Toubi E. An individualized diagnostic approach based on guidelines for chronic urticaria (CU). J Eur Acad Dermatol Venereol. 2015;29 Suppl. 3:3-11.
21. Vestergaard C, Toubi E, Maurer M, Triggiani M, Ballmer-Weber B, Marsland A, et al. Treatment of chronic spontaneous urticaria with an inadequate response to H1-antihistamines: an expert opinion. Eur J Dermatol. 2017;27:10-9.
22. Sussman G, Hebert J, Barron C, Bian J, Caron-Guay RM, Laflamme S, et al. Real-life experiences with omalizumab for the treatment of chronic urticaria. Ann Allergy Asthma Immunol. 2014;112:170-4.
23. Nettis E, Cegolon L, Di Leo E, Lodi Rizzini F, Detoraki A, Canonica GW. Omalizumab chronic spontaneous urticaria: efficacy, safety, predictors of treatment outcome, and time to response. Ann Allergy Asthma Immunol. 2018;121:474-8.
24. Metz M, Ohanyan T, Church MK, Maurer M. Omalizumab is an effective and rapidly acting therapy in difficult-to-treat chronic urticaria: a retrospective clinical analysis. J Dermatol Sci. 2014;73:57-62.
25. Kaplan AP. Treatment of chronic spontaneous urticaria. Allergy Asthma Immunol Res. 2012;4:326-31.
26. Ferrer M, Gimenez-Arnau A, Saldana D, Janssens N, Balp MM, Khalil S, et al. Predicting chronic spontaneous urticaria symptom return after omalizumab treatment discontinuation: exploratory analysis. J Allergy Clin Immunol Pract. 2018;6, 1191-7.e5.
27. Nettis E, Di Leo E, Foti C, Cegolon L, Vacca A. Efficacy and rapid activity of omalizumab retreatment in chronic spontaneous urticaria. J Am Acad Dermatol. 2018;78:1211-3.
28. Maurer M, Kaplan A, Rosen K, Holden M, Iqbal A, Trzaskoma BL, et al. The XTEND-CIU study: long-term use of omalizumab in chronic idiopathic urticaria. J Allergy Clin Immunol. 2018;141, 1138-9.e7.
29. Zuberbier T, Maurer M. Omalizumab for the treatment of chronic urticaria. Expert Rev Clin Immunol. 2015;11:171-80.
30. Casale TB, Bernstein JA, Maurer M, Saini SS, Trzaskoma B, Chen H, et al. Similar efficacy with omalizumab in chronic idiopathic/spontaneous urticaria despite different background therapy. J Allergy Clin Immunol Pract. 2015;3, 743-50.e1.
31. Gonul M, Ozenergun Bittaci A, Ergin C. Omalizumab-induced triphasic anaphylaxis in a patient with chronic spontaneous urticaria. J Eur Acad Dermatol Venereol. 2016;30:e135-6.
32. Ertas R, Ozyurt K, Yildiz S, Ulas Y, Turasan A, Avci A. Adverse reaction to omalizumab in patients with chronic urticaria: flare-up or ineffectiveness? Iran J Allergy Asthma Immunol. 2016;15:82-6.
33. Ghazanfar MN, Sand C, Thomsen SF. Effectiveness and safety of omalizumab in chronic spontaneous or inducible urticaria: evaluation of 154 patients. Br J Dermatol. 2016;175: 404-6.
34. Saini SS. Chronic spontaneous urticaria: etiology and pathogenesis. Immunol Allergy Clin North Am. 2014;34:33-52.
35. Nettis E, Cegolon L, Di Leo E, Lodi Rizzini F, Detoraki A, Canonica GW. Omalizumab in chronic spontaneous urticaria: efficacy, safety, predictors of treatment outcome, and time to response. Ann Allergy Asthma Immunol. 2018;121: 474-8.
Article Sidebar
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.