Long-term outcome of omalizumab-assisted desensitisation to cow’s milk and eggs in patients refractory to conventional oral immunotherapy: real-life study
Main Article Content
Keywords
Oral immunotherapy, desensitization, Omalizumab, anti-IgE, sever food allergy, cow’s milk allergy, hen’s egg allergy, sustained unresponsiveness
Abstract
Background: Oral immunotherapy (OIT) is a promising approach to cow’s milk and egg allergies, but reactions are frequent and some patients cannot be desensitized.
Objective: To evaluate long-term OIT outcomes with omalizumab (OMZ) in paediatric patients with severe egg and/or milk allergies.
Methods: This retrospective real-life study analysed findings in children with Immunoglobulin E-mediated allergy to cow’s milk and/or hen eggs refractory to conventional OIT, who underwent OIT with OMZ in our department between 1 January 2010 and 31 December 2015.
Results: In all, 41 patients were included (median age: 7 years; interquartile range [IQR]: 5.5–9.5); 26/41 (63.4%) underwent OIT for milk, 8/41 (19.5%) for egg and 7/41 (17.1%) for both. The median time between initiation of OMZ and OIT was 27 weeks (IQR: 22–33). Forty (97.56%) patients reached the maintenance phase (200 mL of cow’s milk and 30 mL of raw egg or 1 cooked egg) in a median time of 27 weeks (IQR: 18–37). The median total time with OMZ was 117 weeks (IQR: 88–144). During the OMZ period, 2.44% (1/41) of patients presented anaphylaxis. After discontinuation of OMZ, 29.3% (12/41) presented anaphylaxis, 50% of them had a poor adherence to daily ingestion. One patient (2.44%) was diagnosed with eosinophilic esophagitis after 2 years of discontinuation of OMZ. Currently, after a median time of 9 years (IQR: 7–10) since the initiation of OMZ, 75.6% (31/41) are desensitized (27/31 without OMZ).
Conclusions: Omalizumab allows desensitisation of children with severe allergies to cow’s milk and/or egg without developing severe reactions while receiving this treatment. However, discontinuation of OMZ leads to severe allergic reactions, and hence must be monitored carefully.
References
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2. Fleischer DM, Perry TT, Atkins D, Wood RA, Burks AW, Jones SM, et al. Allergic reactions to foods in preschool-aged children in a prospective observational food allergy study. Pediatrics. 2012;130(1):e25–32. 10.1542/peds.2011-1762
3. Martorell A, Alonso E, Echeverría L, Escudero C, García-Rodríguez R, Blasco C, et al. Oral immunotherapy for food allergy: A Spanish guideline. Immunotherapy egg and milk Spanish guide (ITEMS GUIDE). Part I: Cow milk and egg oral immunotherapy: Introduction, methodology, rationale, current state, indications contraindications and oral immunotherapy build-up phase. Allergol Immunopathol (Madr). 2017;45(4):393–404. 10.1016/j.aller.2017.05.001
4. Martorell A, Alonso E, Echeverría L, Escudero C, García-Rodríguez R, Blasco C, et al. Oral immunotherapy for food allergy: A Spanish guideline. Egg and milk immunotherapy Spanish guide (ITEMS GUIDE). Part 2: Maintenance phase of cow milk (CM) and egg oral immunotherapy (OIT), special treatment dosing schedules. Models of dosing schedules of OIT with CM and EGG. Allergol Immunopathol (Madr). 2017;45(5):508–18. 10.1016/j.aller.2017.05.002
5. García-Ara C, Pedrosa M, Belver MT, Martín-Muñoz MF, Quirce S, Boyano-Martínez T. Efficacy and safety of oral desensitization in children with cow's milk allergy according to their serum specific IgE level. Ann Allergy Asthma Immunol. 2013;110(4):290–4. 10.1016/j.anai.2013.01.013
6. Begin P, Chinthrajah RS, Nadeau KC. Oral immunotherapy for the treatment of food allergy. Hum Vaccin Immunother. 2014;10(8):2295–302. 10.4161/hv.29233
7. Leung DY, Sampson HA, Yunginger JW, Burks AWJr., Schneider LC, Wortel CH, et al. Effect of anti-IgE therapy in patients with peanut allergy. N Engl J Med. 2003;348(11):986–93. 10.1056/NEJMoa022613
8. Nadeau KC, Schneider LC, Hoyte L, Borras I, Umetsu DT. Rapid oral desensitization in combination with omalizumab therapy in patients with cow's milk allergy. J Allergy Clin Immunol. 2011;127(6):1622–4. 10.1016/j.jaci.2011.04.009
9. Wood RA, Kim JS, Lindblad R, Nadeau K, Henning AK, Dawson P, et al. A randomized, double-blind, placebo-controlled study of omalizumab combined with oral immunotherapy for the treatment of cow's milk allergy. J Allergy Clin Immunol. 2016;137(4):1103–10.e11. 10.1016/j.jaci.2015.10.005
10. Martorell-Calatayud C, Michavila-Gómez A, Martorell-Aragonés A, Molini-Menchón N, Cerdá-Mir JC, Félix-Toledo R, et al. Anti-IgE-assisted desensitization to egg and cow's milk in patients refractory to conventional oral immunotherapy. Pediatr Allergy Immunol. 2016;27(5):544–6. 10.1111/pai.12567
11. Massanari M, Nelson H, Casale T, Busse W, Kianifard F, Geba GP, et al. Effect of pretreatment with omalizumab on the tolerability of specific immunotherapy in allergic asthma. J Allergy Clin Immunol. 2010;125(2):383–9. 10.1016/j.jaci.2009.11.022
12. Babu KS, Polosa R, Morjaria JB. Anti-IgE—Emerging opportunities for omalizumab. Expert Opin Biol Ther. 2013;13(5):765–77. 10.1517/14712598.2013.782391
13. Savage JH, Courneya JP, Sterba PM, Macglashan DW, Saini SS, Wood RA. Kinetics of mast cell, basophil, and oral food challenge responses in omalizumab-treated adults with peanut allergy. J Allergy Clin Immunol. 2012;130(5):1123–9.e2. 10.1016/j.jaci.2012.05.039
14. European Medicines Agency (EMEA). Informe público europeo de evaluación (EPAR) Xolair (Denominación Común Internaciona, DCI) omalizumab EMEA© 2020, No. EMEA/H/C/606; pp. 1–138. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000606/WC500057298.pdf
15. Ayats-Vidal R, Valdesoiro-Navarrete L, García-González M, Asensio-De la Cruz O, Larramona-Carrera H, Bosque-García M. Predictors of a positive oral food challenge to cow's milk in children sensitized to cow's milk. Allergol Immunopathol (Madr). 2020;48(6):568–75. 10.1016/j.aller.2020.03.007
16. Fiocchi A, Pecora V, Valluzzi RL, Fierro V, Mennini M. Use of biologics in severe food allergies. Curr Opin Allergy Clin Immunol. 2017;17(3):232–8. 10.1097/ACI.0000000000000357
17. Rafi A, Do LT, Katz R, Sheinkopf LE, Simons CW, Klaustermeyer W. Effects of omalizumab in patients with food allergy. Allergy Asthma Proc. 2010;31(1):76–83. 10.2500/aap.2010.31.3304
18. MacGinnitie AJ, Rachid R, Gragg H, Little SV, Lakin P, Cianferoni A, et al. Omalizumab facilitates rapid oral desensitization for peanut allergy. J Allergy Clin Immunol. 2017;139(3):873–81.e8. 10.1016/j.jaci.2016.08.010
19. Umetsu DT, Rachid R, Schneider LC. Oral immunotherapy and anti-IgE antibody treatment for food allergy. World Allergy Organ J. 2015;8(1):20. 10.1186/s40413-015-0070-3
20. Schneider LC, Rachid R, LeBovidge J, Blood E, Mittal M, Umetsu DT. A pilot study of omalizumab to facilitate rapid oral desensitization in high-risk peanut-allergic patients. J Allergy Clin Immunol. 2013;132(6):1368–74. 10.1016/j.jaci.2013.09.046
21. Bégin P, Dominguez T, Wilson SP, Bacal L, Mehrotra A, Kausch B, et al. Phase 1 results of safety and tolerability in a rush oral immunotherapy protocol to multiple foods using omalizumab. Allergy Asthma Clin Immunol. 2014;10(1):7. 10.1186/1710-1492-10-7
22. Lafuente I, Mazon A, Nieto M, Uixera S, Pina R, Nieto A. Possible recurrence of symptoms after discontinuation of omalizumab in anti-IgE-assisted desensitization to egg. Pediatr Allergy Immunol. 2014;25(7):717–9. 10.1111/pai.12259
23. Andorf S, Purington N, Block WM, Long AJ, Tupa D, Brittain E, et al. Anti-IgE treatment with oral immunotherapy in multifood allergic participants: A double-blind, randomised, controlled trial. Lancet Gastroenterol Hepatol. 2018;3(2):85–94. 10.1016/S2468-1253(17)30392-8
24. Andorf S, Purington N, Kumar D, Long A, O'Laughlin KL, Sicherer S, et al. A phase 2 randomized controlled multisite study using omalizumab-facilitated rapid desensitization to test continued vs discontinued dosing in multifood allergic individuals. E Clin Med. 2019;7:27–38. 10.1016/j.eclinm.2018.12.006
25. Brandström J, Vetander M, Sundqvist AC, Lilja G, Johansson SGO, Melén E, et al. Individually dosed omalizumab facilitates peanut oral immunotherapy in peanut allergic adolescents. Clin Exp Allergy. 2019;49(10):1328–41. 10.1111/cea.13469
26. Stranks AJ, Minnicozzi SC, Miller SJ, Burton OT, Logsdon SL, Spergel JM, et al. Immunoglobulin E blockade during food allergen ingestion enhances the induction of inhibitory immunoglobulin G antibodies. Ann Allergy Asthma Immunol. 2019;122(2):213–5. 10.1016/j.anai.2018.10.024
27. Loh W, Tang M. Adjuvant therapies in food immunotherapy. Immunol Allergy Clin North Am. 2018;38(1):89–101. 10.1016/j.iac.2017.09.008
28. Virkud YV, Wang J, Shreffler WG. Enhancing the safety and efficacy of food allergy immunotherapy: A review of adjunctive therapies. Clin Rev Allergy Immunol. 2018;55(2):172–89. 10.1007/s12016-018-8694-z
29. Sampson HA, Leung DY, Burks AW, Lack G, Bahna SL, Jones SM, et al. A phase II randomized, double-blind, parallel-group, placebo-controlled oral food challenge trial of Xolair (omalizumab) in peanut allergy. J Allergy Clin Immunol. 2011;127:1309–10.e1. 10.1016/j.jaci.2011.01.051
30. Vázquez-Ortiz M, Alvaro-Lozano M, Alsina L, Garcia-Paba MB, Piquer-Gibert M, Giner-Muñoz MT, et al. Safety and predictors of adverse events during oral immunotherapy for milk allergy: Severity of reaction at oral challenge, specific IgE and prick test. Clin Exp Allergy. 2013;43(1):92–102. 10.1111/cea.12012
31. Meglio P, Giampietro PG, Gianni S, Galli E. Oral desensitization in children with immunoglobulin E-mediated cow's milk allergy—Follow-up at 4 yr and 8 months. Pediatr Allergy Immunol. 2008;19(5):412–9. 10.1111/j.1399-3038.2007.00670.x
32. Staden U, Rolinck-Werninghaus C, Brewe F, Wahn U, Niggemann B, Beyer K. Specific oral tolerance induction in food allergy in children: Efficacy and clinical patterns of reaction. Allergy. 2007;62(11):1261–9. 10.1111/j.1398-9995.2007.01501.x
33. Mota I, Piedade S, Gaspar Â, Benito-Garcia F, Sampaio G, Borrego LM, et al. Cow's milk oral immunotherapy in real life: 8-Year long-term follow-up study. Asia Pac Allergy. 2018;8(3):e28. 10.5415/apallergy.2018.8.e28
34. Lucendo AJ, Arias A, Tenias JM. Relation between eosinophilic esophagitis and oral immunotherapy for food allergy: A systematic review with meta-analysis. Ann Allergy Asthma Immunol. 2014;113(6):624–9. 10.1016/j.anai.2014.08.004
35. González Jiménez D, Larrea Tamayo E, Díaz Martin JJ, Molinos Norniella C, Pérez Solis D, Menéndez Arias C, et al. Oral rush desensitization for cow milk allergy: Clinical and immunological follow-up. Ann Pediatr (Barc). 2013;79(6):346–51. 10.1016/j.anpedi.2013.04.006
36. Celik-Bilgili S, Mehl A, Verstege A, Staden U, Nocon M, Beyer K, et al. The predictive value of specific immunoglobulin E levels in serum for the outcome of oral food challenges. Clin Exp Allergy. 2005;35(3):268–73. 10.1111/j.1365-2222.2005.02150.x
37. Jones SM, Burks AW, Keet C, Vickery BP, Scurlock AM, Wood RA, et al. Long-term treatment with egg oral immunotherapy enhances sustained unresponsiveness that persists after cessation of therapy. J Allergy Clin Immunol. 2016;137(4):1117–27.e10. 10.1016/j.jaci.2015.12.1316
38. Escudero C, Rodríguez Del Río P, Sánchez-García S, Pérez-Rangel I, Pérez-Farinós N, García-Fernández C, et al. Early sustained unresponsiveness after short-course egg oral immunotherapy: A randomized controlled study in egg-allergic children. Clin Exp Allergy. 2015;45(12):1833–43. 10.1111/cea.12604
39. Burks AW, Jones SM, Wood RA, Fleischer DM, Sicherer SH, Lindblad RW, et al. Oral immunotherapy for treatment of egg allergy in children. N Engl J Med. 2012;367(3):233–43. 10.1056/NEJMoa1200435
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