Results of Therapy Including Omalizumab in Adolescents With Recurrent Urticaria: Retrospective Cohort Study

Relevance. Omalizumab is recommended for treatment of severe forms of recurrent urticaria in children since 12 years old. Though the Omalizumab efficiency and safety in children with recurrent urticaria have not been studied specifically.

Objective. To estimate results of the therapy including Omalizumab in adolescents with recurrent urticaria.

Methods. We have studied clinical records of day hospital patients aged from 12 to 17 with recurrent urticaria uncontrolled with second-generation antihistamines and/or immunosuppressive drugs at least for a month (in standard or higher dose), but receiving Omalizumab (300 mg once in 4 weeks subcutaneously). The main result of this therapy is disease control (urticaria activity score over 7 days, UAS7, equal to zero) at 3 and 6 months of therapy. Additional outcomes of therapy: number of significant recrudescence (use of glucocorticosteroids or emergency hospitalization) at 6th month of therapy and in 6 and 12 months after its end; end of concomitant treatment (antihistamines and/or immunosuppressive drugs) at 3 and 6 months and genetically engineered biological agent (GEBD); remission (UAS7 = 0) after 6 and 12 months after GEBD cessation; adverse effects of Omalizumab therapy (any medical cases connected with GEBD).

Results. The disease control at 3 months of treatment was reached in 12 (67%) patients out of 18 children with recurrent urticaria, at 6 months — at 13 (72%) patients. During Omalizumab therapy and at 6 months after therapy cessation there were no significant recrudescence, at 12 months after therapy cessation — at 1 (6%) adolescent. The concomitant treatment was ended after 3 months at 3 (17%) patients, after 6 months — at 10 (56%) patients. Remission was sustained at 11 (61%) out of 18 patients at 6 months and at 9 (60%) out of 15 patients at 12 months after the therapy end. Adverse effects of Omalizumab have not been noted.

Conclusion. Addition of Omalizumab to the therapy in adolescents with uncontrolled recurrent urticaria let us reach remission of disease in most cases by 6 months of treatment.

1. Ulrich W. Anti-IgE for chronic urticaria — are children little adults after all? Pediatr Allergy Immunol. 2015;26(6):488-489. doi: 10.1111/pai.12424.

2. Zuberbier T, Aberer W, Asero R, et al. The EAACI/GA2LEN/ EDF/WAO guideline for the definition, classification, diagnosis and management of urticaria. Allergy. 2018;73(7):1393-1414. doi: 10.1111/all.13397.

3. Krapivnitsa u detej. Klinicheskie rekomendatsii [Internet]. Moscow: Soyuz pediatrov Rossii; Rossijskaya assotsiatsiya allergologov i klinicheskikh immunologov; 2018. (In Russ). Доступно по: http://cr.rosminzdrav.ru/#!/schema/218#doc_g. Ссылка активна на 12.01.2019.

4. Ben-Shoshan M. Omalizumab: not only for asthma. Recent Pat Inflamm Allergy Drug Discov. 2008;2(3):191-201. doi: 10.2174/187221308786241910.

5. Novartis announces US FDA approval of Xolair® for chronic idiopathic urticaria (CIU). Novartis Institutes for BioMedical research. [cited 2014 Mar 21]. Novartis Media Relations; 2015. Available from: https://cutt.us/4Ueuu.

6. Государственный реестр лекарственных средств. Инструкция к препарату Ксолар [интернет].Доступно по https://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=b90c60e3-61d3-4aa7-bf8c-c0663ed1394b&t=. Ссылка активна на 24.04.2019.

7. Busse WW, Morgan WJ, Gergen PJ, et al. Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children. N Engl J Med. 2011;364(11):1005-1015. doi: 10.1056/NEJMoa1009705.

8. Deschildre A, Marguet C, Salleron J, et al. Add-on omalizumab in children with severe allergic asthma: a 1-year real life survey. Eur Respir J. 2013;42(5):1224-1233. doi: 10.1183/09031936.00149812.

9. Maurer M, Rosen K, Hsieh HJ, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. N Engl J Med. 2013;368(10):924-935. doi: 10.1056/NEJMoa1215372.

10. Saini SS, Bindslev-Jensen C, Maurer M, 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(1):67-75. doi: 10.1038/jid.2014.306.

11. Kaplan A, Ledford D, Ashby M, et al. Omalizumab in patients with symptomatic chronic idiopathic/spontaneous urticaria despite standard combination therapy. J Allergy Clin Immunol. 2013;132(1):101-109. doi: 10.1016/j.jaci.2013.05.013

12. Netchiporouk E, Nguyen CH, Thuraisingham T, et al. Management of pediatric chronic spontaneous and physical urticaria patients with omalizumab: case series. Pediatr Allergy Immunol. 2015;26(6):585-588. doi: 10.1111/pai.12407.

13. Order № 433n Ministry Of Health Russia «Ob utverzhdenii polozheniya ob organizatsii klinicheskoj aprobatsii metodov profilaktiki, diagnostiki, lecheniya i reabilitatsii i okazaniya meditsinskojpomoshchi»; dated July 10, 2015. (In Russ). Доступно по: https://www.rosminzdrav.ru/documents/9211-prikaz-. Ссылка активна на 24.04.2019.

14. Mathias SD, Crosby RD, Zazzali JL, et al. Evaluating the minimally important difference of the urticaria activity score and other measures of disease activity in patients with chronic idiopathic urticaria. Ann Allergy Asthma Immunol. 2012;108(1):20-24. doi: 10.1016/j.anai.2011.09.008.

15. Pite H, Wedi B, Borrego LM, et al. Management of childhood urticaria: current knowledge and practical recommendations. Acta Derm Venereol. 2013;93(5):500-508. doi: 10.2340/00015555-1573.

16. Goldstein S, Gabriel S, Kianifard F, et al. Clinical features of adolescents with chronic idiopathic or spontaneous urticaria: review of omalizumab clinical trials. Ann Allergy Asthma Immunol. 2017;118(4):500-504. doi: 10.1016/j.anai.2017.02.003.

17. Casale TB, Bernstein JA, Maurer M, et al. Similar efficacy with omalizumab in chronic idiopathic/spontaneous urticaria despite different background therapy. J Allergy Clin Immunol Pract. 2015;3(5):743-750.e1. doi: 10.1016/j.jaip.2015.04.015.

18. Намазова-Баранова Л.С., Вишнёва Е.А., Калугина В.Г., и др. Современные возможности терапии хронической крапивницы у детей // Педиатрическая фармакология. — 2018. — Т.15. — №3. — С. 233-237. [Namazova-Baranova LS, Vishneva EA, Kalugina VG, et al. Modern possibilities of chronic urticaria therapy in children. Pediatric pharmacology. 2018;15(3):233-237. (In Russ.)] doi: 10.15690/pf.v15i3.1903.

19. Maurer M, Altrichter S, Bieber T, et al. Efficacy and safety of omalizumab in patients with chronic urticaria who exhibit IgE against thyroperoxidase. J Allergy Clin Immunol. 2011;128(1):202-209.e5. doi: 10.1016/j.jaci.2011.04.038.

20. Uysal P, Eller E, Mortz CG, Bindslev-Jensen C. An algorithm for treating chronic urticarial with omalizumab: dose interval should be individualized. J Allergy Clin Immunol. 2014;133(3):914-915.e2. doi: 10.1016/j.jaci.2013.10.015.