Omalizumab for the treatment of chronic spontaneous urticaria: a systematic review

Authors

  • Nishitha Gopal Rao Department of Dermatology, Taihe Hospital, Hubei University of Medicine, Shiyan, Hubei Province, P. R. China
  • Hai Xia Jing Department of Dermatology, Taihe Hospital, Hubei University of Medicine, Shiyan, Hubei Province, P. R. China
  • Ahmed Raihan Kabir Department of Dermatology, Taihe Hospital, Hubei University of Medicine, Shiyan, Hubei Province, P. R. China
  • Rohit Surthi Department of Pediatrics, Taihe Hospital, Hubei University of Medicine, Shiyan, Hubei Province, P. R. China

DOI:

https://doi.org/10.18203/issn.2455-4529.IntJResDermatol20214213

Keywords:

Omalizumab, Chronic spontaneous urticaria, Efficacy, Safety, H1-antihistaminic

Abstract

Chronic spontaneous urticaria (CSU) is a mast cell-driven skin disease characterized by the recurrence of transient wheals, angioedema or both lasting for more than 6 weeks duration. Omalizumab is a newer humanized anti IgE immunoglobulin along with many new antibody treatments has shown beneficial effect in treatment of chronic spontaneous urticaria. Although many randomized clinical trials have been conducted, as of now, the effectiveness of omalizumab in the real world management of CSU is largely unknown. A systematic review of all studies should be done. The objective was to study the efficacy and safety of different doses of omalizumab in the treatment of chronic spontaneous urticaria which was refractory to treatment with H1 antihistamines. Suitable studies were recognized after searching Wiley online library, PubMed, Google scholar, NEJM/NEJ dermatology, JAAD, JACI, clinicaltrials.gov. Only randomized, double-blind, placebo-controlled clinical trials with omalizumab versus antihistamine or leukotriene antagonists as placebo were involved in this study. 10 randomized, placebo-controlled studies were involved with 1692 patients with CSU. Patients treated with omalizumab (75-600 mg every 4 weeks) had reduced UAS7 score, improved QoL (quality of life), reduced WISS, when compared to the placebo group. The effects of omalizumab were found to be dose dependent, with maximum reduction in UAS7 at a dose of 300 mg when given at an interval of 4 weeks’ duration. The incidences of adverse events were almost similar in both control and placebo groups and across various dose ranges. The best effect in reduction of clinical symptoms and QoL in CSU patients was found at a dose of 300 mg subcutaneous injection once a month of omalizumab for 12 to 24 weeks. Omalizumab was found to reduce the clinical symptoms and signs in patients with CSU who were symptomatic despite treatment with upscaling dose of H1 antihistamines.

References

Zuberbier T, Aberer W, Asero R, Latiff AHA, Baker D, Ballmer-Weber B, et al. The EAACI/GA²LEN/EDF/WAO guideline for the definition, classification, diagnosis and management of urticaria. Allergy. 2018;73(7):1393-414.

Zuberbier T, Bindslev-Jensen C, Canonica W, Grattan CE, Greaves MW, Henz BM, et al. EAACI/GA2LEN/EDF guideline: definition, classification and diagnosis of urticaria. Allergy. 2006;61(3):316-20.

Kulthanan K, Jiamton S, Thumpimukvatana N, Pinkaew S. Chronic idiopathic urticaria: prevalence and clinical course. J Dermatol. 2007;34(5):294-301.

Nam YH, Kim JH, Jin HJ, Hwang EK, Shin YS, Ye YM, et al. Effects of omalizumab treatment in patients with refractory chronic urticaria. Allergy Asthma Immunol Res. 2012;4(6):357-61.

Saini SS. Chronic spontaneous urticaria: etiology and pathogenesis. Immunol Allergy Clin North Am. 2014;34(1):33-52.

Maurer M, Weller K, Bindslev-Jensen C, Giménez-Arnau A, Bousquet PJ, Bousquet J, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA²LEN task force report. Allergy. 2011;66(3):317-30.

Carrillo DC, Borges MS, García E, Egea E, Serrano CD. Omalizumab vs. placebo in the management of chronic idiopathic urticaria: a systematic review. World Allergy Organ J. 2014;7(1):72.

Ertas R, Ozyurt K, Atasoy M, Hawro T, Maurer M. The clinical response to omalizumab in chronic spontaneous urticaria patients is linked to and predicted by IgE levels and their change. Allergy. 2018;73(3):705-12.

Kolkhir P, Altrichter S, Munoz M, Hawro T, Maurer M. New treatments for chronic urticaria. Ann Allergy Asthma Immunol. 2020;124(1):2-12.

Min TK, Saini SS. Emerging Therapies in Chronic Spontaneous Urticaria. Allergy Asthma Immunol Res. 2019;11(4):470-81.

Maurer M, Kaplan A, Rosén 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.

Hide M, Park HS, Igarashi A, Ye YM, Kim TB, Yagami A, et al. Efficacy and safety of omalizumab in Japanese and Korean patients with refractory chronic spontaneous urticaria. J Dermatol Sci. 2017;87(1):70-8.

Kolkhir P, Altrichter S, Munoz M, Hawro T, Maurer M. New treatments for chronic urticaria. Ann Allergy Asthma Immunol. 2020;124(1):2-12.

Zhao ZT, Ji CM, Yu WJ, Meng L, Hawro T, Wei JF, et al. Omalizumab for the treatment of chronic spontaneous urticaria: a meta-analysis of randomized clinical trials. J Allergy Clin Immunol. 2016;137(6):1742-50.

Maurer M, Altrichter S, Bieber T, Biedermann T, Bräutigam M, Seyfried S, et al. Efficacy and safety of omalizumab in patients with chronic urticaria who exhibit IgE against thyroperoxidase. J Allergy Clin Immunol. 2011;128(1):202-9.

Saini S, Rosen KE, Hsieh HJ, Wong DA, Conner E, Kaplan A, et al. A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine-refractory chronic idiopathic urticaria. J Allergy Clin Immunol. 2011;128:567-73.

Kumar S, Dhillon SS, Brar B, Singh A. Comparative evaluation of the therapeutic efficacy and safety of injected histaglobulin versus autologous serum therapy in chronic urticaria. J Clin Aesthet Dermatol. 2021;14(3):38-41.

Metz M, Staubach P, Bauer A, Brehler R, Gericke J, Kangas M, et al. Clinical efficacy of omalizumab in chronic spontaneous urticaria is associated with a reduction of FcεRI-positive cells in the skin. Theranostics. 2017;7(5):1266-76.

Higgins JP, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, et al. The Cochrane collaboration’s tool for assessing risk of bias in randomised trials. BMJ. 2011;343:5928.

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(2):474-81.

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(5):743-50.

Agache I, Rocha C, Pereira A, Song Y, Alonso-Coello P, Solà I, et al. Efficacy and safety of treatment with omalizumab for chronic spontaneous urticaria: a systematic review for the EAACI Biologicals Guidelines. Allergy. 2021;76(1):59-70.

Jörg L, Pecaric-Petkovic T, Reichenbach S, Coslovsky M, Stalder O, Pichler W, et al. Double-blind placebo-controlled trial of the effect of omalizumab on basophils in chronic urticaria patients. Clin Exp Allergy. 2018;48(2):196-204.

Staubach P, Metz M, Chapman-Rothe N, Sieder C, Bräutigam M, Maurer M, et al. Omalizumab rapidly improves angioedema-related quality of life in adult patients with chronic spontaneous urticaria: X-ACT study data. Allergy. 2018;73(3):576-84.

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Published

2021-10-27

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Section

Systematic Reviews