Abstract
Omalizumab is a humanized mouse monoclonal IgG1 antibody directed against the third heavy chain domain of IgE. It has been approved for moderate to severe asthma since 2003, for adults and adolescents with chronic spontaneous urticaria unresponsive to antihistamines since 2014. The evidence base for its efficacy and safety in chronic urticaria is strong. Its introduction has changed the outlook for patients with chronic spontaneous urticaria not responding to older medications including up-dosed H1 antihistamines with complete disease control being achieved in over 40% and partial control in the majority of patients when administered subcutaneously at the approved dose of 300 mg every 4 weeks. Shortening or lengthening the interval between doses may be appropriate for a few patients with a consistent pattern of symptomatic relapse before or after 4 weeks. Increasing the dose to 450 or 600 mg may benefit poor responders. Lengthening the interval between doses in completely controlled patients can be used to assess whether patients are ready to stop treatment. Clinical experience has shown that treatment with omalizumab is not disease modifying but can be maintained until natural remission occurs. Stopping and restarting treatment does not lead to lack of efficacy. Patients with normal or high baseline total IgE (indicative of autoallergic urticaria) tend to be fast and complete responders. Delayed responses may be seen in patients with evidence of functional autoantibodies (Type IIb autoimmune urticaria). Angioedema burdened days are reduced. There is increasing clinical evidence that chronic urticaria patients with inducible urticarias may also respond to omalizumab. Apart from a very low risk of anaphylaxis, omalizumab is safe and well tolerated. It has been used off label in children. There is no evidence to date of harm in pregnancy (FDA category B). Self-administration by patients or trained care-givers from the fourth dose onwards was approved by the European Commission in 2018.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Kaplan AP, Gimenez-Arnau AM, Saini SS. Mechanisms of action that contribute to efficacy of omalizumab in chronic spontaneous urticaria. Allergy. 2017;72(4):519–33.
DrugBank. Omalizumab. 2020. https://www.drugbank.ca/drugs/DB00043.
Tabrizi MA, Tseng CM, Roskos LK. Elimination mechanisms of therapeutic monoclonal antibodies. Drug Discov Today. 2006;11(1-2):81–8.
EuropeanMedicinesAgency. Xolair: EPAR—Summary for the public. 2014. https://www.ema.europa.eu/en/documents/product-information/xolair-epar-product-information_en.pdf.
Milgrom H, Berger W, Nayak A, Gupta N, Pollard S, McAlary M, et al. Treatment of childhood asthma with anti-immunoglobulin E antibody (omalizumab). Pediatrics. 2001;108(2):E36.
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(3):567–73.e1.
Maurer M, Altrichter S, Bieber T, Biedermann T, Brautigam 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.e5.
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(3):925.
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(1):101–9.
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(10):924–35.
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(3):1138–9.
Sussman G, Hebert J, Gulliver W, Lynde C, Yang WH, Papp K, et al. Omalizumab re-treatment and step-up in patients with chronic spontaneous urticaria: OPTIMA trial. J Allergy Clin Immunol Pract. 2020;8(7):2372–8.e5.
Staubach P, Metz M, Chapman-Rothe N, Sieder C, Brautigam M, Canvin J, et al. Effect of omalizumab on angioedema in H1 -antihistamine-resistant chronic spontaneous urticaria patients: results from X-ACT, a randomized controlled trial. Allergy. 2016;71(8):1135–44.
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(1):57–62.
Labrador-Horrillo M, Valero A, Velasco M, Jauregui I, Sastre J, Bartra J, et al. Efficacy of omalizumab in chronic spontaneous urticaria refractory to conventional therapy: analysis of 110 patients in real-life practice. Expert Opin Biol Ther. 2013;13(9):1225–8.
Metz M, Ohanyan T, Church MK, Maurer M. Retreatment with omalizumab results in rapid remission in chronic spontaneous and inducible urticaria. JAMA Dermatol. 2014;150(3):288–90.
Turk M, Carneiro-Leao L, Kolkhir P, Bonnekoh H, Buttgereit T, Maurer M. How to treat patients with chronic spontaneous urticaria with omalizumab: questions and answers. J Allergy Clin Immunol Pract. 2020;8(1):113–24.
Maurer M, Metz M, Brehler R, Hillen U, Jakob T, Mahler V, et al. Omalizumab treatment in patients with chronic inducible urticaria: a systematic review of published evidence. J Allergy Clin Immunol. 2018;141(2):638–49.
Tharp MD, Bernstein JA, Kavati A, Ortiz B, MacDonald K, Denhaerynck K, et al. Benefits and harms of omalizumab treatment in adolescent and adult patients with chronic idiopathic (spontaneous) urticaria: a meta-analysis of “real-world” evidence. JAMA Dermatol. 2019;155(1):29–38.
Gericke J, Metz M, Ohanyan T, Weller K, Altrichter S, Skov PS, et al. Serum autoreactivity predicts time to response to omalizumab therapy in chronic spontaneous urticaria. J Allergy Clin Immunol. 2017;139(3):1059–61.e1.
Palacios T, Stillman L, Borish L, Lawrence M. Lack of basophil CD203c-upregulating activity as an immunological marker to predict response to treatment with omalizumab in patients with symptomatic chronic urticaria. J Allergy Clin Immunol Pract. 2016;4(3):529–30.
Maurer M, Gimenez-Arnau AM, Sussman G, Metz M, Baker DR, Bauer A, et al. Ligelizumab for chronic spontaneous urticaria. N Engl J Med. 2019;381(14):1321–32.
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(7):1393–414.
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(5):1270–7.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2021 Springer Nature Switzerland AG
About this chapter
Cite this chapter
Zuberbier, T., Dörr, T., Grattan, C., Maurer, M. (2021). Omalizumab in the Treatment of Urticaria. In: Zuberbier, T., Grattan, C., Maurer, M. (eds) Urticaria and Angioedema. Springer, Cham. https://doi.org/10.1007/978-3-030-84574-2_12
Download citation
DOI: https://doi.org/10.1007/978-3-030-84574-2_12
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-030-84573-5
Online ISBN: 978-3-030-84574-2
eBook Packages: MedicineMedicine (R0)