Abstract
Background
Omalizumab is approved for the treatment of chronic spontaneous urticaria (CSU) not responding to antihistamines. Data on omalizumab use in real-world settings and in different populations are lacking.
Objectives
To record our five-year experience of omalizumab use in patients with refractory CSU in a real-world setting.
Materials & Methods
A retrospective analysis of medical records of 80 patients with refractory CSU was performed. Demographic, and clinical characteristics, patterns of response, discontinuation strategies and rate of recurrence were analysed.
Results
Eighty individuals were included. UAS7 and DLQI significantly decreased from baseline. Complete response was achieved in 86.3%. Late response was observed at 27.5% of the patients. After discontinuation, 21.7% of patients reinitiated omalizumab due to relapse. The mean number of omalizumab administrations up to first discontinuation was 6.8 (based on an approach to shorten the treatment interval). Only 15.0% of patients experienced adverse events during treatment.
Conclusion
Omalizumab, with long-term management, was highly effective and safe in achieving control of refractory CSU, with more favourable responses compared to Phase III clinical trials.
Article PDF
Similar content being viewed by others
Avoid common mistakes on your manuscript.
References
Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA2 LEN task force report? Allergy 2011;66:317–30.
Larenas-Linnemann DES, Parisi CAS, Ritchie C, et al. Update on omalizumab for urticaria: what’s new in the literature. Curr Allergy Asthma Rep 2018; 18:33.
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: 101–9.
Mlynek A, Zalewska-Janowska A, Martus P, et al. How to assess disease activity in patients with chronic urticaria?. Allergy 2008;63:777–80.
Maurer M, Sofen H, Ortiz B, et al. Positive impact of omalizumab on angioedema and quality of life in patients with refractory chronic idiopathic/spontaneous urticaria: analyses according to the presence or absence of angioedema. J Eur Acad Dermatol Venereol 2017; 31:1056–63.
Zuberbier T, Aberer W, Asero R, et al. The EAACI/GA(2)LEN/EDF/WAO guideline for the definition, classification, diagnosis and management of urticaria. The 2017 revision and update. Allergy 2018;73:1393–414.
Sharma M, Bennett C, Carter B, Cohen SN. H1-antihistamines for chronic spontaneous urticaria: an abridged Cochrane Systematic Review. J Am Acad Dermatol 2015; 73: 710–6.
Ferrer M, Sastre J, Jauregui I, et al. Effect of antihistamine up-dosing in chronic urticaria. Inv Allergol Clin Immunol 2011; 21: 34–9.
Ferrer M, Boccon-Gibod I, Goncalo M, et al. Expert opinion: defining response to omalizumab. Eur J Dermatol 2017; 27: 455–63.
Maurer M, Rosern K, Hsieh HJ, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. N Engl J Med 2013;368:924–35.
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: 65–75.
Zhao ZT, Ji CM, Yu WJ, et al. Omalizumab for the treatment of chronic spontaneous urticaria: a meta-analysis of randomized clinical trials. J Allergy Clin Immunol 2016; 137: 1742–50.
Tharp M, Bernstein JA, Kavati A, et al. Benefits and harms of omalizumab treatment in adolescent and adult patients with chronic idiopathic (spontaneous) urticaria. JAMA Dermatol 2019; 155: 29–38.
Giménez Arnau AM, Valero Santiago A, Bartra Tomás J, et al. Therapeutic strategy according to differences in response to omalizumab in patients with chronic spontaneous urticaria. J Investig Allergol Clin Immunol 2019; 29: 338–48.
Weller K, Ohanyan T, Hawro T, et al. Total IgE levels are linked to the response of chronic spontaneous urticaria patients to omalizumab. Allergy 2018;73:2406–8.
Deza G, Ricketti PA, Giménez-Arnau AM, Casale TB. Emerging biomarkers and therapeutic pipelines for chronic spontaneous urticaria. J Allergy Clin Immunol Pract 2018; 6: 1108–17.
Ferrer M, Giménez-Arnau A, Saldana D, et al. Predicting chronic spontaneous urticaria symptom return after omalizumab treatment discontinuation: exploratory analysis. J Allergy Clin Immunol Pract 2018;6: 1191–7.
Deza G, Bertolín-Colilla M, Sánchez S, et al. Basophil FcεRI expression is linked to time to omalizumab response in chronic spontaneous urticaria. J Allergy Clin Immunol 2018; 141: 2313–6.
Curto-Barredo L, Spertino J, Figueras-Nart I, et al. Omalizumab updosing allows disease activity control in patients with refractory chronic spontaneous urticaria. Br J Dermatol 2018; 179: 210–21.
Deza G, Bertolín-Colilla M, Pujol RM, et al. Basophil FcεRI expression in chronic spontaneous urticaria: a potential immunological predictor of response to omalizumab therapy. Acta Derm Venereol 2017; 97:698–704.
Giménez-Arnau AM, Toubi E, Marsland AM, Maurer M. Clinical management of urticaria using omalizumab: the first licensed biological therapy available for chronic spontaneous urticaria. J Eur Acad Dermatol Venereol 2016; 30: 25–32.
Syrigos N, Grapsa D, Zande M, Tziotou M, Syrigou E. Treatment response to omalizumab in patients with refractory chronic spontaneous urticaria. Int J Derm 2018; 57: 417–22.
Kyriakou A, Trigoni A, Sotiriadis D, Patsatsi A. Efficacy of omalizumab in severe chronic spontaneous urticaria: Real life from a Greek tertiary center. Dermatol Ther 2018; 31: 12739.
Kaplan A, Ferrer M, Bernstein JA, et al. Timing and duration of omalizumab response in patients with chronic idiopathic/spontaneous urticaria. J Allergy Clin Immunol 2016; 137:474–81.
Eghari-Sabet J, Sher E, Kavati A, et al. Real-world use of omalizumab in patients with chronic idiopathic/spontaneous urticaria in the United States. Allergy Asthma Proc 2018; 39: 191–200.
Kocaturk E, Deza G, Kiziltac K, Gimenez-Arnau AM. Omalizumab updosing for better disease control in chronic spontaneous urticaria patients. Int Arch Allergy Immunol 2018; 177: 360–4.
Lapeere H, Baeck M, Stockman A, et al. A retrospective analysis omalizumab treatment patterns in patients with chronic spontaneous urticaria: a real-world study in Belgium. J Eur Acad Dermatol 2020; 34:127–34.
Kolkhir P, Church KM, Weller K, Meltz M, Schmetzer O, Maurer M. Autoimmune chronic spontaneous urticaria: what we know and what we do not know. J Allergy Clin Immunol 2017; 139: 1772–82.
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;3:705–12.
Gericke J, Metz M, Ohanyan T, et al. Serum autoreactivity predicts time to response to omalizumab therapy in chronic spontaneous urticaria. J Allergy Clin Immunol 2017;3: 1059–61.e1.
Palacios T, Stillman I, Borish I, Lawrence M. Lack of basophil CD203c -upregulating activity as an immunological marker to predic response to treatment with omalizumab in patients with symptomatic chronic urticaria. J Allergy Clin Immunol Pract 2016;4:529–30.
Author information
Authors and Affiliations
Corresponding author
Additional information
Disclosure
Funding sources: none. Conflicts of interest: none.
About this article
Cite this article
Apalla, Z., Sidiropoulos, T., Kampouropoulou, E. et al. Real-life, long-term data on efficacy, safety, response and discontinuation patterns of omalizumab in a Greek population with chronic spontaneous urticaria. Eur J Dermatol 30, 716–722 (2020). https://doi.org/10.1684/ejd.2020.3919
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1684/ejd.2020.3919