Omalizumab dosing patterns and drug survival in adult patients with chronic spontaneous urticaria

Ditte Georgina Zhang; Mia-Louise Nielsen; Jennifer Astrup Sørensen; Somaia Naassan; Christian Vestergaard; Emek Kocatürk; Zarqa Ali; Jacob P Thyssen; Alexander Egeberg; Simon Francis Thomsen

doi:10.1111/jdv.20737

Omalizumab dosing patterns and drug survival in adult patients with chronic spontaneous urticaria

J Eur Acad Dermatol Venereol. 2025 May 13. doi: 10.1111/jdv.20737. Online ahead of print.

Authors

Affiliations

¹ Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark.
² Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark.
³ Institute of Allergology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität Zu Berlin, Berlin, Germany.
⁴ Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology, Berlin, Germany.
⁵ Bahçeşehir University School of Medicine, Department of Dermatology, Istanbul, Turkey.
⁶ Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
⁷ Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.

PMID: 40357715
DOI: 10.1111/jdv.20737

Abstract

Background: Omalizumab is an effective treatment for chronic spontaneous urticaria (CSU), but strategies and predictors for guiding long-term management and discontinuation remain limited.

Objectives: To examine real-world treatment patterns, including dosing modifications and discontinuation, and identify potential predictive factors for these outcomes.

Methods: This was a retrospective, observational, real-life study of adult patients with CSU treated with omalizumab at a Urticaria Center of Reference and Excellence (UCARE) in Copenhagen, Denmark, between May 20, 2015, and April 4, 2024. The Kaplan-Meier estimator was used to visualize time to discontinuation and dose escalation/reduction (using standard label dosing as reference), and Cox-regressions with hazard ratios (HR) were used to investigate potential predictive variables.

Results: Of 430 patients initiated on omalizumab, 139 (32.4%) escalated treatment, 161 (37.5%) reduced treatment, and 90 (21.0%) discontinued treatment directly from the standard dose. The median survival time for dose escalation was 2 years (95% CI: 1.17-3.55), and the strongest predictor was a positive basophil histamine release assay (BHRA) (HR: 2.79, 95% CI: 1.69-4.61). Fast treatment response (HR: 0.50, 95% CI: 0.33-0.75) and higher baseline UCT scores (HR: 0.89, 95% CI: 0.82-0.97) decreased the risk of dose escalation. The median survival time to dose reduction was 1.2 years (95% CI: 0.98-1.49) and was more likely in males (HR: 1.68, 95% CI: 1.13-2.50) and patients with fast treatment response (HR: 1.66, 95% CI: 1.12-2.48). Median survival time to discontinuation (all reasons) of omalizumab was 3 years (95% CI: 2.35-3.64).

Conclusions: A considerable proportion of patients with CSU require modifications to the recommended omalizumab dosing regimen. A positive BHRA was the strongest predictor for dose escalation, while male sex and fast treatment response were the strongest predictors for dose reduction. Our study highlights the need for individualized strategies in managing CSU.