Early control or gradual relief? Gender-specific real-world insights into omalizumab response in chronic spontaneous urticaria patients

Background: Chronic spontaneous urticaria (CSU) disproportionately affects women, yet gender-specific analyses in treatment response remain scarce. Real-world data on the impact of gender on omalizumab efficacy are limited. Objective: To investigate gender-specific differences in clinical characteristics, comorbidities, and response dynamics to omalizumab in a real-life CSU cohort. Methods: We conducted a retrospective, monocentric cohort study including 250 CSU patients (60% female) treated with omalizumab between 2013 and 2023. Clinical characteristics, comorbidities, laboratory parameters, and treatment timelines were analyzed. Disease control was assessed using the Urticaria Control Test (UCT) at 4 timepoints over 12 months. Statistical comparisons were performed using appropriate univariate tests and linear mixed-effects modeling. Results: Female patients had significantly higher rates of autoimmune thyroiditis, asthma, atopic eczema, allergies, and more frequently received long-term thyroid hormone therapy. While both sexes showed substantial improvement in UCT scores over time, male patients achieved faster and more stable disease control, with significantly higher UCT scores at early timepoints (p = 0.027 at timepoint 2, p = 0.004 at timepoint 3). However, overall treatment outcomes after 12 months did not differ significantly between female and male patients. Variability in response was higher among women, possibly reflecting biological heterogeneity, including hormonal status. Conclusion: Although long-term response to omalizumab is comparable between sexes, male CSU patients demonstrate faster and more consistent clinical improvement. The greater variability in female patients may be linked to immunological or hormonal cofactors. Future studies should consider menopausal status and immune profiles to identify response-modifying subgroups and support personalized treatment strategies in CSU.