Background: Omalizumab, a monoclonal antibody targeting immunoglobulin E, has emerged as an effective treatment option for chronic spontaneous urticaria (CSU), particularly in cases resistant to antihistamines. This study investigates the efficacy and safety of omalizumab in patients with CSU in a real-life context in Iran, marking its first report in this setting. Methodology: This retrospective study was conducted in Shiraz, southwestern Iran, over a period from April 2023 to January 2025. We examined data from patients with antihistamine-refractory CSU who were treated with omalizumab, utilizing medical archives from the CinnaGen Company in Iran. Efficacy was assessed based on the presence of wheals and itching symptoms during the 4 weeks preceding the evaluation call. Any adverse reactions related to drug injection were monitored through patient reports. Results: A total of 245 patients were included in the study (181 females and 64 males), with a mean age of 41.51 ± 12.91 years. The average duration of the disease among participants was 47.90 months. Of the patients, 186 (75.92%) achieved a complete response, 3 (1.22%) had a partial response, 33 (13.47%) were non-responders, and 23 (9.39%) withdrew from treatment. At least 1 adverse event was reported in 17 individuals (6.94%); these adverse effects were generally mild. However, 2 patients experienced serious reactions, both of which were effectively managed. Conclusion: This study is the first to examine Iranian patients with CSU treated with omalizumab. Omalizumab represents a breakthrough for those who do not respond to standard treatments, with more than three-fourths of our patients showing improvement. However, we must consider the potential for severe adverse effects associated with this medication.
Moghtaderi et al. (Thu,) studied this question.
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