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Background: Chronic spontaneous urticaria (CSU) is a mast cell-mediated condition that can cause significant impairment in quality of life. Second-generation H1-antihistamines are recommended as first-line treatment, but a proportion of patients do not achieve adequate control and require add-on therapy. Omalizumab is the preferred biologic for CSU that is unresponsive to high-dose H1-antihistamines. Objective: Our aim was to assess the efficacy and safety of omalizumab in patients with CSU refractory to high-dose second-generation H1-antihistamines within a Middle Eastern tertiary care health care setting and to then relate the findings to current international urticaria guideline recommendations. Methods: A retrospective observational study was undertaken at a tertiary allergy clinic from September 2015 to September 2018. A total of 75 adults with CSU of more than 6 months' duration and unresponsive to 4-fold doses of H1-antihistamines received omalizumab and were followed in the clinic. The primary outcome was change in Urticaria Control Test score before and after treatment. Additional data included responder classification, comorbidities, laboratory findings, treatment intervals, and adverse events. Results: < .001), with no association between outcome and baseline IgE levels. The response rates were 84% complete, 13% partial, and 3% poor. Most complete responders achieved control after 1 or 2 doses. Vitamin D deficiency and raised IgE level were frequent but did not predict response. Adverse events were infrequent and mild. Conclusion: Omalizumab is effective and well tolerated in CSU that is refractory to high-dose H1-antihistamines, providing rapid and sustained symptom control in most patients. Current international guidelines continue to recommend omalizumab as the first-choice add-on therapy in this setting, with other biologics remaining under investigation.
Elkhalifa et al. (Wed,) studied this question.