Omalizumab and ciclosporin are recommended in international clinical guidelines for treating antihistamine-resistant chronic spontaneous urticaria (CSU). This meta-analysis aimed to evaluate their comparative efficacy and safety to inform local treatment practices in Singapore.

The PubMed and EMBASE databases were searched for randomized controlled trials (RCTs) published up to October 2018 involving omalizumab or ciclosporin as an add-on therapy to H1-antihistamines for CSU. Key outcomes were changes in weekly Urticaria Activity Score (UAS7), adverse events, and health-related quality of life. Pairwise meta-analysis was conducted for each outcome. Owing to differences in trial designs and patient characteristics across the studies, a random effects model was employed. In the absence of head-to-head trials, the Bucher method of adjusted indirect comparison was used to estimate the comparative effectiveness between omalizumab and ciclosporin, with placebo as the common comparator.

Eight omalizumab and two ciclosporin placebo-controlled RCTs comprising 1,740 patients were selected. The magnitude of treatment effect for omalizumab was dose-dependent across all efficacy outcomes: 300 mg was superior to 150 mg. Omalizumab 300 mg, although statistically significantly better than placebo for all efficacy outcomes at week 12, did not achieve clinical significance for all measures. The mean change in UAS7 was statistically better for ciclosporin than for placebo (one RCT) at week 4. The indirect comparison between omalizumab and ciclosporin showed no statistically significant differences for mean change in UAS7. Omalizumab had a more favorable short-term safety profile than ciclosporin, but long-term safety data were lacking.

Both omalizumab and ciclosporin were effective in treating CSU, compared with placebo. However, results of the indirect comparison should be interpreted with caution. On the basis of limited available evidence, and taking into account the similar place in therapy of omalizumab and ciclosporin, the results may be considered acceptable to confirm the clinical comparability of the drugs an add-on to H1-antihistamines for CSU.