Cyclosporine for Chronic Spontaneous Urticaria: A Meta-Analysis and Systematic Review

Background: Despite widely recommended usage of cyclosporine A (CsA) in chronic spontaneous urticaria (CSU), there is no meta-analysis concerning its efficacy and safety.

Objective: To meta-analyze and review the efficacy and safety of CsA in CSU.

Methods: Efficacy was assessed by the relative change in urticaria activity score at 4 weeks and response rates at 4, 8, and 12 weeks. Safety was assessed by analyzing the number of patients with 1 or more adverse event.

Results: Eighteen studies (909 participants) including 2 randomized controlled trials were included, with 125, 363, and 266 patients with CSU receiving very low (<2 mg/kg/d), low (from 2 to< 4 mg/kg/d), and moderate (4-5 mg/kg/d) doses of CsA, respectively. After 4 weeks, the mean relative change in urticaria activity score of CsA-treated patients was -17.89, whereas that of controls was -2.3. The overall response rate to CsA treatment with low to moderate doses at 4, 8, and 12 weeks was 54%, 66%, and 73%, respectively. No studies of very low-dose CsA evaluated response rates at 4, 8, and 12 weeks. Among patients treated with very low, low, and moderate doses of CsA, 6%, 23%, and 57% experienced 1 or more adverse event, respectively.

Conclusions: Given the limited number and quality of studies, our results should be interpreted with caution. CsA is effective at low to moderate doses. Adverse events appear to be dose dependent and occur in more than half the patients treated with moderate doses of CsA. We suggest that the appropriate dosage of CsA for CSU may range from 1 to 5 mg/kg/d, and 3 mg/kg/d is a reasonable starting dose for most patients.