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BACKGROUND: Despite widely recommended usage ofcyclosporine 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 safetyof CsA in CSU.METHODS: Efficacy was assessed by the relative change inurticaria activity score at 4 weeks and response rates at 4, 8, and12 weeks. Safety was assessed by analyzing the number ofpatients with 1 or more adverse event.RESULTS: Eighteen studies (909 participants) including 2randomized controlled trials were included, with 125, 363, and266 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 ofCsA, respectively. After 4 weeks, the mean relative change inurticaria activity score of CsA-treated patients wasL17.89,whereas that of controls wasL2.3. The overall response rate toCsA 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. Amongpatients 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 ofstudies, our results should be interpreted with caution. CsA iseffective at low to moderate doses. Adverse events appear to bedose dependent and occur in more than half the patients treatedwith moderate doses of CsA. We suggest that the appropriate dosage of CsA for CSU may range from 1 to 5 mg/kg/d, and 3mg/kg/d is a reasonable starting dose for most patients.