Background: Treatment of severe recalcitrant chronic idiopathic urticaria (CIU) is difficult. Objective: To assess the efficacy and safety of oral cyclosporin A (CsA) in CIU. Methods: The response to CsA was evaluated in 99 CIU patients with a double-blind, randomized, three-armed study: 16-week CsA, 8-week CsA +8-week placebo, and 16-week placebo. All patients received cetirizine throughout the study period and were followed-up after 8 weeks. Results: Fewer therapeutic failures occurred with 16-week CsA (n = 3) than with placebo (n = 11) and 8-week CsA (n = 8). After 8 and 16 weeks, symptom scores significantly improved in both CsA groups over with placebo. Two patients discontinued because of hypertension. Limitations: During the study period, CsA was not administered at a constant dose; from day 28 the daily dose was 3 mg/kg, which is likely to be less effective and better tolerated than higher dosages. Conclusion: CsA in addition to background therapy with cetirizine may be useful in the treatment of CIU.
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