Cyclosporine in chronic idiopathic urticaria: A double-blind, randomized, placebo-controlled trial - 09/08/11
, Nicoletta Cassano, MD a, Delia Colombo, MD b, Elena Peruzzi, BSc b, Paolo Pigatto, MD c
Reprint requests: Gino A. Vena, MD, 2nd Dermatology Clinic, MIDIM Department, University of Bari, Policlinico–Piazza Giulio Cesare, 11, 70124 Bari, Italy.the NEO-I-30 Study Group
Bari, Origgio, and Milan, Italy
Abstract |
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.
Le texte complet de cet article est disponible en PDF.Abbreviations used : CIU, CsA, DLQI, SGA
Plan
| Supported by Novartis Farma SpA, Origgio, Varese, Italy. Disclosure: Dr Colombo and Ms Peruzzi are full-time employees of Novartis Farma SpA. The other authors declare no conflicts of interest. Presented previously as an abstract at the II International Symposium on Urticaria, November 23 and 24, 2001, Rome, Italy and at the 60th Annual Meeting of the American Academy of Dermatology, February 22-27, 2002, New Orleans, La; also presented as a poster and abstract at the Second 20th World Congress of Dermatology, July 1-5, 2002, Paris, France. |
Vol 55 - N° 4
P. 705-709 - octobre 2006 Retour au numéro
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