AIMS: To compare the efficacy of ciclosporine (CsA) versus mycophenolate mofetil (MMF) in psoriasis, a randomized trial was conducted. METHODS: A prospective multicenter randomized open-label clinical trial was performed to compare two parallel groups of patients with chronic plaque psoriasis undergoing different treatments. Therefore, a total of 54 patients with psoriasis were randomly assigned to treatment with either CsA (2.5 mg/kg body weight) or MMF (2 g daily) for 12 weeks, and the drug doses were adjusted according to response. The psoriasis area and severity index (PASI) was used to assess the clinical severity of psoriasis. The primary outcome of this trial was the time to disease relapse. Safety, PASI scores and psoriasis disability index (PDI) were assessed as secondary outcome. RESULTS: There was no difference in time to disease relapse between the two groups. After 12 weeks of treatment, the mean PASI score (+/-SD) decreased from 24.6 +/- 11.1 to 6.6 +/- 7.3 in the CsA group (n = 27) and from 22.4 +/- 9.2 to 10.6 +/- 6.7 in the MMF group (n = 27; p = 0.02). The side effects, time to remission and PDI were similar in both groups. CONCLUSIONS: After 12 weeks, CsA demonstrated a significantly superior efficacy in psoriasis compared to MMF. Copyright 2009 S. Karger AG, Basel.
RCT Entities:
AIMS: To compare the efficacy of ciclosporine (CsA) versus mycophenolate mofetil (MMF) in psoriasis, a randomized trial was conducted. METHODS: A prospective multicenter randomized open-label clinical trial was performed to compare two parallel groups of patients with chronic plaque psoriasis undergoing different treatments. Therefore, a total of 54 patients with psoriasis were randomly assigned to treatment with either CsA (2.5 mg/kg body weight) or MMF (2 g daily) for 12 weeks, and the drug doses were adjusted according to response. The psoriasis area and severity index (PASI) was used to assess the clinical severity of psoriasis. The primary outcome of this trial was the time to disease relapse. Safety, PASI scores and psoriasis disability index (PDI) were assessed as secondary outcome. RESULTS: There was no difference in time to disease relapse between the two groups. After 12 weeks of treatment, the mean PASI score (+/-SD) decreased from 24.6 +/- 11.1 to 6.6 +/- 7.3 in the CsA group (n = 27) and from 22.4 +/- 9.2 to 10.6 +/- 6.7 in the MMF group (n = 27; p = 0.02). The side effects, time to remission and PDI were similar in both groups. CONCLUSIONS: After 12 weeks, CsA demonstrated a significantly superior efficacy in psoriasis compared to MMF. Copyright 2009 S. Karger AG, Basel.
Authors: M M Schoels; J Braun; M Dougados; P Emery; O Fitzgerald; A Kavanaugh; T K Kvien; R Landewé; T Luger; P Mease; I Olivieri; J Reveille; C Ritchlin; M Rudwaleit; J Sieper; J S Smolen; M de Wit; D van der Heijde Journal: Ann Rheum Dis Date: 2013-06-05 Impact factor: 19.103