BACKGROUND:Adalimumab is a fully human monoclonal antibody that binds tumor necrosis factor, a key proinflammatory cytokine involved in the pathogenesis of psoriasis. OBJECTIVE: We sought to evaluate clinical efficacy and safety of adalimumab for moderate to severe psoriasis and investigate continuous versus interrupted therapy. METHODS: We conducted a 52-week, multicenter study of 1212 patients randomized to receiveadalimumab (40 mg) or placebo every other week for the first 15 weeks. At least 75% improvement in the Psoriasis Area and Severity Index (PASI) score was the criterion for advancement through this multiphase study. RESULTS: At week 16, 71% (578 of 814) of adalimumab- and 7% (26 of 398) of placebo-treated patients achieved greater than or equal to 75% improvement in the PASI score. During weeks 33 to 52, the percentage of patients rerandomized to placebo who lost adequate response (defined as <50% improvement in the PASI response relative to baseline and at least a 6-point increase in PASI score from week 33) was 28% compared with 5% of patients treated continuously with adalimumab. LIMITATIONS: Lack of an active comparator and evaluation of maintenance of response beyond week 52 are limitations. CONCLUSION:Adalimumab is efficacious and well-tolerated in the treatment of chronic plaque psoriasis. TRIAL REGISTRATION: Clinical trials.gov. NCT00237887.
RCT Entities:
BACKGROUND:Adalimumab is a fully human monoclonal antibody that binds tumornecrosis factor, a key proinflammatory cytokine involved in the pathogenesis of psoriasis. OBJECTIVE: We sought to evaluate clinical efficacy and safety of adalimumab for moderate to severe psoriasis and investigate continuous versus interrupted therapy. METHODS: We conducted a 52-week, multicenter study of 1212 patients randomized to receive adalimumab (40 mg) or placebo every other week for the first 15 weeks. At least 75% improvement in the Psoriasis Area and Severity Index (PASI) score was the criterion for advancement through this multiphase study. RESULTS: At week 16, 71% (578 of 814) of adalimumab- and 7% (26 of 398) of placebo-treated patients achieved greater than or equal to 75% improvement in the PASI score. During weeks 33 to 52, the percentage of patients rerandomized to placebo who lost adequate response (defined as <50% improvement in the PASI response relative to baseline and at least a 6-point increase in PASI score from week 33) was 28% compared with 5% of patients treated continuously with adalimumab. LIMITATIONS: Lack of an active comparator and evaluation of maintenance of response beyond week 52 are limitations. CONCLUSION:Adalimumab is efficacious and well-tolerated in the treatment of chronic plaque psoriasis. TRIAL REGISTRATION: Clinical trials.gov. NCT00237887.
Authors: Erica D Dommasch; Katrina Abuabara; Daniel B Shin; Josephine Nguyen; Andrea B Troxel; Joel M Gelfand Journal: J Am Acad Dermatol Date: 2011-02-18 Impact factor: 11.527
Authors: Raja K Sivamani; Genevieve Correa; Yoko Ono; Michael P Bowen; Siba P Raychaudhuri; Emanual Maverakis Journal: Indian J Dermatol Date: 2010 Apr-Jun Impact factor: 1.494