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Risk-benefit analysis of adalimumab versus methotrexate for the treatment of moderate-severe psoriasis


A phase III, double-blind, placebo and active-controlled trial (CHAMPION) evaluated the efficacy and safety of adalimumab (n = 107) versus methotrexate (n = 110) in patients with moderate-severe psoriasis. Clinical efficacy was assessed using a composite endpoint: the total number of adverse-event (AE)-free response days (number of days with 75% or greater improvement in Psoriasis Area and Severity Index [PASI] score from baseline and freedom from any AEs). The cumulative number of AE-free response days was evaluated over 17 weeks and the first 30 days. Over 17 weeks, adalimumab patients had more AE-free response days (36.9) versus methotrexate (8.3) or placebo (P < 0.001 for methotrexate and placebo comparisons). Adalimumab also produced ...

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