Abstract

Abstract To perform a systematic review and meta-analysis of randomized controlled trials (RCT’s) reporting efficacy of systematic treatments approved for moderate-to-severe psoriasis by means of the Psoriasis Area And severity Index (PASI). We identified relevant articles by systematic electronic searches (Cochrane Library, Medline,). Efficacy was defined as proportion of participants with > 75% decrease in PASI (PASI-75) at primary efficacy measurement (week8-16). PASI-75 response rates of double-blind placebo-controlled trials were summarized as risk differences (RDs) and pooled using random effect models. Tolerability was assessed from rates of withdrawals and adverse events. Twenty-one RCT’s totaling 7877 patients were analyzed qualitatively. Sixteen double-blind placebo-controlled trials were eligible for meta-analysis. Infliximab was significantly superior to all other interventions (RD 77%, 95% confidence interval (CI) 72-81%). Adalimumab (RD 64%, 95% CI 61-68%) was superior to efalizumab (RD 24%, 95% CI 19-30%). Etanercept 50 mg twice weekly (RD 44%, 95% CI 40-48%) and etanercept 25 mg twice weekly (RD 30%, 95% CI 25-35%). Rates of withdrawals due to adverse events were highest for methotrexate and fumaric acid esters. There are considerable differences in efficacy between systemic biologic therapies which are approved for the treatment of moderate-to-severe psoriasis. Infliximab is most efficacious, followed by adalimumab. Patients receiving infliximab have an excess chance of 77% over placebo to achieve PASI-75 response. Published evidence questions regulatory guidelines that recommend biologics as second-line therapy for moderate-to-severe plaque psoriasis.

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