[Treatment of plaque psoriasis with biologics. A meta-analysis of randomized controlled trials].

BACKGROUND AND PURPOSE: The development of different biological therapies (so-called biologics) is a great progress for the treatment of the psoriasis vulgaris. The evidence from randomized controlled trials (RCTs) of biologics, which have been licensed in Germany for the treatment of moderate-to-severe psoriasis vulgaris, were pooled in this meta-analysis.

MATERIAL AND METHODS: Systematic review and meta-analysis of all RCTs, in which biologics licensed in Germany as of January 2008 for the treatment of moderate-to-severe psoriasis vulgaris were examined. Relevant trials were identified by systematic electronic literature search in MEDLINE, EMBASE, Cochrane Library, and Scopus. Primary endpoint: proportion of patients achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI) Score (PASI75 responder), secondary endpoints: clinically relevant improvement in the quality of life, monthly incidences of study withdrawals and adverse events. PASI75 response rates were statistically pooled and represented as risk differences (RD).

RESULTS: 25 articles on 16 RCTs totaling 8,057 patients with moderate-to-severe psoriasis vulgaris were qualitatively analyzed. 15 double-blind and placebo- controlled trials were compared by meta-analysis. Infliximab had the highest efficacy in the short-term therapy of moderate-to-severe psoriasis vulgaris (RD [95% confidence interval, CI] 76% [72-80%]). Adalimumab (RD [95% CI] 59% [45-73%]) was more effective than efalizumab (RD [95% CI] 24% (19-30%]) and etanercept. Treatment with etanercept showed a clear dose-response effect (50 mg twice weekly: RD [95% CI] 44% (40-48%]; 25 mg twice weekly: RD [95% CI] 30% (25-35%]). All biologics improved the quality of life of psoriasis patients. Monthly incidence rates of withdrawals due to adverse events were 1.2% for infliximab, 0.5% for etanercept, 1.0% for efalizumab, and 0.5% for adalimumab.

CONCLUSION: A patient's chance to reach considerable clinical benefit differs significantly between the different biological therapies currently approved for moderate-to-severe psoriasis vulgaris. Infliximab is most effective, followed by adalimumab. Large controlled studies indicate a high safety of all biologics in the short-term treatment. Recently established registers will provide additional important safety data under real-life conditions.