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Keywords:

  • biologicals;
  • efficacy;
  • meta-analysis;
  • randomized controlled trial;
  • safety event

Summary

Background  The relatively recent introduction of biological agents to treat psoriasis presents clinicians with the need to objectively compare and contrast these agents to allow more effective treatment of their patients.

Objectives  To evaluate and compare the efficacy and safety of biological agents in the treatment of plaque psoriasis.

Methods (i) Data sources: Four parallel systematic reviews conducted through July 2006, including peer-reviewed data and U.S. Food and Drug Administration (FDA) reports. (ii) Study selection: Randomized, controlled, double-blind, monotherapy trials of alefacept (n = 3), efalizumab (n = 5), etanercept (n = 4) and infliximab (n = 4); 16 studies comprising 7931 patients met inclusion criteria. (iii) Data extraction: Efficacy was measured by Psoriasis Area and Severity Index (PASI) 75 achievement after 10–14 weeks of treatment, using intention-to-treat analysis. Safety was evaluated by the incidence of one or more adverse event(s) (AEs) and serious adverse event(s) (SAEs) during 10–30 weeks of treatment.

Results  Pooled relative risk (RR) and number needed to treat (NNT) of PASI 75 achievement compared with placebo was computed using Mantel–Haenszel methods and the random effects model. All biological agents for psoriasis were efficacious (P < 0·001); however, there was a graded response for achievement of PASI 75: infliximab (RR = 17·40, NNT = 2), etanercept (RR = 11·73, NNT = 3), efalizumab (RR = 7·34, NNT = 4) and alefacept (RR = 3·70, NNT = 8). The risk of one or more AEs was evaluated by RR and number needed to harm (NNH). This was increased in the alefacept (RR = 1·09, P = 0·03, NNH = 15), efalizumab (RR = 1·15, P < 0·001, NNH = 9) and infliximab (RR = 1·18, P < 0·001, NNH = 9) groups compared with placebo. SAEs were increased in a sensitivity analysis of four efalizumab trials (n = 2443, RR = 1·92, P = 0·03, NNH = 60).

Conclusions  The decreasing rank order for pooled efficacy was infliximab, etanercept, efalizumab and alefacept when compared with placebo. Pooling safety data revealed a previously unreported increased risk of AEs for alefacept, efalizumab and infliximab.