Efficacy and safety of systemic treatments for moderate-to-severe psoriasis: meta-analysis of randomized controlled trials

Br J Dermatol. 2014 Feb;170(2):274-303. doi: 10.1111/bjd.12663.


Dermatologists may choose from various conventional and biological systemic agents to treat patients with moderate-to-severe psoriasis. We set out to analyse systematically the efficacy and tolerability of approved treatments for moderate-to-severe psoriasis. We undertook a systematic review and meta-analysis of randomized controlled trials (RCTs) investigating the efficacy of systemic treatment approved for moderate-to-severe psoriasis. Efficacy was assessed as the proportion of participants with 75% improvement in Psoriasis Area and Severity Index at primary efficacy measurement (week 8-16). Safety was summarized as rates of adverse events and withdrawals. Direct and indirect comparative efficacy was assessed by random effects meta-analysis of risk differences (RDs). In total, 48 eligible RCTs totalling 16 696 patients (11 178 randomized to biologics, 1888 to conventional treatments) were identified. In placebo-controlled trials, infliximab was the most efficacious [RD 76%, 95% confidence interval (CI) 73-79%]. Adalimumab (RD 61%, 95% CI 56-67%), and ustekinumab 45 mg (RD 63%, 95% CI 59-66%) and 90 mg (RD 67%, 95% CI 60-74%) each had similar efficacy. These biologics are more effective than etanercept and all conventional treatments. Head-to-head trials indicate the superiority of adalimumab and infliximab over methotrexate (MTX), the superiority of ustekinumab over etanercept, the nonsignificant superiority of ciclosporin over MTX, and the dose-dependent efficacy of etanercept and ustekinumab. Fumaric acid is as efficacious as MTX. Safety of treatments could not be pooled due to a lack of standardization in reporting across trials. In conclusion, the qualitative and quantitative evidence is much stronger for biological interventions than for conventional treatments.

Publication types

  • Meta-Analysis
  • Review
  • Systematic Review

MeSH terms

  • Biological Factors / therapeutic use*
  • Cyclosporine / therapeutic use
  • Dermatologic Agents / therapeutic use*
  • Fumarates / therapeutic use
  • Humans
  • Methotrexate / therapeutic use
  • Psoriasis / drug therapy*
  • Randomized Controlled Trials as Topic
  • Retinoids / therapeutic use
  • Risk Factors
  • Treatment Outcome


  • Biological Factors
  • Dermatologic Agents
  • Fumarates
  • Retinoids
  • Cyclosporine
  • Methotrexate