The risk of infection and malignancy with tumor necrosis factor antagonists in adults with psoriatic disease: a systematic review and meta-analysis of randomized controlled trials

J Am Acad Dermatol. 2011 Jun;64(6):1035-50. doi: 10.1016/j.jaad.2010.09.734. Epub 2011 Feb 18.


Background: There is a need to better understand the safety of tumor necrosis factor (TNF) inhibitors in patients with psoriatic disease in whom TNF inhibitors are frequently used as monotherapy.

Objective: We sought to examine the risks of infection and malignancy with the use of TNF antagonists in adult patients with psoriatic disease.

Methods: We conducted a systematic search for trials of TNF antagonists for adults with plaque psoriasis and psoriatic arthritis. We included randomized, placebo-controlled trials of etanercept, infliximab, adalimumab, golimumab, and certolizumab for the treatment of plaque psoriasis and psoriatic arthritis. Twenty of 820 identified studies with a total of 6810 patients were included. Results were calculated using fixed effects models and reported as pooled odds ratios.

Results: Odds ratios for overall infection and serious infection over a mean of 17.8 weeks were 1.18 (95% confidence interval [CI] 1.05-1.33) and 0.70 (95% CI 0.40-1.21), respectively. When adjusting for patient-years, the incidence rate ratio for overall infection was 1.01 (95% CI 0.92-1.11). The odds ratio for malignancy was 1.48 (95% CI 0.71-3.09) and 1.26 (95% CI 0.39-4.15) when nonmelanoma skin cancer was excluded.

Limitations: Short duration of follow-up and rarity of malignancies and serious infections are limitations.

Conclusions: There is a small increased risk of overall infection with the short-term use of TNF antagonists for psoriasis that may be attributable to differences in follow-up time between treatment and placebo groups. There was no evidence of an increased risk of serious infection and a statistically significant increased risk in cancer was not observed with short-term use of TNF inhibitors.

Publication types

  • Meta-Analysis
  • Research Support, N.I.H., Extramural
  • Review
  • Systematic Review

MeSH terms

  • Adalimumab
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal / therapeutic use
  • Antibodies, Monoclonal, Humanized
  • Arthritis, Psoriatic / drug therapy*
  • Certolizumab Pegol
  • Etanercept
  • Humans
  • Immunoglobulin Fab Fragments / adverse effects
  • Immunoglobulin Fab Fragments / therapeutic use
  • Immunoglobulin G / adverse effects
  • Immunoglobulin G / therapeutic use
  • Infliximab
  • Neoplasms / chemically induced*
  • Neoplasms / epidemiology
  • Odds Ratio
  • Polyethylene Glycols / adverse effects
  • Polyethylene Glycols / therapeutic use
  • Psoriasis / drug therapy*
  • Randomized Controlled Trials as Topic
  • Receptors, Tumor Necrosis Factor / therapeutic use
  • Tumor Necrosis Factor Inhibitors*
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors


  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Immunoglobulin Fab Fragments
  • Immunoglobulin G
  • Receptors, Tumor Necrosis Factor
  • Tumor Necrosis Factor Inhibitors
  • Tumor Necrosis Factor-alpha
  • Polyethylene Glycols
  • golimumab
  • Infliximab
  • Adalimumab
  • Etanercept
  • Certolizumab Pegol