Short-term risk of total malignancy and nonmelanoma skin cancers with certolizumab and golimumab in patients with rheumatoid arthritis: metaanalysis of randomized controlled trials

J Rheumatol. 2012 Apr;39(4):712-5. doi: 10.3899/jrheum.110982. Epub 2012 Mar 1.


Objective: To assess the risk of total malignancy and nonmelanoma skin cancers (NMSC) in patients with rheumatoid arthritis (RA) receiving certolizumab and golimumab through a metaanalysis of data from randomized control trials (RCT).

Methods: We systematically reviewed the literature up to May 2011 in Medline databases, as well as abstracts from the 2009 and 2010 annual meetings of the European League Against Rheumatism and the American College of Rheumatology. Mantel-Haenszel method was used to determine a common odds ratio (OR). Statistical heterogeneity was assessed by chi-square Q test. We selected only RCT including more than 30 RA subjects randomly assigned to an anti-tumor necrosis factor (TNF) or a nonbiological disease-modifying antirheumatic drug (DMARD) control group.

Results: The literature search identified 793 articles; 6 (2 with certolizumab and 4 with golimumab) were selected for metaanalysis. A total of 2710 patients received at least 1 dose of certolizumab or golimumab. For anti-TNF-treated patients, 18 cancers (excluding NMSC) and 9 NMSC were observed versus 4 cases of total malignancy and 3 NMSC in control groups. Metaanalysis revealed a pooled OR of 1.06 (95% CI 0.39-2.85) for risk of total malignancy and 0.69 (95% CI 0.23-2.11) for risk of NMSC with certolizumab and golimumab versus DMARD. Heterogeneity was not significant.

Conclusion: Metaanalysis of RCT of golimumab and certolizumab did not find an increased risk of total malignancy and NMSC. These results must be confirmed with longterm extension studies and registry studies, and careful monitoring remains mandatory.

Publication types

  • Meta-Analysis
  • Review

MeSH terms

  • Antibodies, Monoclonal / adverse effects*
  • Antibodies, Monoclonal, Humanized / adverse effects*
  • Carcinoma, Basal Cell / epidemiology*
  • Carcinoma, Basal Cell / immunology
  • Carcinoma, Squamous Cell / epidemiology*
  • Carcinoma, Squamous Cell / immunology
  • Certolizumab Pegol
  • Humans
  • Immunoglobulin Fab Fragments / adverse effects*
  • Polyethylene Glycols / adverse effects*
  • Skin Neoplasms / epidemiology*
  • Skin Neoplasms / immunology


  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Immunoglobulin Fab Fragments
  • Polyethylene Glycols
  • golimumab
  • Certolizumab Pegol