Ann Rheum Dis doi:10.1136/annrheumdis-2012-203102
  • Clinical and epidemiological research
  • Concise Report

The risk of gastrointestinal perforations in patients with rheumatoid arthritis treated with anti-TNF therapy: results from the BSRBR-RA

  1. on behalf of the British Society for Rheumatology Biologics Register (BSRBR) Control Centre Consortium
  1. 1Arthritis Research UK Epidemiology Unit, The University of Manchester, Manchester, UK
  2. 2Institute of Rheumatology, Prague, Czech Republic
  1. Correspondence to Dr Kimme Hyrich, Arthritis Research UK Epidemiology Unit, Centre for Musculoskeletal Research, Institute of Inflammation and Repair, The University of Manchester, Manchester Academic Health Science Centre, Room 2.800 Stopford Building, Oxford Road, Manchester, M13 9PT, UK; kimme.hyrich{at}
  • Accepted 14 April 2013
  • Published Online First 5 May 2013


Objectives To evaluate the risk of gastrointestinal perforation (GIP) in subjects with rheumatoid arthritis (RA) treated with antitumour necrosis factor (anti-TNF) therapy compared with non-biological disease-modifying antirheumatic drugs (nbDMARDs).

Methods Using data from the British Society for Rheumatology Biologics Register, we compared the incidence of GIPs between 11 881 anti-TNF-treated and 3393 nbDMARD-treated RA patients using Cox regression modelling. Hazard ratios (HRs) with confidence intervals (CI) were calculated. Adjustment was made for potential confounders including current steroid use. The study covered the time period between 2001 and 2011.

Results There were 42 (upper 20, lower 22) GI perforations: five in the nbDMARD cohort and 37 in the anti-TNF cohort. After adjustment, treatment with TNF antagonists was associated with an HR of 1.6 (95% CI 0.4 to 6.0) for all GIPs, 2.7 (95% CI 0.4 to 18.1) for lower GIPs and 0.9 (95% CI 0.1 to 5.8) for upper GIPs. Current use of steroids was the single most important predictor of GI perforation with an adjusted HR of 2.9 (95% CI 1.5 to 5.4), but this risk was confined to lower GIPs (HR 8.0, 95% CI 2.6 to 24.1).

Conclusions We have not found a statistically significant association between anti-TNF treatment and the risk of GIP.