Table 3

Crude incidence rates of and hazard ratios for gastrointestinal perforations in nbDMARD and anti-TNF-treated patients (on drug+90 days analysis)

 DMARDAnti-TNFEtanerceptInfliximabAdalimumab
N=3393N=11 881N=4129N=3483N=4269
Exposure (person years)13 16851 74822 51812 51616 713
All GI perforations
 N53719810
 Rate per 100 000 person years (95% CI)38 (12 to 89)72 (50 to 99)84 (51 to 132)64 (28 to 126)60 (29 to 110)
 Unadjusted HR (95% CI)Referent2.0 (0.8 to 5.0)2.4 (0.9 to 6.4)1.7 (0.6 to 5.3)1.6 (0.5 to 4.7)
 Adjusted HR (95% CI)*Referent1.6 (0.4 to 6.0)1.8 (0.5 to 7.5)1.4 (0.3 to 6.0)1.4 (0.3 to 5.8)
Lower GI perforations
 N2201235
 Rate per 100 000 person years (95% CI)15 (2 to 55)39 (24 to 60)53 (28 to 93)24 (5 to 70)30 (10 to 70)
 Unadjusted HR (95% CI)Referent2.7 (0.6 to 11.7)4.0 (0.9 to 17.7)1.7 (0.3 to 9.9)2.0 (0.4 to 10.5)
 Adjusted HR (95% CI)*Referent2.7 (0.4 to 18.1)3.9 (0.6 to 27.3)1.6 (0.2 to 14.5)2.2 (0.3 to 17.0)
Upper GI perforations
 N317755
 Rate per 100 000 person years (95% CI)23 (5 to 67)33 (19 to 53)31 (13 to 64)40 (13 to 93)30 (10 to 70)
 Unadjusted HR (95% CI)Referent1.4 (0.4 to 4.9)1.4 (0.4 to 5.4)1.7 (0.7 to 5.3)1.3 (0.3 to 5.4)
 Adjusted HR (95% CI)*Referent0.9 (0.1 to 5.8)0.8 (0.1 to 5.9)1.0 (0.1 to 7.9)0.9 (0.1 to 6.3)
  • *Adjusted for 10 strata of propensity score for anti-TNF treatment and for current steroid use.

  • Anti-TNF, antitumour necrosis factor; GI, gastrointestinal; nbDMARD, non-biological disease-modifying antirheumatic drug.