Table 3

Crude incidence and risk of non-viral OI among patients who were new users of TNFI or non-biological DMARD

ExposuresEvents*Person-yearsCrude rate
(per 1000 person-years), 95% CI
Adjusted HR†
Rheumatoid arthritis
 Non-biological DMARD1371881.8 (1.1 to 3.1)1.00 (Reference)
 New users of TNFI6722 2133.0 (2.4 to 3.8)1.6 (0.9, 3.1)
 Any baseline glucocorticoid use1.7 (1.0, 2.8)
 AZA/6MP945952.0 (1.0 to 3.8)1.00 (Reference)
 New users of TNFI (infliximab or adalimumab)523152.2 (0.9 to 5.2)0.97 (0.3, 2.8)
Psoriasis, psoriatic arthritis, ankylosing spondylitis
 Non-biological DMARD539511.3 (0.5 to 3.0)1.00 (Reference)
 New users of TNFI641161.5 (0.7 to 3.2)1.4 (0.3, 6.4)
 Any baseline glucocorticoid use4.7 (1.2, 19.6)
All diseases
 Comparator2715 7341.7 (1.2 to 2.5)1.00 (Reference)
 New users of TNFI7828 4932.7 (2.2 to 3.4)1.6 (1.0, 2.6)
 Any baseline glucocorticoid use2.5 (1.5, 4.0)
  • Estimates were stratified by site and all 95% CI were based on robust SE.

  • *Two patients had two OI each documented. In analysis, only the first OI was counted as an event, totalling 78 in the table above.

  • †Adjusted by propensity score quintile and baseline glucocorticoid use 1 year before time zero (reference=no use), except for IBD model, in which inclusion of steroids produced unstable estimates.

  • ‡The model including baseline glucocorticoid use for IBD patients resulted in unstable HR estimates.

  • AZA, azathioprine; DMARD, disease-modifying anti rheumatic drug; IBD, inflammatory bowel disease; OI, opportunistic infections; TNFI, tumour necrosis factor α inhibitor; 6MP, 6 mercaptopurine.