Table 5

Sensitivity analyses of risk of composite cardiovascular endpoint associated with TNF antagonist use

Sensitivity analysisNo of events (N)HR95% CI
Adjudicated cardiovascular events only480.210.09 to 0.48
Shorter drug exposure period740.390.19 to 0.79
Shorter follow-up for cardiovascular deaths*720.390.19 to 0.82
Longer follow-up for cardiovascular deaths780.330.17 to 0.64
Longer follow-up interval for non-fatal cardiovascular events830.350.18 to 0.67
New drug users only240.450.13 to 1.56
RF-positive patients only410.570.22 to 1.43
Limit to 12-month follow-up370.330.14 to 0.78
Forced in baseline CDAI750.320.16 to 0.64
Exclude patients with previous cardiovascular disease670.320.15 to 0.66
Anti-TNF monotherapy830.630.27 to 1.49
Anti-TNF combination therapy830.280.14 to 0.60
Exclude patients with history of anti-TNF use680.570.22 to 1.48
Exclude person time after switching drug exposure category640.300.14 to 0.63
Maintain initial drug exposure category after drug switch640.410.19 to 0.85
  • The composite cardiovascular endpoint includes myocardial infarction (MI), transient ischaemic attack/stroke and cardiovascular-related deaths. All HR reflect fully adjusted models for each endpoint, adjusting for age, gender, smoking status, diabetes, hypertension, dyslipidaemia, previous MI or stroke, modified health assessment questionnaire score, aspirin use, naproxen use, non-selective non-steroidal anti-inflammatory drug (NSAID) use and cyclooxygenase-2 inhibitor use.

  • * Shorter follow-up interval (<90 days) after last study visit for cardiovascular death ascertainment.

  • Longer follow-up interval (no limit) after last study visit for cardiovascular death ascertainment.

  • CDAI, clinical disease activity index; RF, rheumatoid factor; TNF, tumour necrosis factor.