Sensitivity analyses of risk of composite cardiovascular endpoint associated with TNF antagonist use
| Sensitivity analysis | No of events (N) | HR | 95% CI |
|---|---|---|---|
| Adjudicated cardiovascular events only | 48 | 0.21 | 0.09 to 0.48 |
| Shorter drug exposure period | 74 | 0.39 | 0.19 to 0.79 |
| Shorter follow-up for cardiovascular deaths* | 72 | 0.39 | 0.19 to 0.82 |
| Longer follow-up for cardiovascular deaths† | 78 | 0.33 | 0.17 to 0.64 |
| Longer follow-up interval for non-fatal cardiovascular events | 83 | 0.35 | 0.18 to 0.67 |
| New drug users only | 24 | 0.45 | 0.13 to 1.56 |
| RF-positive patients only | 41 | 0.57 | 0.22 to 1.43 |
| Limit to 12-month follow-up | 37 | 0.33 | 0.14 to 0.78 |
| Forced in baseline CDAI | 75 | 0.32 | 0.16 to 0.64 |
| Exclude patients with previous cardiovascular disease | 67 | 0.32 | 0.15 to 0.66 |
| Anti-TNF monotherapy | 83 | 0.63 | 0.27 to 1.49 |
| Anti-TNF combination therapy | 83 | 0.28 | 0.14 to 0.60 |
| Exclude patients with history of anti-TNF use | 68 | 0.57 | 0.22 to 1.48 |
| Exclude person time after switching drug exposure category | 64 | 0.30 | 0.14 to 0.63 |
| Maintain initial drug exposure category after drug switch | 64 | 0.41 | 0.19 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.