Table 3.
Composite endpoint of disease worsening requiring acute care (primary outcome) | Composite endpoint of disease worsening requiring acute care or treatment failure (secondary outcome) | |||
---|---|---|---|---|
Odds ratio, 95% CI | P value | Odds ratio, 95% CI | P value | |
Infliximab-dyyb vs. RP infliximab | 0.50 (0.36–0.68) | < 0.01 | 0.95 (0.77–1.17) | 0.63 |
CCI (reference = 0) | 1.46 (1.14–1.85) | < 0.01 | 1.11 (0.95–1.30) | 0.19 |
Use of IBD-related acute care within prior 6 months | 2.28 (1.40–3.72) | < 0.01 | 1.93 (1.33–2.78) | < 0.01 |
Use of steroid within prior 6 monthsa | 3.29 (1.43–7.57) | < 0.01 | 2.22 (1.28–3.84) | < 0.01 |
Ulcerative colitis (vs. Crohn’s disease) | 0.93 (0.63–1.36) | 0.70 | 0.94 (0.71–1.24) | 0.64 |
Additional covariables in the conditional logistic regression included age, sex, race, smoking status, Kaiser Permanente region (KPNC vs. KPSC), length of IBD history, infliximab dose on index date, number of RP infliximab infusions within the prior 3 months, and use of aminosalicylates, immunomodulators, or biological products within prior 6 months
CCI Charlson Comorbidity Index, CI confidence interval, IBD inflammatory bowel disease, KPNC Kaiser Permanente Northern California, KPSC Kaiser Permanente Southern California, RP reference product
aUse of steroids = a cumulative of > 1800 mg prednisone dose equivalents of systemic steroid within 6 months prior to index date