Abstract
Background & Aims: We compared the safety and effectiveness of tumor necrosis factor α (TNF-α) antagonists vs vedolizumab vs ustekinumab in patients with Crohn's disease (CD) in a multicenter cohort (CA-IBD). Methods: We created an electronic health record–based cohort of adult patients with CD who were initiating a new biologic agent (TNF-α antagonists, ustekinumab, vedolizumab) from 5 health systems in California between 2010 and 2017. We compared the risk of serious infections (safety) and all-cause hospitalization and inflammatory bowel disease–related surgery (effectiveness) between different biologic classes using propensity score (PS) matching. Results: As compared with TNF-α antagonists (n = 1030), 2:1 PS-matched, ustekinumab-treated patients with CD (n = 515) experienced a lower risk of serious infections (hazard ratio [HR], 0.36; 95% CI, 0.20–0.64), without any difference in the risk of hospitalization (HR, 0.99; 95% CI, 0.89–1.21) or surgery (HR, 1.08; 95% CI, 0.69–1.70). Compared with vedolizumab (n = 221), 1:1 PS-matched, ustekinumab-treated patients with CD (n = 221) experienced a lower risk of serious infections (HR, 0.20; 95% CI, 0.07–0.60), without significant differences in risk of hospitalization (HR, 0.76; 95% CI, 0.54–1.07) or surgery (HR, 1.42; 95% CI, 0.54–3.72). Compared with TNF-α antagonists (n = 442), 2:1 PS-matched, vedolizumab-treated patients with CD (n = 221) had a similar risk of serious infections (HR, 1.53; 95% CI, 0.84–2.78), hospitalization (HR, 1.32; 95% CI, 0.98–1.77), and surgery (HR, 0.63; 95% CI, 0.27–1.47). High comorbidity burden, concomitant opiate use, and prior hospitalization were associated with serious infections and hospitalization in biologic-treated patients with CD. Conclusion: In a multicenter cohort of biologic-treated patients with CD, ustekinumab was associated with a lower risk of serious infections compared with TNF-α antagonists and vedolizumab, without any differences in risk of hospitalization or surgery. The risk of serious infections was similar for TNF-α antagonists vs vedolizumab.
Original language | English (US) |
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Pages (from-to) | 2359-2369.e5 |
Journal | Clinical Gastroenterology and Hepatology |
Volume | 21 |
Issue number | 9 |
DOIs | |
State | Published - Aug 2023 |
Funding
Funding This study was funded by AbbVie. AbbVie provided suggestions on protocol, but were not involved in the study execution, data analysis, interpretation, or writing the manuscript. Also s upported by National Institute of Diabetes and Digestive and Kidney Diseases grants K23DK117058 and R03DK129631, an International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) Operating Grant, and a Litwin Pioneers in Inflammatory Bowel Disease grant (S.S.); and supported by National Institutes of Health grants R01HG011066, R01HL136835, OT2OD026552, and U24LM013755 (L.O.-M.). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Keywords
- Biologics
- Comparative Effectiveness
- Immunosuppressives
- Inflammatory Bowel Diseases
- Positioning
ASJC Scopus subject areas
- Gastroenterology
- Hepatology