Comparative Safety and Effectiveness of Biologic Therapy for Crohn's Disease: A CA-IBD Cohort Study

Siddharth Singh*, Jihoon Kim, Jiyu Luo, Paulina Paul, Vivek Rudrapatna, Sunhee Park, Kai Zheng, Gaurav Syal, Christina Ha, Phillip Fleshner, Dermot McGovern, Jenny S. Sauk, Berkeley Limketkai, Parambir S. Dulai, Brigid S. Boland, Samuel Eisenstein, Sonia Ramamoorthy, Gil Melmed, Uma Mahadevan, William J. SandbornLucila Ohno-Machado

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

25 Scopus citations

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 languageEnglish (US)
Pages (from-to)2359-2369.e5
JournalClinical Gastroenterology and Hepatology
Volume21
Issue number9
DOIs
StatePublished - 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

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