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 Sandborn; Lucila Ohno-Machado

doi:10.1016/j.cgh.2022.10.029

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

Clin Gastroenterol Hepatol. 2023 Aug;21(9):2359-2369.e5. doi: 10.1016/j.cgh.2022.10.029. Epub 2022 Nov 5.

Authors

Siddharth Singh¹, Jihoon Kim², Jiyu Luo³, Paulina Paul², Vivek Rudrapatna⁴, Sunhee Park⁵, Kai Zheng⁶, Gaurav Syal⁷, Christina Ha⁸, Phillip Fleshner⁹, Dermot McGovern⁷, Jenny S Sauk¹⁰, Berkeley Limketkai¹⁰, Parambir S Dulai¹¹, Brigid S Boland¹², Samuel Eisenstein¹³, Sonia Ramamoorthy¹³, Gil Melmed⁷, Uma Mahadevan⁴, William J Sandborn¹², Lucila Ohno-Machado²

Affiliations

¹ Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California; Division of Biomedical Informatics, Department of Medicine, University of California San Diego, La Jolla, California. Electronic address: sis040@ucsd.edu.
² Division of Biomedical Informatics, Department of Medicine, University of California San Diego, La Jolla, California.
³ Division of Biostatistics and Bioinformatics, Department of Family Medicine and Public Health, University of California San Diego, La Jolla, California.
⁴ Division of Gastroenterology, Department of Medicine, University of California San Francisco, California.
⁵ Division of Gastroenterology, Department of Medicine, University of California Irvine, Orange, California.
⁶ Department of Informatics, Donald Bren School of Information and Computer Sciences, University of California Irvine, Orange, California.
⁷ Karsh Division of Gastroenterology and Hepatology, Department of Medicine, Cedars-Sinai Medical System, Los Angeles, California.
⁸ Division of Gastroenterology, Department of Medicine, Mayo Clinic, Scottsdale, Arizona.
⁹ Division of Colorectal Surgery, Department of Surgery, Cedars-Sinai Medical System, Los Angeles, California.
¹⁰ Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, University of California Los Angeles, Los Angeles, California.
¹¹ Division of Gastroenterology, Department of Medicine, Northwestern University, Chicago, Illinois.
¹² Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California.
¹³ Division of Colon and Rectal Surgery, Department of Surgery, University of California San Diego, La Jolla, California.

PMID: 36343846
DOI: 10.1016/j.cgh.2022.10.029

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.

Keywords: Biologics; Comparative Effectiveness; Immunosuppressives; Inflammatory Bowel Diseases; Positioning.

Publication types

Multicenter Study
Research Support, Non-U.S. Gov't
Research Support, N.I.H., Extramural

MeSH terms

Adult
Biological Products* / adverse effects
Biological Therapy / adverse effects
Cohort Studies
Crohn Disease* / drug therapy
Crohn Disease* / surgery
Humans
Inflammatory Bowel Diseases* / chemically induced
Retrospective Studies
Treatment Outcome
Tumor Necrosis Factor Inhibitors
Tumor Necrosis Factor-alpha
Ustekinumab / adverse effects

Substances

Ustekinumab
Tumor Necrosis Factor-alpha
Tumor Necrosis Factor Inhibitors
Biological Products

Abstract

Publication types

MeSH terms

Substances

Grants and funding