TY - JOUR
T1 - Comparative Safety and Effectiveness of Biologic Therapy for Crohn's Disease
T2 - A CA-IBD Cohort Study
AU - Singh, Siddharth
AU - Kim, Jihoon
AU - Luo, Jiyu
AU - Paul, Paulina
AU - Rudrapatna, Vivek
AU - Park, Sunhee
AU - Zheng, Kai
AU - Syal, Gaurav
AU - Ha, Christina
AU - Fleshner, Phillip
AU - McGovern, Dermot
AU - Sauk, Jenny S.
AU - Limketkai, Berkeley
AU - Dulai, Parambir S.
AU - Boland, Brigid S.
AU - Eisenstein, Samuel
AU - Ramamoorthy, Sonia
AU - Melmed, Gil
AU - Mahadevan, Uma
AU - Sandborn, William J.
AU - Ohno-Machado, Lucila
N1 - Funding Information:
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.
Publisher Copyright:
© 2022 AGA Institute
PY - 2022
Y1 - 2022
N2 - 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.
AB - 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.
KW - Biologics
KW - Comparative Effectiveness
KW - Immunosuppressives
KW - Inflammatory Bowel Diseases
KW - Positioning
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U2 - 10.1016/j.cgh.2022.10.029
DO - 10.1016/j.cgh.2022.10.029
M3 - Article
C2 - 36343846
AN - SCOPUS:85147012806
SN - 1542-3565
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
ER -