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

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

Medicine, Gastroenterology Division

Research output: Contribution to journal › Article › peer-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 language	English (US)
Pages (from-to)	2359-2369.e5
Journal	Clinical Gastroenterology and Hepatology
Volume	21
Issue number	9
DOIs	https://doi.org/10.1016/j.cgh.2022.10.029
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

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.cgh.2022.10.029

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Singh, S., Kim, J., Luo, J., Paul, P., Rudrapatna, V., Park, S., Zheng, K., Syal, G., Ha, C., Fleshner, P., McGovern, D., Sauk, J. S., Limketkai, B., Dulai, P. S., Boland, B. S., Eisenstein, S., Ramamoorthy, S., Melmed, G., Mahadevan, U., ... Ohno-Machado, L. (2023). Comparative Safety and Effectiveness of Biologic Therapy for Crohn's Disease: A CA-IBD Cohort Study. Clinical Gastroenterology and Hepatology, 21(9), 2359-2369.e5. https://doi.org/10.1016/j.cgh.2022.10.029

@article{29a51ae9dbc74b98bdcc388bc0ccc6bb,

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

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",

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

note = "Publisher Copyright: {\textcopyright} 2023 AGA Institute",

year = "2023",

month = aug,

doi = "10.1016/j.cgh.2022.10.029",

language = "English (US)",

volume = "21",

pages = "2359--2369.e5",

journal = "Clinical Gastroenterology and Hepatology",

issn = "1542-3565",

publisher = "W.B. Saunders",

number = "9",

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Singh, S, Kim, J, Luo, J, Paul, P, Rudrapatna, V, Park, S, Zheng, K, Syal, G, Ha, C, Fleshner, P, McGovern, D, Sauk, JS, Limketkai, B, Dulai, PS, Boland, BS, Eisenstein, S, Ramamoorthy, S, Melmed, G, Mahadevan, U, Sandborn, WJ & Ohno-Machado, L 2023, 'Comparative Safety and Effectiveness of Biologic Therapy for Crohn's Disease: A CA-IBD Cohort Study', Clinical Gastroenterology and Hepatology, vol. 21, no. 9, pp. 2359-2369.e5. https://doi.org/10.1016/j.cgh.2022.10.029

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

PY - 2023/8

Y1 - 2023/8

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

UR - http://www.scopus.com/inward/record.url?scp=85147012806&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85147012806&partnerID=8YFLogxK

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

VL - 21

SP - 2359-2369.e5

JO - Clinical Gastroenterology and Hepatology

JF - Clinical Gastroenterology and Hepatology

IS - 9

ER -

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

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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