Comparative Safety and Effectiveness of Vedolizumab to Tumor Necrosis Factor Antagonist Therapy for Ulcerative Colitis

Dana Lukin; David Faleck; Ronghui Xu; Yiran Zhang; Aaron Weiss; Satimai Aniwan; Siri Kadire; Gloria Tran; Mahmoud Rahal; Adam Winters; Shreya Chablaney; Jenna L. Koliani-Pace; Joseph Meserve; James P. Campbell; Gursimran Kochhar; Matthew Bohm; Sashidhar Varma; Monika Fischer; Brigid Boland; Siddharth Singh; Robert Hirten; Ryan Ungaro; Karen Lasch; Eugenia Shmidt; Vipul Jairath; David Hudesman; Shannon Chang; Arun Swaminath; Bo Shen; Sunanda Kane; Edward V. Loftus; Bruce E. Sands; Jean Frederic Colombel; Corey A. Siegel; William J. Sandborn; Parambir S. Dulai

doi:10.1016/j.cgh.2020.10.003

Comparative Safety and Effectiveness of Vedolizumab to Tumor Necrosis Factor Antagonist Therapy for Ulcerative Colitis

Dana Lukin, David Faleck, Ronghui Xu, Yiran Zhang, Aaron Weiss, Satimai Aniwan, Siri Kadire, Gloria Tran, Mahmoud Rahal, Adam Winters, Shreya Chablaney, Jenna L. Koliani-Pace, Joseph Meserve, James P. Campbell, Gursimran Kochhar, Matthew Bohm, Sashidhar Varma, Monika Fischer, Brigid Boland, Siddharth SinghRobert Hirten, Ryan Ungaro, Karen Lasch, Eugenia Shmidt, Vipul Jairath, David Hudesman, Shannon Chang, Arun Swaminath, Bo Shen, Sunanda Kane, Edward V. Loftus, Bruce E. Sands, Jean Frederic Colombel, Corey A. Siegel, William J. Sandborn, Parambir S. Dulai

Research output: Contribution to journal › Article › peer-review

34 Scopus citations

Abstract

Background & Aims: We aimed to compare safety and effectiveness of vedolizumab to tumor necrosis factor (TNF)-antagonist therapy in ulcerative colitis in routine practice. Methods: A multicenter, retrospective, observational cohort study (May 2014 to December 2017) of ulcerative colitis patients treated with vedolizumab or TNF-antagonist therapy. Propensity score weighted comparisons for development of serious adverse events and achievement of clinical remission, steroid-free clinical remission, and steroid-free deep remission. A priori determined subgroup comparisons in TNF-antagonist–naïve and –exposed patients, and for vedolizumab against infliximab and subcutaneous TNF-antagonists separately. Results: A total of 722 (454 vedolizumab, 268 TNF antagonist) patients were included. Vedolizumab-treated patients were more likely to achieve clinical remission (hazard ratio [HR], 1.651; 95% confidence interval [CI], 1.229-2.217), steroid-free clinical remission (HR, 1.828; 95% CI, 1.135-2.944), and steroid-free deep remission (HR, 2.819; 95% CI, 1.496-5.310) than those treated with TNF antagonists. Results were consistent across subgroup analyses in TNF-antagonist–naïve and −exposed patients, and for vedolizumab vs infliximab and vs subcutaneous TNF-antagonist agents separately. Overall, there were no statistically significant differences in the risk of serious adverse events (HR, 0.899; 95% CI, 0.502-1.612) or serious infections (HR, 1.235; 95% CI, 0.608-2.511) between vedolizumab-treated and TNF-antagonist−treated patients. However, in TNF-antagonist−naïve patients, vedolizumab was less likely to be associated with serious adverse events than TNF antagonists (HR, 0.192; 95% CI, 0.049-0.754). Conclusions: Treatment of ulcerative colitis with vedolizumab is associated with higher rates of remission than treatment with TNF-antagonist therapy in routine practice, and lower rates of serious adverse events in TNF-antagonist−naïve patients.

Original language	English
Pages (from-to)	126-135
Number of pages	10
Journal	Clinical Gastroenterology and Hepatology
Volume	20
Issue number	1
DOIs	https://doi.org/10.1016/j.cgh.2020.10.003
State	Published - Jan 2022

Keywords

Biologics
Comparative Research
Health Outcomes

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10.1016/j.cgh.2020.10.003

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Lukin, D., Faleck, D., Xu, R., Zhang, Y., Weiss, A., Aniwan, S., Kadire, S., Tran, G., Rahal, M., Winters, A., Chablaney, S., Koliani-Pace, J. L., Meserve, J., Campbell, J. P., Kochhar, G., Bohm, M., Varma, S., Fischer, M., Boland, B., ... Dulai, P. S. (2022). Comparative Safety and Effectiveness of Vedolizumab to Tumor Necrosis Factor Antagonist Therapy for Ulcerative Colitis. Clinical Gastroenterology and Hepatology, 20(1), 126-135. https://doi.org/10.1016/j.cgh.2020.10.003

@article{1e90d7cb688947f1bfe847b94b5d78d1,

title = "Comparative Safety and Effectiveness of Vedolizumab to Tumor Necrosis Factor Antagonist Therapy for Ulcerative Colitis",

abstract = "Background & Aims: We aimed to compare safety and effectiveness of vedolizumab to tumor necrosis factor (TNF)-antagonist therapy in ulcerative colitis in routine practice. Methods: A multicenter, retrospective, observational cohort study (May 2014 to December 2017) of ulcerative colitis patients treated with vedolizumab or TNF-antagonist therapy. Propensity score weighted comparisons for development of serious adverse events and achievement of clinical remission, steroid-free clinical remission, and steroid-free deep remission. A priori determined subgroup comparisons in TNF-antagonist–na{\"i}ve and –exposed patients, and for vedolizumab against infliximab and subcutaneous TNF-antagonists separately. Results: A total of 722 (454 vedolizumab, 268 TNF antagonist) patients were included. Vedolizumab-treated patients were more likely to achieve clinical remission (hazard ratio [HR], 1.651; 95% confidence interval [CI], 1.229-2.217), steroid-free clinical remission (HR, 1.828; 95% CI, 1.135-2.944), and steroid-free deep remission (HR, 2.819; 95% CI, 1.496-5.310) than those treated with TNF antagonists. Results were consistent across subgroup analyses in TNF-antagonist–na{\"i}ve and −exposed patients, and for vedolizumab vs infliximab and vs subcutaneous TNF-antagonist agents separately. Overall, there were no statistically significant differences in the risk of serious adverse events (HR, 0.899; 95% CI, 0.502-1.612) or serious infections (HR, 1.235; 95% CI, 0.608-2.511) between vedolizumab-treated and TNF-antagonist−treated patients. However, in TNF-antagonist−na{\"i}ve patients, vedolizumab was less likely to be associated with serious adverse events than TNF antagonists (HR, 0.192; 95% CI, 0.049-0.754). Conclusions: Treatment of ulcerative colitis with vedolizumab is associated with higher rates of remission than treatment with TNF-antagonist therapy in routine practice, and lower rates of serious adverse events in TNF-antagonist−na{\"i}ve patients.",

keywords = "Biologics, Comparative Research, Health Outcomes",

author = "Dana Lukin and David Faleck and Ronghui Xu and Yiran Zhang and Aaron Weiss and Satimai Aniwan and Siri Kadire and Gloria Tran and Mahmoud Rahal and Adam Winters and Shreya Chablaney and Koliani-Pace, {Jenna L.} and Joseph Meserve and Campbell, {James P.} and Gursimran Kochhar and Matthew Bohm and Sashidhar Varma and Monika Fischer and Brigid Boland and Siddharth Singh and Robert Hirten and Ryan Ungaro and Karen Lasch and Eugenia Shmidt and Vipul Jairath and David Hudesman and Shannon Chang and Arun Swaminath and Bo Shen and Sunanda Kane and Loftus, {Edward V.} and Sands, {Bruce E.} and Colombel, {Jean Frederic} and Siegel, {Corey A.} and Sandborn, {William J.} and Dulai, {Parambir S.}",

note = "Publisher Copyright: {\textcopyright} 2022",

year = "2022",

month = jan,

doi = "10.1016/j.cgh.2020.10.003",

language = "English",

volume = "20",

pages = "126--135",

journal = "Clinical Gastroenterology and Hepatology",

issn = "1542-3565",

publisher = "W.B. Saunders Ltd",

number = "1",

}

Lukin, D, Faleck, D, Xu, R, Zhang, Y, Weiss, A, Aniwan, S, Kadire, S, Tran, G, Rahal, M, Winters, A, Chablaney, S, Koliani-Pace, JL, Meserve, J, Campbell, JP, Kochhar, G, Bohm, M, Varma, S, Fischer, M, Boland, B, Singh, S, Hirten, R , Ungaro, R, Lasch, K, Shmidt, E, Jairath, V, Hudesman, D, Chang, S, Swaminath, A, Shen, B, Kane, S, Loftus, EV, Sands, BE , Colombel, JF, Siegel, CA, Sandborn, WJ & Dulai, PS 2022, 'Comparative Safety and Effectiveness of Vedolizumab to Tumor Necrosis Factor Antagonist Therapy for Ulcerative Colitis', Clinical Gastroenterology and Hepatology, vol. 20, no. 1, pp. 126-135. https://doi.org/10.1016/j.cgh.2020.10.003

TY - JOUR

T1 - Comparative Safety and Effectiveness of Vedolizumab to Tumor Necrosis Factor Antagonist Therapy for Ulcerative Colitis

AU - Lukin, Dana

AU - Faleck, David

AU - Xu, Ronghui

AU - Zhang, Yiran

AU - Weiss, Aaron

AU - Aniwan, Satimai

AU - Kadire, Siri

AU - Tran, Gloria

AU - Rahal, Mahmoud

AU - Winters, Adam

AU - Chablaney, Shreya

AU - Koliani-Pace, Jenna L.

AU - Meserve, Joseph

AU - Campbell, James P.

AU - Kochhar, Gursimran

AU - Bohm, Matthew

AU - Varma, Sashidhar

AU - Fischer, Monika

AU - Boland, Brigid

AU - Singh, Siddharth

AU - Hirten, Robert

AU - Ungaro, Ryan

AU - Lasch, Karen

AU - Shmidt, Eugenia

AU - Jairath, Vipul

AU - Hudesman, David

AU - Chang, Shannon

AU - Swaminath, Arun

AU - Shen, Bo

AU - Kane, Sunanda

AU - Loftus, Edward V.

AU - Sands, Bruce E.

AU - Colombel, Jean Frederic

AU - Siegel, Corey A.

AU - Sandborn, William J.

AU - Dulai, Parambir S.

PY - 2022/1

Y1 - 2022/1

N2 - Background & Aims: We aimed to compare safety and effectiveness of vedolizumab to tumor necrosis factor (TNF)-antagonist therapy in ulcerative colitis in routine practice. Methods: A multicenter, retrospective, observational cohort study (May 2014 to December 2017) of ulcerative colitis patients treated with vedolizumab or TNF-antagonist therapy. Propensity score weighted comparisons for development of serious adverse events and achievement of clinical remission, steroid-free clinical remission, and steroid-free deep remission. A priori determined subgroup comparisons in TNF-antagonist–naïve and –exposed patients, and for vedolizumab against infliximab and subcutaneous TNF-antagonists separately. Results: A total of 722 (454 vedolizumab, 268 TNF antagonist) patients were included. Vedolizumab-treated patients were more likely to achieve clinical remission (hazard ratio [HR], 1.651; 95% confidence interval [CI], 1.229-2.217), steroid-free clinical remission (HR, 1.828; 95% CI, 1.135-2.944), and steroid-free deep remission (HR, 2.819; 95% CI, 1.496-5.310) than those treated with TNF antagonists. Results were consistent across subgroup analyses in TNF-antagonist–naïve and −exposed patients, and for vedolizumab vs infliximab and vs subcutaneous TNF-antagonist agents separately. Overall, there were no statistically significant differences in the risk of serious adverse events (HR, 0.899; 95% CI, 0.502-1.612) or serious infections (HR, 1.235; 95% CI, 0.608-2.511) between vedolizumab-treated and TNF-antagonist−treated patients. However, in TNF-antagonist−naïve patients, vedolizumab was less likely to be associated with serious adverse events than TNF antagonists (HR, 0.192; 95% CI, 0.049-0.754). Conclusions: Treatment of ulcerative colitis with vedolizumab is associated with higher rates of remission than treatment with TNF-antagonist therapy in routine practice, and lower rates of serious adverse events in TNF-antagonist−naïve patients.

AB - Background & Aims: We aimed to compare safety and effectiveness of vedolizumab to tumor necrosis factor (TNF)-antagonist therapy in ulcerative colitis in routine practice. Methods: A multicenter, retrospective, observational cohort study (May 2014 to December 2017) of ulcerative colitis patients treated with vedolizumab or TNF-antagonist therapy. Propensity score weighted comparisons for development of serious adverse events and achievement of clinical remission, steroid-free clinical remission, and steroid-free deep remission. A priori determined subgroup comparisons in TNF-antagonist–naïve and –exposed patients, and for vedolizumab against infliximab and subcutaneous TNF-antagonists separately. Results: A total of 722 (454 vedolizumab, 268 TNF antagonist) patients were included. Vedolizumab-treated patients were more likely to achieve clinical remission (hazard ratio [HR], 1.651; 95% confidence interval [CI], 1.229-2.217), steroid-free clinical remission (HR, 1.828; 95% CI, 1.135-2.944), and steroid-free deep remission (HR, 2.819; 95% CI, 1.496-5.310) than those treated with TNF antagonists. Results were consistent across subgroup analyses in TNF-antagonist–naïve and −exposed patients, and for vedolizumab vs infliximab and vs subcutaneous TNF-antagonist agents separately. Overall, there were no statistically significant differences in the risk of serious adverse events (HR, 0.899; 95% CI, 0.502-1.612) or serious infections (HR, 1.235; 95% CI, 0.608-2.511) between vedolizumab-treated and TNF-antagonist−treated patients. However, in TNF-antagonist−naïve patients, vedolizumab was less likely to be associated with serious adverse events than TNF antagonists (HR, 0.192; 95% CI, 0.049-0.754). Conclusions: Treatment of ulcerative colitis with vedolizumab is associated with higher rates of remission than treatment with TNF-antagonist therapy in routine practice, and lower rates of serious adverse events in TNF-antagonist−naïve patients.

KW - Biologics

KW - Comparative Research

KW - Health Outcomes

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U2 - 10.1016/j.cgh.2020.10.003

DO - 10.1016/j.cgh.2020.10.003

M3 - Article

C2 - 33039584

AN - SCOPUS:85100470091

SN - 1542-3565

VL - 20

SP - 126

EP - 135

JO - Clinical Gastroenterology and Hepatology

JF - Clinical Gastroenterology and Hepatology

IS - 1

ER -

Comparative Safety and Effectiveness of Vedolizumab to Tumor Necrosis Factor Antagonist Therapy for Ulcerative Colitis

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