Comparative Efficacy for Infliximab Vs Vedolizumab in Biologic Naive Ulcerative Colitis.


Journal

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
ISSN: 1542-7714
Titre abrégé: Clin Gastroenterol Hepatol
Pays: United States
ID NLM: 101160775

Informations de publication

Date de publication:
07 2022
Historique:
received: 27 05 2021
revised: 20 07 2021
accepted: 21 07 2021
pubmed: 31 7 2021
medline: 22 6 2022
entrez: 30 7 2021
Statut: ppublish

Résumé

Comparative effectiveness studies are needed to help position therapies for ulcerative colitis (UC). We compared the efficacy of infliximab vs vedolizumab for moderate to severe biologic-naïve UC using patient-level data from clinical trial program data sets. This was a post hoc analysis of 3 UC clinical trial programs that included data on 795 biologic-naïve UC patients. Differences in proportions of patients achieving week 6 clinical remission (CR) and response, and 1-year CR, corticosteroid-free CR, and endoscopic remission (ER), are reported. Multivariate logistic regression was used to adjust for potential confounders. As a sensitivity analysis, propensity scores were calculated and a cohort of matched participants with similar distribution of baseline covariates was created. All analyses were intention-to-treat. At week 6, comparable proportions of patients achieved clinical response and CR with infliximab vs vedolizumab (clinical response, 60.5% [138 of 228] vs 60.0% [340 of 567]; P = .884; and CR, 39.9% [91 of 228] vs 38.6% [219 of 567]; P = .736). Similar proportions of patients achieved 1-year CR with infliximab vs vedolizumab (39.9% [91 of 228] vs 38.6% [219 of 567]; adjusted odds ratio [aOR], 1.02; 95% CI, 0.74-1.40). Infliximab-treated patients had significantly higher rates of 1-year ER (36.0% [82 of 228] vs 25.6% [145 of 567]; aOR, 1.60; 95% CI, 1.12-2.28) and corticosteroid-free CR (29.5% [23 of 78] vs 15.0% [38 of 254]; aOR, 2.36; 95% CI, 1.27-4.39). Similar results were observed in the propensity score matched cohort. Although infliximab and vedolizumab have similar efficacy in clinical symptom improvement, infliximab had higher rates of 1-year corticosteroid-free CR and ER in treatment of biologic-naïve UC.

Sections du résumé

BACKGROUND & AIMS
Comparative effectiveness studies are needed to help position therapies for ulcerative colitis (UC). We compared the efficacy of infliximab vs vedolizumab for moderate to severe biologic-naïve UC using patient-level data from clinical trial program data sets.
METHODS
This was a post hoc analysis of 3 UC clinical trial programs that included data on 795 biologic-naïve UC patients. Differences in proportions of patients achieving week 6 clinical remission (CR) and response, and 1-year CR, corticosteroid-free CR, and endoscopic remission (ER), are reported. Multivariate logistic regression was used to adjust for potential confounders. As a sensitivity analysis, propensity scores were calculated and a cohort of matched participants with similar distribution of baseline covariates was created. All analyses were intention-to-treat.
RESULTS
At week 6, comparable proportions of patients achieved clinical response and CR with infliximab vs vedolizumab (clinical response, 60.5% [138 of 228] vs 60.0% [340 of 567]; P = .884; and CR, 39.9% [91 of 228] vs 38.6% [219 of 567]; P = .736). Similar proportions of patients achieved 1-year CR with infliximab vs vedolizumab (39.9% [91 of 228] vs 38.6% [219 of 567]; adjusted odds ratio [aOR], 1.02; 95% CI, 0.74-1.40). Infliximab-treated patients had significantly higher rates of 1-year ER (36.0% [82 of 228] vs 25.6% [145 of 567]; aOR, 1.60; 95% CI, 1.12-2.28) and corticosteroid-free CR (29.5% [23 of 78] vs 15.0% [38 of 254]; aOR, 2.36; 95% CI, 1.27-4.39). Similar results were observed in the propensity score matched cohort.
CONCLUSIONS
Although infliximab and vedolizumab have similar efficacy in clinical symptom improvement, infliximab had higher rates of 1-year corticosteroid-free CR and ER in treatment of biologic-naïve UC.

Identifiants

pubmed: 34329776
pii: S1542-3565(21)00820-X
doi: 10.1016/j.cgh.2021.07.038
pii:
doi:

Substances chimiques

Adrenal Cortex Hormones 0
Antibodies, Monoclonal, Humanized 0
Biological Products 0
Gastrointestinal Agents 0
vedolizumab 9RV78Q2002
Infliximab B72HH48FLU

Types de publication

Journal Article Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1588-1597.e3

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2022 AGA Institute. Published by Elsevier Inc. All rights reserved.

Auteurs

Neeraj Narula (N)

Division of Gastroenterology, Department of Medicine, Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada. Electronic address: Neeraj.narula@medportal.ca.

Emily C L Wong (ECL)

Division of Gastroenterology, Department of Medicine, Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada.

John K Marshall (JK)

Division of Gastroenterology, Department of Medicine, Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada.

Jean-Frederic Colombel (JF)

Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.

Parambir S Dulai (PS)

Division of Gastroenterology, University of California San Diego, La Jolla, California.

Walter Reinisch (W)

Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.

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Classifications MeSH