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Colectomy incidence rates in five-year data from the observational postmarketing ulcerative colitis study of originator infliximab

Panés, Julián ; Lindsay, James O. ; Teich, Niels ; Lindgren, Stefan LU ; Colombel, Jean Frédéric ; Flynn, Heather Ann ; Huyck, Susan ; Yao, Ruji ; Philip, George and Reinisch, Walter (2021) In Inflammatory Bowel Diseases 27(12). p.1963-1967
Abstract

Background: This analysis of the Observational Postmarketing Ulcerative Colitis Study examined incidence rates of colectomy in patients with ulcerative colitis who received originator infliximab (IFX) or conventional therapies (ConvRx) as per their treating physician. Methods: Cox proportional hazards models compared time to colectomy for both treatment groups. A secondary analysis examined colectomy incidence rates based on IFX exposure timing (defined by a 90-day window after the last IFX dose date). Results: Of 2239 patients with data, 1059 enrolled in IFX and 1180 enrolled in ConvRx (including 296 patients who switched to IFX). Patients in the IFX group had more severe disease at baseline vs the ConvRx group (percentage with... (More)

Background: This analysis of the Observational Postmarketing Ulcerative Colitis Study examined incidence rates of colectomy in patients with ulcerative colitis who received originator infliximab (IFX) or conventional therapies (ConvRx) as per their treating physician. Methods: Cox proportional hazards models compared time to colectomy for both treatment groups. A secondary analysis examined colectomy incidence rates based on IFX exposure timing (defined by a 90-day window after the last IFX dose date). Results: Of 2239 patients with data, 1059 enrolled in IFX and 1180 enrolled in ConvRx (including 296 patients who switched to IFX). Patients in the IFX group had more severe disease at baseline vs the ConvRx group (percentage with baseline partial Mayo score 7-9: 46.0% vs 30.5%, respectively). During 5 years of follow-up, 271 patients (12.1% of enrolled patients) had colectomy. Enrollment in the IFX group was associated with a higher risk of colectomy (hazard ratio = 3.12; 95% confidence interval, 2.25-4.34; P < 0.001) compared with enrollment in the ConvRx group. A total of 174 colectomies occurred in the IFX group, but 97 of these colectomies occurred ≥90 days after the last IFX dose date. Conclusions: Colectomy was reported at a higher rate in the IFX group than in the ConvRx group, although patients in the IFX group had more severe disease at baseline and most of the colectomies occurred after patients had been off of IFX for ≥90 days.

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author
; ; ; ; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Colectomy, Infliximab, Real-world clinical practice safety registry
in
Inflammatory Bowel Diseases
volume
27
issue
12
pages
5 pages
publisher
Oxford University Press
external identifiers
  • scopus:85121105131
  • pmid:33577644
ISSN
1078-0998
DOI
10.1093/ibd/izab026
language
English
LU publication?
yes
id
8aa7d6e1-c761-4996-92cc-7ef7befa1d37
date added to LUP
2022-01-27 12:19:19
date last changed
2024-06-01 23:57:25
@article{8aa7d6e1-c761-4996-92cc-7ef7befa1d37,
  abstract     = {{<p>Background: This analysis of the Observational Postmarketing Ulcerative Colitis Study examined incidence rates of colectomy in patients with ulcerative colitis who received originator infliximab (IFX) or conventional therapies (ConvRx) as per their treating physician. Methods: Cox proportional hazards models compared time to colectomy for both treatment groups. A secondary analysis examined colectomy incidence rates based on IFX exposure timing (defined by a 90-day window after the last IFX dose date). Results: Of 2239 patients with data, 1059 enrolled in IFX and 1180 enrolled in ConvRx (including 296 patients who switched to IFX). Patients in the IFX group had more severe disease at baseline vs the ConvRx group (percentage with baseline partial Mayo score 7-9: 46.0% vs 30.5%, respectively). During 5 years of follow-up, 271 patients (12.1% of enrolled patients) had colectomy. Enrollment in the IFX group was associated with a higher risk of colectomy (hazard ratio = 3.12; 95% confidence interval, 2.25-4.34; P &lt; 0.001) compared with enrollment in the ConvRx group. A total of 174 colectomies occurred in the IFX group, but 97 of these colectomies occurred ≥90 days after the last IFX dose date. Conclusions: Colectomy was reported at a higher rate in the IFX group than in the ConvRx group, although patients in the IFX group had more severe disease at baseline and most of the colectomies occurred after patients had been off of IFX for ≥90 days. </p>}},
  author       = {{Panés, Julián and Lindsay, James O. and Teich, Niels and Lindgren, Stefan and Colombel, Jean Frédéric and Flynn, Heather Ann and Huyck, Susan and Yao, Ruji and Philip, George and Reinisch, Walter}},
  issn         = {{1078-0998}},
  keywords     = {{Colectomy; Infliximab; Real-world clinical practice safety registry}},
  language     = {{eng}},
  number       = {{12}},
  pages        = {{1963--1967}},
  publisher    = {{Oxford University Press}},
  series       = {{Inflammatory Bowel Diseases}},
  title        = {{Colectomy incidence rates in five-year data from the observational postmarketing ulcerative colitis study of originator infliximab}},
  url          = {{http://dx.doi.org/10.1093/ibd/izab026}},
  doi          = {{10.1093/ibd/izab026}},
  volume       = {{27}},
  year         = {{2021}},
}