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Clinical effectiveness of golimumab in ulcerative colitis : a prospective multicentre study based on the Swedish IBD Quality Register, SWIBREG

Eriksson, Carl ; Visuri, Isabella ; Vigren, Lina LU ; Nilsson, Linda LU ; Kärnell, Anders ; Hjortswang, Henrik ; Bergemalm, Daniel ; Almer, Sven LU ; Hertervig, Erik LU and Karlén, Per , et al. (2021) In Scandinavian Journal of Gastroenterology 56(11). p.1304-1311
Abstract

Objectives: Clinical trials demonstrated that golimumab is effective in anti-TNF naïve patients with ulcerative colitis. We aimed to assess the clinical effectiveness of golimumab in a real-world setting. Materials and methods: This was a prospective cohort study, conducted at 16 Swedish hospitals. Data were collected using an electronic case report form. Patients with active ulcerative colitis, defined as Mayo endoscopic subscore ≥2 were eligible for inclusion. The primary outcomes were clinical effectiveness at 12 weeks and 52 weeks, i.e. response (defined as a decrease in Mayo score by ≥3 points or 30% from baseline) and remission (defined as a Mayo score of ≤2 with no individual subscores >1). Results: Fifty patients were... (More)

Objectives: Clinical trials demonstrated that golimumab is effective in anti-TNF naïve patients with ulcerative colitis. We aimed to assess the clinical effectiveness of golimumab in a real-world setting. Materials and methods: This was a prospective cohort study, conducted at 16 Swedish hospitals. Data were collected using an electronic case report form. Patients with active ulcerative colitis, defined as Mayo endoscopic subscore ≥2 were eligible for inclusion. The primary outcomes were clinical effectiveness at 12 weeks and 52 weeks, i.e. response (defined as a decrease in Mayo score by ≥3 points or 30% from baseline) and remission (defined as a Mayo score of ≤2 with no individual subscores >1). Results: Fifty patients were included. At study entry, 70% were previously exposed to anti-TNF, 16% to vedolizumab, and 96% to immunomodulators. The 12 and 52-week drug continuation rates were 37/50 (74%) and 23/50 (46%), respectively. The 12-week response rate was 14/50 (28%), the remission rate, 8/50 (16%) and the corresponding figures at week 52 were 13/50 (26%) and 10/50 (20%). Among patients who continued golimumab, the median Mayo score decreased from 7 (6–9) at baseline to 1 (0–5) at 52 weeks (p <.01) and the faecal calprotectin decreased from 862 (335–1759) µg/g to 90 (34–169) µg/g (p <.01). Clinical response at week 12 was highly predictive of clinical remission at week 52 (adjusted OR: 73.1; 95% CI: 4.5‒1188.9). Conclusions: The majority of golimumab treated patients represented a treatment refractory patient-group. Despite this, our results confirm that golimumab is an effective therapy in ulcerative colitis.

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contributor
Bark, Lars Åke ; LU and Thörn, Mari
author collaboration
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
clinical effectiveness, Golimumab, inflammatory bowel disease, ulcerative colitis
in
Scandinavian Journal of Gastroenterology
volume
56
issue
11
pages
1304 - 1311
publisher
Taylor & Francis
external identifiers
  • pmid:34415803
  • scopus:85113310015
ISSN
0036-5521
DOI
10.1080/00365521.2021.1963466
language
English
LU publication?
yes
additional info
Publisher Copyright: © 2021 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
id
ff31f61b-b5b9-4838-8af5-bf7ea0aa044c
date added to LUP
2021-10-13 07:41:53
date last changed
2022-08-12 00:41:36
@article{ff31f61b-b5b9-4838-8af5-bf7ea0aa044c,
  abstract     = {{<p>Objectives: Clinical trials demonstrated that golimumab is effective in anti-TNF naïve patients with ulcerative colitis. We aimed to assess the clinical effectiveness of golimumab in a real-world setting. Materials and methods: This was a prospective cohort study, conducted at 16 Swedish hospitals. Data were collected using an electronic case report form. Patients with active ulcerative colitis, defined as Mayo endoscopic subscore ≥2 were eligible for inclusion. The primary outcomes were clinical effectiveness at 12 weeks and 52 weeks, i.e. response (defined as a decrease in Mayo score by ≥3 points or 30% from baseline) and remission (defined as a Mayo score of ≤2 with no individual subscores &gt;1). Results: Fifty patients were included. At study entry, 70% were previously exposed to anti-TNF, 16% to vedolizumab, and 96% to immunomodulators. The 12 and 52-week drug continuation rates were 37/50 (74%) and 23/50 (46%), respectively. The 12-week response rate was 14/50 (28%), the remission rate, 8/50 (16%) and the corresponding figures at week 52 were 13/50 (26%) and 10/50 (20%). Among patients who continued golimumab, the median Mayo score decreased from 7 (6–9) at baseline to 1 (0–5) at 52 weeks (p &lt;.01) and the faecal calprotectin decreased from 862 (335–1759) µg/g to 90 (34–169) µg/g (p &lt;.01). Clinical response at week 12 was highly predictive of clinical remission at week 52 (adjusted OR: 73.1; 95% CI: 4.5‒1188.9). Conclusions: The majority of golimumab treated patients represented a treatment refractory patient-group. Despite this, our results confirm that golimumab is an effective therapy in ulcerative colitis.</p>}},
  author       = {{Eriksson, Carl and Visuri, Isabella and Vigren, Lina and Nilsson, Linda and Kärnell, Anders and Hjortswang, Henrik and Bergemalm, Daniel and Almer, Sven and Hertervig, Erik and Karlén, Per and Strid, Hans and Halfvarson, Jonas}},
  issn         = {{0036-5521}},
  keywords     = {{clinical effectiveness; Golimumab; inflammatory bowel disease; ulcerative colitis}},
  language     = {{eng}},
  number       = {{11}},
  pages        = {{1304--1311}},
  publisher    = {{Taylor & Francis}},
  series       = {{Scandinavian Journal of Gastroenterology}},
  title        = {{Clinical effectiveness of golimumab in ulcerative colitis : a prospective multicentre study based on the Swedish IBD Quality Register, SWIBREG}},
  url          = {{http://dx.doi.org/10.1080/00365521.2021.1963466}},
  doi          = {{10.1080/00365521.2021.1963466}},
  volume       = {{56}},
  year         = {{2021}},
}