Advanced

Long-term effectiveness of vedolizumab in inflammatory bowel disease : a national study based on the Swedish National Quality Registry for Inflammatory Bowel Disease (SWIBREG)

Eriksson, Carl; Marsal, Jan LU ; Bergemalm, Daniel; Vigren, Lina LU ; Björk, Jan; Eberhardson, Michael; Karling, Pontus; Söderman, Charlotte; Myrelid, Pär and Cao, Yang, et al. (2017) In Scandinavian Journal of Gastroenterology 52(6-7). p.722-729
Abstract

Objectives: Clinical trials have demonstrated the efficacy of vedolizumab in inflammatory bowel disease (IBD). However, these findings may not reflect the clinical practice. Therefore, we aimed to describe a vedolizumab-treated patient population and assess long-term effectiveness. Materials and methods: Patients initiating vedolizumab between 1 June 2014 and 30 May 2015 were identified through the Swedish National Quality Registry for IBD. Prospectively collected data on treatment and disease activity were extracted. Clinical remission was defined as Patient Harvey Bradshaw index <5 in Crohn’s disease (CD) and Patient Simple Clinical Colitis Activity index <3 in ulcerative colitis (UC). Results: Two-hundred forty-six patients... (More)

Objectives: Clinical trials have demonstrated the efficacy of vedolizumab in inflammatory bowel disease (IBD). However, these findings may not reflect the clinical practice. Therefore, we aimed to describe a vedolizumab-treated patient population and assess long-term effectiveness. Materials and methods: Patients initiating vedolizumab between 1 June 2014 and 30 May 2015 were identified through the Swedish National Quality Registry for IBD. Prospectively collected data on treatment and disease activity were extracted. Clinical remission was defined as Patient Harvey Bradshaw index <5 in Crohn’s disease (CD) and Patient Simple Clinical Colitis Activity index <3 in ulcerative colitis (UC). Results: Two-hundred forty-six patients (147 CD, 92 UC and 7 IBD-Unclassified) were included. On study entry, 86% had failed TNF-antagonist and 48% of the CD patients had undergone ≥1 surgical resection. After a median follow-up of 17 (IQR: 14–20) months, 142 (58%) patients remained on vedolizumab. In total, 54% of the CD- and 64% of the UC patients were in clinical remission at the end of follow-up, with the clinical activity decreasing (p < .0001 in both groups). Faecal-calprotectin decreased in CD (p < .0001) and in UC (p = .001), whereas CRP decreased in CD (p = .002) but not in UC (p = .11). Previous anti-TNF exposure (adjusted HR: 4.03; 95% CI: 0.96–16.75) and elevated CRP at baseline (adjusted HR: 2.22; 95% CI: 1.10–4.35) seemed to be associated with discontinuation because of lack of response. Female sex was associated with termination because of intolerance (adjusted HR: 2.75; 95% CI: 1.16–6.48). Conclusion: Vedolizumab-treated patients represent a treatment-refractory group. A long-term effect can be achieved, even beyond 1 year of treatment.

(Less)
Please use this url to cite or link to this publication:
author
, et al. (More)
(Less)
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
clinical practice, Crohn’s disease, inflammatory bowel disease, ulcerative colitis, Vedolizumab
in
Scandinavian Journal of Gastroenterology
volume
52
issue
6-7
pages
722 - 729
publisher
Taylor & Francis
external identifiers
  • scopus:85018512957
  • scopus:85016559934
  • wos:000399808100018
ISSN
0036-5521
DOI
10.1080/00365521.2017.1304987
language
English
LU publication?
yes
id
9e42ba30-6534-4878-bde1-40140c44c42e
date added to LUP
2017-04-26 16:15:49
date last changed
2018-01-07 12:01:03
@article{9e42ba30-6534-4878-bde1-40140c44c42e,
  abstract     = {<p>Objectives: Clinical trials have demonstrated the efficacy of vedolizumab in inflammatory bowel disease (IBD). However, these findings may not reflect the clinical practice. Therefore, we aimed to describe a vedolizumab-treated patient population and assess long-term effectiveness. Materials and methods: Patients initiating vedolizumab between 1 June 2014 and 30 May 2015 were identified through the Swedish National Quality Registry for IBD. Prospectively collected data on treatment and disease activity were extracted. Clinical remission was defined as Patient Harvey Bradshaw index &lt;5 in Crohn’s disease (CD) and Patient Simple Clinical Colitis Activity index &lt;3 in ulcerative colitis (UC). Results: Two-hundred forty-six patients (147 CD, 92 UC and 7 IBD-Unclassified) were included. On study entry, 86% had failed TNF-antagonist and 48% of the CD patients had undergone ≥1 surgical resection. After a median follow-up of 17 (IQR: 14–20) months, 142 (58%) patients remained on vedolizumab. In total, 54% of the CD- and 64% of the UC patients were in clinical remission at the end of follow-up, with the clinical activity decreasing (p &lt; .0001 in both groups). Faecal-calprotectin decreased in CD (p &lt; .0001) and in UC (p = .001), whereas CRP decreased in CD (p = .002) but not in UC (p = .11). Previous anti-TNF exposure (adjusted HR: 4.03; 95% CI: 0.96–16.75) and elevated CRP at baseline (adjusted HR: 2.22; 95% CI: 1.10–4.35) seemed to be associated with discontinuation because of lack of response. Female sex was associated with termination because of intolerance (adjusted HR: 2.75; 95% CI: 1.16–6.48). Conclusion: Vedolizumab-treated patients represent a treatment-refractory group. A long-term effect can be achieved, even beyond 1 year of treatment.</p>},
  author       = {Eriksson, Carl and Marsal, Jan and Bergemalm, Daniel and Vigren, Lina and Björk, Jan and Eberhardson, Michael and Karling, Pontus and Söderman, Charlotte and Myrelid, Pär and Cao, Yang and Sjöberg, Daniel and Thörn, Mari and Karlén, Per and Hertervig, Erik and Strid, Hans and Ludvigsson, Jonas F. and Almer, Sven and Halfvarson, Jonas},
  issn         = {0036-5521},
  keyword      = {clinical practice,Crohn’s disease,inflammatory bowel disease,ulcerative colitis,Vedolizumab},
  language     = {eng},
  month        = {03},
  number       = {6-7},
  pages        = {722--729},
  publisher    = {Taylor & Francis},
  series       = {Scandinavian Journal of Gastroenterology},
  title        = {Long-term effectiveness of vedolizumab in inflammatory bowel disease : a national study based on the Swedish National Quality Registry for Inflammatory Bowel Disease (SWIBREG)},
  url          = {http://dx.doi.org/10.1080/00365521.2017.1304987},
  volume       = {52},
  year         = {2017},
}