Long-term effectiveness of vedolizumab in inflammatory bowel disease : a national study based on the Swedish National Quality Registry for Inflammatory Bowel Disease (SWIBREG)
(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)
- author
- organization
- publishing date
- 2017-03-30
- 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
- pmid:28362144
- 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
- 2024-09-30 01:10:52
@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 <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.</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}}, keywords = {{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}}, doi = {{10.1080/00365521.2017.1304987}}, volume = {{52}}, year = {{2017}}, }