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Long-term effectiveness of vedolizumab in inflammatory bowel disease: a national study based on the Swedish National Quality Registry for Inflammatory Bowel Disease (SWIBREG)
Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Gastroenterology, Faculty of Medicine and Health, Örebro university, Örebro, Sweden.ORCID iD: 0000-0002-1046-383X
Immunology Section, Lund University, Lund, Sweden; Department of Gastroenterology, Skåne University Hospital, Lund, Sweden.
Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.ORCID iD: 0000-0002-1906-0746
Department of Internal Medicine, Ystad Hospital, Ystad, Sweden.
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2017 (English)In: Scandinavian Journal of Gastroenterology, ISSN 0036-5521, E-ISSN 1502-7708, Vol. 52, no 6-7, p. 722-729Article in journal (Refereed) Published
Abstract [en]

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 (147CD, 92 UC and 7 IBD-Unclassified) were included. On study entry, 86% had failed TNF-antagonist and 48% of the CD patients had undergone1 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.

Place, publisher, year, edition, pages
Taylor & Francis, 2017. Vol. 52, no 6-7, p. 722-729
Keyword [en]
Vedolizumab, clinical practice, inflammatory bowel disease, Crohn's disease, ulcerative colitis
National Category
Gastroenterology and Hepatology
Identifiers
URN: urn:nbn:se:oru:diva-57787DOI: 10.1080/00365521.2017.1304987ISI: 000399808100018PubMedID: 28362144Scopus ID: 2-s2.0-85018512957OAI: oai:DiVA.org:oru-57787DiVA, id: diva2:1097857
Note

Funding Agencies:

Swedish Government  OLL-549221  OLL-526131  ALFSKANE-539811 

Hedlund Foundation  

Österlund Foundation  

Available from: 2017-05-23 Created: 2017-05-23 Last updated: 2018-04-19Bibliographically approved
In thesis
1. Epidemiological and therapeutic aspects of Inflammatory Bowel Disease
Open this publication in new window or tab >>Epidemiological and therapeutic aspects of Inflammatory Bowel Disease
2018 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Introduction: The two main forms of inflammatory bowel disease (IBD) are Crohn’s disease and ulcerative colitis. These are chronic inflammatory disorders, mainly affecting the gastrointestinal tract.

Aims: The overall aims of this thesis were to study the epidemiology of ulcerative colitis in Örebro, Sweden; to examine certain aspects of anaemia in IBD; and to determine the clinical effectiveness of medical treatments.

Material and methods: Cohort studies with the sampling frame defined by the geographic boundaries of the primary catchment area of Örebro University Hospital (Papers I‒III), or by the entire IBD population in Sweden registered in the Swedish national quality registry for IBD (SWIBREG; paper IV), were performed to determine the epidemiology of ulcerative colitis, the incidence and prevalence of anaemia in IBD, and the clinical effectiveness of thiopurine drugs and vedolizumab in routine care.

Results: A fivefold increase in the incidence and a tenfold increase in the prevalence of ulcerative colitis was observed in Örebro during the past 50 years. In parallel, the prognosis, in terms of risk for colectomy within 10 years from diagnosis, improved during the same time period. Earlier and more widespread use of thiopurine drugs may have contributed to the decrease in colectomies. Anaemia is common in IBD, particularly in Crohn’s disease. Vedolizumab, a new drug targeting leucocyte migration to the gut, appears to be well tolerated and effective in Swedish real-world IBD care.

Conclusion: Ulcerative colitis is on the rise, and data from Örebro indicate that the number of IBD patients in Sweden already exceeds 70,000. Improved knowledge of long-term outcomes of medical therapy may have far-reaching implications for future IBD management.

Place, publisher, year, edition, pages
Örebro: Örebro University, 2018. p. 99
Series
Örebro Studies in Medicine, ISSN 1652-4063 ; 178
Keyword
Inflammatory bowel disease, ulcerative colitis, Crohn’s disease, cohort study, population-based, colectomy, disease course, anaemia, azathioprine, 6-mercaptopurine, vedolizumab
National Category
General Practice Gastroenterology and Hepatology
Identifiers
urn:nbn:se:oru:diva-65419 (URN)978-91-7529-242-7 (ISBN)
Public defence
2018-05-09, Örebro universitet, Campus USÖ, hörsal C2, Södra Grev Rosengatan 32, Örebro, 09:15 (Swedish)
Opponent
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Available from: 2018-03-02 Created: 2018-03-02 Last updated: 2018-04-20Bibliographically approved

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Eriksson, CarlBergemalm, DanielCao, YangLudvigsson, Jonas F.Halfvarson, Jonas

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