Vedolizumab as first-line biological therapy in elderly patients and those with contraindications for anti-TNF therapy: a real-world, nationwide cohort of patients with inflammatory bowel diseases

Mohamed Attauabi, Camilla Höglund, Janne Fassov, Kenneth Bo Pedersen, Heidi Bansholm Hansen, Signe Wildt, Michael Dam Jensen, Anders Neumann, Cecilie Lind, Henrik Albaek Jacobsen, Ana-Maria Popa, Jens Kjeldsen, Natalia Pedersen, Akbar Molazahi, Kent Haderslev, Claus Aalykke, Torben Knudsen, Wojciech Cebula, Pia Munkholm, Flemming BendtsenJakob Benedict Seidelin, Johan Burisch

2 Citations (Scopus)

Abstract

BACKGROUND: Data from real-life populations about vedolizumab as first-line biological therapy for ulcerative colitis (UC) and Crohn's disease (CD) are emerging.

OBJECTIVE: To investigate the efficacy and safety of vedolizumab in bio-naïve patients with UC and CD.

METHODS: A Danish nationwide cohort study was conducted between November 2014 and November 2019. Primary outcomes were clinical remission, steroid-free clinical remission, and sustained clinical remission from weeks 14 through 52.

RESULTS: The study included 56 patients (UC:31, CD:25) who initiated treatment with vedolizumab mainly because of contraindications to anti-TNFs, of whom 54.8 and 24.0%, respectively received systemic steroids at the initiation. Rates of clinical remission at weeks 6, 14, and 52 were 32.0, 48.0, and 40.0%, respectively, in UC, and 36.8, 36.8, and 47.4% in CD. Steroid-free clinical remission at week 52 was achieved among 36.0 and 47.4% of UC and CD patients, while sustained clinical remission was achieved in 32.0 and 36.8%. Lack of remission was associated with being female (68.8 vs. 11.1%, p = .01) in UC and non-structuring, non-penetrating behavior in CD (90.0 vs. 44.4%, p = .03); however, this was not confirmed in multivariate analysis. Discontinuation due to primary non-response occurred in 20.0 and 5.3% of UC and CD patients, respectively, while rates of secondary loss of response were 12.0 and 5.3% after 52 weeks of follow-up. Vedolizumab was well-tolerated as only one UC patient experienced a serious adverse event.

CONCLUSION: Vedolizumab is effective in the achievement of short-term, long-term, and steroid-free clinical remission in bio-naïve UC and CD patients.

Original languageEnglish
Article number1946588
JournalScandinavian Journal of Gastroenterology
Volume56
Issue number9
Pages (from-to)1040-1048
Number of pages9
ISSN0036-5521
DOIs
Publication statusPublished - Sep 2021

Keywords

  • Crohn's disease
  • Inflammatory bowel disease
  • bio-naive
  • efficacy
  • first-line biologics
  • nationwide
  • population-based
  • real-world
  • safety
  • ulcerative colitis
  • vedolizumab
  • bio-naïve
  • Crohn’s disease

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