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

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  • Mohamed Attauabi, Københavns Universitet
  • ,
  • Camilla Höglund, Syddansk Universitet
  • ,
  • Janne Fassov
  • Kenneth Bo Pedersen, Syddansk Universitet
  • ,
  • Heidi Bansholm Hansen, Københavns Universitet
  • ,
  • Signe Wildt, Københavns Universitet
  • ,
  • Michael Dam Jensen, Syddansk Universitet
  • ,
  • Anders Neumann
  • Cecilie Lind, Viborg Regional Hospital
  • ,
  • Henrik Albaek Jacobsen, Aalborg Universitet
  • ,
  • Ana-Maria Popa, Medical Department, Nykøbing Falster Hospital, Nykøbing Falster, Denmark.
  • ,
  • Jens Kjeldsen, Department of Medical Gastroenterology, Odense University Hospital (OUH)
  • ,
  • Natalia Pedersen, Slagelse Hospital Region Zealand, Slagelse
  • ,
  • Akbar Molazahi, Holbaek Hospital, Holbaek, Denmark.
  • ,
  • Kent Haderslev, Københavns Universitet
  • ,
  • Claus Aalykke, Syddansk Universitet
  • ,
  • Torben Knudsen, Syddansk Universitet
  • ,
  • Wojciech Cebula, Medical Department, Nykøbing Falster Hospital, Nykøbing Falster, Denmark.
  • ,
  • Pia Munkholm, Københavns Universitet
  • ,
  • Flemming Bendtsen, Københavns Universitet
  • ,
  • Jakob Benedict Seidelin, Københavns Universitet
  • ,
  • Johan Burisch, Københavns Universitet

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.

OriginalsprogEngelsk
TidsskriftScandinavian Journal of Gastroenterology
Vol/bind56
Nummer9
Sider (fra-til)1040-1048
Antal sider9
ISSN0036-5521
DOI
StatusUdgivet - sep. 2021

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