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. 2021 Sep;56(9):1040-1048.
doi: 10.1080/00365521.2021.1946588. Epub 2021 Jul 5.

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  1   2   3 , Camilla Höglund  4 , Janne Fassov  5 , Kenneth Bo Pedersen  6 , Heidi Bansholm Hansen  7 , Signe Wildt  8 , Michael Dam Jensen  9 , Anders Neumann  10 , Cecilie Lind  10 , Henrik Albaek Jacobsen  11 , Ana-Maria Popa  12 , Jens Kjeldsen  13 , Natalia Pedersen  14 , Akbar Molazahi  15 , Kent Haderslev  16 , Claus Aalykke  4 , Torben Knudsen  6 , Wojciech Cebula  12 , Pia Munkholm  7 , Flemming Bendtsen  1   2 , Jakob Benedict Seidelin  3 , Johan Burisch  1   2
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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 et al. Scand J Gastroenterol. 2021 Sep.

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.

Keywords: Crohn’s disease; Inflammatory bowel disease; bio-naïve; efficacy; first-line biologics; nationwide; population-based; real-world; safety; ulcerative colitis; vedolizumab.

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