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

• Published in: Scandinavian journal of gastroenterology Vol. 56; no. 9; p. 1040
• Main Authors: Attauabi, Mohamed, Höglund, Camilla, Fassov, Janne, Pedersen, Kenneth Bo, Hansen, Heidi Bansholm, Wildt, Signe, Jensen, Michael Dam, Neumann, Anders, Lind, Cecilie, Jacobsen, Henrik Albaek, Popa, Ana-Maria, Kjeldsen, Jens, Pedersen, Natalia, Molazahi, Akbar, Haderslev, Kent, Aalykke, Claus, Knudsen, Torben, Cebula, Wojciech, Munkholm, Pia, Bendtsen, Flemming, Seidelin, Jakob Benedict, Burisch, Johan
• Format: Journal Article
• Language: English
• Published: England 02.09.2021
• Subjects: Aged; Antibodies, Monoclonal, Humanized - therapeutic use; Cohort Studies; Contraindications; Female; Humans; Immunotherapy; Inflammatory Bowel Diseases - drug therapy; Male; Tumor Necrosis Factor Inhibitors; Inflammatory bowel disease; real-world; vedolizumab; safety; nationwide; ulcerative colitis; first-line biologics; efficacy; population-based; Crohn’s disease; bio-naïve
• DOI: 10.1080/00365521.2021.1946588

Data from real-life populations about vedolizumab as first-line biological therapy for ulcerative colitis (UC) and Crohn's disease (CD) are emerging. To investigate the efficacy and safety of vedolizumab in bio-naïve patients with UC and CD. 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. 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 11.1%,  .01) in UC and non-structuring, non-penetrating behavior in CD (90.0 44.4%,  = .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. Vedolizumab is effective in the achievement of short-term, long-term, and steroid-free clinical remission in bio-naïve UC and CD patients.