Effectiveness and Treatment Persistence of Vedolizumab Compared to Anti-Tumour Necrosis Factor-α in Patients With Crohn's Disease: A Systematic Literature Review and Meta-Analysis

Alessandro Armuzzi; Séverine Vermeire; María Chaparro; Patricia Biedermann; Rebecca Brown; Megan McStravick; Marlies Meyer; Stefan Schreiber

doi:10.1002/ueg2.12705

Effectiveness and Treatment Persistence of Vedolizumab Compared to Anti-Tumour Necrosis Factor-α in Patients With Crohn's Disease: A Systematic Literature Review and Meta-Analysis

United European Gastroenterol J. 2024 Dec 21. doi: 10.1002/ueg2.12705. Online ahead of print.

Authors

Alessandro Armuzzi^{1

2}, Séverine Vermeire³, María Chaparro^{4

5}, Patricia Biedermann⁶, Rebecca Brown⁷, Megan McStravick⁸, Marlies Meyer⁹, Stefan Schreiber¹⁰

Affiliations

¹ IBD Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
² Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
³ Department of Gastroenterology and Hepatology, University Hospital Leuven, Leuven, Belgium.
⁴ Department of Gastroenterology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid, Madrid, Spain.
⁵ Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.
⁶ Global Medical Evidence, Takeda Pharmaceuticals International AG, Zurich, Switzerland.
⁷ Market Access Department, Putnam Associates, Newcastle upon Tyne, UK.
⁸ Real-World Evidence & Biostatistics Department, Putnam Associates, Newcastle upon Tyne, UK.
⁹ Medical affairs, Takeda Pharma AG, Zurich, Switzerland.
¹⁰ Institute of Clinical Molecular Biology and Clinic for Internal Medicine, Kiel University, Kiel, Germany.

PMID: 39707930
DOI: 10.1002/ueg2.12705

Abstract

Background: Vedolizumab is approved for the treatment of moderately to severely active Crohn's disease (CD). Real-world evidence is essential for understanding the effectiveness and benefit-risk profile of vedolizumab outside clinical trial settings.

Objective: To identify, systematically review and assess the real-world effectiveness and treatment persistence of vedolizumab in patients with CD, particularly over long-term follow-up periods and among populations with differing treatment experience, and to compare with the treatment persistence of anti-tumour necrosis factor (TNF)-α treatment.

Methods: Literature searches were conducted to identify studies published from 2014 to 2022. Relevant congress searches were conducted (2015-2022) using Embase or by hand. Data on adults with CD treated with vedolizumab or anti-TNFα treatment in a real-world setting were extracted for meta-analysis.

Results: Data from 73 studies, including 29,894 patients with CD, reported ≥ 1 outcome of interest for this analysis. Vedolizumab treatment persistence rate was 65.3% (95% confidence interval [CI] 60.2-70.1) at 1 year and 54.8% (95% CI 43.9-65.3) at 2 years. The treatment persistence rate with vedolizumab versus anti-TNFα treatment was 84.6% (95% CI 70.2-92.8) versus 75.3% (95% CI 69.7-80.2) at 1 year and 70.6% (95% CI 60.7-78.8) versus 64.6% (95% CI 56.7-71.8) at 2 years. The mucosal healing rate at 1 year was 40.6% (95% CI 34.2-47.3). Clinical remission rates were 39.4% (95% CI 33.9-45.1) at 1 year and 34.3% (95% CI 18.1-55.2) at 2 years. Corticosteroid-free clinical remission rates were 33.2% (95% CI 28.5-38.3) at 1 year and 20.4% (95% CI 12.5-31.5) at 2 years. All clinical outcome rates were higher in biologic-naive than in biologic-experienced patients.

Conclusion: Real-world use of vedolizumab was associated with favourable long-term effectiveness and treatment persistence. Vedolizumab is a suitable first-line biological option for biologic-naive patients with CD.

Keywords: Crohn's disease; adalimumab; anti‐tumour necrosis factor; certolizumab pegol; golimumab; infliximab; vedolizumab.

Grants and funding

Takeda Pharmaceuticals International AG, Zurich, Switzerland