BACKGROUND: While indirect comparison of infliximab (IFX) and vedolizumab (VDZ) in adults with Crohn's disease (CD) or ulcerative colitis (UC) shows that IFX has better effectiveness during induction, and comparable efficacy during maintenance treatment, comparative data specific to subcutaneous (SC) IFX (i.e., CT-P13 SC) versus VDZ are limited. AIM: Pooled analysis of randomised studies to compare efficacy and safety with IFX SC and VDZ in moderate-to-severe inflammatory bowel disease. METHODS: Parallel-group, randomised studies evaluating IFX SC and VDZ in patients with moderate-to-severe CD or UC were identified. Eligible studies reported ≥ 1 prespecified outcome of interest at Week 6 (reflecting treatment during the induction phase) and/or at 1 year (Weeks 50-54; reflecting treatment during the maintenance phase). Prespecified efficacy and safety outcomes considered in this pooled analysis included the proportions of patients achieving disease-specific clinical responses, clinical remission, or discontinuing due to lack of efficacy, and the proportions of patients experiencing adverse events (AEs), serious AEs, infections, serious infections, or discontinuing due to AEs. Data from multiple studies or study arms were extracted and pooled using a random-effect model; comparative analyses were performed separately for patients with CD and UC. RESULTS: We identified three eligible CD trials and four eligible UC trials that assigned over 1200 participants per disease cohort to either IFX SC or VDZ. In patients with CD, intravenous induction therapy with IFX demonstrated better efficacy (non-overlapping 95% confidence intervals [CIs]) compared with VDZ; during the maintenance phase, IFX SC showed numerically better efficacy (overlapping 95% CIs) than VDZ. A lower proportion of IFX SC-treated patients discontinued therapy due to lack of efficacy over 1 year. In patients with UC, efficacy profiles were similar with IFX SC and VDZ during the induction and maintenance phases, and a lower proportion of IFX SC-treated patients discontinued therapy due to lack of efficacy over 1 year. In both cohorts, safety profiles for IFX SC and VDZ were generally comparable during 1 year. CONCLUSION: IFX SC demonstrated better efficacy than VDZ in patients with CD, and similar efficacy to VDZ in patients with UC; 1-year safety was comparable with IFX SC and VDZ.

Celltrion Incheon Republic of Korea

Clinical and Research Center for Inflammatory Bowel Diseases ISCARE Clinical Centre Prague Czech Republic

Department of Digestive Diseases Bellvitge University Hospital Bellvitge Biomedical Research Institute IDIBELL University of Barcelona L'Hospitalet de Llobregat Barcelona Spain

Department of Gastroenterology and Hepatology University Hospital of Saint Etienne Saint Etienne France

Department of Gastroenterology and Hepatology University Hospitals Leuven KU Leuven Leuven Belgium

Department of Gastroenterology Centre Hospitalier Régional Universitaire de Nancy Nancy France

Department of Gastroenterology Helsinki University Hospital Helsinki Finland

Department of Gastroenterology Royal Liverpool Hospital Liverpool University Hospitals NHS Foundation Trust Liverpool UK

Department of Gastroenterology University Hospital CHU of Liège Liège Belgium

Department of Internal Medicine 3 Medical University of Vienna Vienna Austria

Gastroenterology and Endoscopy University Vita Salute San Raffaele Milan Italy

IBD Center Humanitas Research Hospital Rozzano Milan Italy

Institute of Clinical Medicine University of Oslo Oslo Norway

Medical Department 1 University Hospital Erlangen Friedrich Alexander University of Erlangen Nürnberg Erlangen Germany

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