Effectiveness and safety of vedolizumab for maintenance treatment in inflammatory bowel disease-The Israeli real world experience

Dig Liver Dis. 2019 Jan;51(1):68-74. doi: 10.1016/j.dld.2018.07.040. Epub 2018 Aug 10.

Abstract

Introduction: Several real-world experience (RWE) studies with vedolizumab (VDZ) for induction of remission in inflammatory bowel diseases (IBD) have been published; however, long-term RWE data is scarce.

Aims: To describe the effectiveness and safety of VDZ in maintenance treatment of IBD.

Methods: A multicenter retrospective national study. The primary outcome of was clinical response at week 52; main secondary aims included clinical remission at week 52, rates of secondary loss of response and treatment discontinuation.

Results: We included 193 (133-CD; 60-UC) patients from 9 Israeli IBD centers. At week 52, response was observed in 62/133 (46.7%) CD patients, including 28 (21%) in clinical remission; 71 (53.3%) discontinued treatment or did not respond. For UC, response at week 52 was observed in 27/60 (45%), including 20 (33%) in clinical remission; 33 (55%) discontinued treatment or did not respond. Secondary non-response by week 52 occurred in 19.4% and 23.5% of week 14 responders in CD and UC, respectively. Week 14 response was associated with treatment continuation at week 52: no predictors of secondary loss of response were identified.

Summary: VDZ is safe and effective for maintenance of response and remission in IBD; week 14 response is positively associated with long-term response in both UC and CD.

Keywords: Crohn’s disease; Ulcerative colitis; Vedolizumab.

Publication types

  • Multicenter Study
  • Observational Study
  • Pragmatic Clinical Trial

MeSH terms

  • Administration, Intravenous
  • Adult
  • Antibodies, Monoclonal, Humanized / administration & dosage*
  • Antibodies, Monoclonal, Humanized / adverse effects
  • Evidence-Based Medicine
  • Female
  • Gastrointestinal Agents / administration & dosage*
  • Gastrointestinal Agents / adverse effects
  • Humans
  • Inflammatory Bowel Diseases / drug therapy*
  • Israel
  • Male
  • Middle Aged
  • Proportional Hazards Models
  • Remission Induction / methods
  • Retrospective Studies
  • Statistics, Nonparametric

Substances

  • Antibodies, Monoclonal, Humanized
  • Gastrointestinal Agents
  • vedolizumab