Short and long-term effectiveness and safety of vedolizumab in inflammatory bowel disease: results from the ENEIDA registry

Aliment Pharmacol Ther. 2018 Oct;48(8):839-851. doi: 10.1111/apt.14930.

Abstract

Background: Effectiveness of vedolizumab in real world clinical practice is unknown.

Aim: To evaluate the short and long-term effectiveness of vedolizumab in patients with inflammatory bowel disease (IBD).

Methods: Patients who received at least 1 induction dose of vedolizumab were included. Effectiveness was defined based on Harvey-Bradshaw index (HBI) in Crohn's disease (CD) and Partial Mayo Score (PMS) in ulcerative colitis (UC). Short-term response was assessed at week 14. Variables associated with short-term remission were identified by logistic regression analysis. The Kaplan-Meier method was used to evaluate the long-term durability of vedolizumab treatment. Cox model was used to identify factors associated with discontinuation of treatment and loss of response.

Results: 521 patients were included (median follow-up 10 months [interquartile range 5-18 months]). At week 14, 46.8% had remission and 15.7% clinical response. CD (vs UC), previous surgery, higher CRP concentration and disease severity at baseline were significantly associated with impaired response. The rate of vedolizumab discontinuation was 37% per patient-year of follow-up (27.6% in UC and 45.3% in CD, P < 0.01). CD (vs UC), anaemia at baseline, steroids during induction and CRP concentration were associated with lower durability of treatment. Seven per cent of patients developed adverse events, infections being the most frequent.

Conclusions: Over 60% of IBD patients respond to vedolizumab. Many patients discontinue treatment over time. CD and disease burden impair both short- and long-term response. Vedolizumab seems to be safe in clinical practice.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antibodies, Monoclonal, Humanized / adverse effects
  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Colitis, Ulcerative / diagnosis
  • Colitis, Ulcerative / drug therapy
  • Colitis, Ulcerative / epidemiology
  • Communicable Diseases / chemically induced
  • Communicable Diseases / diagnosis
  • Communicable Diseases / epidemiology
  • Crohn Disease / diagnosis
  • Crohn Disease / drug therapy
  • Crohn Disease / epidemiology
  • Female
  • Follow-Up Studies
  • Gastrointestinal Agents / adverse effects
  • Gastrointestinal Agents / therapeutic use*
  • Humans
  • Inflammatory Bowel Diseases / diagnosis*
  • Inflammatory Bowel Diseases / drug therapy*
  • Inflammatory Bowel Diseases / epidemiology
  • Male
  • Middle Aged
  • Prospective Studies
  • Registries*
  • Remission Induction
  • Spain / epidemiology
  • Treatment Outcome

Substances

  • Antibodies, Monoclonal, Humanized
  • Gastrointestinal Agents
  • vedolizumab