Entyvio lengthen dose-interval study: Lengthening vedolizumab dose interval and the risk of clinical relapse in inflammatory bowel disease

Webber Chan, Nicole Lynch, Peter Bampton, Jeff Chang, Alvin Chung, Timothy Florin, David J. Hetzel, Simon Jakobovits, Gregory Moore, Paul Pavli, Graham Radford-Smith, Lena Thin, Brandon Baraty, Craig Haifer, Yunki Yau, Rupert W.L. Leong

Research output: Contribution to journalArticlepeer-review

3 Citations (Scopus)

Abstract

Background Vedolizumab (VDZ), an α4β7 anti-integrin antibody, is efficacious in the induction and maintenance of remission in ulcerative colitis (UC) and Crohn's disease (CD). In the GEMINI long-term safety study, enrolled patients received 4-weekly VDZ. Upon completion, patients were switched to 8-weekly VDZ in Australia. The clinical success rate of treatment de-escalation for patients in remission on VDZ has not been described previously. Aim To determine the proportion of patients who relapsed after switching from 4 to 8-weekly VDZ, the mean time to relapse, and the recapture rate when switching back to 8-weekly dosing. Materials and methods This was a retrospective, observational, multicenter study of patients previously recruited into GEMINI long-term safety in Australia. Data on the demographics and biochemical findings were collected. Results There were 34 patients [23 men, mean age 49.1 (±13.1) years] and their mean disease duration was 17.6 (±8.5) years. The mean 4-weekly VDZ infusion duration was 286.5 (±48.8) weeks. A total of five (15%) patients relapsed on dose-interval increase (4/17 UC, 1/17 CD) at a median duration from dose interval lengthening to flare of 14 weeks (interquartile range=6-25). Eighty percent (4/5) of patients re-entered remission following dose-interval decrease back to 4-weekly. No clinical predictors of relapse could be determined because of the small cohort size. Conclusion The risk of patients relapsing when switching from 4 to 8-weekly VDZ ∼15% and is similar between CD and UC. Dose-interval decrease recaptures 80% of patients who relapsed. Therapeutic drug monitoring of VDZ may be of clinical relevance.

Original languageEnglish
Pages (from-to)735-740
Number of pages6
JournalEuropean Journal of Gastroenterology and Hepatology
Volume30
Issue number7
DOIs
Publication statusPublished - Jul 2018
Externally publishedYes

Keywords

  • Crohn's disease
  • inflammatory bowel disease
  • relapse
  • ulcerative colitis
  • vedolizumab

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