Entyvio lengthen dose-interval study

Lengthening vedolizumab dose interval and the risk of clinical relapse in inflammatory bowel disease

Webber Chan, Nicole Lynch, Peter A Bampton, Jeff Chang, Alvin Ru Tien Chung, Timothy Florin, David Hetzel, Simon Jakobovits, Gregory Thomas Charles Moore, Paul Pavli, Graham Radford-Smith, Lena Thin, Brandon Baraty, Craig Haifer, Yunk Yau, Rupert Wing Loong Leong

Research output: Contribution to journalArticleResearchpeer-review

1 Citation (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

Cite this

Chan, Webber ; Lynch, Nicole ; Bampton, Peter A ; Chang, Jeff ; Chung, Alvin Ru Tien ; Florin, Timothy ; Hetzel, David ; Jakobovits, Simon ; Moore, Gregory Thomas Charles ; Pavli, Paul ; Radford-Smith, Graham ; Thin, Lena ; Baraty, Brandon ; Haifer, Craig ; Yau, Yunk ; Leong, Rupert Wing Loong. / Entyvio lengthen dose-interval study : Lengthening vedolizumab dose interval and the risk of clinical relapse in inflammatory bowel disease. In: European Journal of Gastroenterology and Hepatology. 2018 ; Vol. 30, No. 7. pp. 735–740.
@article{c42fd9440cfb4265bd6c7bae2726de7b,
title = "Entyvio lengthen dose-interval study: Lengthening vedolizumab dose interval and the risk of clinical relapse in inflammatory bowel disease",
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.",
keywords = "Crohn's disease, inflammatory bowel disease, relapse, ulcerative colitis, vedolizumab",
author = "Webber Chan and Nicole Lynch and Bampton, {Peter A} and Jeff Chang and Chung, {Alvin Ru Tien} and Timothy Florin and David Hetzel and Simon Jakobovits and Moore, {Gregory Thomas Charles} and Paul Pavli and Graham Radford-Smith and Lena Thin and Brandon Baraty and Craig Haifer and Yunk Yau and Leong, {Rupert Wing Loong}",
year = "2018",
month = "7",
doi = "10.1097/MEG.0000000000001150",
language = "English",
volume = "30",
pages = "735–740",
journal = "European Journal of Gastroenterology and Hepatology",
issn = "0954-691X",
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Chan, W, Lynch, N, Bampton, PA, Chang, J, Chung, ART, Florin, T, Hetzel, D, Jakobovits, S, Moore, GTC, Pavli, P, Radford-Smith, G, Thin, L, Baraty, B, Haifer, C, Yau, Y & Leong, RWL 2018, 'Entyvio lengthen dose-interval study: Lengthening vedolizumab dose interval and the risk of clinical relapse in inflammatory bowel disease', European Journal of Gastroenterology and Hepatology, vol. 30, no. 7, pp. 735–740. https://doi.org/10.1097/MEG.0000000000001150

Entyvio lengthen dose-interval study : Lengthening vedolizumab dose interval and the risk of clinical relapse in inflammatory bowel disease. / Chan, Webber; Lynch, Nicole; Bampton, Peter A; Chang, Jeff; Chung, Alvin Ru Tien; Florin, Timothy; Hetzel, David; Jakobovits, Simon; Moore, Gregory Thomas Charles; Pavli, Paul; Radford-Smith, Graham; Thin, Lena; Baraty, Brandon; Haifer, Craig; Yau, Yunk; Leong, Rupert Wing Loong.

In: European Journal of Gastroenterology and Hepatology, Vol. 30, No. 7, 07.2018, p. 735–740.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Entyvio lengthen dose-interval study

T2 - Lengthening vedolizumab dose interval and the risk of clinical relapse in inflammatory bowel disease

AU - Chan, Webber

AU - Lynch, Nicole

AU - Bampton, Peter A

AU - Chang, Jeff

AU - Chung, Alvin Ru Tien

AU - Florin, Timothy

AU - Hetzel, David

AU - Jakobovits, Simon

AU - Moore, Gregory Thomas Charles

AU - Pavli, Paul

AU - Radford-Smith, Graham

AU - Thin, Lena

AU - Baraty, Brandon

AU - Haifer, Craig

AU - Yau, Yunk

AU - Leong, Rupert Wing Loong

PY - 2018/7

Y1 - 2018/7

N2 - 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.

AB - 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.

KW - Crohn's disease

KW - inflammatory bowel disease

KW - relapse

KW - ulcerative colitis

KW - vedolizumab

UR - http://www.scopus.com/inward/record.url?scp=85048210017&partnerID=8YFLogxK

U2 - 10.1097/MEG.0000000000001150

DO - 10.1097/MEG.0000000000001150

M3 - Article

VL - 30

SP - 735

EP - 740

JO - European Journal of Gastroenterology and Hepatology

JF - European Journal of Gastroenterology and Hepatology

SN - 0954-691X

IS - 7

ER -