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

Chan, Webbera,l; Lynch, Nicolea; Bampton, Peterb; Chang, Jeffc; Chung, Alvind; Florin, Timothye; Hetzel, David, J.f; Jakobovits, Simong; Moore, Gregoryh; Pavli, Pauli; Radford-Smith, Grahamj; Thin, Lenak; Baraty, Brandona; Haifer, Craiga; Yau, Yunkia; Leong, Rupert, W.L.a

European Journal of Gastroenterology & Hepatology: July 2018 - Volume 30 - Issue 7 - p 735–740
doi: 10.1097/MEG.0000000000001150
Original Article: Gastroenterology

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.

aGastroenterology and Liver Services, Concord Repatriation General Hospital

bDepartment of Gastroenterology and Hepatology, Flinders Medical Centre, Bedford Park, South Australia

cDepartment of Gastroenterology and Hepatology, Nepean Hospital, Sydney

dDepartment of Gastroenterology, Box Hill Hospital, Melbourne, Victoria

eMater Research, University of Queensland, Queensland

fDepartment of Gastroenterology, Royal Adelaide Hospital, Adelaide

gDepartment of Gastroenterology, Alfred Health

hDepartment of Gastroenterology, Monash Health, Melbourne

iGastroenterology and Hepatology Unit, Canberra Hospital, Canberra, Australian Capital Territory

jDepartment of Gastroenterology and Hepatology, Royal Brisbane and Women’s Hospital, Brisbane

kCentre for Inflammatory Bowel Diseases, Fremantle Hospital, Fremantle, Western Australia, Australia

lDepartment of Gastroenterology and Hepatology, Singapore General Hospital, Singapore

The abstract of the manuscript has been presented in the Asian Pacific Digestive Week (APDW) 2017 as ‘Best of APDW’: 23–26 September at Hong Kong.

Correspondence to Webber Chan, MBBS, MRCP(UK), Gastroenterology and Liver Services, Sydney Local Health District, Concord Hospital, Sydney 2139, Australia Tel: +65 6321 4684; fax: +61 9767 6767; e-mail: webber.chan.p.w@singhealth.com.sg

Received January 7, 2018

Accepted March 16, 2018

Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.