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.
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.
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.
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.
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: firstname.lastname@example.org
Received January 7, 2018
Accepted March 16, 2018