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

Autor:	Chan W; Gastroenterology and Liver Services, Concord Repatriation General Hospital.; Department of Gastroenterology and Hepatology, Singapore General Hospital, Singapore., Lynch N; Gastroenterology and Liver Services, Concord Repatriation General Hospital., Bampton P; Department of Gastroenterology and Hepatology, Flinders Medical Centre, Bedford Park, South Australia., Chang J; Department of Gastroenterology and Hepatology, Nepean Hospital, Sydney., Chung A; Department of Gastroenterology, Box Hill Hospital, Melbourne, Victoria., Florin T; Mater Research, University of Queensland, Queensland., Hetzel DJ; Department of Gastroenterology, Royal Adelaide Hospital, Adelaide., Jakobovits S; Department of Gastroenterology, Alfred Health., Moore G; Department of Gastroenterology, Monash Health, Melbourne., Pavli P; Gastroenterology and Hepatology Unit, Canberra Hospital, Canberra, Australian Capital Territory., Radford-Smith G; Department of Gastroenterology and Hepatology, Royal Brisbane and Women's Hospital, Brisbane., Thin L; Centre for Inflammatory Bowel Diseases, Fremantle Hospital, Fremantle, Western Australia, Australia., Baraty B; Gastroenterology and Liver Services, Concord Repatriation General Hospital., Haifer C; Gastroenterology and Liver Services, Concord Repatriation General Hospital., Yau Y; Gastroenterology and Liver Services, Concord Repatriation General Hospital., Leong RWL; Gastroenterology and Liver Services, Concord Repatriation General Hospital.
Jazyk:	angličtina
Zdroj:	European journal of gastroenterology & hepatology [Eur J Gastroenterol Hepatol] 2018 Jul; Vol. 30 (7), pp. 735-740.
DOI:	10.1097/MEG.0000000000001150
Abstrakt:	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.
Databáze:	MEDLINE
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