Please use this identifier to cite or link to this item:
https://repository.monashhealth.org/monashhealthjspui/handle/1/37496
Title: | Entyvio lengthen dose-interval study: Lengthening vedolizumab dose interval and the risk of clinical relapse in inflammatory bowel disease. | Authors: | Chung A.;Moore G. ;Jakobovits S.;Hetzel D.J.;Chan W.;Lynch N.;Bampton P.;Chang J.;Florin T.;Leong R.W.L.;Yau Y.;Haifer C.;Baraty B.;Thin L.;Radford-Smith G.;Pavli P. | Institution: | (Chan, Lynch, Baraty, Haifer, Yau, Leong) Gastroenterology and Liver Services, Concord Repatriation General Hospital, Bedford-Park, SA, Australia (Bampton) Department of Gastroenterology and Hepatology, Flinders Medical Centre, Bedford-Park, SA, Australia (Chang) Department of Gastroenterology and Hepatology, Nepean Hospital, Sydney, VIC, Australia (Chung) Department of Gastroenterology, Box Hill Hospital, Melbourne, VIC, Australia (Florin) Mater Research, University of Queensland, Queensland, ACT, Australia (Hetzel) Department of Gastroenterology, Royal Adelaide Hospital, Adelaide, ACT, Australia (Jakobovits) Department of Gastroenterology, Alfred Health, Melbourne, ACT, Australia (Moore) Department of Gastroenterology, Monash Health, Melbourne, ACT, Australia (Pavli) Gastroenterology and Hepatology Unit, Canberra Hospital, Canberra, ACT, Australia (Radford-Smith) Department of Gastroenterology and Hepatology, Royal Brisbane and Women's Hospital, Brisbane, WA, Australia (Thin) Centre for Inflammatory Bowel Diseases, Fremantle Hospital, Fremantle, WA, Australia (Chan) Department of Gastroenterology and Hepatology, Singapore General Hospital, Singapore, Singapore | Issue Date: | 19-Jun-2018 | Copyright year: | 2018 | Publisher: | Lippincott Williams and Wilkins (E-mail: agents@lww.com) | Place of publication: | United Kingdom | Publication information: | European Journal of Gastroenterology and Hepatology. 30 (7) (pp 735-740), 2018. Date of Publication: 2018. | Journal: | European Journal of Gastroenterology and Hepatology | Abstract: | Background Vedolizumab (VDZ), an alpha4beta7 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.Copyright © 2018 Wolters Kluwer Health, Inc. | DOI: | http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1097/MEG.0000000000001150 | Link to associated publication: | Click here for full text options | PubMed URL: | 29727386 [http://www.ncbi.nlm.nih.gov/pubmed/?term=29727386] | ISSN: | 0954-691X | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/37496 | Type: | Article | Subjects: | long term care *inflammatory bowel disease/dt [Drug Therapy] human follow up female drug substitution diarrhea/si [Side Effect] abdominal pain/si [Side Effect] adult article body weight clinical article clinical evaluation clinical outcome combination drug therapy middle aged multicenter study multiple cycle treatment observational study priority journal rectum hemorrhage/si [Side Effect] *relapse/dt [Drug Therapy] remission retrospective study sigmoidoscopy treatment duration treatment response ulcerative colitis/dt [Drug Therapy] young adult adalimumab azathioprine/dt [Drug Therapy] calgranulin/ec [Endogenous Compound] ganciclovir/iv [Intravenous Drug Administration] immunomodulating agent infliximab methotrexate/dt [Drug Therapy] tumor necrosis factor antibody unclassified drug valganciclovir *vedolizumab/ae [Adverse Drug Reaction] *vedolizumab/do [Drug Dose] *vedolizumab/dt [Drug Therapy] *vedolizumab/iv [Intravenous Drug Administration] virus DNA/ec [Endogenous Compound] fecal calprotectin/ec [Endogenous Compound] disease activity disease duration drug exposure Crohn disease/dt [Drug Therapy] Cytomegalovirus male drug safety drug exposure drug safety drug substitution female follow up clinical outcome *inflammatory bowel disease / *drug therapy long term care male middle aged multicenter study multiple cycle treatment observational study priority journal rectum hemorrhage / side effect *relapse / *drug therapy remission retrospective study sigmoidoscopy treatment duration treatment response ulcerative colitis / drug therapy young adult clinical evaluation clinical article body weight Article adult abdominal pain / side effect human combination drug therapy Crohn disease / drug therapy Cytomegalovirus diarrhea / side effect disease activity disease duration |
Type of Clinical Study or Trial: | Observational study (cohort, case-control, cross sectional or survey) |
Appears in Collections: | Articles |
Show full item record
Items in Monash Health Research Repository are protected by copyright, with all rights reserved, unless otherwise indicated.