Switching from Dose-Intensified intravenous to SubCutaneoUS infliximab in Inflammatory Bowel Disease (DISCUS-IBD): protocol for a multicentre randomised controlled trial
Jonathan P Segal,
Mayur Garg,
Miles P Sparrow,
Gareth J Walker,
Ashish Srinivasan,
Peter De Cruz,
Desmond Chee,
Alex Boussioutas,
Robert V Bryant,
Georgina Hold,
Gregory T Moore,
Susan J Connor,
Robert D Little,
Mark G Ward,
Jo McKenzie,
Patrick Hilley,
Robert B Gilmore,
Manjeet Sandhu,
Daniel Saitta,
Elizabeth Chow,
Lena Thin,
Kate Lynch,
Jane Andrews,
Yoon K An,
Emily K Wright
Affiliations
Jonathan P Segal
15 Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia
Mayur Garg
Faculty of Medicine, Dentistry & Health Sciences, The University of Melbourne Melbourne Medical School, Melbourne, Victoria, Australia
Miles P Sparrow
Department of Gastroenterology, Alfred Hospital, Melbourne, Victoria, Australia
Gareth J Walker
Department of Gastroenterology and Hepatology, Royal Brisbane and Women`s Hospital, Brisbane, Queensland, Australia
Ashish Srinivasan
Department of Gastroenterology, Austin Health, Melbourne, Victoria, Australia
Peter De Cruz
Faculty of Medicine, Dentistry & Health Sciences, The University of Melbourne Melbourne Medical School, Melbourne, Victoria, Australia
Desmond Chee
Gastroenterology Department, Monash Health, Melbourne, Victoria, Australia
Alex Boussioutas
Department of Gastroenterology, Alfred Hospital, Melbourne, Victoria, Australia
Robert V Bryant
School of Medicine, The University of Adelaide Faculty of Health and Medical Sciences, Adelaide, South Australia, Australia
Georgina Hold
Microbiome Research Centre, University of New South Wales, Sydney, New South Wales, Australia
Gregory T Moore
Monash University, Faculty of Medicine Nursing and Health Sciences, Clayton, Victoria, Australia
Susan J Connor
South West Sydney Clinical Campuses, University of New South Wales Medicine & Health, Sydney, New South Wales, Australia
Robert D Little
Department of Gastroenterology, Alfred Hospital, Melbourne, Victoria, Australia
Mark G Ward
Department of Gastroenterology, Alfred Hospital, Melbourne, Victoria, Australia
Jo McKenzie
Department of Gastroenterology, Alfred Hospital, Melbourne, Victoria, Australia
Patrick Hilley
Department of Gastroenterology, Austin Health, Melbourne, Victoria, Australia
Robert B Gilmore
Department of Gastroenterology, Mater Hospital Brisbane, Brisbane, Queensland, Australia
Manjeet Sandhu
Gastroenterology Department, Monash Health, Melbourne, Victoria, Australia
Daniel Saitta
Department of Gastroenterology, Western Health, Melbourne, Victoria, Australia
Elizabeth Chow
Faculty of Medicine, Dentistry & Health Sciences, The University of Melbourne Melbourne Medical School, Melbourne, Victoria, Australia
Lena Thin
Department of Gastroenterology, Fiona Stanley Hospital, Perth, Western Australia, Australia
Kate Lynch
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, South Australia, Australia
Jane Andrews
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, South Australia, Australia
Yoon K An
Department of Gastroenterology, Mater Hospital Brisbane, Brisbane, Queensland, Australia
Emily K Wright
Faculty of Medicine, Dentistry & Health Sciences, The University of Melbourne Melbourne Medical School, Melbourne, Victoria, Australia
Introduction A substantial proportion of patients with inflammatory bowel disease (IBD) on intravenous infliximab require dose intensification. Accessing additional intravenous infliximab is labour-intensive and expensive, depending on insurance and pharmaceutical reimbursement. Observational data suggest that subcutaneous infliximab may offer a convenient and safe alternative to maintain disease remission in patients requiring dose-intensified infliximab. A prospective, controlled trial is required to confirm that subcutaneous infliximab is as effective as dose-intensified intravenous infliximab, to identify predictors of disease flare and to establish the role of subcutaneous infliximab therapeutic drug monitoring.Methods and analysis The DISCUS-IBD trial is an investigator-initiated, prospective, multicentre, randomised, open-label non-inferiority study comparing the rate of disease flares in participants randomised to continue dose-intensified intravenous infliximab to those switched to subcutaneous infliximab after 48 weeks. Participants are adult patients with IBD in sustained corticosteroid-free remission on any regimen of dose-intensified infliximab up to a maximum of 10 mg/kg 4-weekly intravenously. Participants allocated to intravenous infliximab will continue infliximab at the same dose-intensified regimen they were receiving at study enrolment. Subcutaneous infliximab dosing will be stratified by prior intravenous infliximab dosing. Clinical (Harvey-Bradshaw Index, partial Mayo score), biochemical (C reactive protein, faecal calprotectin), pharmacokinetic (drug-level±antidrug antibodies) and qualitative data are collected 12-weekly until study conclusion at week 48. 13 sites across Australia will participate in recruitment to reach a calculated sample size of 120 participants.Ethics and dissemination Multisite ethics approval was obtained from the Health District Human Research Ethics Committee (HREC) at The Alfred Hospital under a National Mutual Acceptance (NMA) agreement (HREC/90559/Alfred-2022; Local Reference: Project 618/22, version 1.6, 2 March 2023). Findings will be reported at national and international gastroenterology meetings and published in peer-reviewed journals. DISCUS-IBD was prospectively registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR) prior to commencing recruitment.Trial registration number ACTRN12622001458729.
