Evidence map›Paper›PMID 39032928›Full record

ArticleBMJ open2024

Switching from Dose-Intensified intravenous to SubCutaneoUS infliximab in Inflammatory Bowel Disease (DISCUS-IBD): protocol for a multicentre randomised controlled trial.

Robert D Little, Jo McKenzie, Ashish Srinivasan, Patrick Hilley, Robert B Gilmore, Desmond Chee, Manjeet Sandhu, Daniel Saitta, Elizabeth Chow, Lena Thin and 15 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Robert D LittleDepartment of Gastroenterology, Alfred Hospital, Melbourne, Victoria, Australia r.little@alfred.org.au.ORCID 0000-0002-5314-6666
Jo McKenzieDepartment of Gastroenterology, Alfred Hospital, Melbourne, Victoria, Australia.
Ashish SrinivasanDepartment of Gastroenterology, Austin Health, Melbourne, Victoria, Australia.
Patrick HilleyDepartment of Gastroenterology, Austin Health, Melbourne, Victoria, Australia.
Robert B GilmoreDepartment of Gastroenterology, Mater Hospital Brisbane, Brisbane, Queensland, Australia.
Desmond CheeGastroenterology Department, Monash Health, Melbourne, Victoria, Australia.
Manjeet SandhuGastroenterology Department, Monash Health, Melbourne, Victoria, Australia.
Daniel SaittaDepartment of Gastroenterology, Western Health, Melbourne, Victoria, Australia.
Elizabeth ChowFaculty of Medicine, Dentistry & Health Sciences, The University of Melbourne Melbourne Medical School, Melbourne, Victoria, Australia.
Lena ThinDepartment of Gastroenterology, Fiona Stanley Hospital, Perth, Western Australia, Australia.
Gareth J WalkerDepartment of Gastroenterology and Hepatology, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.
Gregory T MooreMonash University, Faculty of Medicine Nursing and Health Sciences, Clayton, Victoria, Australia.
Kate LynchDepartment of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
Jane AndrewsDepartment of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
Yoon K AnDepartment of Gastroenterology, Mater Hospital Brisbane, Brisbane, Queensland, Australia.
Robert V BryantSchool of Medicine, The University of Adelaide Faculty of Health and Medical Sciences, Adelaide, South Australia, Australia.
Susan J ConnorDepartment of Gastroenterology, Liverpool Hospital, Sydney, New South Wales, Australia.
Mayur GargFaculty of Medicine, Dentistry & Health Sciences, The University of Melbourne Melbourne Medical School, Melbourne, Victoria, Australia.
Emily K WrightFaculty of Medicine, Dentistry & Health Sciences, The University of Melbourne Melbourne Medical School, Melbourne, Victoria, Australia.
Georgina HoldMicrobiome Research Centre, University of New South Wales, Sydney, New South Wales, Australia.ORCID 0000-0001-7573-3397
Jonathan P SegalFaculty of Medicine, Dentistry & Health Sciences, The University of Melbourne Melbourne Medical School, Melbourne, Victoria, Australia.
Alex BoussioutasDepartment of Gastroenterology, Alfred Hospital, Melbourne, Victoria, Australia.
Peter De CruzDepartment of Gastroenterology, Austin Health, Melbourne, Victoria, Australia.
Mark G WardDepartment of Gastroenterology, Alfred Hospital, Melbourne, Victoria, Australia.
Miles P SparrowDepartment of Gastroenterology, Alfred Hospital, Melbourne, Victoria, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionA 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.

Indexed as

Gastrointestinal AgentsInflammatory Bowel DiseasesInfliximabAdministration, IntravenousAdultAustraliaDrug MonitoringEquivalence Trials as TopicFemaleHumansInjections, SubcutaneousMaleMulticenter Studies as TopicProspective StudiesGastrointestinal AgentsInfliximabAdult gastroenterologyClinical trialsInflammatory bowel disease

Identifiers

PMID39032928
PMCPMC11261670

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.