Evidence map›Paper›PMID 40446946›Full record

SynthesisGastroenterology2025

An International Consensus on Appropriate Management of Corticosteroids in Clinical Trials in Inflammatory Bowel Disease.

Jurij Hanžel, Virginia Solitano, Sudheer Kumar Vuyyuru, Remo Panaccione, Bruce E Sands, Laurent Peyrin-Biroulet, Silvio Danese, Geert R D'Haens, Raja Atreya, Matthieu Allez and 40 more

Abstract readSystematic ReviewConsensus Statement
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Gastroenterology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–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

5 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Article
  5. Article
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

50 authors.

Jurij HanželDepartment of Gastroenterology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia; Alimentiv Inc, London, Ontario, Canada.
Virginia SolitanoDivision of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada; Division of Gastroenterology and Gastrointestinal Endoscopy, IRCCS Ospedale San Raffaele, Università Vita-Salute San Raffaele, Milan, Italy.
Sudheer Kumar VuyyuruDivision of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada.
Remo PanaccioneInflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
Bruce E SandsDr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
Laurent Peyrin-BirouletDepartment of Gastroenterology, INFINY Institute, FHU-CURE, INSERM NGERE, Nancy University Hospital, F-54500, Vandœuvre-lès-Nancy, France; Groupe Hospitalier privé Ambroise Paré-Hartmann, Paris IBD Center, 92200, Neuilly sur Seine, France; Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada.
Silvio DaneseDivision of Gastroenterology and Gastrointestinal Endoscopy, IRCCS Ospedale San Raffaele, Università Vita-Salute San Raffaele, Milan, Italy; Vita-Salute, San Raffaele University, Milan, Italy.
Geert R D'HaensDepartment of Gastroenterology, Amsterdam UMC campus AMC, Amsterdam, the Netherlands.
Raja AtreyaErlangen University Hospital, Medical Clinic 1, Friedrich-Alexander-University Erlangen-Nürnberg, Erlangen, Germany.
Matthieu AllezDepartment of Gastroenterology & Hepatology, Hôpital Saint-Louis, APHP, Paris, France.
Charles N BernsteinSection of Gastroenterology, IBD Clinical and Research Centre, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.
Peter BossuytImelda GI Clinical Research Center, Imelda General Hospital, Bonheiden, Belgium.
Brian BresslerDivision of Gastroenterology, University of British Columbia, Vancouver, British Columbia, Canada.
Robert V BryantInflammatory Bowel Disease Service, Department of Gastroenterology, The Queen Elizabeth Hospital, Woodville, South Australia, Australia.
Benjamin L CohenDepartment of Gastroenterology, Hepatology and Nutrition, Digestive Diseases Institute, Cleveland Clinic, Cleveland, Ohio.
Jean-Frederic ColombelDr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
Ferdinando D'AmicoDepartment of Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital, Milan, Italy.
Axel DignassDepartment of Medicine I, Agaplesion Markus Hospital, Goethe University, Frankfurt, Germany.
Marla DubinskyDivision of Pediatric Gastroenterology and Nutrition, Susan and Leonard Feinstein IBD Clinical Center, Icahn School of Medicine at Mount Sinai, New York, New York.
Phillip FleshnerDivision of Colorectal Surgery, Cedars Sinai Medical Center, Los Angeles, California.
Richard B GearryDepartment of Medicine, University of Otago, Christchurch, New Zealand.
Stephen B HanauerFeinberg School of Medicine, Northwestern University, Chicago, Illinois.
Ailsa L HartSt. Mark's Hospital and Academic Institute, Imperial College London, Middlesex, United Kingdom.
Maia KayalIcahn School of Medicine at Mount Sinai, New York, New York.
Torsten KucharzikDepartment of Gastroenterology, Lüneburg Hospital, Lüneburg, Germany.
Peter L LakatosMcGill University Health Centre, Montreal General Hospital, McGill University, Montreal, Quebec, Canada; Department of Internal Medicine and Oncology, Semmelweis University, Budapest, Hungary.
Edouard LouisDepartment of Gastroenterology, University Hospital CHU Liege, Liege, Belgium.
Fernando MagroDepartment of Pharmacology and Therapeutics, CINTESIS@RISE, Faculty of Medicine, University of Porto, Porto, Portugal.
Neeraj NarulaDivision of Gastroenterology, Department of Medicine, Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada.
Rupert W LeongConcord Hospital and Macquarie University Hospital, Sydney, New South Wales, Australia.
Julián PanésDepartment of Gastroenterology, Hospital Clinic Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.
Tim RaineDepartment of Gastroenterology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.
Zhihua RanDepartment of Gastroenterology, Zhou Pu Hospital affiliated to Shanghai University of Medicine & Health Sciences, Shanghai, China.
Miguel D RegueiroDepartment of Gastroenterology, Hepatology and Nutrition, Digestive Diseases Institute, Cleveland Clinic, Cleveland, Ohio.
Walter ReinischDivision of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
Siddharth SinghDivision of Gastroenterology, University of California San Diego, La Jolla, California.
A Hillary SteinhartDivision of Gastroenterology and Hepatology, Mount Sinai Hospital, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.
Simon TravisKennedy Institute and Biomedical Research Centre, University of Oxford, Oxford, United Kingdom.
Ryan C UngaroDr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
C Janneke van der WoudeDepartment of Gastroenterology & Hepatology, Erasmus Medical Center, Rotterdam, the Netherlands.
Takayuki YamamotoYokkaichi Hazu Medical Center, Department of Surgery & IBD Center, Yokkaichi, Japan.
Vineet AhujaDepartment of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.
David T RubinThe University of Chicago Medicine, Chicago, Illinois.
Parambir S DulaiFeinberg School of Medicine, Northwestern University, Chicago, Illinois.
Linda J CornfieldAlimentiv Inc, London, Ontario, Canada.
Malcolm HoganAlimentiv Inc, London, Ontario, Canada.
William J SandbornDivision of Gastroenterology, University of California San Diego, La Jolla, California.
Brian G FeaganAlimentiv Inc, London, Ontario, Canada; Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.
Vipul JairathAlimentiv Inc, London, Ontario, Canada; Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.
Christopher MaAlimentiv Inc, London, Ontario, Canada; Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada. Electronic address: christopher.ma@ucalgary.ca.

Funding

San Diego Biomedical Informatics Education & Research (SABER)T15LM011271 · NLM · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI SHAMIM NEMATI · 2012 to 2026
$9.7M
Comparative effectiveness research in Hispanic patients with inflammatory bowel diseasesR01DK135937 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Siddharth Singh · 2024 to 2026
$1.9M
NIDDK NIH HHS R01 DK135937NLM NIH HHS T15 LM011271
6 · The paper itself

Abstract

BACKGROUND &

aimsApproval of new therapies for inflammatory bowel disease (IBD) requires rigorously designed and well-executed randomized controlled trials (RCTs). Corticosteroids remain a cornerstone of IBD induction therapy, and many patients in trials are enrolled while taking corticosteroids. Despite this, approaches to corticosteroid management in RCTs have been highly heterogeneous, often differing from clinical practice. This negatively impacts patients' willingness to participate due to prolonged corticosteroid exposure and may potentially bias outcomes in the clinical trial. Our aim is to provide comprehensive standardized recommendations on key aspects of corticosteroid use in IBD clinical trials through a multiphase, international expert consensus, with a goal to help inform and standardize practice in future RCTs.

methodsThe consensus was informed by a systematic review of MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials, which determined the corticosteroid management rules used in placebo-controlled trials of advanced therapies in IBD. International expert consensus recommendations for all aspects of corticosteroid management in RCTs were then developed using a modified Delphi process with 2 rounds of survey questions and a ratification meeting.

resultsThese recommendations propose management of corticosteroids during screening, induction, and maintenance phases of pharmacologic trials in IBD and define corticosteroid-related end points. We emphasize the need for minimizing corticosteroid exposure through expedited tapering and shorter fixed-dosing periods that more closely reflect clinical care and provide recommendations for standardized definitions of corticosteroid-free remission.

conclusionsThese recommendations will serve to optimize trial design and facilitate appropriate, acceptable, and standardized RCT corticosteroid handling practices.

Indexed as

Adrenal Cortex HormonesInflammatory Bowel DiseasesRandomized Controlled Trials as TopicDelphi TechniqueHumansTreatment OutcomeAdrenal Cortex HormonesCrohn’s DiseaseDelphiSteroidsUlcerative Colitis

Identifiers

PMID40446946
PMCPMC12354294

What OpenQuestion holds

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Registered trials

None linked

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.