IOIBD Recommendations for Clinical Trials in Ulcerative Proctitis: The PROCTRIAL Consensus.

Adult Humans Colitis, Ulcerative / therapy Quality of Life Crohn Disease / drug therapy Endoscopy Proctitis / diagnosis
Consensus Definition Endpoint Ulcerative Proctitis

Journal

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
ISSN: 1542-7714
Titre abrégé: Clin Gastroenterol Hepatol
Pays: United States
ID NLM: 101160775

Informations de publication

Date de publication:
11 2022
Historique:
received: 20 01 2022
accepted: 07 02 2022
pubmed: 22 2 2022
medline: 2 11 2022
entrez: 21 2 2022
Statut: ppublish

Résumé

Clinical trials evaluating biologics and small molecules in patients with ulcerative colitis are predominantly excluding ulcerative proctitis. The objective of the Definition and endpoints for ulcerative PROCtitis in clinical TRIALs initiative was to develop consensus statements for definitions, inclusion criteria, and endpoints for the evaluation of ulcerative proctitis in adults. Thirty-five international experts held a consensus meeting to define ulcerative proctitis, and the endpoints to use in clinical trials. Based on a systematic review of the literature, statements were generated, discussed, and approved by the working group participants using a modified Delphi method. Consensus was defined as at least 75% agreement among voters. The group agreed that the diagnosis of ulcerative proctitis should be made by ileocolonoscopy and confirmed by histopathology, with the exclusion of infections, drug-induced causes, radiation, trauma, and Crohn's disease. Ulcerative proctitis was defined as macroscopic extent of lesions limited to 15 cm distance from the anal verge in adults. Primary and secondary endpoints were identified to capture response of ulcerative proctitis to therapy. A combined clinical and endoscopic primary endpoint for the evaluation of ulcerative proctitis disease activity was proposed. Secondary endpoints that should be evaluated include endoscopic remission, histologic remission, mucosal healing, histologic endoscopic mucosal improvement, disability, fecal incontinence, urgency, constipation, and health-related quality of life. In response to the need for guidance on the design of clinical trials in patients with ulcerative proctitis, the Definition and end points for ulcerative PROCtitis in clinical TRIALs consensus provides recommendations on the definition and endpoints for ulcerative proctitis clinical trials.

Sections du résumé

BACKGROUND & AIMS
Clinical trials evaluating biologics and small molecules in patients with ulcerative colitis are predominantly excluding ulcerative proctitis. The objective of the Definition and endpoints for ulcerative PROCtitis in clinical TRIALs initiative was to develop consensus statements for definitions, inclusion criteria, and endpoints for the evaluation of ulcerative proctitis in adults.
METHODS
Thirty-five international experts held a consensus meeting to define ulcerative proctitis, and the endpoints to use in clinical trials. Based on a systematic review of the literature, statements were generated, discussed, and approved by the working group participants using a modified Delphi method. Consensus was defined as at least 75% agreement among voters.
RESULTS
The group agreed that the diagnosis of ulcerative proctitis should be made by ileocolonoscopy and confirmed by histopathology, with the exclusion of infections, drug-induced causes, radiation, trauma, and Crohn's disease. Ulcerative proctitis was defined as macroscopic extent of lesions limited to 15 cm distance from the anal verge in adults. Primary and secondary endpoints were identified to capture response of ulcerative proctitis to therapy. A combined clinical and endoscopic primary endpoint for the evaluation of ulcerative proctitis disease activity was proposed. Secondary endpoints that should be evaluated include endoscopic remission, histologic remission, mucosal healing, histologic endoscopic mucosal improvement, disability, fecal incontinence, urgency, constipation, and health-related quality of life.
CONCLUSIONS
In response to the need for guidance on the design of clinical trials in patients with ulcerative proctitis, the Definition and end points for ulcerative PROCtitis in clinical TRIALs consensus provides recommendations on the definition and endpoints for ulcerative proctitis clinical trials.

Identifiants

DOI: 10.1016/j.cgh.2022.02.032 PMID: 35189386
pubmed: 35189386
pii: S1542-3565(22)00188-4
doi: 10.1016/j.cgh.2022.02.032
pii:
doi:

Types de publication

Review Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

2619-2627.e1

Informations de copyright

Copyright © 2022 AGA Institute. Published by Elsevier Inc. All rights reserved.

Auteurs

Bénédicte Caron (B)

Nancy University Hospital, Department of Gastroenterology and University of Lorraine, Inserm, Nutrition-Génétique et Exposition aux Risques Environnementaux, F-54000 Nancy, France.

Maria T Abreu (MT)

Division of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida.

Corey A Siegel (CA)

Inflammatory Bowel Disease Center, Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.

Remo Panaccione (R)

Division of Gastroenterology and Hepatology, University of Calgary, Calgary, Alberta, Canada.

Bruce E Sands (BE)

Dr. Henry D. Janowitz Division of Gastroenterology.

Axel Dignass (A)

Department of Medicine I, Agaplesion Markus Hospital, Goethe-University, Frankfurt am Main, Germany.

Dan Turner (D)

Juliet Keidan Institute of Pediatric Gastroenterology Hepatology and Nutrition, Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Jerusalem, Israel.

Iris Dotan (I)

Division of Gastroenterology, Rabin Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Ailsa L Hart (AL)

Inflammatory Bowel Disease Unit, St. Mark's Hospital, Harrow, United Kingdom.

Vineet Ahuja (V)

Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India.

Matthieu Allez (M)

Department of Gastroenterology, Hôpital Saint-Louis, Assistance Publique - Hôpitaux de Paris, INSERM U1160, Université de Paris, Paris, Île-de-France, France.

Ashwin N Ananthakrishnan (AN)

Division of Gastroenterology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.

Subrata Ghosh (S)

College of Medicine and Health, University College Cork, Cork, Ireland.

Anne M Griffiths (AM)

SickKids Inflammatory Bowel Disease Center, Division of Gastroenterology, The Hospital for Sick Children, Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada.

Jonas Halfvarson (J)

Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.

Arthur Kaser (A)

University of Cambridge, Cambridge University Hospitals-Addenbrooke's Hospital, Cambridge, United Kingdom.

Paulo G Kotze (PG)

Inflammatory Bowel Disease Outpatient Clinics, Colorectal Surgery Unit, Catholic University of Paraná, Curitiba, Brazil.

Ioannis E Koutroubakis (IE)

Department of Gastroenterology, University Hospital of Heraklion, Medical School, University of Crete, Crete, Greece.

Peter L Lakatos (PL)

Department of Medicine and Oncology, Semmelweis University, McGill University Health Center, Montreal General Hospital, Montreal, Canada.

Arie Levine (A)

Pediatric Gastroenterology Unit, Paediatric Inflammatory Bowel Diseases Research Center, Wolfson Medical Center, Holon, Israel.

James D Lewis (JD)

Division of Gastroenterology and Hepatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.

Fernando Magro (F)

Department of Biomedicine, Unit of Pharmacology and Therapeutics, Faculty of Medicine, University of Porto, Porto, Portugal; Department of Clinical Pharmacology, São João University Hospital Center (CHUSJ), Porto, Portugal; Faculty of Medicine, University of Porto, Portugal. Center for Health Technology and Services Research (CINTESIS), Porto, Portugal; Center for Health Technology and Services Research (CINTESIS), Porto, Portugal.

Gerassimos J Mantzaris (GJ)

Department of Gastroenterology, Evangelismos-Polykliniki General Hospital, Athens, Greece.

Colm O'Morain (C)

Faculty of Health Sciences, University of Dublin, Trinity College, Dublin, Ireland.

Zhihua Ran (Z)

Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Inflammatory Bowel Disease Research Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, Shanghai, China.

Walter Reinisch (W)

Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.

Gerhard Rogler (G)

Department of Gastroenterology and Hepatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.

David B Sachar (DB)

Chief Emeritus of Gastroenterology and Professor of Medicine, Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.

Britta Siegmund (B)

Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Department of Gastroenterology, Rheumatology and Infectious Disease, Campus Benjamin Franklin, Berlin, Germany.

Mark S Silverberg (MS)

Mount Sinai Hospital Inflammatory Bowel Disease Centre, Toronto, Ontario, Canada.

Ajit Sood (A)

Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiāna, Punjab, India.

Antonino Spinelli (A)

Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Division of Colon and Rectal Surgery, Scientific Institute for Research, Hospitalization and Healthcare Humanitas Research Hospital, Rozzano, Milan, Italy.

Flavio Steinwurz (F)

Department of Gastroenterology, Albert Einstein Israelite Hospital, São Paulo, Brazil.

Curt Tysk (C)

Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.

Jesus K Yamamoto-Furusho (JK)

Inflammatory Bowel Disease Clinic, Department of Gastroenterology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpa, Mexico.

Stefan Schreiber (S)

Department of Internal Medicine, University Hospital Schleswig-Holstein, Kiel, Germany.

David T Rubin (DT)

Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, Illinois.

William J Sandborn (WJ)

Division of Gastroenterology, University of California San Diego, La Jolla, California.

Silvio Danese (S)

Humanitas Research Hospital, University Vita-Salute San Raffaele, Milano, Italy.

Laurent Peyrin-Biroulet (L)

Nancy University Hospital, Department of Gastroenterology and University of Lorraine, Inserm, Nutrition-Génétique et Exposition aux Risques Environnementaux, F-54000 Nancy, France. Electronic address: peyrinbiroulet@gmail.com.

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Classifications MeSH

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