Abstract
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.
| Original language | English |
|---|---|
| Pages (from-to) | 2619-2627.e1 |
| Journal | Clinical Gastroenterology and Hepatology |
| Volume | 20 |
| Issue number | 11 |
| DOIs | |
| State | Published - Nov 2022 |
Bibliographical note
Funding Information:Bénédicte Caron, MD, PhD (Data curation: Supporting; Formal analysis: Equal; Investigation: Equal; Methodology: Equal; Writing – original draft: Lead), Maria T. Abreu, MD, PhD (Methodology: Equal; Validation: Equal; Writing – review & editing: Equal), Corey A Siegel, MD, PhD (Methodology: Equal; Validation: Equal; Writing – review & editing: Equal), Remo Panaccione, MD, PhD (Methodology: Equal; Validation: Equal; Writing – review & editing: Equal), Bruce E. Sands, MD, PhD (Methodology: Equal; Validation: Equal; Writing – review & editing: Equal), Axel Dignass, MD, PhD (Methodology: Equal; Validation: Equal; Writing – review & editing: Equal), Dan Turner, MD, PhD (Methodology: Equal; Validation: Equal; Writing – review & editing: Equal), Iris Dotan, MD, PhD (Methodology: Equal; Validation: Equal; Writing – review & editing: Equal), Ailsa L Hart, MD, PhD (Methodology: Equal; Validation: Equal; Writing – review & editing: Equal), Vineet Ahuja, MD, PhD (Validation: Equal; Writing – review & editing: Equal), Matthieu Allez, MD, PhD (Validation: Equal; Writing – review & editing: Equal), Ashwin N Ananthakrishnan, MD, PhD (Validation: Equal; Writing – review & editing: Equal), Subrata Ghosh, MD, PhD (Validation: Equal; Writing – review & editing: Equal), Anne M Griffiths, MD, PhD (Validation: Equal; Writing – review & editing: Equal), Jonas Halfvarson, MD, PhD (Validation: Equal; Writing – review & editing: Equal), Arthur Kaser, MD, PhD (Validation: Equal; Writing – review & editing: Equal), Paulo G Kotze, MD, PhD (Validation: Equal; Writing – review & editing: Equal), Ioannis E Koutroubakis, MD, PhD (Validation: Equal; Writing – review & editing: Equal), Peter L Lakatos, MD, PhD (Validation: Equal; Writing – review & editing: Equal), Arie Levine, MD, PhD (Validation: Equal; Writing – review & editing: Equal), James D Lewis, MD, PhD (Validation: Equal; Writing – review & editing: Equal), Fernando Magro, MD, PhD (Validation: Equal; Writing – review & editing: Equal), Gerassimos J. Mantzaris, MD, PhD (Validation: Equal; Writing – review & editing: Equal), Colm O'Morain, MD, PhD (Validation: Equal; Writing – review & editing: Equal), Zhihua Ran, MD, PhD (Validation: Equal; Writing – review & editing: Equal), Walter Reinisch, MD, PhD (Validation: Equal; Writing – review & editing: Equal), Gerhard Rogler, MD, PhD (Validation: Equal; Writing – review & editing: Equal), David B Sachar, MD, PhD (Validation: Equal; Writing – review & editing: Equal), Britta Siegmund, MD, PhD (Validation: Equal; Writing – review & editing: Equal), Mark S Silverberg, MD, PhD (Validation: Equal; Writing – review & editing: Equal), Ajit Sood, MD, PhD (Validation: Equal; Writing – review & editing: Equal), Antonino Spinelli, MD, PhD (Validation: Equal; Writing – review & editing: Equal), Flavio Steinwurz, MD, PhD (Validation: Equal; Writing – review & editing: Equal), Curt Tysk, MD, PhD (Validation: Equal; Writing – review & editing: Equal), Jesus K. Yamamoto-Furusho, MD, PhD (Validation: Equal; Writing – review & editing: Equal), Stefan Schreiber, MD, PhD (Methodology: Equal; Validation: Equal; Writing – review & editing: Equal), David T Rubin, MD, PhD (Validation: Equal; Writing – review & editing: Equal), William J Sandborn, MD, PhD (Methodology: Equal; Validation: Equal; Writing – review & editing: Equal), Silvio Danese, MD, PhD (Methodology: Equal; Validation: Equal; Writing – review & editing: Equal), Laurent Peyrin-Biroulet, MD, PhD (Investigation: Lead; Methodology: Lead; Supervision: Lead; Validation: Lead; Writing – review & editing: Lead), The data underlying this article are available in the article and in its online supplementary material. Conflicts of interest These authors disclose the following: Bénédicte Caron has received lecture and/or consulting fees from AbbVie, Amgen, Celltrion, Janssen, and Takeda; Maria T. Abreu has consulted or served on advisory boards for AbbVie, Inc, Bellatrix Pharmaceuticals, Bristol Myers Squibb, Eli Lilly Pharmaceuticals, Gilead, Janssen Ortho, LLC, Prometheus Biosciences, Microba, and UCB Biopharma, has received teaching, lecturing, or speaking fees from Alimentiv, Arena Pharmaceuticals, Janssen, Prime CME, Takeda Pharmaceuticals, Intellisphere, LLC (HCP Live Institutional Perspectives in GI), Bristol Myers Squibb, and Focus Medical, and has received grants/research support from Prometheus, Takeda, and Pfizer; Corey A. Siegel has consulted or served on advisory boards for AbbVie, BMS, Lilly, Janssen, Pfizer, Prometheus, Takeda, and Trellus Health, has lectured for continuing medical education activities for AbbVie, Janssen, Pfizer, and Takeda, and has received grant support from AbbVie, Janssen, Pfizer, and Takeda; Remo Panaccione has consulted for Abbott, AbbVie, Alimentiv (formerly Robarts), Amgen, Arena Pharmaceuticals, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Cosmos Pharmaceuticals, Eisai, Elan, Eli Lilly, Ferring, Galapagos, Fresenius Kabi, Genentech, Gilead Sciences, Glaxo-Smith Kline, Janssen, Merck, Mylan, Oppilan Pharma, Pandion Pharma, Pfizer, Progenity, Protagonist Therapeutics, Roche, Sandoz, Satisfai Health, Shire, Sublimity Therapeutics, Takeda Pharmaceuticals, Theravance Biopharma, Viatris, and UCB, has received speaker's fees from AbbVie, Amgen, Arena Pharmaceuticals, Bristol-Myers Squibb, Celgene, Eli Lilly, Ferring, Gilead Sciences, Janssen, Merck, Pfizer, Roche, Sandoz, Shire, and Takeda Pharmaceuticals, has served on advisory boards for AbbVie, Amgen, Arena Pharmaceuticals, Bristol-Myers Squibb, Celgene, Celltrion, Eli Lilly, Ferring, Galapagos, Genentech, Gilead Sciences, Glaxo-Smith Kline, Janssen, Merck, Mylan, Oppilan Pharma, Pandion Pharma, Pfizer, Sandoz, Shire, Sublimity Therapeutics, Takeda Pharmaceuticals, and Theravance Biopharma, and has received research/educational support from AbbVie, Ferring, Janssen, Pfizer, and Takeda Pharmaceuticals; Bruce E. Sands has received research grants from Takeda, Pfizer, Theravance Biopharma R&D, and Janssen, has received consulting fees from 4D Pharma, Abivax, AbbVie, Alimentiv, Allergan, Amgen, Arena Pharmaceuticals, AstraZeneca, Bacainn Therapeutics, Boehringer-Ingelheim, Boston Pharmaceuticals, Bristol-Myers Squibb, Calibr, Capella Bioscience, Celgene, Celltrion Healthcare, ClostraBio, Enthera, F. Hoffmann-La Roche, Ferring, Galapagos, Gilead, Glaxo SmithKline, GossamerBio, Immunic, Index Pharmaceuticals, Innovation Pharmaceuticals, Ironwood Pharmaceuticals, Janssen, Kaleido, Kallyope, Lilly, MiroBio, Morphic Therapeutic, Oppilan Pharma, OSE Immunotherapeutics, Otsuka, Palatin Technologies, Pfizer, Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonist Therapeutics, Q32 Bio, Redhill Biopharma, Rheos Medicines, Salix Pharmaceuticals, Seres Therapeutics, Shire, Sienna Biopharmaceuticals, Sun Pharma, Surrozen, Takeda, Target PharmaSolutions, Teva Branded Pharmaceutical Products R&D, Thelium, Theravance Biopharma R&D, TLL Pharma, USWM Enterprises, Ventyx Biosciences, Viela Bio, Vivante Health, and Vivelix Pharmaceuticals, and has held stock in Vivante Health and Ventyx Biosciences in the last 3 years; Axel Dignass has received fees for participation in review activities, such as data monitoring boards, statistical analysis, end point committees, and the like from Falk, Pfizer, Takeda, Gilead, and Celgene, consultancy fees from AbbVie, MSD, Ferring, Roche/Genentech, Takeda, Vifor, Falk, Janssen, Pfizer, Sandoz/Hexal, Celgene Tillotts, Amgen, and Fresenius Kabi, payment for lectures including service on speakers bureaus from the Falk Foundation, Ferring, MSD, AbbVie, Vifor, Janssen-Cilag, Med Update GmbH, Pfizer, and Tillotts, payment for manuscript preparation from Falk Foundation, Thieme, Takeda, and UniMed Verlag, and payment for the development of educational presentations from Tillots and Ferring; Dan Turner has received consulting fees, research grants, or honorarium from Janssen, Pfizer, Ferring, AbbVie, Takeda, Atlantic Health, Shire, Celgene, Lilly, Roche, ThermoFisher, BMS, and SorrisoPharma; Irish Dotan has received consultation fees, research grants, or honorarium from AbbVie, Abbott, Altman, Arena, Athos, BMS/Celgene, Cambridge Healthcare, Celltrion, Falk Pharma, Ferring, Food Industries Organiszation, Gilead, Galapagos, Iterative Scopes, Janssen Nestle, Rafa Laboratories, Pfizer, Roche/Genentech, Sublimity, Takeda, and Wild Bio; Matthieu Allez has received grant support from Innate Pharma, Janssen, Takeda, and Genentech/Roche, speaker fees from AbbVie, Ferring, Genentech, Janssen, Pfizer, Roche, Takeda, and Tillots, and consultancy fees from Amgen, Biogen, Boehringer-Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Genentech, Gilead, IQVIA, Janssen, Novartis, Pfizer, Roche, and Takeda; Ashwin N. Ananthakrishnan has served on advisory boards for AbbVie, Takeda, and Ikena Oncology; Subrata Ghosh has consulted, sat on steering committees and advisory boards, and delivered lectures for Janssen, AbbVie, Pfizer, Takeda, Galapagos, Gilead, Eli Lilly, Bristol Myers Sqibb, and Ferring; Anne M. Griffiths has consulted or served on advisory boards for AbbVie, Bristol Myers Squibb, Janssen, Lilly, Merck, and Pfizer, has served as a speaker for AbbVie, Janssen, and Nestle, and received investigator-initiated research support from AbbVie; Jonas Halfvarson has consulted or served on advisory boards for AbbVie, Celgene, Celltrion, Ferring, Galapagos, Gilead Sciences, Index Pharma, Janssen, Lincs, MSD, Novartis, Olink Proteomics, Pfizer, Prometheus Laboratories, Inc, Sandoz, Shire, Takeda, Thermo Fisher Scientific, Tillotts Pharma, and Vifor Pharma, and has received grant support from Janssen, MSD, and Takeda; Paulo G. Kotze has received consultancy and speaking fees from AbbVie, Janssen, Pfizer, Takeda, Novartis, and Ferring, and has received scientific grants from Pfizer and Takeda; Ioannis E. Koutroubakis has served as an advisory board member for AbbVie, Astelas, Genesis, Janssen, MSD, Pharmacosmos, Pfizer, Vianex, Shire, and Takeda, has served as a speaker for AbbVie, Astelas, Genesis, Janssen, MSD, Takeda, Vianex, and Mylan, and has received research support from AbbVie, Vianex, and Ferring; Peter L. Lakatos has been a speaker and/or an advisory board member for AbbVie, Amgen, Arena Pharmaceuticals, Fresenius Kabi, Genetech, Gilead, Janssen, Merck, Mylan, Organon, Pharmacosmos, Pfizer, Roche, Takeda, Tillots, and Viatris, and has received unrestricted research grants from AbbVie, Takeda, and Pfizer; Arie Levine has received grants, speaker fees, intellectual property advisory boards from Nestle Health Science, Janssen, AbbVie, Ferring, Galapagos, Megapharm, and Takeda; James D. Lewis has consulted or served on an advisory board for Eli Lilly and Company, Samsung Bioepis, UCB, Bristol-Myers Squibb, Nestle Health Science, Merck, Celgene, Janssen Pharmaceuticals, Bridge Biotherapeutics, Entasis Therapeutics, AbbVie, Pfizer, Gilead, Arena Pharmaceuticals, Protagonist Therapeutics, and Scipher Medicine, and has received research funding from Nestle Health Science, Takeda, Janssen Pharmaceuticals, and AbbVie; Fernando Magro has received a fee for presenting from AbbVie, Ferring, Falk, Hospira, PharmaKern, MSD, Schering, Laboratórios Vitoria, Vifor Pharma, and OM Pharma; Gerassimos J. Mantzaris has received fees as an advisory board member for AbbVie, Aenorasis, Ferring, Genesis, Janssen, Mylan, MSD, Pharmacosmos, Pfizer, Vianex, Shire, and Takeda, has served as a speaker for AbbVie, Aenorasis, Dr Falk, Dr Schaer, Genesis, Janssen, MSD, Pfizer, Takeda, Vianex, and Mylan, and has received research support from AbbVie, MSD, Ferring, and Vianex; Walter Reinisch has served as a speaker for AbbVie, Aesca, Aptalis, Astellas, Centocor, Celltrion, Danone Austria, Elan, Falk Pharma GmbH, Ferring, Immundiagnostik, Medice, Mitsubishi Tanabe Pharma Corporation, MSD, Otsuka, PDL, Pharmacosmos, PLS Education, Schering-Plough, Shire, Takeda, Therakos, Vifor, and Yakult, has served as a consultant for AbbVie, Aesca, Algernon, Amgen, AM Pharma, AMT, AOP Orphan, Arena Pharmaceuticals, Astellas, Astra Zeneca, Avaxia, Roland Berger GmBH, Bioclinica, Biogen IDEC, Boehringer-Ingelheim, Bristol-Myers Squibb, Calyx, Cellerix, Chemocentryx, Celgene, Centocor, Celltrion, Covance, Danone Austria, DSM, Elan, Eli Lilly, Ernest & Young, Falk Pharma GmbH, Ferring, Galapagos, Gatehouse Bio, Inc, Genentech, Gilead, Grünenthal, ICON, Index Pharma, Inova, Intrinsic Imaging, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Landos Biopharma, Lipid Therapeutics, LivaNova, Mallinckrodt, Medahead, MedImmune, Millenium, Mitsubishi Tanabe Pharma Corporation, MSD, Nash Pharmaceuticals, Nestle, Nippon Kayaku, Novartis, Ocera, OMass, Otsuka, Parexel, PDL, Periconsulting, Pharmacosmos, Philip Morris Institute, Pfizer, Procter & Gamble, Prometheus, Protagonist, Provention, Quell Therapeutics, Robarts Clinical Trial, Sandoz, Schering-Plough, Second Genome, Seres Therapeutics, Setpointmedical, Sigmoid, Sublimity, Takeda, Teva Pharma, Therakos, Theravance, Tigenix, UCB, Vifor, Zealand, Zyngenia, and 4SC, as an advisory board member for AbbVie, Aesca, Amgen, AM Pharma, Astellas, Astra Zeneca, Avaxia, Biogen IDEC, Boehringer-Ingelheim, Bristol-Myers Squibb, Cellerix, Chemocentryx, Celgene, Centocor, Celltrion, Danone Austria, DSM, Elan, Ferring, Galapagos, Genentech, Grünenthal, Inova, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, MedImmune, Millenium, Mitsubishi Tanabe Pharma Corporation, MSD, Nestle, Novartis, Ocera, Otsuka, PDL, Pharmacosmos, Pfizer, Procter & Gamble, Prometheus, Sandoz, Schering-Plough, Second Genome, Setpointmedical, Takeda, Therakos, Tigenix, UCB, Zealand, Zyngenia, and 4SC, and has received research funding from AbbVie, Aesca, Centocor, Falk Pharma GmbH, Immundiagnostik, Janssen, MSD, Sandoz, Takeda; Gerhard Rogler has consulted for AbbVie, Arena, Astelles, Augurix, BMS, Boehringer, Calypso, Celgene, FALK, Ferring, Fisher, Genentech, Gilead, Janssen, MSD, Novartis, Pfizer, Phadia, Roche, UCB, Takeda, Tillots, Vifor, Vital Solutions, and Zeller, has received speaker's honoraria from Astra Zeneca, AbbVie, FALK, Ferring, Janssen, MSD, Pfizer, Phadia, Takeda, Tillots, UCB, Vifor, and Zeller, and has received educational grants and research grants from AbbVie, Ardeypharm, Augurix, Calypso, FALK, Flamentera, MSD, Novartis, Pfizer, Roche, Takeda, Tillots, UCB, and Zeller; David B. Sachar has served as a consultant or advisory board member for TEVA, Vyne, and Douglas Pharmaceuticals; Britta Siegmund has served as a consultant for AbbVie, Arena, BMS, Boehringer, Celgene, Falk, Galapagos, Janssen, Lilly, Pfizer, Prometheus, and Takeda, received speaker's fees from AbbVie, CED Service GmbH, Falk, Ferring, Janssen, Novartis, Pfizer, and Takeda, and served as a representative of Charité; Mark S. Silverberg has received speaker's fees from AbbVie, Janssen, Prometheus, Takeda, Pfizer, Ferring, Novartis, and Lilly, has served on advisory boards for AbbVie, Janssen, Prometheus, Takeda, Pfizer, Gilead, and Amgen, has received research support from AbbVie, Janssen, Prometheus, Takeda, Pfizer, and Gilead, and has served as a consultant for AbbVie, Janssen, Prometheus, Takeda, Pfizer, and Gilead; Antonino Spinelli has served as a speaker, consultant, or advisory board member for Johnson and Johnson, Pfizer, Takeda, Sofar, and Stryker; Jesus K. Yamamoto-Furusho has served as a speaker, consultant, and advisory board member for Schering-Plough, Abbott, AbbVie, Alfasigma, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Carnot, Celltrion, Danone, Farmasa Pharmaceuticals, Ferring, Grunenthal, Janssen, MSD, Pfizer, Takeda, and UCB Pharma, and has received research grants from AbbVie, Celgene, Gilead Sciences, Janssen, Pfizer, Roche, Shire, and Takeda; Stefan Schreiber has served in speaker, advisory, and consulting roles for AbbVie, Amgen, Boehringer-Ingelheim, Bristol-Myers Squibb, Celgene, Eisai Medical Research, Eli Lilly, Ferring, Genentech, Gilead, Janssen, Merck, Pfizer, Shire Pharmaceuticals, Sandoz, Takeda, and Tillotts; David T. Rubin has received grant support from Takeda, and has served as a consultant for AbbVie, Altrubio, Arena Pharmaceuticals, Bristol-Myers Squibb, Genentech/Roche, Gilead Sciences, Iterative Scopes, Janssen Pharmaceuticals, Lilly, Pfizer, Prometheus Biosciences, Takeda, and Techlab, Inc; William J. Sandborn has received research grants from AbbVie, Abivax, Arena Pharmaceuticals, Boehringer Ingelheim, Celgene, Genentech, Gilead Sciences, Glaxo Smith Kline, Janssen, Lilly, Pfizer, Prometheus Biosciences, Seres Therapeutics, Shire, Takeda, and Theravance Biopharma, has received consulting fees from AbbVie, Abivax, Admirx, Alfasigma, Alimentiv (previously Robarts Clinical Trials, owned by Alimentiv Health Trust), Alivio Therapeutics, Allakos, Amgen, Applied Molecular Transport, Arena Pharmaceuticals, Bausch Health (Salix), Beigene, Bellatrix Pharmaceuticals, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Meyers Squibb, Celgene, Celltrion, Cellularity, Cosmo Pharmaceuticals, Escalier Biosciences, Equillium, Forbion, Genentech/Roche, Gilead Sciences, Glenmark Pharmaceuticals, Gossamer Bio, Immunic (Vital Therapies), Index Pharmaceuticals, Intact Therapeutics, Janssen, Kyverna Therapeutics, Landos Biopharma, Lilly, Oppilan Pharma (acquired by Ventyx Biosciences), Otsuka, Pandion Therapeutics, Pfizer, Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonists Therapeutics, Provention Bio, Reistone Biopharma, Seres Therapeutics, Shanghai Pharma Biotherapeutics, Shire, Shoreline Biosciences, Sublimity Therapeutics, Surrozen, Takeda, Theravance Biopharma, Thetis Pharmaceuticals, Tillotts Pharma, UCB, Vendata Biosciences, Ventyx Biosciences, Vimalan Biosciences, Vivelix Pharmaceuticals, Vivreon Biosciences, and Zealand Pharma, has received stock or stock options from Allakos, BeiGene, Gossamer Bio, Oppilan Pharma (acquired by Ventyx Biosciences), Prometheus Biosciences, Prometheus Laboratories Progenity, Shoreline Biosciences, Ventyx Biosciences, Vimalan Biosciences, and Vivreon Biosciences, and is an employee of Shoreline Biosciences; Silvio Danese has served as a speaker, consultant, and advisory board member for Schering-Plough, AbbVie, Actelion, Alphawasserman, AstraZeneca, Cellerix, Cosmo Pharmaceuticals, Ferring, Genentech, Grunenthal, Johnson and Johnson, Millenium Takeda, MSD, Nikkiso Europe GmbH, Novo Nordisk, Nycomed, Pfizer, Pharmacosmos, UCB Pharma, and Vifor; and Laurent Peyrin-Biroulet has received personal fees from Galapagos, AbbVie, Janssen, Genentech, Ferring, Tillots, Pharmacosmos, Celltrion, Takeda, Boerhinger Ingelheim, Pfizer, Index Pharmaceuticals, Sandoz, Celgene, Biogen, Samsung Bioepis, Alma, Sterna, Nestle, Inotrem, Enterome, Allergan, MSD, Roche, Arena, Gilead, Hikma, Amgen, BMS, Vifor, Norgine, Mylan, Lilly, Fresenius Kabi, Oppilan Pharma, Sublimity Therapeutics, Applied Molecular Transport, OSE Immunotherapeutics, Enthera, Theravance, and Pandion Therapeutics, has received grants from AbbVie, MSD, Takeda, and Fresenius Kabi, and has received stock options from CTMA. The remaining authors disclose no conflicts.
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Keywords
- Consensus
- Definition
- Endpoint
- Ulcerative Proctitis