{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T23:07:37Z","timestamp":1790291257997,"version":"4.1.0"},"reference-count":59,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2024,10,5]],"date-time":"2024-10-05T00:00:00Z","timestamp":1728086400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["UEG Journal"],"published-print":{"date-parts":[[2024,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Mucosal healing (MH) is an established treatment goal in inflammatory bowel disease (IBD). However, various definitions of MH exist. We aimed to identify how MH is defined in randomized controlled trials (RCTs) in ulcerative colitis (UC) and Crohn's disease (CD).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We searched MEDLINE, EMBASE, and the Cochrane library from inception to December 2023 for phase 2 and 3 RCTs of advanced therapies in IBD.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>One hundred forty\u2010four studies were included, 72 in UC and 72 in CD, published between 1997 and 2023. In UC, 64% (46\/72) RCTs reported MH as an endpoint. 12 definitions of MH were found, from endoscopic assessment alone (35\/46; 76%) to the more recent combination of histology and endoscopy (10\/46; 22%). 96% (44\/46) of studies used the Mayo Endoscopic Subscore. In CD, reporting of MH lagged behind UC, with only 12% (9\/72) of trials specifically defining MH as an endpoint, 7 as \u201cabsence of ulceration,\u201d 2 as Simplified Endoscopic Score for CD score \u22642 or 0. Histological assessment was performed in 3 RCTs of CD. Centralized reading of endoscopy was used in 48% (35\/72) of RCTs of UC and 22% (16\/72) of CD. Only 1 RCT included transmural healing as an endpoint.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>A standard definition of MH in IBD is lacking. Definitions have evolved particularly in UC, which now includes the addition of histological evaluation. Transmural healing holds promise as a future target in CD. We support a greater standardization of definitions as we expect endpoints to become increasingly stringent and multimodal with computers automating the assessment.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ueg2.12671","type":"journal-article","created":{"date-parts":[[2024,10,5]],"date-time":"2024-10-05T10:40:15Z","timestamp":1728124815000},"page":"1266-1279","source":"Crossref","is-referenced-by-count":21,"title":["Defining mucosal healing in randomized controlled trials of inflammatory bowel disease: A systematic review and future perspective"],"prefix":"10.1002","volume":"12","author":[{"given":"Tommaso Lorenzo","family":"Parigi","sequence":"first","affiliation":[{"name":"Division of Immunology, Transplantation and Infectious Disease Universit\u00e0 Vita\u2010Salute San Raffaele  Milan Italy"},{"name":"Department of Gastroenterology and Endoscopy IRCCS Ospedale San Raffaele  Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Virginia","family":"Solitano","sequence":"additional","affiliation":[{"name":"Division of Immunology, Transplantation and Infectious Disease Universit\u00e0 Vita\u2010Salute San Raffaele  Milan Italy"},{"name":"Division of Gastroenterology Department of Medicine Western University  London Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandro","family":"Armuzzi","sequence":"additional","affiliation":[{"name":"IBD Center IRCCS Humanitas Research Hospital  Milan Italy"},{"name":"Department of Biomedical Sciences Humanitas University  Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5915-1477","authenticated-orcid":false,"given":"Manuel","family":"Barreiro de Acosta","sequence":"additional","affiliation":[{"name":"Gastroenterology Department Hospital Cl\u00ednico Universitario de Santiago de Compostela  Santiago Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jake","family":"Begun","sequence":"additional","affiliation":[{"name":"Faculty of Medicine Mater Research Institute University of Queensland  Brisbane Queensland Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-1586-6056","authenticated-orcid":false,"given":"Shomron","family":"Ben\u2010Horin","sequence":"additional","affiliation":[{"name":"Sheba Medical Center  Tel Aviv Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luc","family":"Biedermann","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology &amp; Hepatology University Hospital Zurich  Zurich Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean\u2010Frederic","family":"Colombel","sequence":"additional","affiliation":[{"name":"The Henry Janowitz Department of Gastroenterology Icahn School of Medicine at Mount Sinai  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Axel","family":"Dignass","sequence":"additional","affiliation":[{"name":"Department of Medicine and Agaplesion Markus Hospital Goethe University  Frankfurt am Main Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mathurin","family":"Fumery","sequence":"additional","affiliation":[{"name":"Gastroenterology Department Centre Hospitalier Universitaire d'Amiens, and PeriTox Universit\u00e9 de Picardie Jules Verne  Amiens France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Subrata","family":"Ghosh","sequence":"additional","affiliation":[{"name":"University College Cork  Cork Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2073-4234","authenticated-orcid":false,"given":"Taku","family":"Kobayashi","sequence":"additional","affiliation":[{"name":"Center for Advanced IBD Research and Treatment Kitasato University Kitasato Institute Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edouard","family":"Louis","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Li\u00e8ge University Hospital  Liege Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2634-9668","authenticated-orcid":false,"given":"Fernando","family":"Magro","sequence":"additional","affiliation":[{"name":"Hospital de Sao Joao  Porto Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Remo","family":"Panaccione","sequence":"additional","affiliation":[{"name":"Inflammatory Bowel Disease Unit University of Calgary  Calgary Alberta Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Astrid","family":"Rausch","sequence":"additional","affiliation":[{"name":"Hospital Britanico de Buenos Aires  Buenos Aires Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Walter","family":"Reinisch","sequence":"additional","affiliation":[{"name":"Division Gastroenterology &amp; Hepatology Department of Internal Medicine III Medical University of Vienna  Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2022-5859","authenticated-orcid":false,"given":"Christian","family":"Selinger","sequence":"additional","affiliation":[{"name":"Leeds Gastroenterology Institute Leeds Teaching Hospitals NHS Trust  Leeds UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1092-0033","authenticated-orcid":false,"given":"Vipul","family":"Jairath","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology Department of Medicine Western University  London Ontario Canada"},{"name":"Alimentiv Inc  London Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvio","family":"Danese","sequence":"additional","affiliation":[{"name":"Division of Immunology, Transplantation and Infectious Disease Universit\u00e0 Vita\u2010Salute San Raffaele  Milan Italy"},{"name":"Department of Gastroenterology and Endoscopy IRCCS Ospedale San Raffaele  Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2536-6618","authenticated-orcid":false,"given":"Laurent","family":"Peyrin\u2010Biroulet","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology INFINY Institute FHU\u2010CURE, Nancy University Hospital, and INSERM Nutrition\u2010Genetics and Environmental Risk Exposure University of Lorraine  Vand\u0153uvre\u2010l\u00e8s\u2010Nancy France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,10,5]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1136\/gut.35.2.231"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2015.233"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2022.06.068"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2013.10.055"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco\u2010jcc\/jjy107"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco\u2010jcc\/jjy093"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2020.12.031"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco\u2010jcc\/jjab135"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco\u2010jcc\/jjab194"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/nejmoa050516"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco\u2010jcc\/jjy049"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1159\/000509393"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2018.10.032"},{"key":"e_1_2_11_15_1","unstructured":"UColitis:Clinical trial endpoints guidance for Industry.2016;"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/s2468\u20101253(22)00233\u20103"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0140\u20106736(22)00581\u20105"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/s2468\u20101253(22)00427\u20107"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1056\/nejmoa1602773"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1056\/nejmoa1513248"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1056\/nejmoa2033617"},{"key":"e_1_2_11_22_1","article-title":"Efficacy and safety of the anti\u2010mucosal addressin cell adhesion molecule\u20101 antibody ontamalimab in patients with moderate\u2010to\u2010severe ulcerative colitis or Crohn\u2019s disease","author":"Vermeire S","year":"2023","journal-title":"J Crohns Colitis"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0140\u20106736(17)30930\u20103"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.gie.2005.08.011"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0140\u20106736(17)30570\u20106"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2013.08.010"},{"key":"e_1_2_11_27_1","volume-title":"Crohn\u2019s disease: developing drugs for treatment [internet]","author":"Research C for DE","year":"2022"},{"key":"e_1_2_11_28_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco\u2010jcc\/jjab133"},{"key":"e_1_2_11_29_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2020.01.047"},{"key":"e_1_2_11_30_1","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000000493"},{"key":"e_1_2_11_31_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2012.01.035"},{"key":"e_1_2_11_32_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco\u2010jcc\/jjad047"},{"key":"e_1_2_11_33_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0016\u20105085(99)70005\u20103"},{"key":"e_1_2_11_34_1","doi-asserted-by":"publisher","DOI":"10.1056\/nejmoa033402"},{"key":"e_1_2_11_35_1","unstructured":"Guideline on the development of new medicinal products for the treatment of Ulcerative Colitis."},{"key":"e_1_2_11_36_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2013.03.025"},{"key":"e_1_2_11_37_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2015.08.044"},{"key":"e_1_2_11_38_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco\u2010jcc\/jjad134"},{"key":"e_1_2_11_39_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2023.03.234"},{"key":"e_1_2_11_40_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2020.03.039"},{"key":"e_1_2_11_41_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2019.11.025"},{"key":"e_1_2_11_42_1","article-title":"Ulcerative colitis: developing drugs for treatment","author":"FDA","year":"2022","journal-title":"Guid Industry [Internet]"},{"key":"e_1_2_11_43_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2020.09.046"},{"key":"e_1_2_11_44_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl\u20102023\u2010329964"},{"key":"e_1_2_11_45_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco\u2010jcc\/jjac006"},{"key":"e_1_2_11_46_1","doi-asserted-by":"publisher","DOI":"10.2147\/ceg.s429039"},{"key":"e_1_2_11_47_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2022.05.055"},{"key":"e_1_2_11_48_1","article-title":"Disease clearance as a new outcome in ulcerative colitis: a systematic review and expert consensus","author":"D\u2019Amico F","year":"2023","journal-title":"Inflamm Bowel Dis"},{"key":"e_1_2_11_49_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2020.12.024"},{"key":"e_1_2_11_50_1","doi-asserted-by":"publisher","DOI":"10.1002\/ueg2.12185"},{"key":"e_1_2_11_51_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2022.10.014"},{"issue":"21","key":"e_1_2_11_52_1","article-title":"Deep neural network for video colonoscopy of ulcerative colitis: a cross\u2010sectional study","volume":"29","author":"Takenaka K","year":"2021","journal-title":"Lancet Gastroenterol Hepatol"},{"key":"e_1_2_11_53_1","doi-asserted-by":"publisher","DOI":"10.1055\/a\u20101960\u20103645"},{"key":"e_1_2_11_54_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2023.02.031"},{"key":"e_1_2_11_55_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2023.09.049"},{"key":"e_1_2_11_56_1","doi-asserted-by":"publisher","DOI":"10.1002\/ueg2.12423"},{"key":"e_1_2_11_57_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl\u20102021\u2010326451"},{"key":"e_1_2_11_58_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco\u2010jcc\/jjad077"},{"key":"e_1_2_11_59_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2021.02.027"},{"key":"e_1_2_11_60_1","doi-asserted-by":"publisher","DOI":"10.1093\/ibd\/izad014"}],"container-title":["United European Gastroenterology Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ueg2.12671","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,21]],"date-time":"2024-11-21T04:56:44Z","timestamp":1732165004000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ueg2.12671"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,10,5]]},"references-count":59,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2024,11]]}},"alternative-id":["10.1002\/ueg2.12671"],"URL":"https:\/\/doi.org\/10.1002\/ueg2.12671","archive":["Portico"],"relation":{},"ISSN":["2050-6406","2050-6414"],"issn-type":[{"value":"2050-6406","type":"print"},{"value":"2050-6414","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,10,5]]}}}