{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T09:13:07Z","timestamp":1790154787284,"version":"4.0.1"},"reference-count":128,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2025,3,13]],"date-time":"2025-03-13T00:00:00Z","timestamp":1741824000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Takeda Development Center Americas, Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,4,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Inflammatory bowel diseases (IBD), Crohn\u2019s disease (CD), and ulcerative colitis (UC) are lifelong chronic, relapsing, and remitting conditions that culminate in disease progression in many patients. Effective management of CD and UC requires consideration of both short- and long-term treatment outcomes. Historically, short-term outcomes such as clinical and endoscopic remission and symptom relief have been evaluated in clinical trials. With the expansion of treatments targeting underlying disease pathophysiology, there is the opportunity to develop management strategies that improve disease control and patients\u2019 lives in both the short and the long term. Researchers have been examining novel outcomes for assessing the efficacy of CD and UC treatments that are important to patients, and also those that go beyond symptomatic improvements or clinical remission. These include new patient-reported outcomes for symptoms, as well as transmural\/histological healing and disease clearance that can be more reflective of deeper remission states and disease modification. This review analyses published clinical studies involving patients with UC and CD treated with biologics or small molecule therapies. It highlights novel IBD endpoints employed in published clinical trials and discusses their likely value for assessing disease activity and disease modification, and as predictors of reduced risk of complications and morbidities.<\/jats:p>","DOI":"10.1093\/ecco-jcc\/jjaf040","type":"journal-article","created":{"date-parts":[[2025,3,7]],"date-time":"2025-03-07T15:26:57Z","timestamp":1741361217000},"source":"Crossref","is-referenced-by-count":26,"title":["Novel outcomes in inflammatory bowel disease"],"prefix":"10.1093","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1092-0033","authenticated-orcid":false,"given":"Vipul","family":"Jairath","sequence":"first","affiliation":[{"name":"Department of Medicine, Division of Gastroenterology, Western University , London, ON ,","place":["Canada"]},{"name":"Alimentiv Inc. , London, ON ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1536-8436","authenticated-orcid":false,"given":"Neeraj","family":"Narula","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Department of Medicine and Farncombe Family Digestive Health Research Institute, McMaster University , Hamilton, ON ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8687-3758","authenticated-orcid":false,"given":"Ryan C","family":"Ungaro","sequence":"additional","affiliation":[{"name":"The Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai , New York, NY ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Itzel","family":"Romo Bautista","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc. , Cambridge, MA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shashi","family":"Adsul","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceuticals, Inc. , Cambridge, MA , (at the time of the analyses)","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2025,3,13]]},"reference":[{"key":"2025042607414852000_CIT0001","doi-asserted-by":"crossref","first-page":"2769","DOI":"10.1016\/S0140-6736(17)32448-0","article-title":"Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies","volume":"390","author":"Ng","year":"2017","journal-title":"Lancet."},{"key":"2025042607414852000_CIT0002","doi-asserted-by":"crossref","first-page":"720","DOI":"10.1038\/nrgastro.2015.150","article-title":"The global burden of IBD: from 2015 to 2025","volume":"12","author":"Kaplan","year":"2015","journal-title":"Nat Rev Gastroenterol Hepatol."},{"key":"2025042607414852000_CIT0003","doi-asserted-by":"crossref","first-page":"1741","DOI":"10.1016\/S0140-6736(16)31711-1","article-title":"Crohn\u2019s disease","volume":"389","author":"Torres","year":"2017","journal-title":"Lancet."},{"key":"2025042607414852000_CIT0004","doi-asserted-by":"crossref","first-page":"1756","DOI":"10.1016\/S0140-6736(16)32126-2","article-title":"Ulcerative colitis","volume":"389","author":"Ungaro","year":"2017","journal-title":"Lancet."},{"key":"2025042607414852000_CIT0005","doi-asserted-by":"crossref","first-page":"798","DOI":"10.1097\/MIB.0000000000001060","article-title":"Patient-reported outcomes of quality of life, functioning, and GI\/psychiatric symptom severity in patients with inflammatory bowel disease (IBD)","volume":"23","author":"IsHak","year":"2017","journal-title":"Inflamm Bowel Dis."},{"key":"2025042607414852000_CIT0006","doi-asserted-by":"crossref","first-page":"otac023","DOI":"10.1093\/crocol\/otac023","article-title":"Work-related productivity loss and associated indirect costs in patients with Crohn\u2019s disease or ulcerative colitis in the United States","volume":"4","author":"Ding","year":"2022","journal-title":"Crohns Colitis 360."},{"key":"2025042607414852000_CIT0007","doi-asserted-by":"crossref","first-page":"14","DOI":"10.1016\/j.cgh.2019.07.005","article-title":"Ulcerative colitis and Crohn\u2019s disease have similar burden and goals for treatment","volume":"18","author":"Le Berre","year":"2020","journal-title":"Clin Gastroenterol Hepatol."},{"key":"2025042607414852000_CIT0008","doi-asserted-by":"crossref","first-page":"1570","DOI":"10.1053\/j.gastro.2020.12.031","article-title":"STRIDE-II: an update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) initiative of the International Organization for the Study of IBD (IOIBD): determining therapeutic goals for treat-to-target strategies in IBD","volume":"160","author":"Turner","year":"2021","journal-title":"Gastroenterology."},{"key":"2025042607414852000_CIT0009","doi-asserted-by":"crossref","first-page":"1452","DOI":"10.1053\/j.gastro.2020.10.065","article-title":"Selecting end points for disease-modification trials in inflammatory bowel disease: the SPIRIT consensus from the IOIBD","volume":"160","author":"Le Berre","year":"2021","journal-title":"Gastroenterology."},{"key":"2025042607414852000_CIT0010","author":"Food and Drug Administration","year":"2022","journal-title":"Crohn\u2019s disease: developing drugs for treatment guidance for industry"},{"key":"2025042607414852000_CIT0011","author":"Food and Drug Administration","year":"2022","journal-title":"Ulcerative colitis: developing drugs for treatment guidance for industry"},{"key":"2025042607414852000_CIT0012","author":"European Medicines Agency","year":"2018","journal-title":"Guideline on the development of new medicinal products for the treatment of Crohn\u2019s disease"},{"key":"2025042607414852000_CIT0013","author":"European Medicines Agency","year":"2018","journal-title":"Guideline on the development of new medicinal products for the treatment of ulcerative colitis"},{"key":"2025042607414852000_CIT0014","doi-asserted-by":"crossref","first-page":"1825","DOI":"10.1016\/S0140-6736(15)00068-9","article-title":"Early combined immunosuppression for the management of Crohn\u2019s disease (REACT): a cluster randomised controlled trial","volume":"386","author":"Khanna","year":"2015","journal-title":"Lancet."},{"key":"2025042607414852000_CIT0015","first-page":"6","article-title":"OP110. 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