{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T20:41:42Z","timestamp":1791492102351,"version":"4.3.4"},"reference-count":32,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2020,9,15]],"date-time":"2020-09-15T00:00:00Z","timestamp":1600128000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,3,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>There is need for biomarkers as predictors of outcome of medical treatment in Crohn\u2019s disease. The purpose of this study was to evaluate the predictive performance of faecal calprotectin for short- and long-term clinical and endoscopic outcomes.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This post-hoc analysis of the UNITI\/IM-UNITI studies [NCT01369329, NCT01369342, and NCT01369355; YODA #2019\u20134026] included 677 patients to evaluate the relationship of Week 6 calprotectin cut-offs and changes from baseline assessments in calprotectin for prediction of outcomes at Weeks 8, 32, and 52, using receiver operating characteristic curves with comparisons of areas under the curve [AUC]. The relationship between clinical and biomarker assessments at Week 6 and endoscopic remission [ER] at Week 52 was evaluated using multivariate logistic regression models adjusted for confounders.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>A Week 6 calprotectin\u2005&amp;lt;250 mg\/kg demonstrated a significant ability to predict Week 52 ER (AUC 0.709, 95% confidence interval [CI] 0.566\u20130.852, p\u2005=\u20050.014) with fair accuracy, and performed better than other calprotectin cut-offs and deltas from baseline for prediction of Week 52 ER. When adjusted for covariates, patients with a Week 6 faecal calprotectin\u2005&amp;lt;250 mg\/kg had 3.48 times [95% CI 1.31\u20139.28, p\u2005=\u20050.013] increased odds of Week 52 ER. No other Week 6 clinical assessment [clinical remission or clinical response] or biomarker [CRP\u2005&amp;lt;5 or drug level] had an association with Week 52 ER.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>In summary, the results of this post-hoc analysis suggest that Week 6 calprotectin levels\u2005&amp;lt;\u2005250 mg\/kg can be predictive of future endoscopic healing and may be more informative than clinical symptom improvement.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Podcast<\/jats:title>\n                  <jats:p>This article has an associated podcast which can be accessed at https:\/\/academic.oup.com\/ecco-jcc\/pages\/podcast<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ecco-jcc\/jjaa189","type":"journal-article","created":{"date-parts":[[2020,9,11]],"date-time":"2020-09-11T19:12:49Z","timestamp":1599851569000},"page":"462-470","source":"Crossref","is-referenced-by-count":23,"title":["Week 6 Calprotectin Best Predicts Likelihood of Long-term Endoscopic Healing in Crohn\u2019s Disease: A Post-hoc Analysis of the UNITI\/IM-UNITI Trials"],"prefix":"10.1093","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1536-8436","authenticated-orcid":false,"given":"Neeraj","family":"Narula","sequence":"first","affiliation":[{"name":"Department of Medicine [Division of Gastroenterology] and Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, ON, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily C L","family":"Wong","sequence":"additional","affiliation":[{"name":"Department of Medicine [Division of Gastroenterology] and Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, ON, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Parambir S","family":"Dulai","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John K","family":"Marshall","sequence":"additional","affiliation":[{"name":"Department of Medicine [Division of Gastroenterology] and Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, ON, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Frederic","family":"Colombel","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology; Icahn School of Medicine at Mount Sinai, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Walter","family":"Reinisch","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2020,9,15]]},"reference":[{"key":"2021031010470272600_CIT0001","doi-asserted-by":"crossref","first-page":"1647","DOI":"10.1016\/0016-5085(92)91725-J","article-title":"Endoscopic monitoring of Crohn\u2019s disease treatment: a prospective, randomized clinical trial. The Groupe d\u2019Etudes Therapeutiques des Affections Inflammatoires Digestives","volume":"102","author":"Landi","year":"1992","journal-title":"Gastroenterology"},{"key":"2021031010470272600_CIT0002","doi-asserted-by":"crossref","first-page":"983","DOI":"10.1136\/gut.30.7.983","article-title":"Development and validation of an endoscopic index of the severity for Crohn\u2019s disease: a prospective multicentre study. Groupe d\u2019Etudes Th\u00e9rapeutiques des Affections Inflammatoires du Tube Digestif [GETAID]","volume":"30","author":"Mary","year":"1989","journal-title":"Gut"},{"key":"2021031010470272600_CIT0003","doi-asserted-by":"crossref","first-page":"811","DOI":"10.1016\/0016-5085(90)90002-I","article-title":"Clinical, biological, and endoscopic picture of attacks of Crohn\u2019s disease. Evolution on prednisolone. Groupe d\u2019Etude Th\u00e9rapeutique des Affections Inflammatoires Digestives","volume":"98","author":"Modigliani","year":"1990","journal-title":"Gastroenterology"},{"key":"2021031010470272600_CIT0004","doi-asserted-by":"crossref","first-page":"317","DOI":"10.1111\/apt.13475","article-title":"Systematic review with meta-analysis: mucosal healing is associated with improved long-term outcomes in Crohn\u2019s disease","volume":"43","author":"Shah","year":"2016","journal-title":"Aliment Pharmacol Ther"},{"key":"2021031010470272600_CIT0005","doi-asserted-by":"crossref","first-page":"1324","DOI":"10.1038\/ajg.2015.233","article-title":"Selecting Therapeutic Targets in Inflammatory Bowel Disease [STRIDE]: determining therapeutic goals for treat-to-target","volume":"110","author":"Peyrin-Biroulet","year":"2015","journal-title":"Am J Gastroenterol"},{"key":"2021031010470272600_CIT0006","doi-asserted-by":"crossref","first-page":"162","DOI":"10.1038\/ajg.2009.545","article-title":"Faecal calprotectin correlates more closely with the Simple Endoscopic Score for Crohn\u2019s disease [SES-CD] than CRP, blood leukocytes, and the CDAI","volume":"105","author":"Schoepfer","year":"2010","journal-title":"Am J Gastroenterol"},{"key":"2021031010470272600_CIT0007","doi-asserted-by":"crossref","first-page":"802","DOI":"10.1038\/ajg.2015.120","article-title":"C-reactive protein, faecal calprotectin, and stool lactoferrin for detection of endoscopic activity in symptomatic inflammatory bowel disease patients: a systematic review and meta-analysis","volume":"110","author":"Mosli","year":"2015","journal-title":"Am J Gastroenterol"},{"key":"2021031010470272600_CIT0008","doi-asserted-by":"crossref","first-page":"2218","DOI":"10.1002\/ibd.22917","article-title":"Faecal calprotectin is a surrogate marker for endoscopic lesions in inflammatory bowel disease","volume":"18","author":"D\u2019Haens","year":"2012","journal-title":"Inflamm Bowel Dis"},{"key":"2021031010470272600_CIT0009","doi-asserted-by":"crossref","first-page":"2779","DOI":"10.1016\/S0140-6736(17)32641-7","article-title":"Effect of tight control management on Crohn\u2019s disease [CALM]: a multicentre, randomised, controlled phase 3 trial","volume":"390","author":"Colombel","year":"2018","journal-title":"Lancet"},{"key":"2021031010470272600_CIT0010","doi-asserted-by":"crossref","first-page":"40","DOI":"10.1002\/ibd.20312","article-title":"Crohn\u2019s disease activity assessed by faecal calprotectin and lactoferrin: correlation with Crohn\u2019s disease activity index and endoscopic findings","volume":"14","author":"Sipponen","year":"2008","journal-title":"Inflamm Bowel Dis"},{"key":"2021031010470272600_CIT0011","doi-asserted-by":"crossref","first-page":"1117","DOI":"10.1177\/2050640618784046","article-title":"Expert opinion for use of faecal calprotectin in diagnosis and monitoring of inflammatory bowel disease in daily clinical practice","volume":"6","author":"Reenaers","year":"2018","journal-title":"United European Gastroenterol J"},{"key":"2021031010470272600_CIT0012","doi-asserted-by":"crossref","first-page":"s1","DOI":"10.1136\/gutjnl-2019-318484","article-title":"British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults","volume":"68","author":"Lamb","year":"2019","journal-title":"Gut"},{"key":"2021031010470272600_CIT0013","doi-asserted-by":"crossref","first-page":"164","DOI":"10.1093\/ecco-jcc\/jju015","article-title":"Prediction of endoscopic disease activity in ulcerative colitis by two different assays for faecal calprotectin","volume":"9","author":"Kristensen","year":"2015","journal-title":"J Crohns Colitis"},{"key":"2021031010470272600_CIT0014","doi-asserted-by":"crossref","first-page":"344","DOI":"10.1080\/00365521.2016.1256424","article-title":"Clinical implications of assay specific differences in f-calprotectin when monitoring inflammatory bowel disease activity over time","volume":"52","author":"Amcoff","year":"2017","journal-title":"Scand J Gastroenterol"},{"key":"2021031010470272600_CIT0015","doi-asserted-by":"crossref","first-page":"495","DOI":"10.1111\/apt.13731","article-title":"The prognostic significance of faecal calprotectin in patients with inactive inflammatory bowel disease","volume":"44","author":"Zhulina","year":"2016","journal-title":"Aliment Pharmacol Ther"},{"key":"2021031010470272600_CIT0016","doi-asserted-by":"crossref","first-page":"1447","DOI":"10.1080\/00365521.2016.1205128","article-title":"Early change in faecal calprotectin predicts primary non-response to anti-TNF\u03b1 therapy in Crohn\u2019s disease","volume":"51","author":"Pavlidis","year":"2016","journal-title":"Scand J Gastroenterol"},{"key":"2021031010470272600_CIT0017","doi-asserted-by":"crossref","first-page":"1946","DOI":"10.1056\/NEJMoa1602773","article-title":"Ustekinumab as induction and maintenance therapy for Crohn\u2019s disease","volume":"375","author":"Feagan","year":"2016","journal-title":"N Engl J Med"},{"key":"2021031010470272600_CIT0018","doi-asserted-by":"crossref","first-page":"711","DOI":"10.1056\/NEJMoa1215739","article-title":"Vedolizumab as induction and maintenance therapy for Crohn\u2019s disease","volume":"369","author":"Sandborn","year":"2013","journal-title":"N Engl J Med"},{"key":"2021031010470272600_CIT0019","doi-asserted-by":"crossref","first-page":"618","DOI":"10.1053\/j.gastro.2014.05.008","article-title":"Effects of vedolizumab induction therapy for patients with Crohn\u2019s disease in whom tumor necrosis factor antagonist treatment failed","volume":"147","author":"Sands","year":"2014","journal-title":"Gastroenterology"},{"key":"2021031010470272600_CIT0020","doi-asserted-by":"crossref","first-page":"1218","DOI":"10.1016\/j.cgh.2008.06.010","article-title":"Relationships between disease activity and serum and faecal biomarkers in patients with Crohn\u2019s disease","volume":"6","author":"Jones","year":"2008","journal-title":"Clin Gastroenterol Hepatol"},{"key":"2021031010470272600_CIT0021","doi-asserted-by":"crossref","first-page":"231","DOI":"10.1136\/gut.35.2.231","article-title":"Correlations between clinical activity, endoscopic severity, and biological parameters in colonic or ileocolonic Crohn\u2019s disease. A prospective multicentre study of 121 cases. The Groupe d\u2019Etudes Th\u00e9rapeutiques des Affections Inflammatoires Digestives","volume":"35","author":"Cellier","year":"1994","journal-title":"Gut"},{"key":"2021031010470272600_CIT0022","doi-asserted-by":"crossref","first-page":"1246","DOI":"10.1016\/j.cgh.2014.02.016","article-title":"Patient-reported outcomes as primary end points in clinical trials of inflammatory bowel disease","volume":"12","author":"Williet","year":"2014","journal-title":"Clin Gastroenterol Hepatol"},{"key":"2021031010470272600_CIT0023"},{"key":"2021031010470272600_CIT0024","doi-asserted-by":"crossref","first-page":"505","DOI":"10.1016\/S0016-5107(04)01878-4","article-title":"Development and validation of a new, simplified endoscopic activity score for Crohn\u2019s disease: the SES-CD","volume":"60","author":"Daperno","year":"2004","journal-title":"Gastrointest Endosc"},{"key":"2021031010470272600_CIT0025","doi-asserted-by":"crossref","first-page":"110","DOI":"10.1186\/s12876-017-0669-7","article-title":"Faecal calprotectin predicts complete mucosal healing and better correlates with the ulcerative colitis endoscopic index of severity than with the Mayo endoscopic subscore in patients with ulcerative colitis","volume":"17","author":"Lee","year":"2017","journal-title":"BMC Gastroenterol"},{"key":"2021031010470272600_CIT0026","doi-asserted-by":"crossref","first-page":"e22796","DOI":"10.5812\/ircmj.22796","article-title":"Faecal calprotectin is an accurate tool and correlated to SEO index in prediction of relapse in Iranian patients with ulcerative colitis","volume":"17","author":"Hosseini","year":"2015","journal-title":"Iran Red Crescent Med J"},{"key":"2021031010470272600_CIT0027","doi-asserted-by":"crossref","first-page":"S171-S","DOI":"10.1093\/ecco-jcc\/jjx180.277","article-title":"Low diagnostic accuracy of faecal calprotectin to predict mucosal inflammation in Crohn\u2019s disease patients with active perianal fistulas","volume":"12","author":"Stevens","year":"2018","journal-title":"J Crohns Colitis"},{"key":"2021031010470272600_CIT0028","doi-asserted-by":"crossref","first-page":"474","DOI":"10.1136\/gut.28.4.474","article-title":"IOIBD report no 1: Observer variation in calculating indices of severity and activity in Crohn\u2019s disease. International Organisation for the Study of Inflammatory Bowel Disease","volume":"28","author":"de Dombal","year":"1987","journal-title":"Gut"},{"key":"2021031010470272600_CIT0029","doi-asserted-by":"crossref","first-page":"351","DOI":"10.1053\/j.gastro.2016.09.046","article-title":"Management strategies to improve outcomes of patients with inflammatory bowel diseases","volume":"152","author":"Colombel","year":"2017","journal-title":"Gastroenterology"},{"key":"2021031010470272600_CIT0030","doi-asserted-by":"crossref","first-page":"978","DOI":"10.1016\/j.cgh.2013.11.005","article-title":"Endoscopic assessment and treating to target increase the likelihood of mucosal healing in patients with Crohn\u2019s disease","volume":"12","author":"Bouguen","year":"2014","journal-title":"Clin Gastroenterol Hepatol"},{"key":"2021031010470272600_CIT0031","doi-asserted-by":"crossref","first-page":"1045","DOI":"10.1053\/j.gastro.2018.06.035","article-title":"Efficacy of ustekinumab for inducing endoscopic healing in patients with Crohn\u2019s disease","volume":"155","author":"Rutgeerts","year":"2018","journal-title":"Gastroenterology"},{"key":"2021031010470272600_CIT0032","doi-asserted-by":"crossref","first-page":"978","DOI":"10.1053\/j.gastro.2013.08.010","article-title":"Validation of endoscopic activity scores in patients with Crohn\u2019s disease based on a post hoc analysis of data from SONIC","volume":"145","author":"Ferrante","year":"2013","journal-title":"Gastroenterology"}],"container-title":["Journal of Crohn's and Colitis"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/academic.oup.com\/ecco-jcc\/advance-article-pdf\/doi\/10.1093\/ecco-jcc\/jjaa189\/33841308\/jjaa189.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"http:\/\/academic.oup.com\/ecco-jcc\/article-pdf\/15\/3\/462\/36463214\/jjaa189.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"http:\/\/academic.oup.com\/ecco-jcc\/article-pdf\/15\/3\/462\/36463214\/jjaa189.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,3,10]],"date-time":"2021-03-10T10:47:38Z","timestamp":1615373258000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/ecco-jcc\/article\/15\/3\/462\/5906029"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,9,15]]},"references-count":32,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2020,9,15]]},"published-print":{"date-parts":[[2021,3,5]]}},"URL":"https:\/\/doi.org\/10.1093\/ecco-jcc\/jjaa189","relation":{},"ISSN":["1873-9946","1876-4479"],"issn-type":[{"value":"1873-9946","type":"print"},{"value":"1876-4479","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2021,3,1]]},"published":{"date-parts":[[2020,9,15]]}}}