{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,6]],"date-time":"2026-05-06T02:08:03Z","timestamp":1778033283387,"version":"3.51.4"},"reference-count":15,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2025,6,14]],"date-time":"2025-06-14T00:00:00Z","timestamp":1749859200000},"content-version":"vor","delay-in-days":74,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,4,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Fecal calprotectin (FC) and C-reactive protein (CRP) are noninvasive biomarkers used in ulcerative colitis (UC) clinical trials; however, thresholds defined as \u201cnormal\u201d in trials may be higher than \u201cnormal\u201d thresholds typically used in clinical practice. We assessed the relationship between FC and CRP improvement in the \u201cnormal\u201d range across different cutoff thresholds for patients with moderately to severely active UC treated with mirikizumab.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Patients achieving clinical response to mirikizumab in LUCENT-1 (Weeks 0-12) proceeded to LUCENT-2 (Weeks 12-52 [52 weeks of continuous mirikizumab]). Associations between FC and CRP levels at multiple thresholds and histologic-endoscopic mucosal improvement (HEMI) and histologic-endoscopic mucosal remission (HEMR) at Weeks 12 and 52 were assessed by Fisher\u2019s exact test. Least squares means of FC and CRP changes from baseline at Weeks 12 and 52 were calculated using analysis of covariance with HEMI or HEMR status as factors and baseline FC or CRP values as covariates.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>At Weeks 12 and 52, greater proportions of patients with FC thresholds of \u2264250, \u2264150, \u2264100, and \u226450 \u00b5g\/g, and CRP thresholds of \u22646 and \u22645\u00a0mg\/L, achieved HEMI and HEMR compared with those not achieving HEMI and HEMR. Changes from baseline in FC and CRP at Week 12 and FC at Week 52 were greater in patients who achieved HEMI and HEMR compared with those not achieving these endpoints.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>These results show that FC and CRP analyses may contribute to a noninvasive monitoring strategy in clinical practice.<\/jats:p>\n                  <jats:p>ClinicalTrials.gov numbers: NCT03518086, NCT03524092.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/crocol\/otaf043","type":"journal-article","created":{"date-parts":[[2025,6,14]],"date-time":"2025-06-14T04:18:56Z","timestamp":1749874736000},"source":"Crossref","is-referenced-by-count":3,"title":["Fecal Calprotectin and C-Reactive Protein Association With Histologic and Endoscopic Endpoints in Mirikizumab-Treated Patients With Ulcerative Colitis"],"prefix":"10.1093","volume":"7","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5247-940X","authenticated-orcid":false,"given":"Remo","family":"Panaccione","sequence":"first","affiliation":[{"name":"Division of Gastroenterology and Hepatology, University of Calgary , Calgary ,","place":["Canada"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Faye","family":"Chan-Diehl","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company , Indianapolis, IN ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Simin","family":"Baygani","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company , Indianapolis, IN ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Deborah A","family":"Fisher","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company , Indianapolis, IN ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard E","family":"Moses","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company , Indianapolis, IN ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0055-958X","authenticated-orcid":false,"given":"Britta","family":"Siegmund","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Infectious Diseases, and Rheumatology, Universit\u00e4tsmedizin Berlin, Corporate Member of Freie Universit\u00e4t Berlin and Humboldt-Universit\u00e4t zu Berlin , Berlin ,","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alissa","family":"Walsh","sequence":"additional","affiliation":[{"name":"Translational Gastroenterology Unit, Oxford Biomedical Research Centre and John Radcliffe Hospital , Oxford ,","place":["UK"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"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 ,","place":["Japan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9514-2321","authenticated-orcid":false,"given":"Parambir S","family":"Dulai","sequence":"additional","affiliation":[{"name":"Department of Medicine (Gastroenterology and Hepatology), Northwestern University , Chicago, IL ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Simon","family":"Travis","sequence":"additional","affiliation":[{"name":"Translational Gastroenterology Unit, Oxford Biomedical Research Centre and John Radcliffe Hospital , Oxford ,","place":["UK"]},{"name":"Kennedy Institute, University of Oxford , Oxford ,","place":["UK"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2025,6,14]]},"reference":[{"issue":"5","key":"2025063005461445700_CIT0001","doi-asserted-by":"publisher","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."},{"issue":"10","key":"2025063005461445700_CIT0002","doi-asserted-by":"publisher","first-page":"1557","DOI":"10.1016\/j.cgh.2017.02.016","article-title":"histologic normalization occurs in ulcerative colitis and is associated with improved clinical outcomes","volume":"15","author":"Christensen","year":"2017","journal-title":"Clin Gastroenterol Hepatol."},{"issue":"3","key":"2025063005461445700_CIT0003","doi-asserted-by":"publisher","first-page":"344","DOI":"10.1053\/j.gastro.2022.12.007","article-title":"AGA clinical practice guideline on the role of biomarkers for the management of ulcerative colitis","volume":"164","author":"Singh","year":"2023","journal-title":"Gastroenterology."},{"issue":"10","key":"2025063005461445700_CIT0004","doi-asserted-by":"publisher","first-page":"1451","DOI":"10.1093\/ibd\/izaa210","article-title":"Defining the path forward for biomarkers to address unmet needs in inflammatory bowel diseases","volume":"26","author":"Honig","year":"2020","journal-title":"Inflamm Bowel Dis."},{"issue":"11","key":"2025063005461445700_CIT0005","doi-asserted-by":"publisher","first-page":"2333","DOI":"10.1016\/j.cgh.2020.08.019","article-title":"diagnostic accuracy of fecal calprotectin concentration in evaluating therapeutic outcomes of patients with ulcerative colitis","volume":"19","author":"Stevens","year":"2021","journal-title":"Clin Gastroenterol Hepatol."},{"issue":"11","key":"2025063005461445700_CIT0006","doi-asserted-by":"publisher","first-page":"1929","DOI":"10.1016\/j.cgh.2015.05.038","article-title":"Level of fecal calprotectin correlates with endoscopic and histologic inflammation and identifies patients with mucosal healing in ulcerative colitis","volume":"13","author":"Theede","year":"2015","journal-title":"Clin Gastroenterol Hepatol."},{"issue":"4","key":"2025063005461445700_CIT0007","doi-asserted-by":"publisher","first-page":"424","DOI":"10.1093\/ecco-jcc\/jjy184","article-title":"Defining faecal calprotectin thresholds as a surrogate for endoscopic and histological disease activity in ulcerative colitis-a prospective analysis","volume":"13","author":"Walsh","year":"2019","journal-title":"J Crohns Colitis."},{"issue":"2","key":"2025063005461445700_CIT0008","doi-asserted-by":"publisher","first-page":"456","DOI":"10.1016\/j.cgh.2022.07.027","article-title":"Prognostic value of fecal calprotectin to inform treat-to-target monitoring in ulcerative colitis","volume":"21","author":"Dulai","year":"2023","journal-title":"Clin Gastroenterol Hepatol."},{"issue":"7","key":"2025063005461445700_CIT0009","doi-asserted-by":"publisher","first-page":"1089","DOI":"10.1093\/ecco-jcc\/jjac014","article-title":"Markers of systemic inflammation in acute attacks of ulcerative colitis: what level of c-reactive protein constitutes severe colitis","volume":"16","author":"Croft","year":"2022","journal-title":"J Crohns Colitis."},{"issue":"4","key":"2025063005461445700_CIT0010","doi-asserted-by":"publisher","first-page":"1032","DOI":"10.1053\/j.gastro.2019.06.018","article-title":"Approaches to integrating biomarkers into clinical trials and care pathways as targets for the treatment of inflammatory bowel diseases","volume":"157","author":"Dulai","year":"2019","journal-title":"Gastroenterology."},{"issue":"3","key":"2025063005461445700_CIT0011","doi-asserted-by":"publisher","first-page":"e00138","DOI":"10.14309\/ctg.0000000000000138","article-title":"Combined use of common fecal and blood markers for detection of endoscopically active inflammatory bowel disease","volume":"11","author":"Mak","year":"2020","journal-title":"Clin Transl Gastroenterol"},{"issue":"2","key":"2025063005461445700_CIT0012","doi-asserted-by":"publisher","first-page":"332","DOI":"10.1097\/MIB.0b013e3182810066","article-title":"Fecal calprotectin more accurately reflects endoscopic activity of ulcerative colitis than the Lichtiger Index, C-reactive protein, platelets, hemoglobin, and blood leukocytes","volume":"19","author":"Schoepfer","year":"2013","journal-title":"Inflamm Bowel Dis."},{"issue":"26","key":"2025063005461445700_CIT0013","doi-asserted-by":"publisher","first-page":"2444","DOI":"10.1056\/NEJMoa2207940","article-title":"Mirikizumab as induction and maintenance therapy for ulcerative colitis","volume":"388","author":"D\u2019Haens","year":"2023","journal-title":"N Engl J Med."},{"key":"2025063005461445700_CIT0014","doi-asserted-by":"publisher","first-page":"197","DOI":"10.1186\/s12876-021-01788-4","article-title":"Extent of disease affects the usefulness of fecal biomarkers in ulcerative colitis","volume":"21","author":"Sakuraba","year":"2021","journal-title":"BMC Gastroenterol."},{"issue":"7","key":"2025063005461445700_CIT0015","doi-asserted-by":"publisher","first-page":"849","DOI":"10.1080\/00365521.2019.1618910","article-title":"Is home monitoring of inflammatory bowel disease feasible? A randomized controlled study","volume":"54","author":"Puolanne","year":"2019","journal-title":"Scand J Gastroenterol."}],"container-title":["Crohn's &amp; Colitis 360"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/crohnscolitis360\/advance-article-pdf\/doi\/10.1093\/crocol\/otaf043\/63488745\/otaf043.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/crohnscolitis360\/article-pdf\/7\/2\/otaf043\/63488745\/otaf043.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/crohnscolitis360\/article-pdf\/7\/2\/otaf043\/63488745\/otaf043.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,6,30]],"date-time":"2025-06-30T09:46:24Z","timestamp":1751276784000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/crohnscolitis360\/article\/doi\/10.1093\/crocol\/otaf043\/8162447"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,4]]},"references-count":15,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2025,4,10]]}},"URL":"https:\/\/doi.org\/10.1093\/crocol\/otaf043","relation":{},"ISSN":["2631-827X"],"issn-type":[{"value":"2631-827X","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2025,4]]},"published":{"date-parts":[[2025,4]]},"article-number":"otaf043"}}