{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T21:02:05Z","timestamp":1792443725380,"version":"4.5.0"},"reference-count":27,"publisher":"MDPI AG","issue":"17","license":[{"start":{"date-parts":[[2024,8,30]],"date-time":"2024-08-30T00:00:00Z","timestamp":1724976000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Ferring Pharmaceuticals"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: Current management of mild-to-moderate ulcerative colitis (UC) involves monitoring clinical markers of disease activity, such as stool frequency (SF) and rectal bleeding (RB), and adjusting treatment accordingly. Our aim was to assess whether targeting treatment based on faecal calprotectin (FC) levels (treat-to-target; T2T) provides greater UC disease control versus a symptom-based approach. Methods: This was a pragmatic, randomised (1:1) controlled study of patients with mild-to-moderate UC (global Mayo score 2\u20136) treated with \u22642.4 g\/day 5-aminosalicylic acid that compared the effectiveness of two management strategies with (interventional arm) and without (reference arm) FC home monitoring over 12 months of follow-up. Treatment was optimised in the interventional arm using FC values and clinical symptoms (PRO-2), while the reference arm used only PRO-2. Results: 193 patients completed the study. No significant difference was found for the primary endpoint (Mayo Endoscopic Subscore [MES] = 0 at 12 months). A numerical advantage for the interventional arm over the reference arm for the primary endpoint (37.0% vs. 33.4%, respectively) and for MES \u2264 1, RB = 0, and SF \u2264 1 at 12 months was found following imputation for missing data. The composite endpoint of MES = 0, RB = 0, and SF \u2264 1 at 12 months was achieved at a significantly higher rate in the interventional arm than the reference arm (effect size [ES]: 0.17, 95% CI 0.02\u20130.32; p &lt; 0.05). A similar result was obtained for MES \u2264 1, RB = 0 and SF \u2264 1 (ES: 0.22; 95% CI 0.07\u20130.37; p &lt; 0.05). Conclusions: T2T using FC monitoring was effective in patients with mild-to-moderate UC at 12 months. Further longer-term studies are required to confirm the results.<\/jats:p>","DOI":"10.3390\/jcm13175147","type":"journal-article","created":{"date-parts":[[2024,8,30]],"date-time":"2024-08-30T07:45:47Z","timestamp":1725003947000},"page":"5147","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Clinical Trial: A Pragmatic Randomised Controlled Study to Assess the Effectiveness of Two Patient Management Strategies in Mild to Moderate Ulcerative Colitis\u2014The OPTIMISE Study"],"prefix":"10.3390","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7341-1351","authenticated-orcid":false,"given":"Silvio","family":"Danese","sequence":"first","affiliation":[{"name":"Department of Gastroenterology and Digestive Endoscopy, San Raffaele Hospital, Vita-Salute San Raffaele University, 20132 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5623-2968","authenticated-orcid":false,"given":"Gionata","family":"Fiorino","sequence":"additional","affiliation":[{"name":"IBD Unit, Department of Gastroenterology and Digestive Endoscopy, San Camillo-Forlanini Hospital, 00152 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6303-8557","authenticated-orcid":false,"given":"Eric","family":"Vicaut","sequence":"additional","affiliation":[{"name":"Clinical Trial Unit, Hospital Lariboisi\u00e8re APHP, 75010 Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6865-5415","authenticated-orcid":false,"given":"Kristine","family":"Paridaens","sequence":"additional","affiliation":[{"name":"Ferring International Center S.A, 1162 Saint-Prex, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-5705-8462","authenticated-orcid":false,"given":"Asiya","family":"Ugur","sequence":"additional","affiliation":[{"name":"Ferring Pharmaceuticals A\/S, 2770 Kastrup, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Clark","sequence":"additional","affiliation":[{"name":"Ferring Pharmaceuticals A\/S, 2770 Kastrup, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomas","family":"Vanasek","sequence":"additional","affiliation":[{"name":"Hepato-Gastroenterologie HK, s.r.o., 50012 Hradec Kr\u00e1lov\u00e9, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Stepek","sequence":"additional","affiliation":[{"name":"Internal Department, Military Hospital Brno, 61500 Brno, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8591-6995","authenticated-orcid":false,"given":"Ferdinando","family":"D\u2019Amico","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Digestive Endoscopy, San Raffaele Hospital, Vita-Salute San Raffaele University, 20132 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachel","family":"West","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Franciscus Gasthuis & Vlietland, 3045 PM Rotterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lennard P. L.","family":"Gilissen","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Catharina Hospital Eindhoven, 5623 EJ Eindhoven, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Wisniewska Jarosinka","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Medical University of Lodz, 92-213 Lodz, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piotr","family":"Drobinski","sequence":"additional","affiliation":[{"name":"Centrum Medyczne Lukamed in Chojnice, 89-600 Chojnice, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Grzegorz","family":"Fronik","sequence":"additional","affiliation":[{"name":"Melita Medical\u2014Centrum Proktologii, Onkologii i Chor\u00f3b Jelit, 50-449 Wroc\u0142aw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miros\u0142aw","family":"Fic","sequence":"additional","affiliation":[{"name":"Polish Society of Gastroenterology, 58-521 Jez\u00f3w Sudecki, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Micha\u0142","family":"Walczak","sequence":"additional","affiliation":[{"name":"Institute of Human Genetics, Polish Academy of Sciences, 61-772 Poznan, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maciej","family":"Kowalski","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Centrum Diagnostyczno\u2014Lecznicze Barska, 87-806 W\u0142oc\u0142awek, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1626-1283","authenticated-orcid":false,"given":"Bartosz","family":"Korczowski","sequence":"additional","affiliation":[{"name":"Institute of Medical Sciences, Medical College, University of Rzesz\u00f3w, 35-310 Rzesz\u00f3w, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michal","family":"Wiatr","sequence":"additional","affiliation":[{"name":"O\u015brodek Bada\u0144 Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak Ma\u0142gorzata Trzaska, Cha\u0142ubi\u0144skiego, 85-004 Bydgoszcz, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"Peyrin-Biroulet","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Inserm NGERE U1256, University Hospital of Nancy, University of Lorraine, 54000 Vandoeuvre-l\u00e8s-Nancy, France"},{"name":"Department of Gastroenterology, Nancy University Hospital, 54500 Vand\u0153uvre-l\u00e8s-Nancy, France"},{"name":"INFINY Institute, Nancy University Hospital, 54500 Vand\u0153uvre-l\u00e8s-Nancy, France"},{"name":"FHU-CURE, Nancy University Hospital, 54500 Vand\u0153uvre-l\u00e8s-Nancy, France"},{"name":"Groupe Hospitalier Priv\u00e9 Ambroise Par\u00e9\u2014Hartmann, Paris IBD Center, 92200 Neuilly sur Seine, France"},{"name":"Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, QC H4A 3J1, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,8,30]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"649","DOI":"10.1093\/ecco-jcc\/jjx008","article-title":"Third European Evidence-Based Consensus on Diagnosis and Management of Ulcerative Colitis. 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