The Effect of Etrasimod on Fecal Calprotectin and High-sensitivity C-reactive Protein: Results From the ELEVATE UC Clinical Program.

Autor:	Jairath V; Department of Medicine and Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada., Rubin DT; University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL, USA., Verstockt B; Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.; Department of Chronic Diseases and Metabolism, Translational Research in Gastrointestinal Disorders, KU Leuven, Leuven, Belgium., Çekin AH; Department of Gastroenterology, University of Health Sciences, Antalya Training and Research Hospital, Antalya, Turkey., Abreu MT; Division of Gastroenterology, Crohn's and Colitis Center, University of Miami Miller School of Medicine, Miami, FL, USA., Lees CW; The Edinburgh Inflammatory Bowel Disease Unit, Western General Hospital, Edinburgh, Scotland, UK., Fellmann M; Pfizer AG, Zürich, Switzerland., Woolcott JC; Pfizer Inc, Collegeville, PA, USA., Crosby C; Pfizer Inc, La Jolla, CA, USA., Wu J; Pfizer Inc, Cambridge, MA, USA., Bhattacharjee A; Pfizer Healthcare India Pvt Ltd, Chennai, Tamil Nadu, India., Herman D; Pfizer Inc, La Jolla, CA, USA., Gu G; Pfizer Inc, La Jolla, CA, USA., Siegmund B; Medizinische Klinik für Gastroenterologie, Infektiologie und Rheumatologie, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin, Germany.
Jazyk:	angličtina
Zdroj:	Inflammatory bowel diseases [Inflamm Bowel Dis] 2024 Jun 20. Date of Electronic Publication: 2024 Jun 20.
DOI:	10.1093/ibd/izae111
Abstrakt:	Background: Biomarkers offer potential alternatives to endoscopies in monitoring ulcerative colitis (UC) progression and therapeutic response. This post hoc analysis of the ELEVATE UC clinical program assessed potential predictive values of fecal calprotectin (fCAL) and high-sensitivity C-reactive protein (hsCRP) as biomarkers and associated responses to etrasimod, an oral, once-daily, selective sphingosine 1-phosphate (S1P)1,4,5 receptor modulator for the treatment of moderately to severely active UC, in 2 phase 3 clinical trials. Methods: In ELEVATE UC 52 and ELEVATE UC 12, patients were randomized 2:1 to 2 mg of etrasimod once daily or placebo for 52 or 12 weeks, respectively. Fecal calprotectin/hsCRP differences between responders and nonresponders for efficacy end points (clinical remission, clinical response, endoscopic improvement-histologic remission [EIHR]) were assessed by Wilcoxon P-values. Sensitivity and specificity were presented as receiver operating characteristics (ROC) curves with area under the curve (AUC). Results: In ELEVATE UC 52 and ELEVATE UC 12, 289 and 238 patients received etrasimod and 144 and 116 received placebo, respectively. Baseline fCAL/hsCRP concentrations were generally balanced. Both trials had lower week-12 median fCAL levels in week-12 responders vs nonresponders receiving etrasimod for clinical remission, clinical response, and EIHR (all P < .001), with similar trends for hsCRP levels (all P < .01). For etrasimod, AUCs for fCAL/hsCRP and EIHR were 0.85/0.74 (week 12; ELEVATE UC 52), 0.83/0.69 (week 52; ELEVATE UC 52), and 0.80/0.65 (week 12; ELEVATE UC 12). Conclusions: Fecal calprotectin/hsCRP levels decreased with etrasimod treatment; ROC analyses indicated a prognostic correlation between fCAL changes during induction and short-/long-term treatment response. (© 2024 Crohn’s & Colitis Foundation. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu