Crohn’s Colitis Foundation Perspectives

Association of Biomarker Cutoffs and Endoscopic Outcomes in Crohn's Disease: A Post Hoc Analysis From the CALM Study

Walter Reinisch, Remo Panaccione, Peter Bossuyt, Filip Baert, Alessandro Armuzzi, Xavier Hébuterne, Simon Travis, Silvio Danese, William J Sandborn, Stefan Schreiber, Sofie Berg, Qian Zhou, Kristina Kligys, Ezequiel Neimark, Ahmed A Suleiman, Geert D'Haens, Jean-Frederic Colombel

Background: CALM was a randomized phase 3 trial in patients with Crohn's disease (CD) that demonstrated improved endoscopic outcomes when treatment was escalated based on cutoffs for inflammatory biomarkers, fecal calprotectin (FC), C-reactive protein (CRP), and CD Activity Index (CDAI) remission vs CDAI response alone. The purpose of this post hoc analysis of CALM was to identify drivers of treatment escalation and evaluate the association between biomarker cutoff concentrations and endoscopic end points.

Methods: The proportion of patients achieving CD Endoscopic Index of Severity (CDEIS) <4 and no deep ulcers 48 weeks after randomization was evaluated according to CRP <5 mg/L or ≥5 mg/L and FC <250 μg/g or ≥250 μg/g. Subgroup analyses were performed according to disease location, and sensitivity analyses were conducted in patients with elevated CRP and/or FC at baseline. The association between endoscopic end points and biomarker cutoffs was performed using …

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