Risankizumab Is Associated With Normalization of Biomarkers in Patients With Crohn's Disease: Results From the Phase 3 ADVANCE, MOTIVATE, and FORTIFY Studies.

ABSTRACT:

Background and aims

Normalization of high-sensitivity C-reactive protein (hs-CRP) and fecal calprotectin (FCP) are suggested as intermediate treatment targets for Crohn's disease (CD). This analysis evaluates achievement of biomarker normalization and the relationship between improvements in biomarker concentrations and clinical and endoscopic outcomes among patients treated with risankizumab.

Methods

This post hoc analysis included patients with moderately to severely active CD and elevated baseline hs-CRP (>5 mg/L) or FCP (>250 µg/g) concentrations from the 12-week ADVANCE and MOTIVATE induction studies, and the 52-week FORTIFY maintenance study. We assessed the proportion of patients achieving biomarker normalization, defined as hs-CRP ≤5 mg/L and FCP ≤250 µg/g, and the a

SUBMITTER: Atreya R 

PROVIDER: S-EPMC12001336 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature