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ABSTRACT: Introduction
To assess the effectiveness and safety of Risankizumab (RZB) in a large, nationwide real-world cohort of patients with Crohn's disease (CD).Methods
We conducted a multicenter, retrospective observational cohort of adults initiating RZB with assessments at weeks 12, 26, and 52. Coprimary end points were (i) week-12 steroid-free clinical remission (SFCR) (Harvey-Bradshaw Index <5 in the absence of systemic corticosteroids or budesonide) and (ii) week-52 endoscopic remission (Simple Endoscopic Score-CD 0-2 or Rutgeerts i0-i1 postoperatively). The main effectiveness analysis was as-observed; a preplanned sensitivity analysis included patients expected to reach week-52 before database lock and applied nonresponder imputation.Results
We included 520 patients,
SUBMITTER: Scaldaferri F
PROVIDER: S-EPMC13629653 | biostudies-literature | 2026 Oct
REPOSITORIES: biostudies-literature