Efficacy and safety of risankizumab in patients with moderately to severely active Crohn's disease: interim results from the SEQUENCE open-label extension study.

ABSTRACT:

Background and aims

Risankizumab, a selective interleukin-23 p19 inhibitor, is approved to treat moderately to severely active Crohn's disease (CD) in adults. We report interim results from part 2 of the ongoing SEQUENCE trial evaluating long-term efficacy and safety of risankizumab in patients with active CD and previous anti-tumor necrosis factor failure.

Methods

Patients randomized to risankizumab who completed the part 1 Week 48 visit could continue receiving open-label subcutaneous risankizumab 360 mg every 8 weeks (part 2). Patients with inadequate response could receive rescue therapy (intravenous risankizumab 600 mg) before continuing regular treatment. This interim analysis assessed efficacy at Weeks 52, 76, and 100 of treatment; safety was evaluated throughout.

SUBMITTER: Peyrin-Biroulet L 

PROVIDER: S-EPMC12726915 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature