DOP82 Achievement of steroid-free remission in patients with moderately to severely active Crohn’s Disease during treatment with risankizumab

Abstract

Background: The efficacy and safety of risankizumab (RZB) as induction and maintenance therapy for patients with moderately to severely active Crohn's disease (CD) has been documented. Steroid-free clinical remission is an important additional treatment goal in CD. The efficacy of RZB by baseline steroid use during induction and steroid-free outcomes during maintenance was examined. Method(s): In ADVANCE (NCT03105128) and MOTIVATE (NCT03104413), patients with moderately to severely active CD received intravenous (IV) RZB induction therapy or placebo (PBO) for 12 weeks. Patients with clinical response to RZB were re-randomised in a 52-week maintenance study (FORTIFY; NCT03105102) to subcutaneous (SC) RZB or PBO (ie, withdrawal). Patients receiving steroids (maximum prednisone or equivalent < .001), and steroid-free endoscopic remission (P < .001) were significantly higher with RZB 360 mg SC vs withdrawal (PBO SC) at week 52 of maintenance (Figure 2B-2C). Conclusion(s): Efficacy of RZB induction therapy was independent of baseline steroid use. RZB maintenance promotes high rates of steroidfree clinical and endoscopic outcomes, demonstrating a benefit of RZB treatment in CD.