S5 Sustained Improvements in Health-Related Quality of Life Outcomes With Long-Term Risankizumab Treatment in Patients With Moderately to Severely Active Crohn’s Disease: Results from the FORTIFY Open-Label, Long-Term Extension

Abstract

Background: Due to the debilitating and progressive nature of Crohn's disease (CD), the healthrelated quality of life (HRQoL) of affected individuals is often negatively impacted. Risankizumab (RZB) is an interleukin-23 p19 inhibitor approved for the treatment of moderately to severely active CD, with demonstrated efficacy in improving HRQoL outcomes through 52 weeks of treatment in the phase 3 trial.1 Here, we evaluated the ability of RZB to sustain HRQoL improvements in patients with CD who completed 52 weeks of maintenance and 52 weeks of treatment in the ongoing FORTIFY open-label, long-term extension (OLE). Method(s): The FORTIFY (NCT03105102) OLE enrolled patients who completed 52 weeks of RZB maintenance dosing in the FORTIFY substudies or RZB phase 2 OLE.2 Patients received RZB 180 mg subcutaneous (SC) every 8 weeks, except for patients who had prior rescue therapy or who received rescue during OLE, who continued RZB 360 mg SC. This analysis pooled data from both treatment groups (RZB 180 mg and 360 mg) who completed 52 weeks of the OLE (week 104). HRQoL outcomes included Inflammatory Bowel Disease Questionnaire (IBDQ) response ( =170 points), improvement in 36-Item Short Form Survey (SF-36) physical component score (PCS,