S1979 Real-World Impact of Risankizumab on Health-Related Quality of Life in Adults With Crohn’s Disease: Initial Results From the ASPIRE-CD Study

Introduction: Restoring health-related quality of life (HRQL) is an important long-term treatment target for patients with Crohn’s disease (CD). Risankizumab (RZB), an IL-23 p19 inhibitor, has shown improvements in HRQL for patients with moderate to severe CD in clinical trials. Here, we report initial results of real-world impact of RZB treatment on HRQL in patients with CD from the prospective, observational ASPIRE-CD study. Methods: Adult patients who enrolled in the RZB patient support program in the USA were invited to participate in ASPIRE-CD. Patients were asked to complete a survey at baseline and at weeks (wks) 2, 4, and 12 after the first RZB induction dose. The survey assessed different CD-related aspects of HRQL via the Inflammatory Bowel Disease Questionnaire (IBDQ), the Short-Form 12-Item Survey (SF-12 v2) physical and mental component scores (PCS and MCS), the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-Fatigue), and the impact of CD on sexual interest/activity. Results: Of 286 patients who received the first RZB induction dose, 241 (84.3%) completed the 12-wk survey. Those completing the wk12 survey had an average age of 46.1 years, 57.7% were women, and 74.3% had prior biologic or Janus kinase inhibitor (JAKi) exposure with 43.6% having ≥2 prior biologics or JAKis in their treatment history at baseline. The proportion of patients who achieved IBDQ response at wks 4 and 12 were 36.5% and 38.2%, respectively. At wk12, patients achieving IBDQ remission increased from 34.3% at baseline to 54.8% (P < .001) and the mean SF-12 PCS increased from 46.2 to 49.0 (P < .001). The mean SF-12 MCS remained stable overall and for most MCS domains through 12 wks, except for the mean social functioning domain score, which increased from 45.4 to 48.2 (P < .01). Among patients who experienced fatigue (FACIT-Fatigue score of < 40) at baseline (189/286 [66.1%]), 23.1% achieved FACIT-Fatigue response by wk12. At wk12, patients reporting that CD “very much” negatively affected sexual interest/activity decreased from 19.8% at baseline to 12.6%; whereas those who answered “not at all” increased from 31.6% to 44.2% (P < .01). Conclusion: Initial results from the ASPIRE-CD study showed improvements in HRQL, including reduced fatigue and improved sexual interest/satisfaction, from baseline to as early as 4 wks of RZB initiation, which continued through wk12. Future data will characterize the long-term real-world experiences of these patients.