S1543 Real-World Effectiveness of Risankizumab on Clinical and Patient-Reported Outcomes in Patients With Moderate-to-Severe Crohn’s Disease in the PPD CorEvitas Inflammatory Bowel Disease Registry

Introduction: Risankizumab (RZB) is an interleukin-23A inhibitor approved for treatment of moderate-to-severe Crohn’s disease (CD); however, real-world evidence on RZB use is limited. This study investigated the impact of RZB on clinical and patient-reported outcomes (PROs) among patients with CD in a real-world setting. Methods: This prospective cohort study included patients with CD who enrolled in the PPD™ CorEvitas™ Inflammatory Bowel Diseases Registry and initiated RZB at or after a Registry visit from 05/03/2017–03/01/2025. Disease activity (Harvey Bradshaw Index [HBI]), PRO Measurement Information System measures (PROMIS), and Work Productivity and Activity Impairment (WPAI) questionnaire scores were assessed at RZB initiation (baseline) and 6-month follow-up visits; mean changes were calculated and significance was assessed using paired Student’s t-tests. Results: Of 127 patients who initiated RZB, 55.1% were women, the mean (standard deviation [SD]) age was 44.7 (15.6) years, and time since diagnosis was 15.3 (13.1) years. At baseline, 20.5% of patients were naive to advanced therapy, 21.3% had 1 and 58.3% had ≥2 prior advanced therapies. Mean (SD) HBI significantly decreased (P = 0.014) from 5.3 (5.0) at baseline to 4.2 (4.3) at 6 months and more patients were in remission (HBI <5) at 6 months (67.0%, 61/91) than at baseline (56.0%, 51/91). Specifically, patients reporting general well-being as very well and no abdominal pain increased from 32.0% (40/125) to 49.6% (62/125; P < 0.001) and 44.0% (55/125) to 61.6% (77/125; P = 0.009), respectively. At 6 months, mean (SD) fatigue (N = 123) and pain interference (N = 124) scores decreased from 54.6 (11.9) to 51.6 (12.2; P < 0.001) and 53.0 (11.1) to 50.4 (10.7; P = 0.004), respectively. At baseline, 56.9% (n = 70) and 48.4% (n = 60) of patients had above normal (≥55) fatigue and pain levels, which decreased to 45.5% (n = 56, P = 0.011) and 33.9% (n = 42, P = 0.002) at 6 months, respectively. Among RZB initiators, 65.1% were employed (82/126); reductions in WPAI impairment while working (81.5% [53/65] to 63.1% [41/65]; P = 0.003), WPAI absenteeism (28.8% [19/66] to 15.2% [10/66]; P = 0.052) and WPAI activity impairment (76.6% [95/124] to 64.5% [80/124]; P = 0.009) were observed from baseline to 6 months. Conclusion: This real-world analysis found RZB significantly reduced disease activity and improved PROs 6 months after initiation, indicating that RZB is an effective treatment in patients with CD who were predominantly advanced-therapy experienced.