P1104 - 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

Raymond K. Cross, MD, MS, FACG¹, Jenny M. Griffith, PharmD², Alicia Beeghly, MPH, PhD³, Margaux Crabtree, MPH³, Jae Rok Kim, PharmD, MS⁴, Marie Gurrola, MPH³
1The Melissa L. Posner Institute for Digestive Health & Liver Disease, Mercy Medical Center, Baltimore, MD; 2AbbVie Inc, North Chicago, IL; 3Thermo Fisher Scientific, Waltham, MA; 4AbbVie Inc, Irvine, CA

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^TM CorEvitas^TM 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 female, 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) (Figure 1). 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 (Figure 2). 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.

Discussion: 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.


Figure: Figure 1


Figure: Figure 2

Disclosures:
Raymond K. Cross: Abbvie – Advisor or Review Panel Member, Consultant, Speakers Bureau. BMS – Advisor or Review Panel Member, Consultant, Speakers Bureau. CorEvitas – Advisory Committee/Board Member. Fresenius Kabi – Advisory Committee/Board Member, Consultant. Genetech – Advisory Committee/Board Member, Consultant. Gilead – Advisory Committee/Board Member, Consultant. IBD Education Group – Advisory Committee/Board Member. Janssen – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Magellan Health – Advisory Committee/Board Member, Consultant. Option Care – Advisory Committee/Board Member, Consultant. Pfizer – Advisory Committee/Board Member, Consultant, Speakers Bureau. Pharmacosmos – Advisory Committee/Board Member, Consultant. Samsung Bioepis – Advisory Committee/Board Member, Consultant. Sandoz – Advisory Committee/Board Member, Consultant. Takeda – Grant/Research Support.
Jenny M. Griffith: AbbVie – Employee, Stock Options.
Alicia Beeghly: Thermo Fisher Scientific, Inc – Employee, Stock-publicly held company(excluding mutual/index funds).
Margaux Crabtree: Thermo Fisher Scientific, Inc – Employee, Stock-publicly held company(excluding mutual/index funds).
Jae Rok Kim: AbbVie – Employee, Stock Options.
Marie Gurrola: Thermo Fisher Scientific, Inc – Employee.

Raymond K. Cross, MD, MS, FACG¹, Jenny M. Griffith, PharmD², Alicia Beeghly, MPH, PhD³, Margaux Crabtree, MPH³, Jae Rok Kim, PharmD, MS⁴, Marie Gurrola, MPH³. P1104 - 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, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.