S1737 Patient-Reported Use of Concomitant Treatments for Crohn’s Disease Among Adults Treated With Risankizumab in Clinical Practice: Initial Results From the ASPIRE-CD Study

Introduction: Risankizumab (RZB) is an IL-23 p19 inhibitor biologic therapy approved for the treatment of moderately to severely active Crohn’s disease (CD). Here, we report initial results of the real-world impact of RZB on the use of concomitant treatments in patients with CD enrolled in the prospective, observational ASPIRE-CD study. Methods: The ASPIRE-CD study included adult patients who initiated RZB for CD and enrolled in the RZB patient support program in the USA. Patients were asked to complete surveys before (baseline) and at weeks (wks) 2, 4, 12, and every 8 wks after the first RZB induction dose. Concomitant treatment was defined as using the treatment within the past 2 weeks for wk2 and wk4 surveys, and within the past 4 weeks for all other surveys. Patients were asked whether they were taking any concomitant treatments for CD in the last 2 to 4 weeks, including corticosteroids, over-the-counter (OTC) medications, and dietary adjustments (nutritional supplements, dietary restriction). Results: Of the 286 patients who received the first induction RZB dose, 212 (76.0%) completed the wk20 survey. Most patients had prior biologic or Janus kinase inhibitor (JAKi) experience (75.2%) at baseline, with 45.5% having ≥2 prior biologics or JAKis. Patient-reported corticosteroid use reduced from 33.9% at baseline to 14.6% at wk20 (P < .001). The proportion of patients taking prescribed treatments other than steroids was low at baseline (5-aminosalicylates: 7.0%; immunosuppressants: 9.4%; antibiotics: 7.7%) and remained stable over 20 weeks. At wk20, the proportion of patients taking OTC treatments for CD was 53.8% vs 72.0% at baseline (P < .001). Patients taking OTC treatments for pain (acetaminophen, ibuprofen, or naproxen) decreased from 42.0% at baseline to 29.2% at wk20 (P < .01). Patients making dietary adjustments also reduced from 30.8% at baseline to 17.0% (P < .01). The proportion of patients taking vitamin or mineral supplementation decreased from baseline to wk20, as did the proportion of patients restricting their diet. Conclusion: Initial results from this real-world study demonstrate that patients with moderately to severely active CD treated with RZB quickly (as early as wk4) reduced their use of concomitant corticosteroids, OTC medications to treat pain, and their need for diet restrictions and supplements. Future analyses of the ASPIRE-CD study will evaluate the long-term impact of RZB on concomitant treatment use.