P433 Efficacy of risankizumab by baseline clinical, biochemical, and endoscopic disease severity in moderately to severely active Crohn's disease

Abstract Background Risankizumab (RZB), a p19-anti-interleukin-23 monoclonal antibody, has demonstrated efficacy as induction and maintenance therapy in patients with moderately to severely active Crohn’s disease (CD). This post hoc analysis evaluates the of RZB by baseline clinical, biochemical, endoscopic severity. Methods In ADVANCE (NCT03105128) MOTIVATE (NCT03104413) studies, CD intolerance/inadequate response ≥ 1 biologic (both studies) and/or conventional (ADVANCE) were randomized receive intravenous (IV) or placebo (PBO) for 12 weeks. Patients achieving stool frequency abdominal pain score clinical weeks rerandomized FORTIFY (NCT03105102) study subcutaneous (SC) (180 mg 360 mg) PBO (withdrawal). Clinical endpoints evaluated characteristics (Crohn’s Disease Activity Index [CDAI: ≤ 300, > 300], highsensitivity C-reactive protein [hs-CRP: < 10 mg/L, mg/L], Simple Endoscopic Score [SES-CD: 6−15, 15]). Induction analyses included who received 600 PBO; data from studies pooled. Nonresponder imputation incorporating multiple handle missing due COVID-19 was used. Results The 527 IV 362 PBO. treated achieved significantly higher rates vs at week 12, regardless subgroup (P .05 all; Figure 1). study, SC continued achieve (withdrawal) group 52 not 2). Improvements outcomes generally observed treatment across all subgroups. Response similar subgroups both studies; remission ulcer-free endoscopy (resolution ulcer) numerically lower increased inflammation (hs-CRP mg/mL) activity (SES-CD 15). Conclusion resulted compared also showed durable therapy, supporting long-term use range severity activity.