D0383 - Baseline and Early Predictors of Response to Risankizumab Induction and Maintenance Treatment in Patients With Moderate to Severe Crohn's Disease

Introduction: Pivotal phase 3 induction (ADVANCE and MOTIVATE) and maintenance (FORTIFY) studies established that treatment with risankizumab (RZB), a humanized monoclonal antibody with high specificity for the p19 subunit of interleukin-23, was superior to placebo for achieving clinical remission and endoscopic response in patients with moderate to severe Crohn's disease (CD). This exploratory analysis aimed to determine predictors of response to risankizumab induction and maintenance therapy.

Methods: Pooled data from patients in the RZB 600 mg intravenous (IV) dosing groups in ADVANCE + MOTIVATE induction studies (n=527) and data from the RZB 360 mg subcutaneous (SC) dosing group in FORTIFY (n=141) were evaluated. Multivariate logistic regression models were used to determine predictors of clinical and endoscopic outcomes at Weeks 12 and 52. For FORTIFY, separate logistic regression models were used to access end-of-induction characteristics for the achievement of outcomes at Week 52.

Results: Baseline characteristics found to be predictive of clinical and/or endoscopic outcomes at Week 12 and Week 52 are highlighted in the table. Age and duration of disease were evaluated but were not predictive. Compared to patients with ileal disease, patients with colonic disease were more likely to achieve endoscopic endpoints at Week 12, while patients with ileal-colonic disease were more likely to achieve endoscopic response at Week 12; patients with either colonic or ileal-colonic disease were more likely to achieve endoscopic response at Week 52. Conversely, patients with prior bio-failure at BL were less likely to achieve endoscopic response at Week 12, and clinical and endoscopic responses at Week 52. Patients using corticosteroids at BL were less likely to achieve clinical endpoints at Weeks 12 and 52. Patients achieving clinical or endoscopic endpoints at Week 12 were more likely to achieve these endpoints at Week 52.

Discussion: For patients treated with risankizumab, baseline disease location predicted achievement of endoscopic responses, corticosteroid use predicted achievement of clinical endpoints, and prior bio-failure status predicted achievement of both clinical and endoscopic endpoints at Week 52. Notably, achievement of clinical or endoscopic outcomes after induction with risankizumab were associated with a higher likelihood of achieving long-term clinical and endoscopic outcomes.