S695 Risankizumab Induces Early Clinical Remission and Response in Patients With Moderate-To-Severe Crohn’s Disease: Results From the Phase 3 ADVANCE and MOTIVATE Studies

Introduction: Present therapies leave an unmet need for early and effective treatment for patients with Crohn’s disease (CD). Risankizumab (RZB), a humanized immunoglobulin G1 monoclonal antibody against the p19 subunit of interleukin-23, was evaluated as an induction therapy to induce early clinical remission and response in patients with moderate-to-severe CD in two double-blind, randomized, placebo (PBO)-controlled studies (ADVANCE [NCT03104413] and MOTIVATE [NCT03105128]). Methods: Patients with moderate-to-severe CD (CD Activity Index [CDAI] of 220–450, Simple Endoscopic Score for CD [SES-CD] ≥ 6 [≥ 4 for isolated ileal disease] excluding the narrowing component, and average daily [liquid/very soft] stool frequency [SF] ≥ 4 and/or average daily abdominal pain [AP] score ≥ 2) who had inadequate response or intolerance to conventional and/or biologic treatment (ADVANCE), or biologic treatment only (MOTIVATE) were randomised 2:2:1 (ADVANCE) or 1:1:1 (MOTIVATE) to receive intravenous RZB 600 mg, RZB 1200 mg, or PBO as induction therapy at weeks 0, 4, and 8. Clinical remission and clinical response were defined by either CDAI or a composite of SF and AP criteria, at weeks 4, 8, and 12 (endpoints defined in Figure 1 footnotes). Safety was assessed throughout the studies. Results: A total of 1419 patients from ADVANCE (N = 850) and MOTIVATE (N = 569) respectively, were randomised and included in the intention-to-treat population. In both studies, greater proportions of RZB- vs PBO-treated patients achieved clinical remission and clinical response per CDAI or SF/AP criteria starting at week 4 (P ≤ .05) and sustained through week 12 (P ≤ 0.001) (Figure 1). Treatment with RZB 600 mg or 1200 mg was well tolerated, and no new safety risks were identified. Conclusion: Induction therapy with both RZB 600 mg and 1200 mg intravenous resulted in significantly greater clinical remission and response vs PBO as early as week 4 and sustained through week 12 in patients with moderate-to-severe CD who had inadequate response or intolerance to conventional and/or biologic treatment.Figure 1.: Clinical Remission and Response Over Time *P ≤ .05, **P ≤ .01, ***P ≤ .001 vs PBO. Clinical remission per CDAI criterion: CDAI < 150 Clinical remission per SF/AP criteria: average daily SF ≤ 2.8 and not worse than baseline plus average daily AP score ≤ 1 and not worse than baseline. Clinical response per CDAI criterion: ≥ 100-point decrease from baseline in CDAI. Clinical response per SF/AP criteria: ≥ 30% decrease in average daily SF and/or ≥ 30% decrease in average daily AP and both not worse than baseline. AP, abdominal pain; CDAI, Crohn's Disease Activity Index; PBO, placebo; SF, stool frequency; RZB, risankizumab.

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