OP26 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

Abstract Background Present therapies leave an unmet need for early and effective treatment patients with Crohn’s disease (CD). Risankizumab (RZB), a humanized immunoglobulin G1 monoclonal antibody against the p19 subunit of interleukin-23, was evaluated as induction therapy to induce clinical remission response in moderate-to-severe CD two double-blind, randomized, placebo (PBO)-controlled studies (ADVANCE [NCT03104413] MOTIVATE [NCT03105128]). Methods Patients (CD Activity Index [CDAI] 220–450, Simple Endoscopic Score [SES-CD] ≥ 6 [≥ 4 isolated ileal disease] excluding narrowing component, average daily [liquid/very soft] stool frequency [SF] and/or abdominal pain [AP] score 2) who had inadequate or intolerance conventional biologic (ADVANCE), only (MOTIVATE) were randomised 2:2:1 (ADVANCE) 1:1:1 receive intravenous RZB 600 mg, 1200 PBO at weeks 0, 4, 8. Clinical (per either CDAI composite SF AP criteria), criterion), enhanced criteria) 8, 12 (endpoints defined Figure 1 footnotes). Safety assessed throughout studies. Results A total 1419 from ADVANCE (N = 850) 569) respectively, included intention-to-treat population. In both studies, starting week (the first prespecified measurement), greater proportions mg mg- vs PBO-treated achieved per (P .01/P < .05) SF/AP criteria .01), criterion .001/P .14) (Figure 1). For efficacy effect increased through ≤ .001) Treatment well tolerated, no new safety risks identified.1,2 Conclusion Induction resulted significantly sustained treatment. References