OWE-05 Interim long-term safety/efficacy of risankizumab treatment in crohn’s disease patients from the open-label extension study

Introduction Adults with moderate-to-severe Crohn’s disease (CD) who responded to risankizumab (RZB) in the phase 2 induction and maintenance study (Feagan, 2017) could enroll in an open-label extension (OLE) study. Interim efficacy and safety of RZB maintenance treatment from the OLE, up to 2 years, are reported. Methods Patients (pts) achieving clinical response (decrease from baseline [BL] in CD Activity Index [CDAI] ≥100) without remission (CDAI Results A total of 65 pts were enrolled (including 4 who were re-induced). Mean (standard deviation) exposure to RZB was 657.2 (190.73) days. At the data cut-off, 14 (21.5%) pts have discontinued the study. Up to wk 48, clinical remission rates were sustained and the proportion of pts with endoscopic remission increased from BL (table 1). Adverse events (AEs) were reported for 58 (89.2%) pts; 18(27.7%) pts had serious AEs. AEs occurring in >10% of pts were nasopharyngitis (26.2%), fatigue (16.9%), arthralgia and worsening CD (15.4% each). Four serious infections in 5 pts were perianal abscess (n=1), Campylobacter (n=1), viral gastroenteritis (n=2), and peritonitis (n=2). No events of tuberculosis, malignancies or deaths occurred. Conclusions In this interim analysis, clinical remission and endoscopic remission were sustained in CD pts receiving long-term RZB treatment. The safety profile of RZB was consistent with previously published data (Feagan, 2017). References Feagan BG, et al. Lancet 2017,29;389(10080):1699–1709. Feagan BG, et al. Gastroenterology 2017;152(5):S1310.