806 Long-Term Safety and Efficacy of Risankizumab Treatment in Patients With Crohn’s Disease: 3-Year Interim Results From the Ongoing Phase 2 Open-Label Extension Study

Abstract

INTRODUCTION: Efficacy/safety of the interleukin (IL)-23 inhibitor risankizumab (RZB) were previously assessed in patients (pts) with moderate-to-severe Crohn’s disease (CD) following induction and maintenance treatments.1,2 Pts who responded to RZB in the Phase 2 induction and maintenance study2,3 could enrol in an open-label extension (OLE) study4. Interim safety/efficacy of RZB maintenance treatment, up to 3 years, are reported from this ongoing OLE. METHODS: Pts who achieved clinical response (decrease from baseline [BL] in CD Activity Index [CDAI] ≥ 100) without remission (CDAI < 150) after Week (wk) 26 or clinical response and/or remission after Wk 52 of the preceding study 1 were enrolled to receive open-label 180 mg subcutaneous RZB every 8 wks for up to 206 wks. Pts who lost clinical response or remission after completing preceding study were re-induced with open-label 600 mg intravenous RZB at Wks 0, 4, 8. Ileocolonoscopy was performed yearly. Treatment-emergent adverse events (AEs) were collected throughout the study up to 20 wks after last dose of study drug or data cut-off date of Feb 04, 2019. Efficacy endpoints as listed and defined in the Table 1, are reported up to Wk 104. RESULTS: A total of 65 adults with CD were enrolled, including 4 pts who were re-induced. Median CD duration was 10 (range 2–38) yrs. Sixty pts (92.3%) were previously exposed to TNF antagonists; 13 pts (20%) and 21 pts (32.3%) were receiving corticosteroids only and immunomodulators only, respectively, and 9 (11.8%) pts were receiving both, prior to BL of the preceding study. At the data cut-off date, mean (SD) exposure to RZB was 866.8 (316.6) days, and 18 (27.7%) pts had prematurely discontinued from the study. The efficacy endpoints were sustained up to Wk 104 (Table 1). After a median follow-up of 31 months, AEs were reported for 58 (89.2%) pts; 22 (33.8%) pts experienced serious AEs. The most common AEs were nasopharyngitis (29.2%), gastroenteritis (20.0%), fatigue, abdominal pain, and worsening CD (18.5% each), and arthralgia (15.4%). Serious infections included anal or subcutaneous abscess (1 pt each), Campylobacter infection (1 pt), viral gastroenteritis (2 pts), and peritonitis (2 pts). No events of tuberculosis, malignancies, or deaths occurred in the study. CONCLUSION: In this 3-yr interim analysis, efficacy endpoints were sustained in pts with CD receiving long-term open-label RZB treatment. The safety profile of RZB remains consistent with previously results.2 No new safety signals were identified.