OP27 Long-term safety and efficacy of risankizumab treatment in patients with Crohn’s disease: Final results from the Phase 2 open-label extension study

Abstract

Background Efficacy and safety of the IL-23 inhibitor risankizumab (RZB) have been assessed in patients with moderate-to-severe Crohn’s disease (CD) following induction/maintenance treatment.1,2 Responders to RZB in a Phase 2 induction/maintenance study2,3 could enrol in an open-label extension (OLE), NCT02513459.4 Final safety and efficacy results from this RZB OLE study are reported here. Methods Patients achieving clinical response (CResp) (decrease from baseline [BL] in CD Activity Index [CDAI] ≥100) without remission (CRem) (CDAI <150) after Period 2 (Week 26) or CResp/CRem after Period 3 (Week 52) of the preceding study1 received open-label 180 mg subcutaneous (SC) RZB every 8 weeks (Q8W) for up to 206 weeks. Patients who lost CResp/CRem at screening of the OLE were re-induced with open-label 600 mg IV RZB at Weeks 0, 4, and 8. Patients receiving re-induction treatment only received subsequent 180 mg SC RZB Q8W if they regained CResp/CRem following re-induction. A centrally read ileocolonoscopy was performed yearly. Treatment-emergent adverse events (AEs) were collected up to 20 weeks after the last RZB dose. CRem and endoscopic remission (ER [CD Endoscopic Index of Severity (CDEIS) ≤4 or CDEIS ≤2 for patients with isolated ileitis at BL]) were reported up to Week 152. Non-responder imputation (NRI) and observed case analysis were used for binary endpoints. Results Sixty-five patients with CD were enrolled in the OLE, with 4 patients re-induced. At BL of the preceding study, median (range) age was 34 (19–67) years and median (range) disease duration was 10 (2–38) years. Sixty patients (92%) were previously exposed to TNF antagonists. In the OLE, median (range) exposure to RZB was 1014.0 (114–1317) days. Twenty-one (32%) patients prematurely discontinued RZB, including 6 (9%) who had developed an AE. AEs were reported in 60 (92%) patients; 23 (35%) experienced serious AEs. The most common AEs were nasopharyngitis (31%), gastroenteritis (23%), and fatigue (20%). Serious infections were reported in 6 (9%) patients and opportunistic infections in 3 (5%) patients. No tuberculosis, malignancies, or deaths occurred. At Week 0 of the current study, 47 (72%) patients were in CRem and 27 (42%) patients had ER. Both CRem and ER were sustained up to Week 152 (Table). Conclusion In this final analysis of patients with CD receiving long-term open-label RZB treatment, the safety profile of RZB remained consistent with previous data² with no new safety signals. Clinical and endoscopic remissions were sustained. References

Novel and Emerging Therapies for Inflammatory Bowel Disease

“…Nine percent of patients had serious infections while 5% of patients reported opportunistic infections. There were no malignancies or deaths (Ferrante et al, 2020).…”

“…The long-term safety of risankizumab was studied in the phase 2 OLE study and no new safety signals were noted; 92% of patients reported AEs and 35% of patients experienced serious adverse events (Ferrante et al, 2020). The most common AEs included nasopharygnitis (31%), gastroenteritis (23%), and fatigue (20%) (Ferrante et al, 2020). Nine percent of patients had serious infections while 5% of patients reported opportunistic infections.…”

Inflammatory Bowel Disease Treatment in Cancer Patients—A Comprehensive Review

“…Risankizumab, an IL-23 inhibitor, has shown good treatment outcomes for CD [ 41 ]. The leukocyte migrating inhibitor sphingosine 1-phosphate (S1P) receptor modulator, ozanimod, is already used for UC treatment in the United States [ 42 ].…”

Letter: Early real‐world evidence from the United Arab Emirates of the persistence, effectiveness and safety of risankizumab for the treatment of Crohn's disease

“…Risankizumab is a selective IL-23 inhibitor that is effective and safe in treating CD with significant rates of long-term clinical remission in both advanced therapy-naïve and multi-refractory patients in clinical trials and real-world experience data from the USA and Europe. [2][3][4][5][6][7] As the Middle Eastern region is often under-represented in registration trials for therapies in IBD, clinical efficacy and safety data for advanced therapies in this emerging cohort of patients with IBD is lacking. 8 Here, we present our early experience from a tertiary IBD centre in the United Arab Emirates of risankizumab persistence, efficacy and safety in an advanced therapy-naïve and exposed group of 15 patients with CD with a median follow-up of 52 weeks (IQR 43 weeks).…”