Long-Term Risankizumab Safe for Patients With Crohn’s Disease, Rates of Remission Sustained: Presented at ECCO-IBD

By Eric Ramos

VIENNA, Austria -- February 13, 2020 -- Final data from the risankizumab open-label extension study, presented here at the 15th Congress of the European Crohn’s and Colitis Organisation - Inflammatory Bowel Diseases (ECCO-IBD), showed that maintenance treatment with risankizumab following induction therapy is safe and effective for patients with moderate to severe Crohn’s disease.

“In this final analysis of patients with Crohn’s disease receiving long-term, open-label risankizumab treatment, the safety profile of risankizumab remained consistent with previous data with no new safety signals,” reported Marc Ferrante, University Hospitals Leuven, Leuven, Belgium. “Clinical and endoscopic remissions were sustained.”

A total of 65 patients with Crohn’s disease who responded to risankizumab in the initial phase 2 study were enrolled in the open-label extension study where they received maintenance subcutaneous risankizumab 180 mg every 8 weeks.

Among the 65 patients were 4 who lost response in the initial study. These patients were re-induced with intravenous risankizumab 600 mg at weeks 0, 4, and 8, and only received subsequent subcutaneous risankizumab 180 mg every 8 weeks if they regained response following re-induction.

At week 0, 47 (72%) patients achieved clinical remission and 27 (42%) had endoscopic remission, which was maintained to week 48 (71% and 54%, respectively) and week 104 (65% and 42%, respectively).

By week 152, almost half (32%) of the patients had prematurely discontinued treatment, but those who continued treatment continued to show clinical and endoscopic remission (77% and 59%, respectively).

Most (92%) patients experienced adverse events (AEs) and 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.

[Presentation title: 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 OP27]

To read more Conference Dispatch articles, click here.