Open-label extension study of risankizumab: final results

In a final analysis of long-term treatment with open-label risankizumab in Crohn’s disease (CD), its safety profile remained consistent with previous data, with no new safety signals. Clinical remission as well as endoscopic remission was sustained [1].

Responders to risankizumab, an IL-23A antibody, in a phase 2 induction/maintenance study could enrol in an open-label extension (OLE). They received open-label 180 mg subcutaneous risankizumab every 8 weeks for up to 206 weeks. There were 65 CD patients who enrolled in the OLE, with 4 patients re-induced; 60 patients (92%) had been previously treated with TNF antagonists. In the OLE, median exposure to risankizumab was 1,014 (range: 114–1,317) days.

At baseline of the current study, 47 patients (72%) had clinical remission, defined as Crohn’s disease Activity Index (CDAI) <150. At baseline, 27 patients (42%) were in endoscopic remission, defined as Crohn’s disease Endoscopic Index of Severity (CDEIS) ≤4 or CDEIS ≤2 for patients with isolated ileitis at baseline. Both clinical remission and endoscopic remission were sustained up to week 152 (see Table).

Table. Clinical and endoscopic remission in patients receiving open-label risankizumab maintenance treatment [1]



NRI, non-responder imputation.

A third of the patients (n=21) prematurely discontinued risankizumab, including 6 (9%) who experienced an adverse event (AE). Sixty patients (92%) reported AEs; in 23 (35%) these were serious. The most common AEs were nasopharyngitis (31%), gastroenteritis (23%), and fatigue (20%). Serious infections were reported in 6 patients (9%) and opportunistic infections in 3 patients (5%).

1. 
   
   1. Ferrante M, et al. ECCO-IBD 2020, OP27.

Posted on 14 April, 20208 April, 2024