The study drug at 600 mg was associated with significant improvements in Crohn’s Disease Activity Index scores as early as Week 2.
Brian Feagan, MD
In a phase 2 trial, risankizumab, a biologic approved for the treatment of psoriasis and in development for the treatment of inflammatory bowel disease, has shown early symptom improvement in a highly refractory patient population with Crohn’s disease (CD). Post-hoc analysis data were presented at the American College of Gastroenterology’s Annual Scientific Meeting (ACG 2019) in San Antonio, Texas.
An international group of investigators sought to assess early symptom improvement during the randomized, double-blind, placebo-controlled induction phase of a phase 2 study of the IL-23 p19 inhibitor. Participants comprised adult patients with moderate-to-severe CD with a Crohn’s Disease Activity Index (CDAI) of 220—450, ulcers in the ileum and/or colon, and a Crohn’s Disease Endoscopic Index of Severity (CDEIS) ≥7 (≥4 for patients with isolated ileitis) assessed by ileocolonoscopy confirmed by a blinded central reader.
Study end points in this analysis included changes from baseline at Weeks 2, 4, 8, and 12 in CDAI, average daily stool frequency (SF) and average daily abdominal pain score (AP) for all patients with available data, and newly defined clinical remission at Week 12, based on symptom improvement, defined as SF ≤2.8 and AP ≤1, both not worse than baseline, in patients with baseline SF ≥4 or AP ≥2.
A total of 121 patients were randomized 1:1:1 in the induction phase to receive intravenous risankizumab (200 mg or 600 mg) or placebo at Weeks 0, 4, and 8. Among the treatment arms, baseline characteristics were similar, with a mean disease duration of 13.4 (9.4) years and 94.2% of patients having been on anti-TNF therapy previously.
Compared with placebo, the study drug at 600 mg was associated with significant improvements in CDAI and AP as early as Week 2 and in SF at Week 8.
“The proportion of patients with clinical remission based on symptom improvement was significantly higher in the 600 mg [risankizumab] group versus placebo at Week 12 (23.7% versus 6.1%; p< 0.05), supporting the previously reported superiority of [risankizumab] versus placebo for inducing CDAI remission at Week 12 (36.6% of 600 mg [risankizumab] versus 15% of placebo; p< 0.05),” investigators reported.
The research team concluded that risankizumab induction treatment was associated with significant early improvements in clinical symptoms and disease activity in this highly refractory patient population, providing a strong foundation for the next stage of development.
The poster, “Early Symptom Improvement With Risankizumab Treatment in Patients With Moderately to Severely Active Crohn’s Disease: Analysis From a Phase 2 Study,” was presented Tuesday, October 29, 2019, at the American College of Gastroenterology Annual Scientific Meeting (ACG 2019) in San Antonio, Texas.