A significantly greater proportion of patients with Crohn disease achieved both primary endpoints with overall safety results generally consistent with the known safety profile of risankizumab.
New results from a pair of phase 3 induction studies have found that risankizumab (Skyrizi, AbbVie) at both 600 mg and 1200 mg doses demonstrated significant improvements in both primary endpoints—clinical remission and endoscopic response—in patients with Crohn’s disease.
According to AbbVie, a significantly greater proportion of patients with Crohn’s disease achieved both primary endpoints with overall safety results generally consistent with the known safety profile of risankizumab. The ADVANCE study enrolled patients who had an inadequate response or were intolerant to conventional or biologic therapies, while the MOTIVATE study involved patients who had responded inadequately or were intolerant to biologic therapy.
Crohn disease is a chronic disease characterized by inflammation in the gastrointestinal tract, persistent diarrhea, abdominal pain, and rectal bleeding. It is a progressive disease with a significant burden on individual living with it, including physical, emotional, and economic burdens.
The ADVANCE and MOTIVATE studies are both phase 3, multicenter, randomized, double-blind, placebo-controlled induction studies designed to evaluate the efficacy and safety of risankizumab in adults with moderate to severe Crohn disease. The primary endpoints were achievement of clinical remission and endoscopic response at week 12. Endoscopic response is defined as a decrease in the Simple Endoscopic Score for Crohn Disease (SES-CD) of greater than 50% from baseline.
In the ADVANCE study, 45% of patients receiving risankizumab 600 mg, and 42% of patients receiving 1200 mg achieved clinical remission, compared to 25% of patients receiving the placebo. Furthermore, 40% of patients receiving 600 mg, and 32% of patients receiving 1200 mg achieved endoscopic response at week 12, compared to 12% in the placebo group.
The MOTIVATE study saw similar results, with 42% and 41% of patients treated with risankizumab 600 mg and 1200 mg achieved clinical remission at week 12, respectively, compared to 19% of patients receiving the placebo. In addition, 29% and 34% of patients receiving 600 mg and 1200 mg achieved endoscopic response, respectively, compared to 11% in the placebo group.
Multiplicity-adjusted key secondary endpoints also showed significant clinical and endoscopic outcomes, with symptom improved observed as early as week 4 according to AbbVie. After 4 weeks of treatment in the ADVANCE trial, 41% and 37% of patients receiving risankizumab 600 mg or 1200 mg achieved clinical response, respectively, compared to 25% in the placebo group. In MOTIVATE, 36% and 33% of patients achieved clinical response, respectively, compared to 21% of those receiving the placebo.
“Helping patients achieve both clinical remission and endoscopic response early is paramount when treating Crohn disease,” said Remo Panaccione, MD, director of the inflammatory bowel disease unit at the University of Calgary, in a prepared statement. “It was exciting to see that a significant proportion of patients treated with risankizumab achieved both measures after 12 weeks of treatment, as well as achieving symptom improvement at week 4. These data are encouraging as we continue to evaluate the potential of risankizumab in Crohn’s disease.”
Risankizumab (Skyrizi) Demonstrates Significant Improvements in Clinical Remission and Endoscopic Response in Two Phase 3 Induction Studies in Patients with Crohn’s Disease [news release]. AbbVie; January 7, 2021. Accessed January 8, 2020. https://news.abbvie.com/article_display.cfm?article_id=12235