AbbVie Inc.'s psoriasis drug Skyrizi improved symptoms of a type of inflammatory bowel disease in two phase 3 clinical trials.
The North Chicago, Ill.-base drugmaker is evaluating Skyrizi, or risankizumab, as a treatment for Crohn's disease, a condition that causes inflammation of the digestive tract, leading to stomach pain, severe diarrhea and weight loss, among other signs and symptoms.
In a late-stage study called Advance, patients with Crohn's disease who had not responded well to conventional or biologic therapy or were intolerant to such therapies received either 600 milligrams or 1,200 milligrams of Skyrizi, or placebo. In the low and high dose groups, 45% and 42% of patients, respectively, experienced an improvement in symptoms compared with 25% of patients in the placebo group as measured by Crohn's Disease Activity Index.
Another late-stage study, dubbed Motivate, showed that 42% and 41% of patients who respectively received the low and high doses of Skyrizi achieved symptom improvement compared with 19% of patients given placebo based on the same index. Patients in this study had not responded well or were intolerant to biologic therapy.
Two deaths were reported in the placebo group in the Advance study. Both studies showed higher adverse events occurring in the placebo group compared with the treatment groups.
Abbvie is collaborating with Boehringer Ingelheim International GmbH to develop and commercialize Skyrizi worldwide.
The drug, an interleukin-23 inhibitor, was approved in the U.S. and the EU in 2019 to treat severe plaque psoriasis in adults.