Risankizumab Meets Primary Endpoint of Clinical Remission for Moderate to Severe Ulcerative Colitis

Risankizumab (Skyrizi; AbbVie, Boehringer Ingelheim) met the primary endpoint of clinical remission, per Adapted Mayo Score, at week 12, as well as all secondary endpoints in adults with moderately to severely active ulcerative colitis, according to positive topline results from the INSPIRE (NCT03398148) trial.

The results of the study demonstrated that 20.3% of individuals receiving risankizumab achieved clinical remission compared to 6.2% of individuals who received the placebo.

Investigators enrolled patients who had intolerance or an inadequate response to conventional therapies and/or advanced therapies, including biologics, JAK inhibitors, and S1P receptor modulators.

"It is impressive to see the meaningful responses that were achieved in the INSPIRE study, which demonstrates the potential of risankizumab to serve as an option across inflammatory bowel diseases [(IBD)]," Edouard Louis, MD, PhD, professor and head of the department of gastroenterology at University Hospital CHU of Liège Belgium, said in a statement. "These results suggest that risankizumab may help patients coping with the challenging symptoms of ulcerative colitis, which include abdominal pain, bowel urgency and fecal incontinence."

A significantly greater proportion of individuals treated with risankizumab achieved endoscopic improvement at week 12 at 36.5% compared to the placebo at 12.1%.

Further, approximately 24.5% of individuals treated with risankizumab achieved histologic-endoscopic mucosal improvement at week 12 compared to 7.7% of those receiving the placebo.

During the 12-week period, the safety profile of risankizumab in the cohort administered 1200 mg intravenously was consistent with the safety profile observed in previous studies across other indications, and there were no new safety risks observed.

The most common adverse events (AEs) observed in the risankizumab arm were COVID-19, anemia, and arthralgia. Serious AEs occurred in 2.3% of individuals in the risankizumab group compared to 10.2% of individuals in the placebo group. Additionally, rates of serious infections were 0.6% and 1.2%, respectively. There was 1 death in the risankizumab arm due to COVID-19 pneumonia on day 33.

There were no adjudicated major adverse cardiac events, adjudicated anaphylactic reaction events, or malignancy events reported with risankizumab.

The use of risankizumab for ulcerative colitis is not approved by the FDA, and its safety and efficacy data have not been evaluated by regulatory authorities. The maintenance study for ulcerative colitis is ongoing.

Ulcerative colitis is a chronic and immune-mediated inflammatory bowel disease of the large intestine that causes continuous mucosal inflammation extending from the rectum to the proximal colon.

Risankizumab is an interleukin (IL)-23 inhibitor that selectively blocks IL-23 by binding to its p19 subunit. It is approved by the FDA and the European Medicines Agency for the treatment of plaque psoriasis, psoriatic arthritis, and Crohn disease. Phase 3 trials of risankizumab are currently on going in psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis.

Risankizumab is approved for patients with moderate to severe plaque psoriasis who could benefit from taking injections or pills or treatment using ultraviolet light, active psoriatic arthritis, and moderate to severe Crohn disease.

Reference

Risankizumab (Skyrizi) achieves primary and all secondary endpoints in phase 3 induction study in patients with ulcerative colitis. News release. AbbVie. March 23, 2023. Accessed March 23, 2023. https://news.abbvie.com/news/press-releases/risankizumab-skyrizi-achieves-primary-and-all-secondary-endpoints-in-phase-3-induction-study-in-patients-with-ulcerative-colitis.htm