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Risankizumab (SKYRIZI®) Demonstrates Significant Improvements in Clinical Remission and Endoscopic Response in Two Phase 3 Induction Studies in Patients with Crohn's Disease

Published: 2021-01-07 13:45:00 ET
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- A significantly greater proportion of patients with Crohn's disease treated with either dose of risankizumab (600 mg or 1200 mg) achieved both primary endpoints, demonstrating statistically significant results for clinical remission and endoscopic response at week 12 compared to placebo[1,2]

- The overall safety results in these studies were generally consistent with the known safety profile of risankizumab, with no new safety risks observed[1-6]

- Risankizumab (SKYRIZI), an interleukin-23 (IL-23) inhibitor, is being evaluated as a treatment for adults with moderate to severe Crohn's disease and several other immune-mediated conditions[1,2,7,8]

- More than 3.5 million people globally live with inflammatory bowel diseases (IBD), including Crohn's disease, and the incidence continues to rise[9]

NORTH CHICAGO, Ill., Jan. 7, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive results from two Phase 3 induction studies, ADVANCE and MOTIVATE, showing both doses of risankizumab (600 mg and 1200 mg) met both primary endpoints of clinical remission and endoscopic response at week 12 in adult patients with moderate to severe Crohn's disease.1,2 The ADVANCE study enrolled patients who had an inadequate response or were intolerant to conventional and/or biologic therapy.1 The MOTIVATE study evaluated patients who had responded inadequately or were intolerant to biologic therapy.2

"The progressive nature of Crohn's disease makes it critical that treatment options go beyond symptoms to help patients achieve endoscopic response," said Michael Severino, M.D., vice chairman and president, AbbVie. "Despite the availability of current treatments, many patients still do not achieve disease control. These positive results show how targeting IL-23 can rapidly induce improvements for people living with this condition. We look forward to advancing research showing risankizumab's potential to improve clinical and endoscopic outcomes and minimize the burden of Crohn's disease for patients."

In both studies, clinical remission was measured by CDAI (Crohn's Disease Activity Index) and PRO-2 (two-component patient-reported outcome).1,2 In the ADVANCE study, a significantly greater proportion of patients treated with risankizumab 600 mg or 1200 mg achieved clinical remission per CDAI at week 12 (45 and 42 percent of patients, respectively, compared to 25 percent of patients receiving placebo; p