NORTH CHICAGO, IL, USA I March 23, 2023 I AbbVie (NYSE: ABBV) today announced positive top-line results from INSPIRE, a Phase 3 induction study, showing risankizumab (SKYRIZI®,1200 mg intravenous [IV], at weeks 0, 4 and 8) met the primary endpoint of clinical remission (per Adapted Mayo Score) at week 12, as well as all secondary endpoints in adult patients with moderately to severely active ulcerative colitis.1 In the study, 20.3% of patients receiving risankizumab achieved clinical remission compared to 6.2% of patients receiving placebo (p1 The INSPIRE study enrolled patients that demonstrated intolerance or inadequate response to conventional therapies and/or advanced therapies (biologics, JAK inhibitorsJAK inhibitors and S1P receptor modulators).1
"Our commitment to people living with gastroenterological conditions continues to grow," said Roopal Thakkar, M.D., senior vice president, development, regulatory affairs and chief medical officer, AbbVie. "These encouraging results help support the potential risankizumab has to improve clinical, endoscopic and histologic outcomes in patients with ulcerative colitis."
A significantly greater proportion of patients treated with risankizumab achieved endoscopic improvement at week 12 compared to placebo (36.5% vs 12.1%; p1 Furthermore, 24.5% of patients treated with risankizumab achieved histologic-endoscopic mucosal improvement at week 12 vs 7.7% of those receiving placebo (p1
During the 12-week, double-blind, placebo-controlled period, the safety profile of risankizumab 1200 mg IV was consistent with the safety profile observed in previous studies across other indications, with no new safety risks observed.1 The most common adverse events observed in the risankizumab group were COVID-19, anemia and arthralgia. Serious adverse events occurred in 2.3% of patients in the risankizumab 1200 mg IV group compared to 10.2% of patients in the placebo group.1 Rates of serious infections were 0.6% in those treated with risankizumab 1200 mg IV and 1.2% in patients who received placebo.1 There was one death in the risankizumab 1200 mg group due to COVID-19 pneumonia on study day 33. There were no adjudicated major adverse cardiac events (MACE), no adjudicated anaphylactic reaction events and no malignancy events reported in the risankizumab group.1
Use of risankizumab in ulcerative colitis is not approved and its safety and efficacy have not been evaluated by regulatory authorities. The maintenance study for ulcerative colitis is ongoing.
INSPIRE is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of risankizumab 1200 mg IV administered every four weeks as induction therapy in subjects with moderately to severely active ulcerative colitis.
The primary endpoint is clinical remission (per adapted Mayo Score, defined as SFS ≤1 and not greater than baseline, RBS of 0 and endoscopic subscore ≤1 without friability) at week 12. Secondary endpoints include clinical response (decrease from baseline in the Adapted Mayo score ≥2 points and ≥30% from baseline, plus a decrease in RBS ≥1 or an absolute RBS ≤1), endoscopic improvement (endoscopic subscore ≤1 without friability), and histologic endoscopic mucosal improvement (HEMI, endoscopic subscore of 0 or 1 without friability and Geboes score ≤3.1) at week 12. More information can be found on www.clinicaltrials.gov (NCT03398148).
With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD. For more information on AbbVie in gastroenterology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.html.
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.
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