Try our mobile app
INDIANAPOLIS, Oct. 12, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) announced today new efficacy and safety data from the Phase 2 SERENITY study evaluating mirikizumab in patients with moderately to severely active Crohn's disease, a form of inflammatory bowel disease (IBD) that can cause systemic inflammation manifested as abdominal pain, diarrhea, fever, weight loss and lead to intestinal obstruction, fibrosis and other complications. SERENITY included a 12-week induction period and 40-week continued treatment period, which evaluated the safety and efficacy of multiple dosing regimens and two methods of administration through Week 52 as measured by endoscopic response, which reflects substantial reduction in inflammation of the lining of the bowel as seen during an endoscopy, and by Patient Reported Outcomes (PRO) remission, two important treatment goals in Crohn's disease. Detailed results from the trial are being presented virtually today in an abstract session at the United European Gastroenterology Week (UEG Week) 2020.
In the induction period, patients were randomized across four treatment arms to receive placebo or one of three doses of mirikizumab intravenously. At 12 weeks, patients who showed endoscopic improvement were randomized to continue mirikizumab treatment, administered either intravenously or subcutaneously. Patients who did not show endoscopic improvement or who had been randomized to the placebo arm in induction were assigned to receive mirikizumab treatment intravenously.
In the continued treatment period of the study, patients achieved key secondary outcomes at Week 52 including endoscopic response (defined as at least 50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease [SES-CD]), PRO remission (defined as an average daily stool frequency of ≤2.5 and abdominal pain ≤1 and no worse than baseline) and endoscopic remission (defined as achieving an SES-CD score
