Try our mobile app

Nearly Two-Thirds of Patients Respond to Mirikizumab Treatment at 12 Weeks in Lilly's First-in-Class Ulcerative Colitis Phase 3 LUCENT-1 Study

Published: 2022-02-18 15:45:00 ET
<<<  go to LLY company page

At Four Weeks, Patients Treated with Mirikizumab Achieved Rapid and Clinically Meaningful Symptomatic Remission and Bowel Urgency Reduction Compared to Placebo

INDIANAPOLIS, Feb. 18, 2022 /PRNewswire/ -- Patients with moderately-to-severely active ulcerative colitis (UC) who took mirikizumab achieved statistically superior rates of clinical remission at 12 weeks compared to patients taking placebo in Eli Lilly and Company's (NYSE: LLY) pivotal LUCENT-1 Phase 3 study. Patients who took mirikizumab also achieved statistically significant improvements across key secondary endpoints including clinical, symptomatic, endoscopic and histologic (cellular level of tissue) measures, compared to those taking placebo. Results from Lilly's first-in-class induction study are being presented virtually at the 17th Congress of the European Crohn's and Colitis Organisation (ECCO), taking place Feb. 16-19, 2022.

"People with ulcerative colitis have mucosal inflammation in the colon, which causes rectal bleeding, frequent trips to the bathroom and the urgent need to have a bowel movement," said Geert D'Haens, M.D., Ph.D., lead author and Professor of Gastroenterology at Amsterdam University Medical Centers. "Mirikizumab has the potential to significantly reduce inflammation, help people achieve remission and reduce bowel urgency, which is a novel, patient-centric outcome that hasn't been studied before in a Phase 3 trial for ulcerative colitis."

This global study of 1,162 patients included patients who had never tried a biologic treatment (biologic-naïve) and harder-to-treat patients who had previously taken a biologic that failed. One in four patients treated with mirikizumab (24.2%, n=210/868) achieved the primary endpoint of clinical remission at 12 weeks, compared to one in seven on placebo (13.3%, n= 39/294, p=0.00006), indicating improved symptom relief and resolution or near resolution of inflammation. Nearly two-thirds of patients taking mirikizumab (63.5%, n=551/868) achieved clinical response, compared to less than half of patients treated with placebo (42.2%, n=124/294, p