At DDW 2022, Dr. Sands highlights the positive findings from the LUCENT-1 study on the efficacy and safety of mirikizumab.
New findings from the phase 3 LUCENT-1 study in patients with moderately to severely active ulcerative colitis (UC) show 300 mg intravenous mirikizumab had statistically significant and clinically meaningful improvement compared to placebo in all primary and key secondary endpoints.
In an interview with presenting author Bruce Sands, MD, Mount Sinai at the 2022 Annual Digestive Disease Week Meeting in San Diego, he discussed the interest in this class of agents as treatment for UC and the pivotal trial data in LUCENT-1.
In LUCENT-1, Sands noted more than 1100 patients were randomized to either mirikizumab dose every 4 weeks or placebo and then followed out to week 12 for clinical remission. Data show the effectiveness of the agent, with a treatment effect size 11% superior to placebo. It additionally succeeded in secondary outcomes, including endoscopic improvement and histologic improvement, Sands said.
“Uniquely studied in this trial was bowel urgency, which was a new factor that's been looked at that has not been examined in other clinical trials,” Sands said. “And showing that even as early as two weeks you can see benefits that exceed placebo rates and improvement of bowel urgency.”
Moreover, the safety profile saw no increased risk of malignancies, infections, or other serious adverse events with mirikizumab compared to placebo, according to Sands. He noted it is currently being studied in Crohn’s patients and appears to be effective in phase 2 studies as well.
“I think you can expect that the drug should be approved in the maybe the next year or so we're not sure exactly when,” Sands said. “But I think you can also look for other studies of more niche indications.”
The study, “Efficacy and Safety of Mirikizumab As Induction Therapy in Patients with Moderately to Severely Active Ulcerative Colitis: Results from the Phase 3 LUCENT-1 Study,” was presented at DDW 2022.