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Marla Dubinsky, MD, discusses findings from the LUCENT program and their role in the recent FDA approval of mirikizumab for ulcerative colitis.
Results from the ongoing open-label LUCENT-3 extension study of mirikizumab highlighted the treatment’s safety and efficacy through 104 weeks in patients with moderately to severely active ulcerative colitis (UC) in whom conventional or advanced therapy failed.
Data presented at United European Gastroenterology Week 2023 showed 74.5% of participants who were responders at week 52 and 76.6% of participants who were remitters at week 52 achieved clinical response at week 104, further supporting clinical, endoscopic, histologic, and symptomatic endpoints through 104 weeks regardless of response at week 52.1
The US Food and Drug Administration (FDA) approved mirikizumab on October 26, 2023, making it the first interleukin-23p19 (IL-23p19) antagonist for the treatment of moderately to severely active UC. The approval was based on results from the LUCENT program, which included 2 randomized, double-blind, placebo-controlled phase 3 clinical trials consisting of a 12-week induction study (LUCENT-1) and a 40-week maintenance study for 52 weeks of continuous treatment (LUCENT-2). A phase 3, multicenter, open-label extension study, LUCENT-3 sought to assess the long-term safety and efficacy of mirikizumab through 104 weeks of continuous treatment.1
Upon analysis, week 52 clinical responders and remitters achieved the following rates of remission after 104 weeks:
Investigators pointed out data in the biologic failed and non-failed subgroups were generally similar and symptom score reductions from baseline were sustained through week 104.1
Severe treatment-emergent adverse events were reported in 4.5% of patients, the most common of which were COVID-19 (12.1%), colitis ulcerative (7.6%), arthralgia (6.2%), headache (6.2%), and nasopharyngitis (5.9%). Serious adverse events were prevalent among 5.2% of participants and 2.8% discontinued treatment due to an adverse event. Adverse events of interest were opportunistic infection (1.7%), cerebrocardiovascular events (0.7%), malignancy (0%), hepatic (2.1%), and injection site reaction (5.5%).1
The editorial team of HCPLive Gastroenterology sat down with Marla Dubinsky, MD, chief of the division of pediatric gastroenterology at Mount Sinai Kravis Children’s Hospital, to discuss the importance of a patient-centric approach to treatment, how the LUCENT programs embodied this concept, and their contributions to the FDA approval of mirikizumab.1
Sands BE, D’Haens G, Clemow DB, et al. TWO-YEAR EFFICACY AND SAFETY OF MIRIKIZUMAB FOLLOWING 104 WEEKS OF CONTINUOUS TREATMENT: INTERIM RESULTS FROM THE LUCENT-3 OPEN-LABEL EXTENSION STUDY. Paper presented at: UEG 2023 Annual Scientific Meeting. October 14 – 17, 2023.