BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
Mirikizumab as Induction and Maintenance Therapy in Chinese Patients with Ulcerative Colitis: A Subpopulation Analysis of the Randomized, Global Phase 3 LUCENT-1 and LUCENT-2 Trials.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыНазвание и аннотация: Перевод в очереди
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Ran Zhihua, Chen Yan, Miao Yinglei, Wang Yufang, Gao Xiang, Zhong Jie, Ding Xueli, Wang Chengdang, Zhang Xiaolan, Ding Yijuan, Hu Naizhong, Tang Dan, Yu Jiao, Qian Chenxi, Shen Jun
Аннотация
BACKGROUND: Mirikizumab, a p19-directed anti-interleukin-23 antibody, demonstrated efficacy in patients with moderately-to-severely active ulcerative colitis in the global phase 3 LUCENT-1 induction (NCT03518086) and LUCENT-2 maintenance (NCT03524092) trials.
OBJECTIVE: The aim was to conduct a pre-specified Chinese subpopulation analysis of LUCENT-1 and LUCENT-2.
METHODS: In LUCENT-1, patients were randomized 3:1 to mirikizumab 300 mg or placebo intravenously every 4 weeks (Q4W) for 12 weeks. In LUCENT-2, patients with a clinical response to mirikizumab at week 12 of LUCENT-1 were re-randomized 2:1 to mirikizumab 200 mg or placebo via subcutaneous injection Q4W for 40 weeks. The primary endpoint in both trials was clinical remission at study end, defined as a Mayo stool frequency subscore of 0, or 1 with a ≥ 1-point decrease from baseline, rectal bleeding subscore of 0, and an endoscopic subscore of 0 or 1 (excluding friability).
RESULTS: Among 183 Chinese patients included in the LUCENT-1 induction trial, clinical remission rates at week 12 were higher with mirikizumab 300 mg (n = 140) versus placebo (n = 43) (18.6% vs. 7.0%; common risk difference 11.5%). Among 80 patients who responded to mirikizumab and underwent randomization again in the LUCENT-2 maintenance trial, clinical remission rates at week 40 were higher with mirikizumab 200 mg (n = 56) versus placebo (n = 24) (50.0% vs. 12.5%; common risk difference 40.4%). During induction and maintenance, the incidence of adverse events was comparable between the mirikizumab and placebo groups.
CONCLUSIONS: Mirikizumab was effective and well tolerated in the subpopulation of Chinese patients with moderately-to-severely active ulcerative colitis, consistent with the overall trial population.
TRIAL REGISTRATIONS: Clinicaltrials.gov (NCT03518086 and NCT03524092).
OBJECTIVE: The aim was to conduct a pre-specified Chinese subpopulation analysis of LUCENT-1 and LUCENT-2.
METHODS: In LUCENT-1, patients were randomized 3:1 to mirikizumab 300 mg or placebo intravenously every 4 weeks (Q4W) for 12 weeks. In LUCENT-2, patients with a clinical response to mirikizumab at week 12 of LUCENT-1 were re-randomized 2:1 to mirikizumab 200 mg or placebo via subcutaneous injection Q4W for 40 weeks. The primary endpoint in both trials was clinical remission at study end, defined as a Mayo stool frequency subscore of 0, or 1 with a ≥ 1-point decrease from baseline, rectal bleeding subscore of 0, and an endoscopic subscore of 0 or 1 (excluding friability).
RESULTS: Among 183 Chinese patients included in the LUCENT-1 induction trial, clinical remission rates at week 12 were higher with mirikizumab 300 mg (n = 140) versus placebo (n = 43) (18.6% vs. 7.0%; common risk difference 11.5%). Among 80 patients who responded to mirikizumab and underwent randomization again in the LUCENT-2 maintenance trial, clinical remission rates at week 40 were higher with mirikizumab 200 mg (n = 56) versus placebo (n = 24) (50.0% vs. 12.5%; common risk difference 40.4%). During induction and maintenance, the incidence of adverse events was comparable between the mirikizumab and placebo groups.
CONCLUSIONS: Mirikizumab was effective and well tolerated in the subpopulation of Chinese patients with moderately-to-severely active ulcerative colitis, consistent with the overall trial population.
TRIAL REGISTRATIONS: Clinicaltrials.gov (NCT03518086 and NCT03524092).