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- Efficacy and safety of mirikizumab as induction and maintenance therapy for Japanese patients with moderately to severely active ulcerative colitis: a subgroup analysis of the global phase 3 LUCENT-1 and LUCENT-2 studies
- Taku Kobayashi, Katsuyoshi Matsuoka, Mamoru Watanabe, Tadakazu Hisamatsu, Fumihito Hirai, Joe Milata, Xingyuan Li, Nathan Morris, Vipin Arora, Tomoko Ishizuka, Koji Matsuo, Yoichi Satoi, Catherine Milch, Toshifumi Hibi
- Intest Res 2024;22(2):172-185. Published online April 25, 2024
- DOI: https://doi.org/10.5217/ir.2023.00043
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Abstract
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Supplementary Material
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ePub - Background/Aims
Mirikizumab is a p19-directed anti-interleukin-23 antibody with potential efficacy against ulcerative colitis (UC). We evaluated the efficacy and safety of mirikizumab in a Japanese subpopulation with moderately to severely active UC from the LUCENT-1 and LUCENT-2 studies.
Methods
LUCENT-1 and LUCENT-2 were phase 3, randomized, double-blind, placebo-controlled trials of mirikizumab therapy in adults with moderately to severely active UC. LUCENT-1 was a 12-week induction trial where patients were randomized 3:1 to receive intravenous mirikizumab 300 mg or placebo every 4 weeks (Q4W). Patients achieving a clinical response with mirikizumab following the induction study were re-randomized 2:1 to double-blind treatment with either mirikizumab 200 mg or placebo subcutaneously Q4W during the 40-week maintenance study. The primary outcomes were clinical remission at week 12 of LUCENT-1 and week 40 of LUCENT-2.
Results
A total of 137 patients enrolled in Japan were randomized to mirikizumab (n = 102) or placebo (n = 35). Compared with placebo, patients who received mirikizumab showed numerically higher clinical remission at week 12 of induction (32.4% [n = 33] vs. 2.9% [n = 1]) and at week 40 of maintenance (48.9% [n = 23] vs. 28.0% [n = 7]). A greater number of patients achieved key secondary endpoints in the mirikizumab group compared with placebo. The frequency of treatment-emergent adverse events was similar across mirikizumab and placebo groups. Efficacy and safety results observed in the Japanese subpopulation were generally consistent with those in the overall population.
Conclusions
Mirikizumab induction and maintenance treatments were effective in Japanese patients with moderately to severely active UC. No new safety concerns were identified. -
Citations
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- Mirikizumab – a new option in treatment of inflammatory bowel diseases
Jakub Olszewski, Katarzyna Kozon, Magdalena Sitnik, Katarzyna Herjan, Karolina Mikołap, Bartłomiej Gastoł, Maciej Bara, Piotr Armański, Marcin Sawczuk
Prospects in Pharmaceutical Sciences.2024; 22(3): 178. CrossRef - Key Interleukins in Inflammatory Bowel Disease—A Review of Recent Studies
David Aebisher, Dorota Bartusik-Aebisher, Agnieszka Przygórzewska, Piotr Oleś, Paweł Woźnicki, Aleksandra Kawczyk-Krupka
International Journal of Molecular Sciences.2024; 26(1): 121. CrossRef
- Mirikizumab – a new option in treatment of inflammatory bowel diseases
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