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
| Title: | 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 |
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| Authors: | 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 |
| Source: | Intestinal Research, Vol 22, Iss 2, Pp 172-185 (2024) |
| Publisher Information: | Korean Association for the Study of Intestinal Diseases, 2024. |
| Publication Year: | 2024 |
| Collection: | LCC:Medicine LCC:Diseases of the digestive system. Gastroenterology |
| Subject Terms: | bowel urgency, interleukin-23 p19, japan, mirikizumab, ulcerative colitis, Medicine, Diseases of the digestive system. Gastroenterology, RC799-869 |
| More Details: | 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. |
| Document Type: | article |
| File Description: | electronic resource |
| Language: | English |
| ISSN: | 1598-9100 2288-1956 |
| Relation: | http://irjournal.org/upload/pdf/ir-2023-00043.pdf; https://doaj.org/toc/1598-9100; https://doaj.org/toc/2288-1956 |
| DOI: | 10.5217/ir.2023.00043 |
| Access URL: | https://doaj.org/article/d73b47e8a614419ea0a3a92df36cd045 |
| Accession Number: | edsdoj.73b47e8a614419ea0a3a92df36cd045 |
| Database: | Directory of Open Access Journals |
| ISSN: | 15989100 22881956 |
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| DOI: | 10.5217/ir.2023.00043 |
| Published in: | Intestinal Research |
| Language: | English |