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  1. 医学部
  1. 医学部
  2. 学術雑誌掲載論文  (医学部)

Momelotinib versus ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis: an efficacy/safety analysis in the Japanese subgroup of the phase 3 randomized SIMPLIFY-1 trial

http://hdl.handle.net/10458/0002001035
http://hdl.handle.net/10458/0002001035
10692d89-8536-4760-a7e0-6c1b39f50652
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s12185-024-03822-z.pdf article (842 KB)
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アイテムタイプ 学術雑誌論文 / Journal Article(1)
公開日 2025-03-25
タイトル
タイトル Momelotinib versus ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis: an efficacy/safety analysis in the Japanese subgroup of the phase 3 randomized SIMPLIFY-1 trial
言語 en
言語
言語 eng
キーワード
言語 en
キーワード Japan
キーワード
言語 en
キーワード Momelotinib
キーワード
言語 en
キーワード Myelofibrosis
キーワード
言語 en
キーワード Phase 3
キーワード
言語 en
キーワード Ruxolitinib
資源タイプ
資源タイプ journal article
アクセス権
アクセス権 open access
著者 下田, 和哉

× 下田, 和哉

WEKO 7997
e-Rad_Researcher 90311844

en Shimoda, Kazuya
University of Miyazaki

ja 下田, 和哉
宮崎大学

ja-Kana シモダ, カズヤ

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Komatsu, Norio

× Komatsu, Norio

en Komatsu, Norio

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Matsumura, Itaru

× Matsumura, Itaru

en Matsumura, Itaru

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Ikeda, Kazuhiko

× Ikeda, Kazuhiko

en Ikeda, Kazuhiko

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Hino, Masayuki

× Hino, Masayuki

en Hino, Masayuki

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Hidaka, Michihiro

× Hidaka, Michihiro

en Hidaka, Michihiro

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Maeda, Yoshinobu

× Maeda, Yoshinobu

en Maeda, Yoshinobu

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Kondo, Takeshi

× Kondo, Takeshi

en Kondo, Takeshi

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Fujisaki, Tomoaki

× Fujisaki, Tomoaki

en Fujisaki, Tomoaki

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Shoshi, Keita

× Shoshi, Keita

en Shoshi, Keita

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Azuma, Kyoichi

× Azuma, Kyoichi

en Azuma, Kyoichi

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Fukushima, Ryuichi

× Fukushima, Ryuichi

en Fukushima, Ryuichi

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Kawashima, Jun

× Kawashima, Jun

en Kawashima, Jun

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Kosugi, Hiroshi

× Kosugi, Hiroshi

en Kosugi, Hiroshi

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抄録
内容記述タイプ Abstract
内容記述 Momelotinib, an oral Janus kinase (JAK) 1/2 and activin A receptor type 1 inhibitor, improved symptoms, splenomegaly, and anemia in patients with myelofibrosis (MF). This sub-analysis of SIMPLIFY-1 evaluated the efficacy and safety of momelotinib versus ruxolitinib in Japanese patients with JAK inhibitor (JAKi)-naïve MF. Patients were randomized 1:1 to receive momelotinib 200 mg once daily or ruxolitinib 20 mg twice daily (or modified based on label) for 24 weeks, after which patients could receive open-label momelotinib. The primary endpoint was splenic response rate (SRR; ≥ 35% reduction in spleen volume) at 24 weeks; main secondary endpoints were total symptom score (TSS) response (≥ 50% reduction) and transfusion independence (TI) rates. Fifteen Japanese patients (momelotinib, n = 6; ruxolitinib, n = 9) were enrolled; all completed treatment. At Week 24, SRR was 50.0% with momelotinib and 44.4% with ruxolitinib. TSS response rates were 33.3% and 0%, and TI rates were 83.3% and 44.4%. Any-grade treatment-related adverse event (TRAE) rates were 83.3% with momelotinib and 88.9% with ruxolitinib. Grade 3/4 TRAE rates were 0% and 55.6%, with specific events being anemia (55.6%) and vertigo (11.1%) with ruxolitinib. Momelotinib was well tolerated, improved spleen and symptom responses, and reduced transfusion requirements in Japanese patients with JAKi-naïve MF.
言語 en
内容記述
内容記述タイプ Other
内容記述 Citation: Kazuya Shimoda, Norio Komatsu, Itaru Matsumura, Kazuhiko Ikeda, Masayuki Hino, Michihiro Hidaka, Yoshinobu Maeda, Takeshi Kondo, Tomoaki Fujisaki, Keita Shoshi, Kyoichi Azuma, Ryuichi Fukushima, Jun Kawashima, Hiroshi Kosugi, Momelotinib versus ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis: an efficacy/safety analysis in the Japanese subgroup of the phase 3 randomized SIMPLIFY-1 trial, International Journal of Hematology, 120(3), 314-324, 2024-08-07, https://doi.org/10.1007/s12185-024-03822-z
言語 en
bibliographic_information en : International Journal of Hematology

巻 120, 号 3, p. 314-324, 発行日 2024-08-07
出版者
出版者 Springer Science and Business Media LLC
言語 en
ISSN
収録物識別子タイプ PISSN
収録物識別子 0925-5710
ISSN
収録物識別子タイプ EISSN
収録物識別子 1865-3774
item_10001_relation_14
関連タイプ isVersionOf
識別子タイプ DOI
関連識別子 https://doi.org/10.1007/s12185-024-03822-z
権利
権利情報 © The Author(s) 2024
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