二次進行性多発性硬化症におけるシポニモド対プラセボ (EXPAND): ダブルブラインド,ランダム化,第3相試験
Ludwig Kappos1, Amit Bar-Or2, Bruce A C Cree3
1Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital, University of Basel, Basel, Switzerland.
Lancet (London, England)
|March 27, 2018
まとめ
シポニモドは,二次進行性多発性硬化症 (SPMS) の患者の障害の進行を有意に減少させた. この選択的スフィンゴシン1-リン酸 (S1P) 受容体調節器は,SPMS患者にとって新しい治療法を提供します.
科学分野:
- 神経学
- 免疫学
- 薬理学について
背景:
- 二次進行性多発性硬化症 (SPMS) は,神経障害の進行が絶え間なく進んでいることが特徴です.
- 現在,SPMSの進行を遅らせる効果を一貫して示す治療法はありません.
研究 の 目的:
- SPMS患者における障害の進行を遅らせる選択性スフィンゴシン1- リン酸 (S1P) 受容体調節剤のシポニモドの有効性と安全性を評価する.
主な方法:
- 31カ国の1651人のSPMS患者を対象とした二重盲検,ランダム化,プラセボ対照の第3相試験です.
- 患者は最大3年間,経口シポニモド (毎日2mg) またはプラセボを投与された.
- 主なエンドポイントは,確認された障害の進行までの時間 (CDP) でした.
主要な成果:
- シポニモドの治療は,プラセボと比較して3ヶ月のCDPで21%の相対リスク低下をもたらした (危険比0. 79; p=0. 013).
- リンパ減量,肝臓酵素値上昇,ブラジカルディアなど,シポニモドの副作用の頻度は高かったが,重篤な症例と死亡例の違いはなかった.
- 初期投与量調整により,心臓への影響が効果的に軽減されました.
結論:
- シポニモドは,SPMSにおける障害の進行を減少させるのに有意な効果を示した.
- この薬は,他のS1P調節剤と比べ,好ましい安全性プロファイルを示し,SPMSの有望な治療選択肢となっています.
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