オクレリズマブ (Ocrelizumab) が再発寛解性多発性硬化症の治療:第2相,ランダム化,プラセボ対照,多センター試験
Ludwig Kappos1, David Li, Peter A Calabresi
1University Hospital, Basel, Switzerland. lkappos@uhbs.ch
Lancet (London, England)
|November 4, 2011
まとめ
オクレリズマブは,プラセボと比較して,再発・リミート性多発性硬化症患者のガドリニウム強化病変を有意に減少させた. このB細胞枯渇治療は,B細胞をサポートし,MSの管理に有望であることを示しています.
科学分野:
- 神経免疫学 神経免疫学とは
- 薬理学 薬理学とは
- クリニック・トライアル 臨床試験
背景:
- B型リンパ球は,多発性硬化症 (MS) の病原性において役割を果たします.
- オクレリズマブ (Ocrelizumab) は,B細胞を標的にするヒト化された抗CD20モノクローナル抗体である.
研究 の 目的:
- 2つのオクレリズマブ投与レジメントの有効性と安全性を再発性寛解性多発性硬化症の患者で評価する.
- オクレリズマブの効果をプラセボとインターフェロンβ-1aと比較するために.
主な方法:
- 220人の患者が参加した多センター,ランダム化,ダブルブラインド,プラセボ対照試験です.
- 患者はプラセボ,低用量 (600 mg) または高用量 (2000 mg) のオクレリズマブ,またはインターフェロンβ-1aを受けた.
- 主要エンドポイント:24週後のMRIでガドリニウム増強病変 (GEL) の数.
主要な成果:
- 600 mgと2000 mgのオクレリズマブ投与は,プラセボと比較してGELを著しく低下させた (それぞれ89%と96%の減少).
- オクレリズマブ (Ocrelizumab) は,探索的分析において,インターフェロンベータ-1aと比較して,GELを減らすのに優越した有効性を示しました.
- 不良事象の発生率は,治療グループ間で比較可能でした.
結論:
- オクレリズマブによるB細胞減少は,再発性寛解性MSにおけるMRI病変を効果的に減少させます.
- これらの発見は,MSの病原性におけるB細胞の役割を支持しています.
- オクレリズマブの完全な可能性を評価するために,さらなる長期試験が必要である.
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