発症再発性寛解性多発性硬化症 (SELECT) のダクリズマブ高収量プロセス:ランダム化,ダブルブラインド,プラセボ対照試験
Ralf Gold1, Gavin Giovannoni, Krzysztof Selmaj
1St Josef-Hospital, Ruhr-University Bochum, Bochum, Germany. ralf.gold@ruhr-uni-bochum.de
Lancet (London, England)
|April 9, 2013
まとめ
ダクリズマブHYPは,リクライシング・リミッティング型多発性硬化症の患者で1年以上にわたり,リクライシング・リミッティング型多発性硬化症患者のリクライシング・リミッティング型多発性硬化症のリクライシング率を著しく低下させた. この研究は,ダクリズマブHYPを,活発なMSの潜在的な新しい治療法として示唆しています.
科学分野:
- 免疫学 免疫学とは
- 神経学 神経学とは
- 薬理学 薬理学とは
背景:
- ダクリズマブは,IL-2受容体アルファサブユニット (CD25) を標的にするモノクローナル抗体です.
- 免疫反応において極めて重要なインターリューキン-2シグナリングを調節する.
- この研究では,再発性寛解性多発性硬化症 (RRMS) のダクリズマブ高収量プロセス (HYP) を調査しました.
研究 の 目的:
- RRMS患者におけるダクリズマブHYPの単独療法としての有効性を評価する.
- 1年間の治療期間中,病気の活動に対するその影響を評価するために.
- ダクリズマブHYPがRRMSの新たな治療法を提供できるかどうかを判断する.
主な方法:
- 76のセンターを対象としたランダム化,ダブルブラインド,プラセボ対照試験です.
- RRMSの患者は,52週間にわたって4週間に1度,皮膚下ダクリズマブHYP (150mgまたは300mg) またはプラセボを投与された.
- 主なエンドポイントは,治療の意図によって分析された,年間再発率でした.
主要な成果:
- ダクリズマブHYP (150 mg,300 mg) は,プラセボと比較して,年間再発率を大幅に低下させました (それぞれ54%と50%の減少).
- ダクリズマブHYP群の患者の割合は,プラセボ (64%) と比較して,再発のない割合がより高い (81%と80%).
- 重篤な有害事象は,各グループで比較可能であり,ダクリズマブHYP 150 mg群では,psoasの合併症による1人の死亡が報告されました.
結論:
- 4週毎に投与された皮膚下ダクリズマブHYPは,多発性硬化症の疾患活動に臨床的に有意な効果を示した.
- この発見は,ダクリズマブHYPを,再発性寛解性多発性硬化症の潜在的な追加の治療法として支持しています.
- 長期的な有効性および安全性プロフィールを調査するためのさらなる研究は可能である.
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