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バリシチニブは,全身性狼症に対する二重盲検,ランダム化,プラセボ対照,第2相試験
Daniel J Wallace1, Richard A Furie2, Yoshiya Tanaka3
1Division of Rheumatology, Cedars-Sinai Medical Center, University of California at Los Angeles, Los Angeles, CA, USA.
Lancet (London, England)
|July 26, 2018
まとめ
バリシチニブ4mgは,第2相試験で全身性狼症の症状を有意に改善した. このジャヌスキナーゼ (JAK) 阻害剤は,狼患者の新しい経口療法として有望である.
科学分野:
- リウマトロジ
- 免疫学
- 薬理学について
背景:
- システミック・ルプス・エリテマトーサス (SLE) は,未解決の重要な医療ニーズを示しています.
- 選択的なジャヌスキナーゼ (JAK) 1およびJAK2阻害剤であるバリシチニブは,SLEにおける潜在的な治療効果について調査されました.
- JAK阻害剤は,自己免疫疾患に対する新しい治療法です.
研究 の 目的:
- 活発な全身性狼症の患者におけるバリシチニブの有効性と安全性を評価する.
- SLEの症状,特に関節炎と発疹の治療に最適なバリシチニブの投与量を決定する.
主な方法:
- ダブルブラインド,ランダム化,プラセボ対照,マルチセンターフェーズ2試験.
- 314人のSLE患者が24週間にわたってバリシチニブ (2mgまたは4mg) またはプラセボを1日1回投与された.
- 主要エンドポイントは,24週目における全身性白血病活動指数-2000 (SLEDAI- 2K) による関節炎または発疹の解消です.
主要な成果:
- バリシチニブ4 mgは,関節炎や発疹のSLEDAI- 2K解消を有意に改善した (67%対プラセボ,p=0. 0414).
- バリシチニブ2mgは改善傾向を示したが,統計的に有意ではなかった (58%対プラセボ,p=0. 39).
- 前回のバリシチニブ試験と安全性プロファイルは一致しており,バリシチニブ群とプラセボ群では重篤な有害事象や感染がより多く見られた.
結論:
- バリシチニブ4mgは,標準療法で不十分にコントロールされた患者で,活発なSLE症状,特に関節炎と発疹の治療に有意な効果を示した.
- バリシチニブの安全性プロファイルは,以前の研究と一致し,SLEの経口療法としての可能性を支持しました.
- この研究は,SLE治療におけるバリシチニブの第3相試験のさらなる調査を支持する.
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