バリシチニブは,全身性白血球性狼に対して,ダブルブラインド,ランダム化,プラセボ対照,第3相試験 (SLE- BRAVE- I)
Eric F Morand1, Edward M Vital2, Michelle Petri3
1Centre for Inflammatory Disease, Monash University, Melbourne, VIC, Australia; School of Clinical Sciences, Monash University Clayton, Melbourne, VIC, Australia.
Lancet (London, England)
|February 27, 2023
まとめ
バリシチニブ4 mgは52週間の研究で,主評価値を満たし,全身性白血球症 (SLE) 疾患の活性性を有意に改善しました. しかし,二次評価値は満たされず,安全性プロファイルは既知のデータと一致しました.
科学分野:
- 免疫学
- リウマトロジ
- 薬理学について
背景:
- バリシチニブは,ジャヌスキナーゼ1および2阻害剤で,リウマチ性関節炎,アトピー性皮膚炎,および白髪症の治療に承認されています.
- 前回の24週間の研究では,バリシチニブ4mgは,全身性白血球性狼 (SLE) の患者の疾患活動を改善した.
研究 の 目的:
- 進行中のSLE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.
主な方法:
- 多センター,ダブルブラインド,ランダム化,プラセボ対照試験 (SLE- BRAVE- I) で,活発なSLE患者の760人がバリシチニブ4 mg,2 mg,またはプラセボ投与を受けました.
- 主要評価項目は,52週にSLE応答者指数 (SRI) - 4の反応を達成した患者の割合でした.
主要な成果:
- バリシチニブ4mgは,プラセボと比較してSRI-4応答率 (57%) を有意に増加させた (46%; p=0. 016).
- バリシチニブ2mgは,プラセボと比較してSRI-4応答の有意な違いを示さなかった (50%).
- グルココルチコイドの縮小と重症発症までの時間など,主要な二次エンドポイントにおいて,グループ間の有意な差異は観察されなかった.
結論:
- バリシチニブ4mgは,活性SLEの患者で主効性エンドポイントを達成しました.
- 重要な二次エンドポイントは満たされず,新しい安全性に関する問題も特定されなかった.
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