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生物学的疾患変異抗レウマティック薬に耐性のあるアクティブなリウマチ性関節炎患者におけるウパダシチニブの安全性と有効性 (SELECT- BEYOND): ダブルブラインド,ランダム化制御フェーズ3試験

Mark C Genovese1, Roy Fleischmann2, Bernard Combe3

  • 1Division of Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA.

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|June 18, 2018
PubMed
まとめ
この要約は機械生成です。

ユパダシチニブ (JAK1阻害剤) は,bDMARDに不十分な反応を示した患者の関節リウマチ症状を有意に改善しました. このフェーズ3試験では,15 mgと30 mgの両方の投与量がプラセボよりも有効であることが示されました.

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科学分野:

  • リウマトロジ
  • 免疫学
  • 薬理学について

背景:

  • リウマチ性関節炎 (RA) は,関節に影響を与える慢性的な自己免疫疾患です.
  • 病気を変化させる生物学的抗レウマティック薬 (bDMARDs) は RA の治療に使用されますが,一部の患者は不十分な反応を示します.
  • ウパダシチニブは,RA治療のために研究されている選択的なジャヌスキナーゼ1 (JAK1) 阻害剤です.

研究 の 目的:

  • bDMARDに対する不十分な反応または不耐性を有するRA患者におけるウパダシチニブの安全性と有効性を評価する.
  • 3期試験におけるウパダシチニブ (15 mg と 30 mg) とプラセボを比較する.

主な方法:

  • bDMARDの失敗を前にした499人の患者で実施された二重盲検のランダム化制御フェーズ3試験です.
  • 患者は1日1回15 mg,30 mg,またはプラセボを12週間投与し,その後はウパダシチニブを投与した.
  • 主要エンドポイントは,ACR20応答とDAS28 (CRP) <=3. 2で第12週でした.

主要な成果:

  • 12週目には,65パーセント (15 mg) と56パーセント (30 mg) の患者でACR20が達成され,プラセボでは28パーセント (p< 0. 0001) であった.
  • DAS28 ((CRP) <=3. 2は,プラセボの14%に対して43% (15 mg) と42% (30 mg) で達成されました (p<0. 0001).
  • 副作用は一般的にプラセボと15 mgのウパダシチニブで類似したが,30 mgのウパダシチニブではより高かった.

結論:

  • プラセボと比較して,bDMARDsに耐性のある患者では,ウパダシチニブが迅速かつ有意にRA症状を改善することが示されました.
  • アパダシチニブの15 mgと30 mgの投与量は有効で,30 mgの投与量では有害事象の発生率が高く見られた.