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このページは機械翻訳されています。他のページは英語で表示される場合があります。View in English
  1. ホーム
  3. 研究分野
  5. 生物医学と臨床科学
  7. 心血管医学と血液学
  9. 心臓病 (心血管疾患を含む)
  11. 巨細胞動脈炎における寛解の誘導と維持のためのトシリズマブ:第2相,ランダム化,ダブルブラインド,プラセボ対照試験

巨細胞動脈炎における寛解の誘導と維持のためのトシリズマブ:第2相,ランダム化,ダブルブラインド,プラセボ対照試験

Peter M Villiger1, Sabine Adler1, Stefan Kuchen1

  • 1Department of Rheumatology, Immunology and Allergology, University Hospital, University of Bern, Bern, Switzerland.

Lancet (London, England)
|March 9, 2016

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PubMed で要約を見る

まとめ
この要約は機械生成です。

トシリズマブは,巨大細胞動脈炎患者の寛解を効果的に誘導し維持し,長期にわたるグルココルチコイドの必要性を減少させます. この研究は,ランダム化臨床試験での有効性を示しています.

科学分野:

  • リウマトロジ
  • 免疫学
  • 臨床試験

背景:

  • 巨大細胞動脈炎 (GCA) は,主に50歳以上の個体において,中大動脈に影響を与える免疫媒介性血管炎である.
  • 現在の標準的なグルココルチコイド治療は合併症を予防しますが,重大な罹病率と死亡率を引き起こします.
  • IL-6受容体阻害剤であるトシリズマブは,GCA寛解の有望性を示しています.

研究 の 目的:

  • 新たに診断されたまたは再発した巨細胞動脈炎に対するランダム化臨床試験において,トシリズマブの有効性と安全性を評価する.
  • 病気の寛解を誘発し維持するトシリズマブの役割を評価する.
  • プレドニソロンと併用したトシリズマブとプレドニソロンと併用したプラセボを比較する.

主な方法:

  • GCAのACR基準を満たした50歳以上の患者による単一センター,第2相,ランダム化,ダブルブラインド,プラセボ対照試験.
  • 患者は52週間にわたって4週間に1度トシリズマブ (8 mg/ kg) またはプラセボを静脈内投与した.
  • 主なアウトカムは,低用量のプレドニソロンで12週間の完全寛解であり,治療意図分析が行われました.

主要な成果:

  • トシリズマブを投与した患者の85%が第12週までに寛解を達成し,プラセボを投与した患者の40%と比較した (p=0. 0301).

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  • 52週間の再発のない生存率は,トシリズマブ群では85%,プラセボ群では20%であった (p=0. 0010).
  • トシリズマブは累積的なプレドニソロン投与量とグルココルチコイド投与停止までの時間を大幅に短縮しました.

    • 結論:

    • トシリズマブは,巨大細胞動脈炎患者の寛解を誘発し維持するのに有効です.
    • この研究は,GCAにおけるトシリズマブの有効性に関する最初の試験に基づく証拠を提供します.
    • トシリズマブは,GCAの管理において,長期にわたるグルココルチコイド療法に対する有望な代替手段である.