最近発症した1型糖尿病患者のアタセプトとの共刺激調節:ランダム化,ダブルブラインド,プラセボ対照試験
Tihamer Orban1, Brian Bundy, Dorothy J Becker
1Joslin Diabetes Center, Boston, MA, USA.
Lancet (London, England)
|July 2, 2011
まとめ
アバタセプトは共刺激調節剤であり,2年間にわたってCペプチドの減少を遅らせることで,最近発症した1型糖尿病におけるβ細胞機能を保存しました. これは,T細胞の活性化が診断の鍵であることを示唆しています.
科学分野:
- 免疫学 免疫学とは
- エンドクリノロジー エンドクリノロジー
- クリニック・トライアル 臨床試験
背景:
- 1型糖尿病 (T1DM) の病原性には,T細胞の自己免疫が含まれています.
- T細胞の活性化には,抗原認識を超えた共刺激信号が必要です.
- アバタセプットは,T細胞活性化を制限するために共刺激を標的とする免疫調節剤です.
研究 の 目的:
- 最近発症したT1DM患者におけるβ細胞機能の保存におけるアタセプトの有効性を評価する.
- 2年間のT1DM進行に対する共刺激調節の影響を評価する.
主な方法:
- 最近発症したT1DMの6~45歳の患者を対象とした多センター,ダブルブラインド,ランダム化制御試験です.
- 患者はアタテセプト (10 mg/kg) またはプラセボを2年間にわたって27回の注射で静脈内投与した.
- 主なアウトカムは,2年後の混合食事耐性試験後の2時間の血清Cペプチド領域の曲線下の変化 (AUC) でした.
主要な成果:
- アバタセプトの治療は,プラセボと比較して2年後に調整されたCペプチドAUCを59%高めました (p=0.0029).
- アバタセプットは,Cペプチド減少の推定9.6ヶ月の遅延を示した.
- アバタセプトとプラセボのグループでは,有害事象,感染症,中性不全の割合が類似していました.
結論:
- アバタセプトとの共刺激調節は,最近発症したT1DMのベータ細胞機能の低下を2年以上にわたって効果的に遅らせました.
- この発見は,臨床T1DMの診断の時間頃に,T細胞の重要な活性化が起こることを示唆しています.
- アタタセプトの中止後に有益な効果が持続するかどうかを判断するために,さらなる研究が必要である.
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