慢性性斑塊性ソーリアシスと心血管疾患の生物学的治療法との関連:ランダム化対照試験のメタ分析
Caitriona Ryan1, Craig L Leonardi, James G Krueger
1Department of Dermatology, Baylor Research Institute, 3900 Junius St, Ste 125, Dallas, TX 75246, USA. caitriona.ryan@baylorhealth.edu
JAMA
|August 25, 2011
まとめ
このメタアナリシスでは,プラセボと比較して,慢性性斑塊性ソーリアーシスに対する抗インターリューキン-12/23または抗腫瘍死滅因子-アルファ療法で治療された患者の主要な有害心血管イベント (MACE) の有意な増加は認められなかった.
科学分野:
- 皮膚科 皮膚科について
- 心臓病学 心臓病学
- 免疫学 免疫学とは
背景:
- IL-12/23を標的にするウステキヌマブとブリアキヌマブを含む生物学的治療法は,慢性プラーク型牛皮病 (CPP) に有効です.
- 牛皮病患者の抗IL-12/23剤に関連した主要な心血管不良事件 (MACE) に関する懸念があります.
研究 の 目的:
- CPPとMACEの生物学的治療法の関連性を評価するメタ分析を実施する.
- 抗IL-12/23および抗腫瘍死滅因子アルファ (TNF-α) 剤の心血管安全性プロファイルを比較する.
主な方法:
- CPPに対する抗IL-12/23および抗TNF-α剤のランダム化対照試験 (RCT) の体系的レビューとメタ解析.
- MACEのアウトカムデータを持つモノセラピーの試験を含む. 牛皮質関節炎試験を除く.
- 絶対的なリスク差に対するMantle-Haenszel固定効果法によるデータ抽出と分析.
主要な成果:
- 10,183人の患者を対象とした22件のRCTを分析した.
- 抗IL-12/23療法とプラセボの間でMACE率の統計的に有意な差は認められなかった (リスク差:0.012事件/人/年;P=.12).
- 同様に,抗TNF-α療法では,プラセボと比較してMACE率の有意な差異は見られなかった (リスクの差異: -0.0005イベント/人/年;P=.94).
結論:
- CPP患者では,抗IL-12/23または抗TNF-α治療とプラセボに対するMACE率の有意な違いは見つかりませんでした.
- MACEの統計的に有意な差を検出するには,研究が不足している可能性があります.
- これらの生物学的薬剤の心血管安全性については,継続的なモニタリングが必要です.
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