中度から重度の牛皮病に対するインフリキシマブ誘導および維持療法:第3相,多センター,ダブルブラインド試験
Kristian Reich1, Frank O Nestle, Kim Papp
1Department of Dermatology, Georg-August University, Göttingen, Germany.
Lancet (London, England)
|October 18, 2005
まとめ
インフリキシマブは,中等から重度の牛皮病を効果的に治療し,患者の80%が10週間以内に皮膚の有意な改善を達成しています. このTNFαα阻害剤の継続的な治療は,1年以上にわたって持続的な有効性と良好な耐容性を示しました.
科学分野:
- 免疫皮膚病学について
- 臨床免疫学 臨床免疫学とは
- 薬理学 薬理学とは
背景:
- 腫瘍死滅因子アルファ (TNFalpha) は,牛皮病の病原性に関与しています.
- TNFαを中和するモノクローナル抗体であるインフリキシマブは,牛皮病の治療のために調査されました.
研究 の 目的:
- 中度重症から重症のプラーク型牛皮病患者のインフリキシマブ継続治療の有効性と安全性を評価する.
- インフリキシマブの効果を1年以上にわたって,誘導療法と維持療法の両方で評価する.
主な方法:
- 第III相,多センター,ダブルブラインド試験で,中等度から重度のプラーク性ソーリアーシスを持つ378人の患者が参加しました.
- 患者は,インフリキシマブ (5 mg/kg) またはプラセボを指定された間隔で注入し,プラセボ患者は24週目にクロスオーバーした.
- 牛皮病の重症度は,牛皮病領域と重症度指数 (PASI) と爪牛皮病重症度指数 (NAPSI) を使用して評価されました.
主要な成果:
- 10週目には,インフリキシマブを投与した患者の80%がPASI改善率 >=75% (PASI 75) を達成し,プラセボでは3% (p<0.0001) であった.
- 持続的な有効性は50週まで観察され,61%がPASI75を達成し,45%がPASI90を達成しました.
- インフリキシマブは一般的によく耐えられ,好ましい安全性プロファイルを示しました.
結論:
- インフリキシマブは,中等から重度の牛皮病に対する効果的な誘導および維持療法です.
- 1年間の治療で,持続的なPASI 75およびPASI 90改善の高い割合が達成されました.
- この研究は,中等度から重度のの管理におけるインフリキシマブの役割を支持しています.
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