クローン病の誘導療法としてのリサンキズマブ:第3相ADVANCEおよびMOTIVATE誘導試験の結果
Geert D'Haens1, Remo Panaccione2, Filip Baert3
1Inflammatory Bowel Disease Centre, Amsterdam University Medical Center, Amsterdam, Netherlands.
Lancet (London, England)
|June 1, 2022
まとめ
IL - 23 阻害剤であるリサンキズマブは,第3相試験でクローン病を効果的に治療しました. 患者は臨床寛解と内視反応を達成し,中度から重度の症例ではこの治療が良好に耐えることを示した.
科学分野:
- 胃腸内科
- 免疫学
- 臨床薬理学
背景:
- クローン病は慢性的な炎症性疾患で 効果的な治療が必要です
- インタールイウキン-23 (IL-23) は,クローン病の病原性に関与する重要なサイトカインである.
- リサンキズマブはIL-23経路を標的にし,潜在的な治療選択肢を提供します.
研究 の 目的:
- 中等から重度のクローン病に対する誘導療法としてのリサンキズマブの安全性と有効性を評価する.
- 12週間の臨床寛解と内視応答率を評価する.
- この患者集団におけるリサンキズマブの耐受性プロファイルを決定する.
主な方法:
- 2つのランダム化,二重マスク,プラセボ対照のフェーズ3試験 (ADVANCEとMOTIVATE) を実施した.
- 中等から重度のクローン病の患者は,静脈内リサンキズマブ (600 mgまたは1200 mg) またはプラセボを週0,週4,週8に投与された.
- 臨床的寛解 (CDAIまたは患者によるアウトカム) と第12週における内視鏡による応答はコプライマリーエンドポイントであった.
主要な成果:
- 両方のリサンキズマブ投与量は,両試験におけるすべてのコプライマリーエンドポイントを満たした (p ≤ 0. 0001).
- 臨床寛解率は,リサンキズマブ群では40~45%,プラセボ群では19~25%であった.
- リスンキズマブ (29~40%),プラセボ (11-12%) と比較して,内視鏡による応答率が著しく高かった.
結論:
- リサンキズマブは,中等度から重度のクローン病患者の臨床寛解と内視鏡による応答を誘導する有意な効果を示した.
- リサンキズマブの安全性プロファイルはプラセボと同等で,有害事象の発生率は同様でした.
- リサンキズマブは,クローン病の有効でよく耐える誘導療法です.
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