中度から重度の活発な潰瘍性大腸炎に対する誘導および維持療法としてのウパダシチニブ: 3つのフェーズ3,多センター,ダブルブラインド,ランダム化試験の結果
Silvio Danese1, Séverine Vermeire2, Wen Zhou3
1Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy.
Lancet (London, England)
|June 1, 2022
まとめ
ヤヌスキナーゼ1阻害剤であるウパダシチニブは,潰瘍性大腸炎患者の寛解を効果的に誘導し維持しました. 適度から重度の病気に対する新しい治療の選択肢を提供する,安全性プロファイルを示した.
科学分野:
- 胃腸科と肝臓科
- 免疫学と関節病学
- 薬理学と医薬品科学
背景:
- 潰瘍性大腸炎 (UC) の迅速で堅実で持続的な病気制御を提供する先進的な治療法に対する需要は,著しく満たされていない.
- ウパダシチニブは,経口による選択的なジャヌスキナーゼ1 (JAK1) 阻害剤で,UCにおける誘導および維持療法を評価した.
研究 の 目的:
- 中度から重度の活発な潰瘍性大腸炎の患者におけるウパダシチニブの有効性と安全性を評価する.
- UC患者の誘導および維持療法としてのウパダシチニブの可能性を決定する.
主な方法:
- 2つの誘導試験 (UC1,UC2) と1つの維持試験 (UC3) を含む多センター,ランダム化,ダブルブラインド,プラセボ対照の臨床プログラムです.
- 中度から重度のUCを患った患者 (16- 75歳) は,口服によるウパダシチニブ45mgまたはプラセボを8週間の誘導投与を受けた.
- 回答者は,52週間の維持試験に参加し,ウパダシチニブ (15 mgまたは30 mg) またはプラセボにランダムに割り当てられました.
主要な成果:
- 誘導試験において,ウパダシチニブ45 mgはプラセボと比較して臨床寛解率を有意に増加させた (UC1: 26%対5%;UC2: 34%対4%;P< 0. 0001).
- 維持試験では,ウパダシチニブ (15 mg と 30 mg) がプラセボと比較して臨床寛解率を有意に改善した (42% と 52% 対 12%; P< 0. 0001).
- 重篤な有害事象や中止の頻度も低かった.
結論:
- 中度から重度の活動性潰瘍性大腸炎患者の臨床寛解を誘発し維持する際の有効性が示されました.
- プラセボと比較して,重篤な有害事象と治療中止の割合が低かった.
- ウパダシチニブは,中度から重度の潰瘍性大腸炎の患者にとって有望な新しい経口治療法です.
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