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Arcutis' Flagship Psoriasis Treatment Shows Sustained Efficacy, Clearance For Median Of 10 Months

Arcutis' Flagship Psoriasis Treatment Shows Sustained Efficacy, Clearance For Median Of 10 Months

Arcutis 的旗艦銀屑病治療顯示出持續療效，中位數間隙為 10 個月
Benzinga Real-time News ·  2023/01/17 07:48
  • Arcutis Biotherapeutics Inc (NASDAQ:ARQT) announced new safety and efficacy durability data from its open-label Phase 2 long-term safety study of roflumilast cream (0.3%) in adults with chronic plaque psoriasis.
  • Roflumilast cream 0.3% (Zoryve) is a once-daily steroid-free topical phosphodiesterase-4 inhibitor approved by the FDA in July 2022.
  • The study showed that during the trial, 57.1% (n=185) of roflumilast cream-treated patients achieved an Investigator Global Assessment (IGA) score of clear or almost clear (IGA 0/1) at any time.
  • The participants had a median duration of IGA of clear or almost clear of more than ten months (40.1 weeks).
  • IGA success was achieved by 35.3% of participants previously treated with roflumilast cream and 37.5% of roflumilast-naïve participants. IGA success was defined as clear/almost clear plus 2-grade improvement from baseline.
  • 42% of participants previously treated with roflumilast cream and 47.5% of roflumilast-naïve participants achieved an IGA score of clear or almost clear (IGA 0/1) at Week 52.
  • 66.7% of participants in Cohort-21 achieved Intertriginous-IGA (I-IGA) success, defined as clear or almost clear plus 2-grade improvement from baseline.
  • No tachyphylaxis occurred, and efficacy was consistent over time among participants who achieved an IGA of clear or almost clear.
  • Safety data showed low discontinuation rates due to AEs, and ≥97% of patients showed no irritation.
  • Price Action: ARQT shares closed higher by 2.24% at $14.12 on Friday.
  • Photo Via Company
  • Arcutis生物治療公司納斯達克(Sequoia Capital：ARQT)宣佈了羅氟司特乳膏(0.3%)在成人慢性斑塊型銀屑病患者中的開放標籤第二階段長期安全性研究的新的安全性和有效性持久性數據。
  • 0.3%羅氟司特乳膏(Zoryve)是FDA於2022年7月批准的一種每日一次的非類固醇局部磷酸二酯酵素-4抑制劑。
  • 研究表明，在試驗期間，在接受羅氟司特乳膏治療的患者中，57.1%(n=185)的患者在任何時候都達到了調查者全球評估(IGA)評分為清晰或幾乎清晰(IGA 0/1)。
  • 參與者的免疫球蛋白A持續時間的中位數為10個月以上(40.1周)。
  • 接受羅氟司特乳膏治療的受試者中，35.3%的受試者取得了免疫球蛋白A的成功，37.5%的受試者接受了羅氟司特-奈米̈靜脈注射。免疫球蛋白A的成功被定義為明顯/幾乎明顯加上較基線改善2級。
  • 在52周時，42%使用羅氟司特乳膏治療的參與者和47.5%使用羅氟司特-奈米̈VE的參與者的免疫球蛋白A評分達到清晰或幾乎清晰(免疫球蛋白0/1)。
  • 在Cohort-21中，66.7%的參與者獲得了三叉神經間期免疫球蛋白A(I-IGA)的成功，定義為明顯或幾乎明顯+較基線改善2級。
  • 沒有發生快速反應，在IGA達到明確或幾乎明確的參與者中，療效隨著時間的推移是一致的。
  • 安全性數據顯示，由於不良反應，≥的停用率很低，97%的患者沒有刺激性。
  • 價格行動：ARQT股價週五收盤上漲2.24%，至14.12美元。
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