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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的旗舰牛皮癣治疗显示出持续疗效，平均清除率为10个月
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生物治疗公司纳斯达克(Sequoia Capital：ARQT)宣布了罗氟司特乳膏(0.3%)在成人慢性斑块型银屑病患者中的开放标签第二阶段长期安全性研究的新的安全性和有效性持久性数据。
  • 0.3%罗氟司特乳膏(Zoryve)是FDA于2022年7月批准的一种每日一次的非类固醇局部磷酸二酯酶-4抑制剂。
  • 研究表明，在试验期间，在接受罗氟司特乳膏治疗的患者中，57.1%(n=185)的患者在任何时候都达到了调查者全球评估(IGA)评分为清晰或几乎清晰(IGA 0/1)。
  • 参与者的免疫球蛋白A持续时间的中位数为10个月以上(40.1周)。
  • 接受罗氟司特乳膏治疗的受试者中，35.3%的受试者取得了免疫球蛋白A的成功，37.5%的受试者接受了罗氟司特-奈米̈静脉注射。免疫球蛋白A的成功被定义为明显/几乎明显加上较基线改善2级。
  • 在52周时，42%使用罗氟司特乳膏治疗的参与者和47.5%使用罗氟司特-奈米̈VE的参与者的免疫球蛋白A评分达到清晰或几乎清晰(免疫球蛋白0/1)。
  • 在Cohort-21中，66.7%的参与者获得了三叉神经间期免疫球蛋白A(I-IGA)的成功，定义为明显或几乎明显+较基线改善2级。
  • 没有发生快速反应，在IGA达到明确或几乎明确的参与者中，疗效随着时间的推移是一致的。
  • 安全性数据显示，由于不良反应，≥的停用率很低，97%的患者没有刺激性。
  • 价格行动：ARQT股价周五收盘上涨2.24%，至14.12美元。
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