AbbVie's Dermatitis Drug Shown 'Superior' To Sanofi/Regeneron's Dupixent In Head-To-Head Study
AbbVie's Dermatitis Drug Shown 'Superior' To Sanofi/Regeneron's Dupixent In Head-To-Head Study
Thursday, AbbVie Inc (NASDAQ:ABBV) released topline results from LEVEL UP, an open-label, efficacy assessor-blinded head-to-head Phase 3b/4 study of upadacitinib (Rinvoq, 15 mg once daily starting dose and dose-adjusted based on clinical response) versus dupilumab (Dupixent, per its labeled dose) for atopic dermatitis.
周四，艾伯维公司（纳斯达克股票代码：ABBV）公布了LEVEL UP的主要结果，这是一项针对特应性皮炎的upadacitinib（Rinvoq，起始剂量为15 mg，每日一次起始剂量并根据临床反应调整剂量）对比dupilumab（Dupixent，按其标示剂量计算）的3b/4期开放标签、疗效评估盲目正面交锋研究。
AbbVie said the study is the first head-to-head trial in atopic dermatitis assessing upadacitinib at a starting dose of 15 mg daily versus dupilumab at its labeled dose.
艾伯维说，该研究是首项针对特应性皮炎的正面交锋试验，评估了起始剂量为每天15 mg的upadacitinib与标示剂量的dupilumab对比。
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The study enrolled adults and adolescents with moderate-to-severe atopic dermatitis (AD) who had an inadequate response to systemic therapy or when the use of those therapies was inadvisable.
该研究招收了患有中度至重度特应性皮炎（AD）的成人和青少年，他们对全身治疗反应不足或不建议使用这些疗法。
Dupixent is the flagship drug of Sanofi SA (NASDAQ:SNY) and Regeneron Pharmaceutical Inc (NASDAQ:REGN).
Dupixent是赛诺菲公司（纳斯达克股票代码：SNY）和再生元制药公司（纳斯达克股票代码：REGN）的旗舰药物。
In the study, upadacitinib showed superior efficacy versus dupilumab in the primary endpoint, demonstrating that a significantly higher proportion of patients simultaneously achieved both a 90% or greater reduction in Eczema Area and Severity Index (EASI 90) and a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16.
在这项研究中，与杜匹鲁单抗相比，upadacitinib在主要终点显示出更优异的疗效，这表明在第16周，同时实现湿疹面积和严重程度指数（EASI 90）降低90％或更高的患者比例以及最差瘙痒数值评级表为0或1（WP-NRS 0/1）。
- Rinvoq helped 19.9% of patients achieve 90% skin clearance with a no-to-little itch, compared with 8.9% of patients treated with Dupixent.
- The EASI is a clinically validated measure used to assess the severity and extent of atopic dermatitis.
- WP-NRS is an assessment tool that patients use to report the intensity of their pruritus daily (with 0 being 'no itch' and 10 being the 'worst imaginable itch').
- Rinvoq帮助19.9％的患者实现了90％的皮肤清除率，几乎没有瘙痒，而接受Dupixent治疗的患者中，这一比例为8.9％。
- EASI 是一项经过临床验证的衡量标准，用于评估特应性皮炎的严重程度和程度。
- WP-NRS是一种评估工具，患者每天使用它来报告瘙痒强度（0表示 “不痒”，10表示 “可以想象的最严重的瘙痒”）。
Upadacitinib also showed superiority over dupilumab for all ranked secondary endpoints, including the rapid onset of nearly complete skin clearance and little to little itch.
Upadacitinib在所有次要终点方面也显示出优于dupilumab的优势，包括皮肤清除率几乎完全快速发作以及几乎没有瘙痒。
For the first two ranked secondary endpoints, the study showed that a significantly higher proportion of patients treated with upadacitinib:
对于前两个排名的次要终点，该研究表明，接受upadacitinib治疗的患者比例明显更高：
- Achieved EASI 90 at Week 16 (40.8% vs 22.5%).
- Achieved a WP-NRS of 0/1 at Week 16 (30.2% vs 15.5%).
- 在第 16 周达到了 EASI 90（40.8% 对 22.5%）。
- 在第 16 周实现了 0/1 的 WP-NRS（30.2% 对 15.5%）。
Price Action: ABBV shares were down 0.15% at $167.54 at the last check Thursday.
价格走势：在周四的最后一次检查中，ABBV股价下跌0.15％，至167.54美元。
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