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.
週四，艾伯維公司（納斯達克股票代碼：ABBV）公佈了LEVEL UP的主要結果，這是一項針對特應性皮炎的upadacitinib（Rinvoq，起始劑量爲15 mg，每日一次起始劑量並根據臨床反應調整劑量）對比dupilumab（Dupixent，按其標示劑量計算）的3b/4期開放標籤、療效評估盲目正面交鋒研究。
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.
艾伯維說，該研究是首項針對特應性皮炎的正面交鋒試驗，評估了起始劑量爲每天15 mg的upadacitinib與標示劑量的dupilumab對比。
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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.
該研究招收了患有中度至重度特應性皮炎（AD）的成人和青少年，他們對全身治療反應不足或不建議使用這些療法。
Dupixent is the flagship drug of Sanofi SA (NASDAQ:SNY) and Regeneron Pharmaceutical Inc (NASDAQ:REGN).
Dupixent是賽諾菲公司（納斯達克股票代碼：SNY）和再生元製藥公司（納斯達克股票代碼：REGN）的旗艦藥物。
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.
在這項研究中，與杜匹魯單抗相比，upadacitinib在主要終點顯示出更優異的療效，這表明在第16周，同時實現溼疹面積和嚴重程度指數（EASI 90）降低90％或更高的患者比例以及最差瘙癢數值評級表爲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幫助19.9％的患者實現了90％的皮膚清除率，幾乎沒有瘙癢，而接受Dupixent治療的患者中，這一比例爲8.9％。
- EASI 是一項經過臨床驗證的衡量標準，用於評估特應性皮炎的嚴重程度和程度。
- WP-NRS是一種評估工具，患者每天使用它來報告瘙癢強度（0表示 “不癢”，10表示 “可以想象的最嚴重的瘙癢”）。
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在所有次要終點方面也顯示出優於dupilumab的優勢，包括皮膚清除率幾乎完全快速發作以及幾乎沒有瘙癢。
For the first two ranked secondary endpoints, the study showed that a significantly higher proportion of patients treated with upadacitinib:
對於前兩個排名的次要終點，該研究表明，接受upadacitinib治療的患者比例明顯更高：
- 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 周達到了 EASI 90（40.8% 對 22.5%）。
- 在第 16 周實現了 0/1 的 WP-NRS（30.2% 對 15.5%）。
Price Action: ABBV shares were down 0.15% at $167.54 at the last check Thursday.
價格走勢：在週四的最後一次檢查中，ABBV股價下跌0.15％，至167.54美元。
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譯文內容由第三人軟體翻譯。