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Eli Lilly's Newly FDA-Approved Eczema Drug Improves Skin And Itch In Patients Previously Treated With Sanofi/Regeneron's Dupixent

Eli Lilly's Newly FDA-Approved Eczema Drug Improves Skin And Itch In Patients Previously Treated With Sanofi/Regeneron's Dupixent

以前接受賽諾菲安萬特/再生元的杜哌仙的患者,艾利·莉莉公司新獲得的溼疹藥物改善了皮膚和瘙癢
Benzinga ·  10/26 01:57

On Friday, Eli Lilly and Company (NYSE:LLY) revealed new results from the Phase 3b ADapt study of Ebglyss (lebrikizumab), which will be presented at the Fall Clinical Dermatology Conference.

週五,Eli Lilly and Company(紐交所: LLY)公佈了Ebglyss(lebrikizumab)的第30億期ADapt研究的新結果,這將在秋季臨床皮膚病學會議上進行展示。

The results show that Ebglyss improved skin (including hand and face) and itch among patients with moderate-to-severe atopic dermatitis (eczema) who were previously treated with Sanofi SA (NASDAQ:SNY) / Regeneron Pharmaceuticals Inc's (NASDAQ:REGN) Dupixent (dupilumab).

結果顯示,Ebglyss改善了先前接受賽諾菲安萬特(NASDAQ: SNY)/再生元製藥公司(NASDAQ: REGN)Dupixent(dupilumab)治療的中重度特應性皮炎(溼疹)患者的皮膚(包括手部和麪部)和瘙癢。

The study's primary endpoint was measured by at least a 75% improvement in the Eczema Area and Severity Index (EASI-75) score at 16 weeks, which evaluates the extent and severity of the skin disease.

該研究的主要終點是在16周時,通過至少75%的溼疹面積和嚴重指數(EASI-75)評分改善程度,以評估皮膚疾病的範圍和嚴重程度。

Secondary endpoints at 16 and 24 weeks included Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) skin with a reduction of at least two points from baseline and at least a four-point improvement in Pruritus NRS from baseline.

輔助終點在16周和24周時包括,調查員全球評估(IGA)評分爲清晰(0)或幾乎清晰(1)的皮膚,與基線相比至少降低兩分,以及自基線至少提高四分的瘙癢NRS。

With Ebglyss, 57% of patients in Week 16 and 60% in Week 24 who had previously been treated with dupilumab achieved EASI-75.

使用Ebglyss後,在接受過dupilumab治療的患者中,57%的患者在第16周,60%的患者在第24周達到了EASI-75。

In addition, 46% of patients who were inadequate responders to dupilumab achieved EASI-75 response with Ebglyss at Week 16.

此外,對於對dupilumab反應不足的患者,有46%的患者在第16周通過Ebglyss實現了EASI-75的反應。

53% and 62% of ADapt patients who discontinued dupilumab and began treatment with Ebglyss also experienced itch relief (Pruritus NRS) with at least a four-point improvement from baseline at Week 16 and Week 24, respectively.

ADapt研究中有53%和62%的患者停用dupilumab並開始使用Ebglyss的患者在第16周和第24周分別也經歷了瘙癢緩解(瘙癢NRS),而且至少比基線提高了四分。

Patients in this study saw improvements in difficult-to-treat areas when treated with Ebglyss.

在這項研究中,接受Ebglyss治療的患者在難治區域看到了改善。

52% treated with Ebglyss saw clear or almost clear face dermatitis at Week 24.

在第24周,52%接受Ebglyss治療的患者面部皮炎清晰或幾乎清晰。

Among patients with moderate-to-severe hand dermatitis at baseline, the modified total lesion-symptom score, which measures the extent and severity of hand dermatitis, decreased by 75 percent at Week 24.

在基線爲中度至重度手部皮炎的患者中,第24周修改後的總病變症狀評分下降了75% ,該評分衡量手部皮炎的程度和嚴重程度。

Less than 6% of patients treated with Ebglyss experienced an adverse event that led to treatment discontinuation.

接受Ebglyss治療的患者中不到6%經歷導致停止治療的不良事件。

Last month, the FDA approved Ebglyss, a targeted IL-13 inhibitor, for adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe atopic dermatitis (eczema) that is not well controlled despite treatment with topical prescription therapies.

上個月,FDA批准了Ebglyss,這是一種針對IL-13的靶向抑制劑,用於12歲及以上,體重至少88磅(40公斤)的成人和兒童,他們患有中度至重度無法通過局部處方療法有效控制的特應性皮炎(溼疹)。

Ebglyss was also approved in the European Union in 2023 and Japan in January 2024, with additional markets expected later this year.

Ebglyss還獲得了2023年在歐盟和2024年1月在日本批准,並預計後續市場將在今年晚些時候上市。

Price Action: LLY stock is up 0.32% at $894.15 at last check Friday.

股價表現:LLY股票在最後查看的星期五上漲了0.32%,報894.15美元。

Image via Shutterstock

圖片來自shutterstock。

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譯文內容由第三人軟體翻譯。


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