INDIANAPOLIS, Oct. 25, 2024 /PRNewswire/ -- New results show Eli Lilly and Company's (NYSE: LLY) EBGLYSS improved skin (including hand and face) and itch among patients with moderate-to-severe atopic dermatitis (eczema) who were previously treated with dupilumab. These results from the Phase 3b ADapt study will be presented at the Fall Clinical Dermatology (FCD) Conference from Oct.

印第安纳波利斯，2024年10月25日/PRNewswire/--新结果显示，礼来公司（纽约证券交易所：LLY）的EBGLYSS改善了先前接受过dupilumab治疗的中度至重度特应性皮炎（湿疹）患者的皮肤（包括手和脸）和瘙痒。3b期ADapt研究的这些结果将在10月的秋季临床皮肤病学（FCD）会议上发表。

24-27 in Las Vegas.1.

拉斯维加斯24-27。

EBGLYSS is an interleukin-13 (IL-13) inhibitor that selectively blocks IL-13 signaling with high binding affinity.2,3,4 The cytokine IL-13 is key in atopic dermatitis, driving the type-2 inflammatory cycle in the skin, leading to skin barrier dysfunction, itch, skin thickening and infection.5,6

EBGLYSS是一种白细胞介素-13（IL-13）抑制剂，以高结合亲和力选择性阻断IL-13信号传导。2,3,4细胞因子IL-13是特应性皮炎的关键，驱动皮肤中的2型炎症周期，导致皮肤屏障功能障碍，瘙痒，皮肤增厚和感染

'Treatment isn't one-size-fits-all, and many patients with moderate-to-severe atopic dermatitis remain in need of an effective medicine to help manage the impact of the disease, especially in difficult-to-treat areas like face and hands,' said Linda Stein Gold, M.D., investigator of the ADapt study, director of dermatology research and head of the Division of Dermatology for Henry Ford Health System in Detroit, Michigan.

ADapt研究研究员、密歇根州底特律亨利·福特健康系统皮肤病研究主任兼皮肤病学部门负责人琳达·斯坦·戈尔德（LindaSteinGold）医学博士说：“治疗并非一刀切，许多中重度特应性皮炎患者仍然需要一种有效的药物来帮助控制疾病的影响，尤其是在面部和手部等难以治疗的部位。”。

'These data showed that EBGLYSS improved skin symptoms and reduced itch for the majority of patients who had stopped using dupilumab and complement previously presented EBGLYSS data in biologic-naive patients, further supporting that a broad range of patients could benefit from this new and effective treatment option.'.

“这些数据表明，对于大多数停止使用dupilumab和补体的患者，EBGLYSS改善了皮肤症状并减少了瘙痒，之前在未接受生物学治疗的患者中提供了EBGLYSS数据，进一步支持了广泛的患者可以从这种新的有效治疗选择中受益。”。

The ADapt study evaluated the efficacy and safety of EBGLYSS in patients with moderate-to-severe atopic dermatitis who were previously treated with dupilumab. To qualify for ADapt, patients must have discontinued dupilumab treatment due to inadequate response, intolerance or an adverse event, or other reasons (including cost or loss of access to the medicine).

ADapt研究评估了EBGLYSS在先前接受dupilumab治疗的中度至重度特应性皮炎患者中的疗效和安全性。为了获得ADapt的资格，患者必须由于反应不足，不耐受或不良事件或其他原因（包括费用或无法获得药物）而停止dupilumab治疗。

View an EBGLYSS patient photo from the ADapt study here.1.

在此处查看ADapt研究中的EBGLYSS患者照片。1。

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

该研究的主要终点是通过在16周时湿疹面积和严重程度指数（EASI-75）评分至少改善75%来衡量的，该评分评估了皮肤病的程度和严重程度。第16周和第24周的次要终点包括透明（0）或几乎透明（1）皮肤的研究者全球评估（IGA）评分，与基线相比至少减少了两个点，瘙痒NRS从基线至少改善了四个点。

Other secondary and exploratory endpoints were also included.1 The reported endpoints were as observed..

还包括其他次要和探索性终点。1报告的终点如观察到的。。

With EBGLYSS, 57 percent of patients at Week 16, and 60 percent of patients at Week 24 who were previously treated with dupilumab, achieved EASI-75. These results are similar to what was observed in the Phase 3 monotherapy trials of EBGLYSS in patients without prior exposure to dupilumab (ADvocate 1 and ADvocate 2).

使用EBGLYSS，在第16周时有57%的患者和在第24周时接受过dupilumab治疗的患者中有60%达到了EASI-75。。

In addition, 46 percent of patients who were inadequate responders to dupilumab achieved EASI-75 response with EBGLYSS at Week 16.1.

此外，46%对dupilumab反应不足的患者在第16.1周时获得了EBGLYSS的EASI-75反应。

Fifty-three percent and 62 percent 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.1

停用dupilumab并开始使用EBGLYSS治疗的ADapt患者中，有53%和62%的患者在第16周和第24周也经历了瘙痒缓解（瘙痒NRS），分别比基线改善了至少四点。1

Patients in this study saw improvements in difficult-to-treat areas when treated with EBGLYSS. More than half of patients (52 percent) treated with EBGLYSS saw clear or almost clear face dermatitis at Week 24 (F-IGA 0,1 with a reduction of at least two points from baseline). Among patients with moderate-to-severe hand dermatitis at baseline (defined as ≥12), patients' modified total lesion symptom score (mTLSS), which measures extent and severity of hand dermatitis, decreased by 75 percent at Week 24.1*.

这项研究中的患者在接受EBGLYSS治疗时，在难以治疗的区域有所改善。接受EBGLYSS治疗的患者中，超过一半（52%）在第24周时出现了明显或几乎明显的面部皮炎（F-IGA 0,1，比基线降低了至少两个点）。在基线时患有中度至重度手部皮炎（定义为≥12）的患者中，患者的改良总病变症状评分（mTLSS）在第24.1周时下降了75%，该评分用于衡量手部皮炎的程度和严重程度*。

Less than six percent of patients treated with EBGLYSS experienced an adverse event that led to treatment discontinuation.1

接受EBGLYSS治疗的患者中，不到6%的患者出现了导致治疗中断的不良事件。1

The safety profile of EBGLYSS in ADapt was consistent with previous EBGLYSS Phase 3 studies in patients with moderate-to-severe atopic dermatitis, and no new safety signals were observed. The majority of adverse events were mild or moderate. Reported treatment-related side effects in the study were conjunctivitis and injection site reactions..

ADapt中EBGLYSS的安全性与先前针对中度至重度特应性皮炎患者的EBGLYSS 3期研究一致，未观察到新的安全信号。大多数不良事件为轻度或中度。研究中报道的治疗相关副作用是结膜炎和注射部位反应。。

Of the 14 patients who discontinued dupilumab due to an adverse event, two patients discontinued EBGLYSS due to an adverse event. Of the 10 patients who discontinued dupilumab due to eye-related events, facial dermatitis or inflammatory arthritis, none reported similar events with EBGLYSS.1

在因不良事件停用dupilumab的14名患者中，有2名患者因不良事件停用了EBGLYSS。

'This trial supports the growing body of data showing that health care providers can have confidence prescribing EBGLYSS as a first-line biologic treatment for moderate-to-severe atopic dermatitis, and reinforces that EBGLYSS provided a meaningful benefit among individuals who have already tried another biologic treatment such as dupilumab and may have more difficult-to-treat disease,' said Mark Genovese, M.D., senior vice president of Lilly Immunology development..

礼来免疫发展高级副总裁马克·吉诺维斯医学博士说：“这项试验支持了越来越多的数据显示，医疗保健提供者有信心将EBGLYSS作为中重度特应性皮炎的一线生物治疗药物，并强调EBGLYSS为已经尝试过另一种生物治疗（如dupilumab）并且可能更难治疗疾病的个体提供了有意义的益处。”。。

Lilly will also present additional data at the Fall Clinical Dermatology conference, including new analyses from the ADjoin long-term extension study with data up to three years.

。

EBGLYSS was approved in the U.S. by the Food and Drug Administration (FDA) last month as a first-line biologic treatment for adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe atopic dermatitis that is not well controlled with topical prescription therapies..

上个月，美国食品和药物管理局（FDA）批准EBGLYSS作为一线生物治疗药物，用于体重至少88磅（40公斤）的12岁及以上成人和儿童，患有中度至重度特应性皮炎，局部处方治疗效果不佳。。

EBGLYSS 250 mg/2 mL injection is dosed as a single monthly maintenance injection following the initial phase of treatment. The recommended initial starting dose of EBGLYSS is 500 mg (two 250 mg injections) at Week 0 and Week 2, followed by 250 mg every two weeks until Week 16 or later when adequate clinical response is achieved; after this, maintenance dosing is a single monthly injection (250 mg every four weeks).1.

EBGLYSS 250 mg/2 mL注射液在治疗初始阶段后作为每月一次的维持注射给药。；在此之后，维持剂量是每月一次注射（每四周250毫克）。

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

EBGLYSS也于2023年在欧盟获得批准，并于2024年1月在日本获得批准，预计今年晚些时候将有更多市场。

Lilly has exclusive rights for development and commercialization of EBGLYSS in the U.S. and the rest of the world outside Europe. Lilly's partner Almirall S.A. has licensed the rights to develop and commercialize EBGLYSS for the treatment of dermatology indications, including eczema, in Europe.

礼来拥有eBglyS在美国和欧洲以外世界其他地区的独家开发和商业化权利。礼来的合作伙伴Almirall s.A.已授权开发EBGLYSS并将其商业化，用于治疗欧洲的皮肤病适应症，包括湿疹。

*mTLSS is a composite measure of intensity of seven hand dermatitis signs and symptoms (erythema, edema, desquamation, fissures, hyperkeratosis/lichenification, pruritus/pain, and vesiculation, with total scores ranging from 0 to 21), used to assess improvement in hand dermatitis.

*mTLSS是七种手部皮炎体征和症状（红斑，水肿，脱屑，裂缝，角化过度/苔藓化，瘙痒/疼痛和水疱）强度的综合指标，总分从0到21不等，用于评估手部皮炎的改善。

About ADapt ADapt (NCT05369403), is an open-label, Phase 3b, 24-week study that evaluated the efficacy and safety of EBGLYSS in adults and adolescents (12 to less than 18 years of age and weighing ≥40 kg) with moderate-to-severe atopic dermatitis who were previously treated with dupilumab. Four or more weeks after discontinuing dupilumab, patients were treated with EBGLYSS and received a starting dosing of 500 mg (two 250 mg injections) at Week 0 and Week 2, followed by 250 mg every two weeks until Week 16.

关于ADapt ADapt（NCT05369403），是一项开放标签的3b期24周研究，评估EBGLYSS在成人和青少年（12至18岁以下，体重≥40公斤）中度至重度特应性皮炎患者中的疗效和安全性。以前曾用dupilumab治疗过。停用dupilumab 4周或更长时间后，患者接受EBGLYSS治疗，并在第0周和第2周开始服用500 mg（两次250 mg注射），然后每两周服用250 mg，直到第16周。

IGA 0,1 or EASI-75 responders at Week 16 received 250 mg once monthly and non-responders continued on 250 mg every two weeks until Week 24. Patients were allowed to stay on low and mid-potency topical corticosteroids.1.

IGA 0,1或EASI-75应答者在第16周每月接受250毫克，无应答者每两周继续服用250毫克，直到第24周。允许患者服用低效和中效局部皮质类固醇。

From baseline to Week 16, data from the ADapt study was analyzed as observed and with non-responder imputation/multiple imputation (NRI/MI). After Week 16, Q2W and Q4W data from the ADapt study were pooled and analyzed as observed and with NRI/MI.1

从基线到第16周，对ADapt研究的数据进行了观察分析，并使用无应答者插补/多重插补（NRI/MI）进行了分析。第16周后，将ADapt研究的Q2W和Q4W数据汇总并分析为观察到的和NRI/MI。1

INDICATION AND SAFETY SUMMARY  EBGLYSS™ (EHB-glihs) is an injectable medicine used to treat adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe eczema (atopic dermatitis) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies.

适应症和安全性总结EBGLYSS™（EHB-glihs）是一种可注射药物，用于治疗体重至少88磅（40公斤）的成人和12岁及以上的儿童，患有中度至重度湿疹（特应性皮炎），不能很好地控制皮肤上使用的处方疗法（局部），或不能使用局部疗法。

EBGLYSS can be used with or without topical corticosteroids..

EBGLYSS可以与或不与局部皮质类固醇一起使用。。

It is not known if EBGLYSS is safe and effective in children less than 12 years of age or in children 12 years to less than 18 years of age who weigh less than 88 pounds (40 kg).

目前尚不清楚EBGLYSS对12岁以下儿童或体重小于88磅（40公斤）的12岁至18岁以下儿童是否安全有效。

About EBGLYSS  EBGLYSS is a monoclonal antibody that selectively targets and neutralizes IL-13 with high binding affinity and a slow dissociation rate.3,4,7 EBGLYSS binds to the IL-13 cytokine at an area that overlaps with the binding site of the IL-4Rα subunit of the IL-13Rα1/IL-4Rα heterodimer, preventing formation of this receptor complex and inhibiting IL-13 signaling.

关于EBGLYSS EBGLYSS是一种单克隆抗体，它以高结合亲和力和缓慢的解离速率选择性靶向和中和IL-13。3,4,7 EBGLYSS与IL-13细胞因子结合的区域与IL-13Rα1/IL-4Rα异二聚体的IL-4Rα亚基的结合位点重叠，阻止这种受体复合物的形成并抑制IL-13信号传导。

IL-13 is implicated as a primary cytokine tied to the pathophysiology of eczema, driving the type-2 inflammatory loop in the skin, and EBGLYSS selectively targets IL-13.7.

IL-13 被认为是与湿疹病理生理学相关的主要细胞因子，它驱动着皮肤的 2 型炎症循环，而 EBGLYSS 可选择性地靶向 IL-13.7 。

The EBGLYSS Phase 3 program consists of five key global studies evaluating over 1,300 patients, including two monotherapy studies (ADvocate 1 and 2), a combination study with topical corticosteroids (ADhere), as well as long-term extension (ADjoin) and adolescent open label (ADore) studies. Further data results from ADjoin and ADmirable are expected to be shared in 2024 and early 2025.  .

EBGLYSS 3期计划由五项评估1300多名患者的关键全球研究组成，包括两项单一疗法研究（ADvocate 1和2），与局部皮质类固醇（ADhere）的联合研究，以及长期延长（ADjoin）和青少年开放标签（ADore）研究。ADjoin和ADmirable的进一步数据结果预计将在2024年和2025年初共享。

About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases.

关于Lilly Lilly是一家将科学转化为治疗的医药公司，旨在让世界各地的人们生活得更好。近150年来，我们一直在开创改变生活的发现，今天，我们的药物帮助了全球数以千万计的人。利用生物技术、化学和遗传医学的力量，我们的科学家正在迫切推进新发现，以解决世界上一些最重大的健康挑战：重新定义糖尿病护理；治疗肥胖并减少其最具破坏性的长期影响；推进与阿尔茨海默病的斗争；为一些最致命的免疫系统疾病提供解决方案；并将最难治疗的癌症转化为可控制的疾病。

With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn.

在迈向更健康世界的每一步中，我们都有一个动机：让数百万人的生活变得更好。这包括提供反映我们世界多样性的创新临床试验，并努力确保我们的药物可获得且负担得起。要了解更多信息，请访问Lilly.com和Lilly.com/news，或在Facebook、Instagram和LinkedIn上关注我们。