MADISON, N.J.--(BUSINESS WIRE)--NOT FOR UK USE – NOT INTENDED FOR UK MEDIA

新泽西州麦迪逊（BUSINESS WIRE）--不供英国使用-不供英国媒体使用

LEO Pharma A/S, a global leader in medical dermatology, today unveiled new data analyzing the long-term therapeutic response of treatment with Adbry® (tralokinumab-ldrm) in adults (18 years and above) with moderate-to-severe atopic dermatitis (AD). The findings are being shared via an e-poster at the 82nd American Academy of Dermatology (AAD) Congress in San Diego, California.1.

全球医学皮肤病学领导者LEO Pharma A/S今天公布了新的数据，分析了Adbry®（tralokinumab ldrm）治疗成人（18岁及以上）中度至重度特应性皮炎（AD）的长期治疗反应。这些发现正在加利福尼亚州圣地亚哥举行的第82届美国皮肤病学会（AAD）大会上通过电子海报分享。

The results are part of a wide-ranging data program from LEO Pharma at AAD, with eight abstracts accepted in total for the meeting, showcasing an ongoing commitment to advancing the standard of research in medical dermatology.

这些结果是AAD LEO Pharma的广泛数据计划的一部分，会议共接受了八篇摘要，表明了对提高医学皮肤病研究标准的持续承诺。

“The data presented for Adbry at AAD further builds upon an established, wide-ranging collection of clinical evidence that aims to improve the support for those living with moderate-to-severe AD,” said Brian Hilberdink, EVP and President, Region North America, LEO Pharma. “Following the expansion of our indication in the U.S.

LEO Pharma北美地区执行副总裁兼总裁Brian Hilberdink表示：“AAD为Adbry提供的数据进一步建立在广泛收集的临床证据基础上，旨在改善对中度至重度AD患者的支持。”。“随着我们在美国的指示扩大。

late last year for Adbry to encompass pediatric patients aged 12 to 17 years old, this data is the latest, positive step on our ongoing mission to maximize the treatment options available for as many people as possible who live with this condition.”.

去年年底，Adbry纳入了12至17岁的儿科患者，这些数据是我们正在进行的任务中最新的积极步骤，以最大限度地为尽可能多的患有这种疾病的人提供治疗选择。”。

The post hoc analysis included 347 adults (18 years and above) with moderate-to-severe AD who were continuously treated with Adbry for 52 weeks in the phase 3 ECZTRA 1 and 2 trials and subsequently for up to 152 weeks in the ECZTEND open-label extension trial.1

事后分析包括347名患有中度至重度AD的成年人（18岁及以上），他们在3期ECZTRA 1和2试验中连续接受Adbry治疗52周，随后在ECZTEND开放标签延长试验中持续长达152周

Assessments in this analysis focused on timepoints after Week 16 in ECZTEND to allow for re-normalization of response rates due to variable time between the last treatment in the parent trial and the first treatment in ECZTEND.1 The analysis showed that more than 70% of patients who continued treatment with Adbry in ECZTEND maintained a stable Eczema Area and Severity Index (EASI) score (≤7, no to mild disease) at ≥80% of days and over half of responders maintained stable EASI ≤7 at 100% of days for up to three years.1.

这项分析的评估集中在ECZTEND第16周后的时间点，以允许由于parent试验的最后一次治疗与ECZTEND的第一次治疗之间的时间可变而使反应率重新正常化。1分析表明，超过70%的在ECZTEND继续用Adbry治疗的患者保持了稳定的湿疹面积和严重程度指数（EASI）评分（≤7，无至轻度疾病）在≥80%的日子里，超过一半的应答者在100%的日子里保持稳定的EASI≤7长达三年。

“For patients to gain genuine control over their AD, it is critical that disease fluctuations are controlled and safety is established for this long-term approach,” said Dr. Andrew Blauvelt, Blauvelt Consulting, LLC, Lake Oswego, U.S., and International Coordinating Investigator (ICI) of the ECZTEND trial.

美国奥斯威戈湖Blauvelt Consulting，LLC的Andrew Blauvelt博士和ECZTEND试验的国际协调研究员（ICI）说：“对于患者真正控制AD，控制疾病波动并为这种长期方法建立安全性至关重要。”。

“This new analysis demonstrates the benefits of the long-term use of Adbry for adults who live with this chronic condition.”.

“这项新的分析表明，长期使用Adbry对患有这种慢性病的成年人有益。”。

About atopic dermatitis

关于特应性皮炎

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.3 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.4 Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology.3,4 Excessive IL-22 production is also known to contribute to the pathogenesis of AD.5.

特应性皮炎是一种慢性炎症性皮肤病，其特征是强烈的瘙痒和湿疹病变。3特应性皮炎是皮肤屏障功能障碍和免疫失调的结果，导致慢性炎症。4 2型细胞因子，包括IL-13，在特应性皮炎病理生理学的关键方面发挥重要作用。已知过量的IL-22产生也有助于AD的发病机制。

About Adbry® (tralokinumab-ldrm)

关于Adbry® （tralokinumab ldrm）

Adbry® (tralokinumab-ldrm), which is marketed outside of the U.S. under the tradename Adtralza® (tralokinumab), is a high-affinity fully human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.4,6 Adbry® specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).7.

Adbry®（tralokinumab ldrm）在美国境外以商品名Adtralza®（tralokinumab）销售，是一种高亲和力的全人单克隆抗体，开发用于结合和抑制白细胞介素（IL）-13细胞因子，在特应性皮炎体征和症状的免疫和炎症过程中发挥作用。4,6 Adbry®特异性结合IL-13细胞因子，从而抑制与IL-13受体α1和α2亚基（IL-13Rα1和IL-13Rα2）的相互作用。

Adbry is approved for the treatment of adults and pediatric patients (12 years and above) with moderate-to-severe AD in the U.S., Canada, the European Union, the United Arab Emirates, Great Britain, and South Korea. Adtralza is approved for use in adults with moderate-to-severe AD in Saudi Arabia, Switzerland, and Japan..

Adbry在美国、加拿大、欧盟、阿拉伯联合酋长国、英国和韩国被批准用于治疗中度至重度AD的成人和儿科患者（12岁及以上）。Adtralza在沙特阿拉伯、瑞士和日本被批准用于患有中度至重度AD的成年人。。

About the ECZTEND - Long-Term Extension (LTE) Trial

关于ECZTEND-长期扩展（LTE）试验

ECZTEND (Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials) is an ongoing Phase 3, long-term, five-year, open-label, single-arm extension trial to evaluate the safety and efficacy of Adbry in patients with atopic dermatitis who participated in the previous Adbry monotherapy trials (ECZTRA 1 and ECZTRA 2), the combination therapy Adbry plus TCS trial (ECZTRA 3), the Drug-drug interaction (DDI) trial (ECZTRA 4), the vaccine trial (ECZTRA 5), the adolescent trial (ECZTRA 6), the oral cyclosporine A trial (ECZTRA 7), the combination therapy Adbry plus TCS trial in Japanese subjects (ECZTRA 8), and the Adbry monotherapy skin barrier function trial (TraSki).

ECZTEND（参与先前曲单抗试验的特应性皮炎患者的长期延长试验）是一项正在进行的3期，长期，五年，开放标签，单臂延长试验，旨在评估Adbry在参与先前Adbry单一疗法试验（ECZTRA 1和ECZTRA 2）的特应性皮炎患者中的安全性和有效性，联合治疗Adbry加TCS试验（ECZTRA 3），药物相互作用（DDI）试验（ECZTRA 4），疫苗试验（ECZTRA 5），青少年试验（ECZTRA 6），口服环孢素A试验（ECZTRA 7），日本受试者联合治疗Adbry加TCS试验（ECZTRA 8）和Adbry单药治疗皮肤屏障功能试验（TraSki）。

Patients were permitted to enter ECZTEND after completion of the parent trial regardless of their treatment response or whether they were treated with Adbry or placebo.2,8.

父母试验完成后，患者被允许进入ECZTEND，无论他们的治疗反应或是否接受Adbry或安慰剂治疗[2,8]。

U.S. INDICATION AND IMPORTANT SAFETY INFORMATION

U、 S.指示和重要安全信息

What is ADBRY?

ADBRY是什么？

ADBRY® (tralokinumab-ldrm) injection is a prescription medicine used to treat people 12 years of age and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. ADBRY can be used with or without topical corticosteroids..

ADBRY®（tralokinumab ldrm）注射液是一种处方药，用于治疗12岁及以上患有中度至重度特应性皮炎（湿疹）的患者，这些患者的皮肤处方疗法（局部）控制不佳，或者无法使用局部疗法。ADBRY可以与或不与局部皮质类固醇一起使用。。

It is not known if ADBRY is safe and effective in children under 12 years of age.

目前尚不清楚ADBRY对12岁以下儿童是否安全有效。

Do not use ADBRY if you are allergic to tralokinumab or to any of its ingredients.

如果您对创伤单抗或其任何成分过敏，请不要使用ADBRY。

What should I discuss with my healthcare provider before starting ADBRY?

在开始ADBRY之前，我应该与我的医疗保健提供者讨论什么？

Tell your healthcare provider about all your medical conditions, including if you:

告诉您的医疗保健提供者您的所有医疗状况，包括您是否：

have eye problems.

眼睛有问题。

have a parasitic (helminth) infection.

有寄生虫（蠕虫）感染。

are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with ADBRY.

计划接种任何疫苗。如果你接受ADBRY治疗，你不应该接种“活疫苗”。

are pregnant or plan to become pregnant. It is not known whether ADBRY will harm your unborn baby. There is a pregnancy exposure registry for women who use ADBRY during pregnancy. The purpose of this registry is to collect information about the health of you and your baby You or your healthcare provider can get information and enroll you in this registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/..

怀孕或计划怀孕。目前尚不清楚阿德布里是否会伤害您的未出生婴儿。对于怀孕期间使用ADBRY的女性，有一个怀孕暴露登记处。此注册表的目的是收集有关您和宝宝健康的信息您或您的医疗保健提供者可以通过拨打1-877-311-8972或访问https://mothertobaby.org/ongoing-study/adbry-tralokinumab/..

are breastfeeding or plan to breastfeed. It is not known whether ADBRY passes into your breast milk and if it can harm your baby.

正在母乳喂养或计划母乳喂养。目前尚不清楚ADBRY是否会进入您的母乳，以及它是否会伤害您的宝宝。

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

告诉你的医疗保健提供者你服用的所有药物，包括处方药和非处方药、维生素和草药补充剂。

How should I use ADBRY?

我应该如何使用ADBRY？

See the detailed “Instructions for Use” that comes with ADBRY for information on how to prepare and inject ADBRY and how to properly store and throw away (dispose of) used ADBRY prefilled syringes.

有关如何准备和注射ADBRY以及如何正确储存和丢弃（处置）使用过的ADBRY预充注射器的信息，请参阅ADBRY随附的详细“使用说明”。

Use ADBRY exactly as prescribed by your healthcare provider.

严格按照医疗保健提供者的规定使用ADBRY。

Your healthcare provider will tell you how much ADBRY to inject and when to inject it.

你的医疗保健提供者会告诉你注射多少ADBRY以及何时注射。

ADBRY comes as a single-dose (150 mg) prefilled syringe with needle guard.

ADBRY是一种单剂量（150毫克）预填充注射器，带有针头防护装置。

ADBRY is given as an injection under the skin (subcutaneous injection).

ADBRY作为皮下注射（皮下注射）给予。

If your healthcare provider decides that you or a caregiver can give the injection of ADBRY, you or your caregiver should receive training on the right way to prepare and inject ADBRY. Do not try to inject ADBRY until you have been shown the right way by your healthcare provider.

如果您的医疗保健提供者决定您或护理人员可以注射ADBRY，则您或您的护理人员应接受有关正确制备和注射ADBRY方法的培训。在医疗保健提供者向您展示正确方法之前，不要尝试注射ADBRY。

If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time.

如果您错过了一剂，请尽快注射错过的剂量，然后在您的常规计划时间继续服用下一剂。

If you inject -too much ADBRY than prescribed, call your healthcare provider or call Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

如果你注射的ADBRY比规定的多，请致电你的医疗保健提供者或致电1-800-222-1222的毒物帮助热线，或立即前往最近的医院急诊室。

Your healthcare provider may prescribe other medicines to use with ADBRY. Use the other prescribed medicines exactly as your healthcare provider tells you to.

您的医疗保健提供者可能会开其他药物与ADBRY一起使用。请严格按照医疗保健提供者的指示使用其他处方药物。

What are the possible side effects of ADBRY?

ADBRY可能有哪些副作用？

ADBRY can cause serious side effects including:

ADBRY可引起严重的副作用，包括：

Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Stop using ADBRY and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:

过敏反应（超敏反应），包括称为过敏反应的严重反应。如果您出现以下任何症状，请停止使用ADBRY并告诉您的医疗保健提供者或立即寻求紧急帮助：

breathing problems

呼吸问题

itching

瘙痒

skin rash

皮疹

swelling of the face, mouth, and tongue

面部、口腔和舌头肿胀

fainting, dizziness, feeling lightheaded (low blood pressure)

昏厥、头晕、头晕（低血压）

hives

蜂箱

Eye problems. Tell your healthcare provider if you have any worsening eye problems, including eye pain or changes in vision.

眼睛问题。如果您有任何恶化的眼部问题，包括眼部疼痛或视力改变，请告诉您的医疗保健提供者。

The most common side effects of ADBRY include:

ADBRY最常见的副作用包括：

Upper respiratory tract infections

上呼吸道感染

Eye and eyelid inflammation, including redness, swelling, and itching

眼睛和眼睑发炎，包括发红、肿胀和瘙痒

Injection site reactions

注射部位反应

High count of a certain white blood cell (eosinophilia)

某种白细胞计数高（嗜酸性粒细胞增多）

These are not all the possible side effects of ADBRY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

这些并不是ADBRY可能产生的所有副作用。请致电您的医生寻求有关副作用的医学建议。您可以通过1-800-FDA-1088向FDA报告副作用。

Please click here for full U.S. Prescribing Information, including Patient Information and Instructions for Use.

请单击此处获取完整的美国处方信息，包括患者信息和使用说明。

About LEO Pharma

关于LEO Pharma

LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities.

利奥制药（LEO Pharma）是一家全球性公司，致力于提高护理标准，造福皮肤病患者及其家人和社会。LEO Pharma成立于1908年，由LEO基金会拥有多数股权。LEO Pharma致力于数十年的研究和开发，以推动皮肤病学的发展。如今，该公司为所有严重疾病提供了广泛的治疗方法。

LEO Pharma is headquartered in Denmark with a global team of 4,300 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion..

利奥制药（LEO Pharma）总部位于丹麦，拥有4300人的全球团队，为全球数百万患者提供服务。2023年，该公司净销售额为114亿丹麦克朗。。

References

参考文献

Blauvelt A, et al. Stability of long-term therapeutic responses to tralokinumab in adults with moderate-to-severe atopic dermatitis. Presented at the 2024 American Academy of Dermatology Annual Meeting; March 8-12 2024; San Diego, CA.

Blauvelt A等人。中重度特应性皮炎成人对曲洛单抗的长期治疗反应的稳定性。在2024年美国皮肤病学会年会上发表；2024年3月8日至12日；加利福尼亚州圣地亚哥。

ClinicalTrials.gov. National Library of Medicine (U.S.). Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials – ECZTEND. Identifier: NCT03587805. https://clinicaltrials.gov/ct2/show/NCT03587805.

ClinicalTrials.gov。国家医学图书馆（美国）。参加过先前曲拉单抗试验的特应性皮炎患者的长期延长试验-ECZTEND。标识符：NCT03587805。https://clinicaltrials.gov/ct2/show/NCT03587805.

Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016;387(10023):1109-1122.

Weidinger S，Novak N.特应性皮炎。柳叶刀。2016年；387（10023）：1109-1122。

Boguniewicz M, Leung DY. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-246.

Boguniewicz M，Leung DY.特应性皮炎：一种皮肤屏障改变和免疫失调的疾病。Immunol Rev.2011；242（1）：233-246。

Dudakov JA, Hanash AM, van den Brink MR. Interleukin-22: immunobiology and pathology. Annu Rev Immunol. 2015;33:747-785.

Dudakov JA，Hanash AM，van den Brink先生白细胞介素-22：免疫生物学和病理学。Annu Rev免疫。2015年；33:747-785。

Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.

Bieber T.白细胞介素-13：针对特应性皮炎中被低估的细胞因子。过敏。2020；75:54-62。

Popovic B, Breed J, Rees DG, et al. Structural Characterisation Reveals Mechanism of IL-13-Neutralising Monoclonal Antibody Tralokinumab as Inhibition of Binding to IL-13Rα1 and IL-13Rα2. J Mol Biol. 2017;429(2):208-219.

Popovic B，Breed J，Rees DG等。结构表征揭示了IL-13中和单克隆抗体Tralokinumab抑制与IL-13Rα1和IL-13Rα2结合的机制。J摩尔生物学。2017年；429（2）：208-219。

Blauvelt A, Langley RG, Lacour JP, et al. Long-term 2-year safety and efficacy of tralokinumab in adults with moderate-to-severe atopic dermatitis: Interim analysis of the ECZTEND open-label extension trial. J Am Acad Dermatol. 2022;87(4):815-824.

Blauvelt A，Langley RG，Lacour JP等。曲洛单抗在中重度特应性皮炎成人中的长期2年安全性和有效性：ECZTEND开放标签扩展试验的中期分析。J Am Acad Dermatol。2022年；87（4）：815-824。

MAT-71599 March 2024

MAT-71599 2024年3月