This trial is the first and largest study specifically designed to evaluate children and adolescents with severe alopecia areata, a population often underrepresented in clinical trials

这项试验是首个也是规模最大的专门设计来评估患有严重斑秃的儿童和青少年的研究，这一人群在临床试验中常常代表性不足。

New data show 71% of adolescents with severe disease treated with baricitinib 4 mg achieved successful scalp hair regrowth at one year, with continuous improvements observed throughout those 52 weeks

新数据显示，接受4毫克巴瑞替尼治疗的重度疾病青少年中有71%在一年内实现了成功的头皮毛发再生，并且在52周内持续观察到改善。

Lilly intends to submit the BRAVE-AA-PEDS data to global regulators for a potential label update for baricitinib (commercially available as Olumiant)

礼来公司打算向全球监管机构提交BRAVE-AA-PEDS数据，以寻求对巴瑞替尼（商业名称为Olumiant）的标签进行潜在更新。

INDIANAPOLIS

印第安纳波利斯

,

，

Oct. 24, 2025

2025年10月24日

/PRNewswire/ -- New results from

/PRNewswire/ -- 新结果显示

Eli Lilly and Company

礼来公司

(NYSE: LLY) and

(NYSE: LLY) 和

Incyte

英赛特公司

(NASDAQ: INCY) showed once-daily, oral baricitinib 4 mg helped the majority of adolescent patients (ages 12 to <18) with severe alopecia areata (AA) achieve successful hair regrowth on the scalp, eyebrows and eyelashes at one year. These 52-week results from the BRAVE-AA-PEDS trial – the largest Phase 3 study of its kind – will be presented at the 2025 .

(NASDAQ: INCY) 显示，每日一次口服4毫克巴里西替尼（baricitinib）帮助大多数患有严重斑秃（AA）的青少年患者（12至<18岁）在一年内实现了头皮、眉毛和睫毛的毛发成功再生。这些来自BRAVE-AA-PEDS试验的52周结果——这是同类中规模最大的第三阶段研究——将在2025年公布。

Fall Clinical Dermatology (FCD) Conference

秋季临床皮肤病学（FCD）会议

, taking place

，发生

Oct. 23-26

10月23日至26日

in

在

Las Vegas

拉斯维加斯

.

。

1

1

These data build on

这些数据建立在

36-week results

36周结果

from the BRAVE-AA-PEDS trial previously presented at the 2025

来自之前在2025年展示的BRAVE-AA-PEDS试验

American Academy of Dermatology

美国皮肤病学会

(AAD) annual meeting in March.

三月的AAD年会。

'For nearly half of the people with severe alopecia areata, the disease starts before adulthood and can progress quickly, significantly impacting patients' lives,' said

“近一半的严重斑秃患者在成年之前就开始发病，并且可能迅速进展，对患者的生活产生重大影响，”

Nicole Friedland

尼科尔·弗里德兰

, President and CEO,

，总裁兼首席执行官，

National Alopecia Areata Foundation

全国斑秃基金会

(NAAF). 'Given the profound burden of this disease, new treatment options are needed for children and adolescents, populations that have been underrepresented for far too long.'

(NAAF)。 “鉴于这种疾病的沉重负担，我们需要为儿童和青少年提供新的治疗选择，这些人群长期以来一直被忽视。”

At the start of the study, patients had an average of 89% scalp hair loss, with 63.8% of them having very severe AA at baseline (Severity of Alopecia Tool [SALT] score 95-100).

研究开始时，患者的头皮毛发平均脱落了89%，其中63.8%的患者在基线时患有非常严重的AA（脱发严重程度工具[SALT]评分为95-100）。

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1

In addition, 65% had minimal or no eyebrow hair (clinician-reported outcome [ClinRO] score of 2 or 3) and 57% had minimal or no eyelash hair (ClinRO score of 2 or 3).

此外，65% 的患者眉毛毛发极少或没有（临床医生报告结果 [ClinRO] 评分为 2 或 3），57% 的患者睫毛毛发极少或没有（ClinRO 评分为 2 或 3）。

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1

At one year:

在一年时：

54.1% of patients receiving baricitinib 4 mg and 31% receiving baricitinib 2 mg achieved successful hair regrowth (defined as 80% or more scalp hair coverage, SALT ≤20)

54.1%的患者接受4毫克巴瑞替尼和31%接受2毫克巴瑞替尼治疗实现了成功的毛发再生（定义为80%或以上的头皮毛发覆盖，SALT ≤20）。

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1

41.2% of patients receiving baricitinib 4 mg and 26.2% of patients receiving baricitinib 2 mg achieved near-complete scalp hair regrowth (defined as 90% or more scalp hair coverage, SALT ≤10)

接受4毫克巴利替尼治疗的患者中有41.2%，接受2毫克巴利替尼治疗的患者中有26.2%实现了接近完全的头皮毛发再生（定义为90%或以上的头皮毛发覆盖，SALT ≤10）。

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1

64.8% of patients receiving baricitinib 4 mg and 27.8% of patients receiving baricitinib 2 mg achieved significant eyebrow regrowth (ClinRO scores of 0 or 1 with a ≥2 point improvement from baseline)

接受4毫克巴利替尼治疗的患者中有64.8%，接受2毫克巴利替尼治疗的患者中有27.8%实现了显著的眉毛再生（ClinRO评分为0或1，且较基线改善≥2分）。

1

1

63.3% of patients receiving baricitinib 4 mg and 34% receiving baricitinib 2 mg achieved eyelash regrowth

63.3% 的患者在接受 4 毫克巴利西替尼和 34% 的患者在接受 2 毫克巴利西替尼后实现了睫毛再生。

1

1

Among patients with severe disease (baseline SALT score 50-94), 71% receiving baricitinib 4 mg and 58.6% receiving baricitinib 2 mg achieved successful hair regrowth

在患有严重疾病（基线SALT评分50-94）的患者中，接受4毫克巴利替尼治疗的患者中有71%实现了成功的毛发再生，而接受2毫克巴利替尼治疗的患者中有58.6%实现了成功毛发再生。

1

1

In a separate, post-hoc analysis of adolescent patients who had been diagnosed with severe AA less than two years before starting treatment, 80% of those receiving baricitinib 4 mg and 64.3% receiving baricitinib 2 mg achieved successful hair regrowth at one year.

在对青少年患者的单独事后分析中，这些患者在开始治疗前不到两年被诊断为重度AA，接受4毫克巴里西替尼的患者中有80%，接受2毫克巴里西替尼的患者中有64.3%在一年内实现了成功的毛发再生。

2

2

The safety profile of baricitinib in adolescents with AA was consistent with the safety profile seen in clinical trials for adult and adolescent patients, and no new safety signals were observed after one year of treatment. The most common treatment-emergent adverse events included acne, upper respiratory tract infection and influenza.

青少年AA患者中，巴利西替尼的安全性与成年和青少年患者临床试验中观察到的安全性一致，在一年的治疗后未观察到新的安全性信号。最常见的治疗相关不良事件包括痤疮、上呼吸道感染和流感。

No deaths, opportunistic infections, major adverse cardiovascular events or venous thromboembolic events were reported in the trial..

试验中未报告死亡、机会性感染、主要不良心血管事件或静脉血栓栓塞事件。

1

1

'These promising results for adolescents reinforce what we see in clinical practice with adults, which is that starting treatment with baricitinib early can lead to higher rates of scalp hair regrowth, including near-complete regrowth for many patients,' said

“这些针对青少年的有希望的结果印证了我们在成人临床实践中看到的情况，即早期使用巴瑞替尼开始治疗可以提高头皮毛发再生的几率，包括许多患者接近完全再生。”

Brittany Craiglow

布列塔尼·克雷格洛

, M.D., Adjunct Associate Professor of Dermatology,

医学博士，皮肤科兼职副教授，

Yale School of Medicine

耶鲁大学医学院

. 'Systemic treatments for adolescents shouldn't be the last resort, but part of the treatment conversation among doctors, caregivers and patients from the beginning.'

“青少年的系统治疗不应该是最后的手段，而是从一开始就应该成为医生、护理人员和患者之间治疗讨论的一部分。”

Lilly will also present final, long-term results at FCD from the BRAVE-AA1/BRAVE-AA2 studies. Among adults with severe AA who responded to baricitinib at 52 weeks, 86.5% of patients receiving baricitinib 4 mg and 84.7% of patients receiving baricitinib 2 mg achieved sustained scalp hair regrowth through approximately four years of treatment.

礼来公司还将在FCD上展示BRAVE-AA1/BRAVE-AA2研究的最终长期结果。在患有严重AA的成人中，对巴利替尼在52周时有反应的患者中，接受4毫克巴利替尼治疗的患者中有86.5％和接受2毫克巴利替尼治疗的患者中有84.7％在大约四年的治疗中实现了持续的头皮毛发再生。

These data build on previous results from BRAVE-AA1/BRAVE-AA2, reinforcing that high rates of scalp hair regrowth can be maintained with baricitinib over multiple years. The safety profile of baricitinib in this study was consistent up to five years, with no new safety signals observed..

这些数据基于之前来自BRAVE-AA1/BRAVE-AA2的结果，进一步证实了使用巴里替尼可以多年维持高比例的头皮毛发再生。本研究中巴里替尼的安全性特征在长达五年内保持一致，未观察到新的安全性信号。

3

3

Baricitinib is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to Lilly. In 2022, the

巴瑞替尼是一种每日一次的口服JAK抑制剂，由Incyte发现并授权给礼来公司。2022年，

U.S. Food and Drug Administration

美国食品药品监督管理局

(FDA) approved baricitinib (commercially available as Olumiant) for adult patients with severe AA, making it the first systemic treatment approved in the

（FDA）批准了巴瑞替尼（商业名称为Olumiant）用于重度AA成年患者，使其成为首个获批的系统性治疗药物

U.S.

美国

for severe disease. Lilly intends to submit the adolescent data to global regulators for a potential label update for Olumiant, and plans to enroll the next cohort of children ages 6 to under 12 in the

对于重症疾病。礼来公司打算将青少年数据提交给全球监管机构，以寻求Olumiant标签的潜在更新，并计划在下一组6至12岁以下的儿童中进行注册。

U.S.

美国

to BRAVE-AA-PEDS in the next year.

在明年进行BRAVE-AA-PEDS。

'Our decade of firsts in dermatology has been driven by science that has advanced three novel medicines, redefined the standard of care and continues to expand possibilities for people with chronic skin diseases,' said

“我们在皮肤病学领域的十年首创历程，是由科学推动的，推出了三种新型药物，重新定义了护理标准，并继续为慢性皮肤病患者拓展可能性，”

Anabela Cardoso

安娜贝拉·卡多索

, senior vice president, Lilly Immunology Medical Affairs. 'We look forward to submitting these data to global regulators in the coming months. If approved, baricitinib could offer an important new option that raises treatment expectations for adolescents living with the profound burden of this disease.' .

，礼来免疫学医学事务高级副总裁。“我们期待在未来几个月向全球监管机构提交这些数据。如果获得批准，巴利西尼可能会为生活在这一疾病沉重负担下的青少年提供一个重要新选择，提高治疗期望。”

Baricitinib is the most-researched JAK inhibitor in AA, with more than 1,300 adults and 423 adolescents enrolled in clinical trials. In total for all indications, more than 14,600 patients have received baricitinib in completed and ongoing clinical trials; of these, 866 have been patients between the ages of >1 month to <18 years (not including patients enrolled in BRAVE-AA-PEDS)..

巴瑞替尼是AA中研究最多的JAK抑制剂，已有1300多名成人和423名青少年参与临床试验。在所有适应症中，共有超过14,600名患者在已完成和正在进行的临床试验中接受了巴瑞替尼治疗；其中，866名为年龄大于1个月至小于18岁的患者（不包括参加BRAVE-AA-PEDS的患者）。

Lilly continues to raise the standard of care in dermatology and invest in our immunology pipeline, which includes big bets on next-generation modalities and the targeted expansion of small molecules. Lilly's investigational therapies include novel, oral IL-17 inhibitors such as

礼来继续提高皮肤病学的护理标准，并投资于我们的免疫学管线，其中包括对下一代治疗模式和小分子靶向扩展的重大投入。礼来的在研疗法包括新型的口服IL-17抑制剂，例如

DICE Therapeutics'

DICE Therapeutics的

DC-853, which is being studied for psoriasis, and eltrekibart, a novel monoclonal antibody that targets neutrophil-driven inflammation and is being assessed in hidradenitis suppurativa. Lilly is also advancing novel science to explore the potential of incretins in dermatology and has initiated the TOGETHER-PsO trial investigating the efficacy and safety of treating adults with moderate-to-severe plaque psoriasis and obesity with both ixekizumab and an incretin-based therapy. .

DC-853，正在研究用于银屑病，以及eltrekibart，一种新型单克隆抗体，针对中性粒细胞驱动的炎症，正在评估用于化脓性汗腺炎。礼来公司还在推进新的科学研究，探索肠促胰岛素在皮肤病学中的潜力，并已启动TOGETHER-PsO试验，研究使用ixekizumab和基于肠促胰岛素的疗法治疗中度至重度斑块型银屑病和肥胖症成人的疗效和安全性。

About

关于

BRAVE-AA-PEDS

勇敢-AA-儿科

BRAVE-AA-PEDS (NCT05723198) is an ongoing, placebo-controlled, Phase 3 clinical trial involving children ages 6 to under 18 years with severe AA, as measured by a SALT score of ≥50 (i.e., who had ≥ 50% scalp hair loss) and a current episode of severe AA lasting at least six months but no more than eight years. .

BRAVE-AA-PEDS（NCT05723198）是一项正在进行的、安慰剂对照的三期临床试验，涉及6岁至未满18岁患有严重AA的儿童，其衡量标准为SALT评分≥50（即头皮脱发≥50%），并且目前经历的严重AA发作持续至少六个月但不超过八年。

The first two cohorts of patients enrolled in BRAVE-AA-PEDS included adolescents (ages 12 to under 18 years, weighing ≥ 30 kg). The first cohort included 257 adolescent participants who were randomized in a 1:1:1 ratio to receive once-daily placebo, baricitinib 4 mg or baricitinib 2 mg. The primary endpoint of this study was a SALT score ≤20 (i.e., 80% or more scalp hair coverage) by Week 36.

BRAVE-AA-PEDS 研究中前两个队列纳入的患者包括青少年（12至未满18岁，体重≥30公斤）。第一个队列包括257名青少年参与者，他们以1:1:1的比例随机分配接受每日一次安慰剂、4毫克巴瑞替尼或2毫克巴瑞替尼治疗。该研究的主要终点是第36周时SALT评分≤20（即头皮毛发覆盖率≥80%）。

The second cohort of 166 adolescents were randomized 1:1 to baricitinib 4 mg or baricitinib 2 mg to further accumulate safety data..

第二组166名青少年以1:1的比例随机分配至巴瑞替尼4毫克组或巴瑞替尼2毫克组，以进一步积累安全性数据。

The third cohort of children ages 6 to under 12 will be randomized in a 1:1:1 ratio to receive once-daily placebo, baricitinib high dose or baricitinib low dose. Enrollment for this cohort has started outside the

第三组6至12岁以下的儿童将以1:1:1的比例随机分配，接受每日一次的安慰剂、巴利替尼高剂量或巴利替尼低剂量。该组的招募已在外部开始。

U.S.

美国

and will begin enrollment in the

并将开始注册

U.S.

美国

in the next year.

在明年。

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INDICATIONS AND SAFETY SUMMARY WITH WARNINGS

适应症与安全概要（含警告）

Olumiant

巴瑞替尼

®

®

(O-loo-me¯ -ant) is a Janus kinase (JAK) inhibitor used to treat:

(O-loo-me¯ -ant) 是一种 Janus 激酶 (JAK) 抑制剂，用于治疗：

adults with severe alopecia areata.

严重斑秃的成年人。

adults with moderately to severely active rheumatoid arthritis after treatment with 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well enough or could not be tolerated.

中度至重度活动性类风湿关节炎成人患者在使用一种或多种称为肿瘤坏死因子（TNF）抑制剂的药物治疗后，效果不佳或无法耐受。

adult patients hospitalized with COVID-19 requiring oxygen or assistance with breathing.

需要吸氧或呼吸辅助的成年住院患者。

Warnings - Olumiant may cause serious side effects, including:

警告 - Olumiant可能会引起严重的副作用，包括：

Serious infections, including tuberculosis (TB), shingles, and others caused by bacteria, fungi, or viruses. Some people have died from these infections. Olumiant can make you more likely to get infections or make any infections that you have worse. Your doctor should test for TB before starting Olumiant and watch for TB symptoms during treatment.

严重感染，包括结核病 (TB)、带状疱疹，以及由细菌、真菌或病毒引起的其他感染。有些人因这些感染而死亡。Olumiant 可能增加感染的风险，或使您现有的任何感染加重。医生在开始使用 Olumiant 之前应进行结核病检测，并在治疗期间留意结核病症状。

You should not start Olumiant if you have any kind of infection unless your doctor tells you it is okay. While taking Olumiant, tell your doctor right away if you have symptoms of an infection, such as:.

如果您有任何类型的感染，除非医生告诉您可以，否则不应开始使用Olumiant。在服用Olumiant期间，如果出现感染症状（如：），请立即告知医生。

fever, sweating, or chills

发烧、出汗或发冷

muscle aches

肌肉酸痛

cough

咳嗽

shortness of breath

呼吸急促

blood in phlegm

痰中带血

weight loss warm, red, or painful skin or sores on your body

体重减轻，身体上有温暖、红色或疼痛的皮肤或疮疡

diarrhea or stomach pain

腹泻或胃痛

burning with urination or urinating more often than normal

排尿时灼痛或比正常情况更频繁地排尿

feeling tired

感到疲倦

If you get a serious infection, your doctor may stop Olumiant until your infection is controlled.

如果您出现严重感染，您的医生可能会暂停使用 Olumiant，直到您的感染得到控制。

Increased risk of death in people 50 years of age or older who have at least 1 heart disease risk factor and are taking a medicine in a class of medicines called JAK inhibitors.

年龄在50岁或以上且至少有1种心脏病风险因素并正在服用一类称为JAK抑制剂的药物的人群，其死亡风险增加。

Cancer and immune system problems.

癌症和免疫系统问题。

Olumiant may increase your risk of lymphoma and other cancers, including skin cancers. People taking a medicine in the class of medicines called JAK inhibitors have a higher risk of certain cancers, including lymphoma and lung cancer, especially if you are a current or past smoker. Follow your doctor's advice about having your skin checked for skin cancer while taking Olumiant..

Olumiant可能会增加您患淋巴瘤和其他癌症（包括皮肤癌）的风险。服用JAK抑制剂类药物的人患某些癌症的风险更高，包括淋巴瘤和肺癌，尤其是如果您现在或曾经是吸烟者。在服用Olumiant期间，请遵循医生关于检查皮肤癌的建议。

Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease risk factor and taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker.

50岁及以上且至少有1种心脏病风险因素并服用一类被称为JAK抑制剂的药物的人，发生主要心血管事件（如心脏病发作、中风或死亡）的风险增加，尤其是当前或曾经吸烟者。

Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Olumiant, including:

如果在服用 Olumiant 时出现心脏病发作或中风的任何症状，请立即获取紧急帮助，包括：

discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back

胸口中央持续数分钟以上的不适，或消失后又再次出现的不适感

severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw

胸部、喉咙、颈部或下巴出现严重紧绷感、疼痛、压迫感或沉重感

pain or discomfort in your arms, back, neck, jaw, or stomach

手臂、背部、颈部、下巴或胃部感到疼痛或不适

shortness of breath with or without chest discomfort

有或无胸闷的呼吸急促症状

breaking out in a cold sweat

冒冷汗

nausea or vomiting

恶心或呕吐

feeling lightheaded

感到头晕目眩

weakness in one part or on one side of your body

身体某部分或一侧的虚弱

slurred speech

含糊不清的言语

Blood clots

血栓

in the veins of your legs or lungs, and arteries. This may be life-threatening and cause death. Blood clots in the veins of legs and lungs have happened more often in people who are 50 years of age or older and with at least 1 heart disease risk factor taking a medicine in the class of medicines called JAK inhibitors.

在腿部或肺部的静脉和动脉中。这可能危及生命并导致死亡。腿部和肺部静脉中的血栓在50岁或以上且至少有1个心脏病风险因素的人群中发生得更频繁，这些人服用了称为JAK抑制剂的药物。

Stop taking Olumiant and tell your doctor or get emergency help right away if you have any signs and symptoms of blood clots, including swelling, pain or tenderness in the leg, sudden chest pain, or shortness of breath, while taking Olumiant..

在服用 Olumiant 期间，如果您出现任何血栓的迹象或症状，包括腿部肿胀、疼痛或压痛、突发胸痛或呼吸急促，请立即停止服用 Olumiant 并告知您的医生或寻求紧急帮助。

Allergic reactions

过敏反应

. While taking Olumiant, if you have symptoms, such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, stop taking Olumiant and get emergency help right away. Some of these reactions seen in people taking Olumiant were serious.

服用Olumiant期间，如果出现症状，如皮疹（荨麻疹）、呼吸困难、感觉昏厥或头晕，或嘴唇、舌头或喉咙肿胀，应立即停止服用Olumiant并马上寻求紧急帮助。部分服用Olumiant的人群中观察到的这些反应较为严重。

Tears in the stomach or intestines.

胃或肠的撕裂。

This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. While taking Olumiant, tell your doctor right away if you have fever and stomach-area pain that does not go away, and a change in bowel habits.

这种情况最常发生在同时服用非甾体抗炎药 (NSAIDs)、皮质类固醇或甲氨蝶呤的人群中。服用 Olumiant 时，如果出现持续不退的发热和腹部疼痛，以及排便习惯的改变，请立即告知您的医生。

Changes in laboratory test results.

实验室检测结果的变化。

Your doctor should do blood tests before and while taking Olumiant. You should not take Olumiant if your white or red blood cell count is too low or your liver tests are too high. Your doctor may pause your treatment with Olumiant because of changes in these test results. Your doctor should also check your cholesterol levels approximately 12 weeks after you start Olumiant and as needed..

您的医生应在服用 Olumiant 之前和期间进行血液检查。如果您的白细胞或红细胞计数过低，或者肝功能测试结果过高，则不应服用 Olumiant。由于这些测试结果的变化，您的医生可能会暂停您的 Olumiant 治疗。您的医生还应在您开始服用 Olumiant 后大约 12 周检查您的胆固醇水平，并根据需要进行后续检查。

Common side effects

常见的副作用

The most common side effects of Olumiant in people treated for alopecia areata include:

Olumiant 治疗斑秃患者时最常见的副作用包括：

upper respiratory tract infections (cold or sinus infections)

上呼吸道感染（感冒或鼻窦感染）

headache

头痛

acne

痤疮

increased cholesterol levels

胆固醇水平升高

increased muscle enzyme levels

肌酶水平升高

urinary tract infection

尿路感染

increased liver enzyme levels

肝酶水平升高

inflammation of hair follicles (folliculitis)

毛囊炎（folliculitis）

tiredness

疲劳

lower respiratory tract infections

下呼吸道感染

nausea

恶心

genital yeast infection

生殖器酵母菌感染

low red blood cell count (anemia)

低红细胞计数（贫血）

low white blood cell count (neutropenia)

白细胞计数低（中性粒细胞减少症）

stomach-area (abdominal) pain

腹部（腹腔）疼痛

shingles (herpes zoster)

带状疱疹

increased weight

体重增加

The most common side effects of Olumiant in people treated for rheumatoid arthritis include:

治疗类风湿性关节炎的人使用 Olumiant 最常见的副作用包括：

upper respiratory tract infections (cold or sinus infections)

上呼吸道感染（感冒或鼻窦感染）

nausea

恶心

herpes simplex virus infections, including cold sores

单纯疱疹病毒感染，包括唇疱疹

shingles (herpes zoster)

带状疱疹

The most common side effects of Olumiant in people treated for COVID-19 include:

在接受Olumiant治疗COVID-19的人群中最常见的副作用包括：

increased liver enzyme levels

肝酶水平升高

increased platelets in your blood (thrombocytosis)

血液中血小板增多（血小板增多症）

increased blood creatine phosphokinase

血肌酸磷酸激酶升高

low white blood cell count (neutropenia)

白细胞计数低（中性粒细胞减少症）

blood clots in the veins of your legs (DVT)

你腿部静脉中的血块 (DVT)

blood clot in your lungs (pulmonary embolism)

肺部血栓（肺栓塞）

urinary tract infection

尿路感染

These are not all the possible side effects of Olumiant. Tell your doctor if you have any side effects.

这些并非 Olumiant 可能产生的所有副作用。如果您有任何副作用，请告知您的医生。

You can report side effects to the FDA at 1-800-FDA-1088 or

您可以拨打1-800-FDA-1088向FDA报告副作用，或者

www.fda.gov/medwatch

www.fda.gov/medwatch

.

。

Before using

使用前

Before you use Olumiant, tell your doctor if you:

在使用 Olumiant 之前，如果您：

❑ Are being treated for an infection, have an infection that won't go away or keeps coming back, or think you have symptoms of an infection.

❑ 正在接受感染治疗、有持续不愈或反复发作的感染，或者认为自己有感染症状。

❑ Have TB or have been in close contact with someone with TB.

❑ 患有结核病或与结核病患者有过密切接触。

❑ Have had shingles (herpes zoster).

❑ 曾患带状疱疹（herpes zoster）。

❑ Have had hepatitis B or C, cancer, or blood clots in the veins of your legs or lungs.

❑ 曾患有乙型或丙型肝炎、癌症，或腿部或肺部静脉有血栓。

❑ Live, have lived, or have visited parts of the country that increase your risk of fungal infections. These may include the

❑ 生活、曾经生活或访问过该国某些地区，这些地区会增加您感染真菌的风险。这些地区可能包括

Ohio

俄亥俄州

and

和

Mississippi River

密西西比河

valleys and the Southwest. Ask your doctor if you do not know if you have lived in an area where these infections are common.

山谷和西南部。如果你不知道你是否居住在这些感染常见的地区，请咨询你的医生。

❑ Are a current or past smoker.

❑ 是现在或曾经的吸烟者。

❑ Have had a heart attack, other heart problems or stroke.

❑ 曾经心脏病发作、有其他心脏问题或中风。

❑ Have other medical conditions, including kidney or liver problems, low blood cell counts, diabetes, lung disease, HIV, or a weak immune system.

❑ 患有其他疾病，包括肾脏或肝脏问题、血细胞计数低、糖尿病、肺病、艾滋病毒或免疫系统较弱。

❑ Have any stomach-area pain or have been diagnosed with inflammation in the large intestine (diverticulitis) or ulcers in your stomach or intestines.

❑ 有腹部疼痛或被诊断出大肠发炎（憩室炎）或胃肠道溃疡。

❑ Have recently received or plan to receive a vaccine. People taking Olumiant should not receive live vaccines.

❑ 近期已接种或计划接种疫苗。服用 Olumiant 的人不应接种活疫苗。

❑ Are pregnant or plan to become pregnant. It is not known if Olumiant may harm your unborn baby. If you become pregnant while taking Olumiant, call

❑ 如果您怀孕或计划怀孕。目前尚不清楚 Olumiant 是否会伤害您未出生的宝宝。如果您在服用 Olumiant 期间怀孕，请立即致电医生。

Eli Lilly and Company

礼来公司

at 1‑800‑545-5979 to report the pregnancy.

拨打1-800-545-5979报告怀孕情况。

❑ Are breastfeeding or plan to breastfeed. You should not breastfeed while taking Olumiant and for 4 days after the last dose. Talk to your doctor about the best way to feed your baby while taking Olumiant.

❑ 正在哺乳或计划哺乳。在服用Olumiant期间及最后一剂后的4天内，您不应进行哺乳。与您的医生讨论在服用Olumiant期间喂养宝宝的最佳方法。

❑ Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. It is especially important to tell your doctor, if you take:

❑ 正在服用其他药物，包括处方药和非处方药、维生素和草本补充剂。如果服用以下药物，请务必告知医生：

a medicine called probenecid

一种叫做丙磺舒的药物

medicines that affect your immune system, such as biologic medications, other JAK inhibitors, or strong immunosuppressants (such as azathioprine or cyclosporine) since these may increase your risk of infection.

影响免疫系统的药物，如生物制剂、其他JAK抑制剂或强效免疫抑制剂（如硫唑嘌呤或环孢素），因为这些药物可能会增加感染风险。

❑ Are under age 18. It is not known if Olumiant is safe and effective in children.

❑ 年龄未满18岁。目前尚不清楚Olumiant在儿童中是否安全有效。

How to take

如何服用

Take Olumiant exactly as your doctor says.

按照医生的指示准确服用 Olumiant。

Take Olumiant once a day by mouth with or without food.

每天口服一次Olumiant，可与食物同服或不同服。

Talk to your doctor if you cannot swallow tablets whole.

如果无法整片吞服药片，请咨询您的医生。

If you take too much Olumiant, call your doctor or poison control center at 1‑800‑222‑1222, or go to the nearest hospital emergency room right away.

如果您服用过多的Olumiant，请立即致电您的医生或毒物控制中心，电话号码是1-800-222-1222，或者前往最近的医院急诊室。

Learn more

了解更多

Olumiant is a prescription medicine. For more information, call 1-800-545-5979 [or go to

Olumiant 是一种处方药。欲了解更多信息，请拨打 1-800-545-5979 [或访问

www.olumiant.com

www.olumiant.com

]

]

This summary provides basic information about Olumiant but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Olumiant and how to take it.

本摘要提供了有关 Olumiant 的基本信息，但并未包含有关此药物的所有信息。每次填写处方时，请阅读随附的处方信息。此信息不能代替与医生的交流。务必与您的医生或其他医疗保健提供者讨论 Olumiant 及其使用方法。

Your doctor is the best person to help you decide if Olumiant is right for you..

您的医生是帮助您决定 Olumiant 是否适合您的最佳人选。

BA CON BS 14SEP2022

学士学位 14SEP2022

About Olumiant

关于Olumiant

Olumiant, a once-daily, oral JAK inhibitor, was discovered by Incyte and licensed to Lilly. Baricitinib is approved in the

Olumiant 是一种每日一次的口服 JAK 抑制剂，由 Incyte 发现并授权给 Lilly。Baricitinib 已获批在

U.S.

美国

and more than 75 countries as a treatment for adults with moderately to severely active rheumatoid arthritis, in more than 40 countries outside the

并在超过75个国家作为治疗中度至重度活动性类风湿关节炎成人患者的药物，在40多个国家之外的

U.S.

美国

for the treatment of patients down to the age of two with moderate-to-severe atopic dermatitis who are candidates for systemic therapy and in the

用于治疗年龄低至两岁、适合接受系统治疗的中度至重度特应性皮炎患者，并且在

U.S.

美国

,

，

Europe

欧洲

and

和

Japan

日本

for adult patients with severe AA. Marketing authorization for the treatment of hospitalized patients with COVID-19 has been granted for baricitinib in multiple countries.

用于治疗重度AA的成年患者。巴瑞替尼在多国已获准用于治疗住院的COVID-19患者。

The U.S. FDA-approved labeling for Olumiant includes a Boxed Warning for Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis. See the full Prescribing Information

美国食品药品监督管理局（FDA）批准的Olumiant标签包含严重感染、死亡率、恶性肿瘤、主要不良心血管事件和血栓形成的方框警告。请参阅完整的处方信息。

here

这里

.

。

4

4

In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of Olumiant and certain follow-on compounds for patients with inflammatory and autoimmune diseases.

2009年12月，礼来和Incyte宣布了一项独家的全球许可和合作协议，用于开发和商业化Olumiant及某些后续化合物，以治疗炎症和自身免疫性疾病患者。

About Lilly

关于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.

礼来是一家医药公司，将科学转化为治疗手段，以改善世界各地人们的生活。近150年来，我们一直致力于开创改变生命的发现，如今我们的药物已帮助全球数千万人。通过利用生物技术、化学和基因药物的力量，我们的科学家正在加速推进新的发现，以解决一些全球最重要的健康挑战：重新定义糖尿病护理；治疗肥胖症并遏制其最具破坏性的长期影响；推动对抗阿尔茨海默病的斗争；为一些最严重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管理的疾病。

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 .

每迈向更健康的世界一步，我们都受到一个目标的激励：让数百万人的生活更美好。这包括开展反映世界多样性的创新临床试验，并努力确保我们的药品可及且价格合理。欲了解更多信息，请访问。

Lilly.com

莉莉网

and

和

Lilly.com/news

Lilly.com/新闻

, or follow us on

，或者关注我们

Facebook

Facebook

,

，

Instagram

照片墙

, and

，以及

LinkedIn

领英

. P-LLY

. P-LLY

About Incyte

关于Incyte

Incyte

Incyte

is a

是

Wilmington, Delaware

威尔明顿，特拉华州

-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on

基于全球的生物制药公司，专注于通过发现、开发和商业化专有疗法来满足严重未满足的医疗需求。欲了解更多信息，请访问

Incyte

Incyte

, please visit

，请访问

Incyte.com

Incyte.com

and follow

跟随

@Incyte

@Incyte

.

。

Trademarks and

商标和

Trade Names

商品名称

All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto.

本新闻稿中提及的所有商标或商号均为公司财产，或者，若涉及属于其他公司的商标或商号，则为其各自所有者的财产。仅为方便起见，本新闻稿中提及的商标和商号未附带®和™符号，但此类引用不应被解释为表示公司或在适用情况下其各自所有者不会根据适用法律最大限度地主张公司或其对该等权利的所有权。

We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies..

我们无意使用或展示其他公司的商标和商号，以暗示我们与任何其他公司存在关联，或得到其认可或赞助。

Cautionary Statement Regarding Forward-Looking Statements

关于前瞻性陈述的警告声明

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Olumiant (baricitinib) as a treatment for alopecia areata and reflects Lilly's and

本新闻稿包含关于奥伦巴里替尼（Olumiant，巴利西替尼）作为斑秃治疗的前瞻性声明（该术语定义见1995年私人证券诉讼改革法案），并反映了礼来公司和

Incyte's

Incyte的

current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there can be no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with the results to date, and that Olumiant will receive additional regulatory approvals, or be commercially successful.

当前的信念和期望。然而，与任何医药产品一样，在药物研发、开发和商业化的过程中存在重大风险和不确定性。除此之外，无法保证计划中或正在进行的研究会按计划完成，未来的研究结果将与迄今为止的结果一致，也无法保证Olumiant会获得额外的监管批准或取得商业成功。

For further discussion of these and other risks and uncertainties, see Lilly's and .

有关这些风险和其他不确定性的进一步讨论，请参见礼来公司的。

Incyte's

Incyte的

most recent respective Form 10-K and Form 10-Q filings with the

最近的各自表格10-K和表格10-Q的备案文件

United States Securities and Exchange Commission

美国证券交易委员会

. Except as required by law, Lilly and

。除非法律要求，礼来公司和

Incyte

Incyte公司

undertake no duty to update forward-looking statements to reflect events after the date of this release.

不承担更新前瞻性陈述以反映本发布日期之后的事件的责任。

Craiglow B, et al. Baricitinib provides significant hair regrowth in adolescents with severe alopecia areata: 52-week efficacy and safety results from a Phase 3 randomized, controlled trial. 2025

Craiglow B, 等。巴瑞替尼在重度斑秃青少年患者中显著促进头发再生：来自一项三期随机对照试验的52周疗效与安全性结果。2025年。

Fall Clinical Dermatology Conference

秋季临床皮肤病学会议

.

。

October 24, 2025

2025年10月24日

.

。

Craiglow B, et al. Impact of severity and disease course on baricitinib treatment response in adolescent patients with severe AA from the BRAVE-AA-PEDS trial. 2025

Craiglow B, 等。BRAVE-AA-PEDS 试验中严重 AA 青少年患者严重程度及病程对巴瑞替尼治疗反应的影响。2025年。

Fall Clinical Dermatology Conference

秋季临床皮肤病学会议

.

。

October 24, 2025

2025年10月24日

.

。

Vleugels R, et al. Baricitinib provides sustained, long-term efficacy with consistent safety up to 5 years of treatment in adults with severe alopecia areata: final results from BRAVE-AA1 and BRAVE-AA2. 2025

Vleugels R, 等。巴瑞替尼在重度斑秃成年患者中提供持续、长期的疗效，并在长达5年的治疗中保持一致的安全性：BRAVE-AA1和BRAVE-AA2的最终结果。2025年。

Fall Clinical Dermatology Conference

秋季临床皮肤病学会议

.

。

October 24, 2025

2025年10月24日

.

。

Olumiant. Prescribing Information.

奥卢米安特。处方信息。

Lilly USA, LLC

美国礼来公司

.

。

Refer to:

参考：

Julia Brennan

朱莉娅·布伦南

;

；

julia.brennan@lilly.com

朱莉娅·布伦南@礼来公司.com

; 463-245-3586 (Lilly media)

；463-245-3586（莉莉媒体）

Michael Czapar

迈克尔·查帕尔

;

；

czapar_michael_c@lilly.com

czapar_michael_c@lilly.com

; 317-617-0983 (Investors)

；317-617-0983（投资者）

View original content to download multimedia:

查看原始内容以下载多媒体：

https://www.prnewswire.com/news-releases/lillys-baricitinib-delivered-near-complete-scalp-hair-regrowth-at-one-year-for-adolescents-with-severe-alopecia-areata-in-phase-3-brave-aa-peds-trial-302593426.html

https://www.prnewswire.com/news-releases/礼来公司的巴利替尼在3期BRAVE-AA-Peds试验中，对患有严重斑秃的青少年在一年内实现了近乎完全的头皮毛发再生-302593426.html

SOURCE

源代码

Eli Lilly and Company

礼来公司