/ -- AbbVie (NYSE: ABBV) today announced positive topline results from the first of two pivotal studies of the Phase 3 UP-AA clinical program evaluating the safety and efficacy of upadacitinib (RINVOQ

/ -- 艾伯维（AbbVie，纽约证券交易所代码：ABBV）今天宣布了3期UP-AA临床项目中两项关键研究的第一项研究的积极顶线结果，该研究评估了乌帕替尼（RINVOQ）的安全性和有效性。

; 15 mg and 30 mg, once daily) in adult and adolescent patients with severe alopecia areata (AA) with a mean baseline SALT score of 83.8 (approximately 16% scalp hair coverage).

；15毫克和30毫克，每日一次）用于重度斑秃（AA）的成年和青少年患者，其平均基线SALT评分为83.8（约16%头皮毛发覆盖率）。

In Study 2, both doses of upadacitinib achieved the primary endpoint, with 44.6% and 54.3% of patients treated with upadacitinib 15 mg and 30 mg, respectively, reaching 80% or more scalp hair coverage (SALT score ≤ 20) at week 24, compared to 3.4% of patients receiving placebo (p<0.001).

在研究2中，两种剂量的乌帕达西布均达到了主要终点，分别有44.6%和54.3%的患者在使用15毫克和30毫克乌帕达西布治疗后，在第24周达到了80%或以上的头皮毛发覆盖率（SALT评分≤20），而接受安慰剂的患者中仅有3.4%达到该标准（p<0.001）。

'Often misunderstood as a cosmetic issue, AA is a systemic immune-mediated disease that can cause total hair loss, involving the scalp, eyebrows and eyelashes. People living with AA may face difficulties in managing their disease, which can significantly affect their quality of life,' said

“AA通常被误解为一个美容问题，但实际上它是一种系统性免疫介导的疾病，可能导致头发全部脱落，包括头皮、眉毛和睫毛。患有AA的人在管理自己的疾病时可能会遇到困难，这会严重影响他们的生活质量，”

Kori Wallace

科里·华莱士

, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. 'UP-AA is the first pivotal program to have ranked and met the rigorous standard of SALT=0, indicating complete scalp hair regrowth. These data underscore AbbVie's commitment to advancing novel treatments that have the potential to improve the lives of individuals with immune-mediated diseases.'.

医学博士、哲学博士、艾伯维公司全球免疫学临床开发副总裁兼负责人表示：“UP-AA是首个达到并符合SALT=0这一严格标准的关键性项目，这代表着头皮毛发完全再生。这些数据凸显了艾伯维致力于推进有潜力改善免疫介导疾病患者生活的创新疗法。”

36.0% and 47.1% of patients treated with upadacitinib 15 mg and 30 mg, respectively, reached 90% or more scalp hair coverage (SALT ≤ 10), compared to 1.4% of patients receiving placebo at week 24 (p<0.001).

接受15毫克和30毫克乌帕达西替尼治疗的患者中，分别有36.0%和47.1%在第24周达到了90%或以上的头皮毛发覆盖率（SALT ≤ 10），而接受安慰剂的患者中仅有1.4%达到该指标（p<0.001）。

Additional key secondary endpoints that were met included percentage of subjects with improvements in eyebrows and eyelashes, as well as the percentage of subjects with complete scalp hair coverage (SALT=0) with both doses of upadacitinib at week 24.

达成的其他关键次要终点包括眉毛和睫毛改善的受试者百分比，以及在第24周时使用两种剂量的乌帕达西替尼达到头皮毛发完全覆盖（SALT=0）的受试者百分比。

'The sudden and often unpredictable hair loss people living with AA experience can profoundly impact their self-esteem and mental well-being,' said

“生活在AA中的人们经历的突然且常常不可预测的脱发，可能会深刻影响他们的自尊和心理健康，”

Arash Mostaghimi

阿里什·莫斯塔吉米

, M.D., M.P.A., M.P.H., associate professor of dermatology and vice chair of clinical trials and innovation, Brigham & Women's Hospital,

医学博士、公共管理硕士、公共卫生硕士，布里格姆妇女医院皮肤科副教授，临床试验与创新副主任，

Harvard Medical School

哈佛医学院

. 'There is a pressing need for more treatments that help enable regrowth of scalp and non-scalp hair. I am encouraged by these results that demonstrate the potential of upadacitinib to be an important new treatment option.'

“迫切需要更多有助于头皮和非头皮毛发再生的治疗方法。这些结果让我感到鼓舞，表明了upadacitinib有潜力成为一项重要的新治疗选择。”

The safety profile of both doses of upadacitinib in the 24-week, placebo-controlled period (Period A) was generally consistent with that observed in approved indications.

在24周的安慰剂对照期（A期）中，两种剂量的乌帕替尼的安全性特征总体上与已批准适应症中观察到的一致。

Treatment-emergent serious adverse events occurred in 1.4% and 2.8% of patients in the upadacitinib 15 mg and 30 mg groups, respectively, and none in the placebo group.

治疗中出现的严重不良事件分别发生在1.4%和2.8%的接受乌帕替尼15毫克和30毫克治疗的患者中，而安慰剂组未发生。

Discontinuations due to treatment-emergent adverse events (TEAEs) occurred in 0.7% and 1.4% of subjects in the upadacitinib 15 mg and 30 mg groups, respectively, and none in the placebo group.

因治疗中出现的不良事件（TEAEs）而中断治疗的情况发生在乌帕达西替尼15毫克组和30毫克组的受试者中分别占0.7%和1.4%，而安慰剂组中则没有发生。

The most common TEAEs observed were acne, nasopharyngitis and upper respiratory tract infection.

最常见的TEAE包括痤疮、鼻咽炎和上呼吸道感染。

Serious infections were reported infrequently with 0.7% in the upadacitinib 15 mg group and 1.0% in the upadacitinib 30 mg group, and none in the placebo group.

严重感染报告较少，乌帕替尼15 mg组为0.7%，乌帕替尼30 mg组为1.0%，安慰剂组未出现。

There were no adjudicated MACE, malignancies or deaths reported.

没有报告判定的重大不良心血管事件（MACE）、恶性肿瘤或死亡。

One adjudicated venous thromboembolism was reported in the upadacitinib 15 mg group in a patient with multiple risk factors.

在使用乌帕替尼15毫克的组中，报告了一例有多个风险因素的患者发生静脉血栓栓塞事件。

Use of upadacitinib in AA is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

乌帕达西替尼在AA中的使用未经批准，其安全性和有效性尚未由监管机构评估。

About UP-AA Clinical Trial

关于UP-AA临床试验

UP-AA M23-716 was conducted as a single protocol that includes two replicate pivotal studies (Study 1 and Study 2) with randomization, investigative sites, data collection, analysis and reporting independent for each study. The Phase 3 randomized, placebo-controlled, double-blind studies evaluate efficacy and safety of upadacitinib in adult and adolescent subjects with severe alopecia areata.

UP-AA M23-716 作为一项单一方案开展，包含两个重复的关键研究（研究 1 和研究 2），每个研究的随机化、研究地点、数据收集、分析和报告均独立进行。这两项 III 期随机、安慰剂对照、双盲研究评估了乌帕替尼在患有严重斑秃的成年及青少年受试者中的疗效和安全性。

In Study 1 and Study 2 Period A, participants are randomized to one of three groups to receive upadacitinib 15 mg, upadacitinib 30 mg or placebo for 24 weeks. In Study 1 and Study 2 Period B, participants originally randomized to upadacitinib dose groups in Period A will continue their same treatment in Period B for 28 weeks.

在研究1和研究2的A阶段，参与者被随机分配到三个组之一，接受15毫克或30毫克的乌帕替尼或安慰剂，持续24周。在研究1和研究2的B阶段，原先在A阶段随机分配到乌帕替尼剂量组的参与者将在B阶段继续相同的治疗28周。

Participants originally randomized to placebo in Period A will either remain on placebo in Period B, or be randomized in one of two groups, based off of their SALT score at week 24. In total, Study 1 and Study 2 Periods A and B span 52 weeks. Participants who complete Study 1 or Study 2, can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks.

在A阶段最初随机分配到安慰剂组的参与者，将根据他们在第24周的SALT评分，要么在B阶段继续使用安慰剂，要么被随机分配到两个组之一。总体而言，研究1和研究2的A、B阶段共持续52周。完成研究1或研究2的参与者可以加入研究3，并可能被重新随机分配接受两种剂量的乌帕替尼之一，最长持续108周。

The two trials randomized 1,399 participants with severe AA ages 12 to 64 across 248 sites worldwide. More information on this trial can be found at .

这两项试验在全球 248 个地点随机抽取了 1,399 名年龄在 12 至 64 岁之间的重度 AA 参与者。有关此试验的更多信息，请访问 。

About RINVOQ

关于RINVOQ

Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. In human leukocyte cellular assays, RINVOQ inhibited cytokine-induced STAT phosphorylation mediated by JAK1 and JAK1/JAK3 more potently than JAK2/JAK2 mediated STAT phosphorylation..

由AbbVie科学家发现和开发的RINVOQ是一种JAK抑制剂，目前正被研究用于多种免疫介导的炎症性疾病。在人体白细胞细胞实验中，RINVOQ对JAK1和JAK1/JAK3介导的细胞因子诱导的STAT磷酸化抑制作用比对JAK2/JAK2介导的STAT磷酸化更强。

The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.

目前尚不清楚抑制特定 JAK 酶与治疗效果和安全性的相关性。

Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus and vitiligo.

乌帕达西替尼（RINVOQ）正在针对斑秃、化脓性汗腺炎、高安动脉炎、系统性红斑狼疮和白癜风进行三期临床试验。

About AbbVie

关于艾伯维

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio.

AbbVie的使命是发现并提供创新的药物和解决方案，以解决当今严重的健康问题，并应对未来的医学挑战。我们力求在包括免疫学、肿瘤学、神经科学和眼科在内的几个关键治疗领域，以及我们Allergan Aesthetics产品组合中的产品和服务，对人们的生活产生显著影响。