25, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive results from a new post-hoc analysis from the Measure Up 1 and Measure Up 2 Phase 3 studies. The analysis evaluated the efficacy of upadacitinib (15 mg or 30 mg) in patients with moderate-to-severe atopic dermatitis (AD) stratified by the severity of disease in the head and neck region at baseline compared to placebo across 16 weeks.1 .

2024年2月25日/新闻通讯社/--AbbVie（纽约证券交易所：ABBV）今天宣布了来自Measure Up 1和Measure Up 2第三阶段研究的新事后分析的积极结果。该分析评估了upadacitinib（15 mg或30 mg）对中度至重度特应性皮炎（AD）患者的疗效，该患者根据基线时头颈部疾病的严重程度与安慰剂相比，在16周内进行分层。

In this analysis, several optimal and stringent treatment targets – including the achievement of near complete skin clearance in the head and neck region (EASI Head & Neck score <1), near complete skin clearance (EASI 90), no to little itch (WP-NRS 0/1) and minimal or no impact on quality of life (DLQI 0/1) – were assessed with the treatment of upadacitinib across patient subgroups.

在这项分析中，通过在患者亚组中使用upadacitinib治疗，评估了几个最佳和严格的治疗目标，包括在头颈部达到接近完全的皮肤清除率（EASI头颈部评分<1），接近完全的皮肤清除率（EASI 90），没有或几乎没有瘙痒（WP-NRS 0/1）以及对生活质量的影响最小或没有影响（DLQI 0/1）。

Patients were stratified by no-to-mild, moderate, or severe head and neck involvement.1.

患者按无轻度，中度或重度头颈部受累进行分层。

Living with uncontrolled AD can have a substantial physical, emotional and social impact on patients' lives and is often associated with significant long-term disease burden from debilitating symptoms.5 Research shows that AD in specific sites such as the head, neck, face and hands can have a significant impact on symptom frequency and quality of life for patients.2,6 In the real-world observational setting, 70% of AD patients in the UP-TAINED study and at least 74.5% of AD patients in the AD-VISE study had head and neck region involvement at baseline.3,4 The high prevalence reinforces the need for effective therapies in this high impact, challenging to treat area..

生活在不受控制的AD中会对患者的生活产生重大的身体，情绪和社会影响，并且通常与衰弱症状带来的长期疾病负担有关。5研究表明，AD在特定部位，如头部，颈部，面部和手部，可能会对患者的症状频率和生活质量产生重大影响。2,6在现实世界的观察环境中，在后续研究中，70%的AD患者和AD-VISE研究中至少74.5%的AD患者在基线时有头部和颈部区域受累。3,4高流行率加强了对这一高影响，具有挑战性的治疗领域有效治疗的需求。。

'These data stratify the severity of atopic dermatitis in the head and neck region, which is a part of the body that has significant impact on patients and is challenging to treat,' said Kilian Eyerich, MD, PhD, chair and professor at the Department of Dermatology and Venerology of the University of Freiburg, Germany. 'At 16 weeks, RINVOQ showed efficacy in patients with moderate-to-severe atopic dermatitis with various degrees of head and neck involvement, achieving optimal treatment targets with combined measures of EASI 90 and WP-NRS 0/1, along with improvement on the patients' quality of life measured by DLQI 0/1 in a substantial number of patients.'.

德国弗莱堡大学皮肤性病学系主席兼教授、医学博士Kilian Eyerich说：“这些数据对头颈部特应性皮炎的严重程度进行了分层，头颈部是身体的一部分，对患者有重大影响，治疗起来很有挑战性。”。“在16周时，RINVOQ对患有不同程度头颈部受累的中度至重度特应性皮炎患者显示出疗效，通过EASI 90和WP-NRS 0/1的联合测量实现了最佳治疗目标，同时改善了患者的生活质量。通过DLQI 0/1测量了大量患者的生活质量。”。

New post-hoc analysis of the Measure Up 1 and Measure Up 2 studies showed that a higher proportion of patients with moderate-to-severe AD with varying degrees of head and neck involvement treated with upadacitinib (15 mg or 30 mg) achieved the following optimal treatment targets compared to placebo at week 16: near complete skin clearance in the head and neck region (EASI Head & Neck Score <1), minimal or no impact on quality of life (DLQI 0/1), and minimal disease activity, which is the simultaneous achievement of near complete skin clearance (EASI 90) and no to little itch (WP-NRS 0/1)1:.

对Measure Up 1和Measure Up 2研究的新事后分析表明，与安慰剂相比，在第16周接受upadacitinib（15 mg或30 mg）治疗的中度至重度AD患者中，头部和颈部受累程度不同的患者比例更高，达到了以下最佳治疗目标：头部和颈部皮肤接近完全清除（EASI头颈部评分<1），对生活质量的影响最小或没有影响（DLQI 0/1），疾病活动最小，这是同时实现接近完全的皮肤清除（EASI 90）和不到很少的瘙痒（WP-NRS 0/1）1：。

% (N)

%（不适用）

Placebo

安慰剂

Upadacitinib 15 mg

阿帕达替尼15mg

Upadacitinib 30 mg

乌帕他替尼30毫克

EASI Head & Neck Score < 1

EASI头颈评分<1

1 to <4 (moderate)

1至<4（中等）

27.4 (307)

27.4 (307)

67.8 (320)

67.8 (320)

75.9 (323)

75.9 (323)

4 to 7.2 (severe)

4至7.2（严重）

10.5 (152)

10.5 (152)

47.2 (142)

47.2 (142)

63.2 (136)

63.2 (136)

Minimal Disease Activity (MDA; EASI 90 + WP-NRS 0/1)

最小疾病活动（MDA；EASI 90+WP-NRS 0/1）

0 to <1 (no-to-mild)

0至<1（无至轻度）

3.1 (97)

3.1 (97)

37.2 (94)

37.2 (94)

48.1 (108)

48.1 (108)

1 to <4 (moderate)

1至<4（中等）

2.0 (304)

2.0 (304)

22.3 (319)

22.3 (319)

37.5 (320)

37.5 (320)

4 to 7.2 (severe)

4至7.2（严重）

0.7 (150)

0.7 (150)

24.8 (141)

24.8 (141)

37.8 (135)

37.8 (135)

DLQI 0 or 1

DLQI 0或1

0 to <1 (no-to-mild)

0至<1（无至轻度）

5.7 (87)

5.7 (87)

38.4 (86)

38.4 (86)

45.5 (99)

45.5 (99)

1 to <4 (moderate)

1至<4（中等）

4.6 (283)

4.6 (283)

25.3 (296)

25.3 (296)

38.0 (295)

38.0 (295)

4 to 7.2 (severe)

4至7.2（严重）

4.3 (139)

4.3 (139)

25.0 (128)

25.0 (128)

41.5 (123)

41.5 (123)

'Despite taking steps to manage their condition, many patients with atopic dermatitis continue to live with debilitating symptoms, especially in highly visible areas such as head and neck that can intensify one's physical and emotional burden,' said Andrew Anisfeld, PhD, vice president, global medical affairs, immunology, AbbVie. 'These data contribute to our ongoing commitment to elevate the standard of care in atopic dermatitis so patients can strive for the best possible outcomes.'.

AbbVie全球医学事务免疫学副总裁安德鲁·安尼菲尔德博士说：“尽管采取了措施来控制病情，但许多特应性皮炎患者仍然存在衰弱症状，特别是在头颈部等高度可见的区域，这会加重身体和情绪负担。”。“这些数据有助于我们持续致力于提高特应性皮炎的护理标准，以便患者能够争取最佳的结果。”。

Additional abstracts to be presented at EADV 2024 supporting the efficacy and safety profile of RINVOQ (upadacitinib) for moderate-to-severe AD include:

将在EADV 2024上提交的其他摘要支持RINVOQ（upadacitinib）治疗中度至重度AD的疗效和安全性，包括：

Efficacy and safety of upadacitinib vs dupilumab in adults and adolescents with moderate-to-severe atopic dermatitis: results of an open-label, efficacy assessor-blinded head-to-head phase 3b/4 study (LEVEL UP): This study evaluated the efficacy and safety of RINVOQ (15 mg once daily starting dose and dose-adjusted based on clinical response) versus dupilumab (per its labeled dose) in adults and adolescents (≥12 years of age) with moderate-to-severe atopic dermatitis (AD) who had an inadequate response to systemic therapy or when use of those therapies was inadvisable.

upadacitinib与dupilumab在成人和青少年中度至重度特应性皮炎中的疗效和安全性：开放标签，疗效评估者盲法头对头3b/4期研究（LEVEL UP）的结果：本研究评估了RINVOQ（15 mg每日一次起始剂量，并根据临床反应调整剂量）与dupilumab（按其标记剂量）在成人和青少年（≥12岁）中度至重度特应性皮炎（AD）患者中的疗效和安全性，这些患者对全身治疗反应不足或不建议使用这些疗法。

The primary endpoint was achievement of both EASI 90 and WP-NRS 0/1 at Week 16.7 FC08.04 Oral Presentation on Friday, 27 September 2024, 16:30-16:40Effectiveness of upadacitinib in adults and adolescents with atopic dermatitis: 6-month interim analysis of the real-world multicountry AD-VISE study: An interim analysis of the AD-VISE study evaluating the effectiveness and durability of response to upadacitinib for skin clearance (EASI) and itch resolution (WP-NRS) in real-world settings.

主要终点是EASI 90和WP-NRS 0/1在2024年9月27日星期五16:30-16:40的第16.7周FC08.04口头报告中取得的成就。成人和青少年特应性皮炎患者服用upadacitinib的有效性：现实世界多国AD-VISE研究的6个月中期分析：AD-VISE研究的中期分析，评估在现实环境中对upadacitinib的皮肤清除（EASI）和瘙痒消退（WP-NRS）反应的有效性和持久性。

Results include 578 adult and adolescent patients with moderate-to-severe AD treated with upadacitinib (15 mg or 30 mg).3P0683 E-PosterBaseline criteria from a real world non-interventional study with Upadacitinib for the treatment of systemic atopic dermatitis: an analysis based on guideline criteria (UP-TAINED): An interim analysis of the UP-TAINED study including baseline visit data from 351 patients with moderate-to-severe AD treated with upadacitinib in real-world settings in Germany.  Results show that patients treated with upadacitinib met German checklist criteria for systemic therapy.4P0535 E-PosterAbout Atopic DermatitisAtopic dermatitis is a chronic, relapsing inflammatory condition characterized by a cycle of in.

结果包括578名接受upadacitinib（15 mg或30 mg）治疗的中重度AD成人和青少年患者。3P0683 E-PosterBaseline标准来自使用upadacitinib治疗系统性特应性皮炎的现实世界非介入性研究：基于指南标准的分析（补充）：对补充研究的中期分析，包括351名在德国现实环境中接受upadacitinib治疗的中重度AD患者的基线访视数据。结果显示，接受upadacitinib治疗的患者符合德国全身治疗清单标准.4P0535 E-PosterAbout特应性皮炎是一种以in周期为特征的慢性复发性炎症。

About Measure Up 1 and Measure Up 2Measure Up 1 and Measure Up 2 are Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled studies designed to evaluate the safety and efficacy of RINVOQ in adult and adolescent (12 years or older) patients with moderate to severe atopic dermatitis who are candidates for systemic treatment.

关于Measure Up 1和Measure Up 2 Measure Up 1和Measure Up 2是第三阶段，多中心，随机，双盲，平行组，安慰剂对照研究，旨在评估RINVOQ在成人和青少年（12岁或以上）中度至重度特应性皮炎患者中的安全性和有效性，这些患者是全身治疗的候选者。

Patients were randomized to RINVOQ 15 mg, RINVOQ 30 mg or placebo. The co-primary endpoints were the percentage of patients achieving EASI 75 and a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 after 16 weeks of treatment. Patients receiving placebo were switched to either RINVOQ 15 mg or RINVOQ 30 mg at week 16.14,15.

患者被随机分配到RINVOQ 15 mg，RINVOQ 30 mg或安慰剂。共同主要终点是治疗16周后达到EASI 75的患者百分比和经过验证的研究者特应性皮炎全球评估（vIGA AD）评分为0/1。接受安慰剂的患者在第16.14,15周改用RINVOQ 15 mg或RINVOQ 30 mg。

About RINVOQ® (upadacitinib)Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.16.

关于由AbbVie科学家发现和开发的RINVOQ®（upadacitinib），RINVOQ是一种选择性和可逆的JAK抑制剂，正在几种免疫介导的炎症性疾病中进行研究。在人类细胞测定中，RINVOQ优先抑制JAK1或JAK1/3的信号传导，其功能选择性优于通过JAK2.16对发出信号的细胞因子受体。

Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, giant cell arteritis, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo.17-22

Upadacitinib（RINVOQ）正在进行斑秃、巨细胞动脉炎、化脓性汗腺炎、大动脉炎、系统性红斑狼疮和白癜风的3期临床试验

EU Indications and Important Safety Information about RINVOQ® (upadacitinib)23

关于RINVOQ®（upadacitinib）23的欧盟适应症和重要安全信息

Indications

适应症

Rheumatoid arthritis

类风湿性关节炎

RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate..

RINVOQ适用于治疗对一种或多种缓解疾病的抗风湿药物（DMARDs）反应不足或不耐受的成年患者的中度至重度活动性类风湿性关节炎（RA）。RINVOQ可作为单一疗法或与甲氨蝶呤联合使用。。

Psoriatic arthritis

银屑病关节炎

RINVOQ is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.

RINVOQ适用于治疗对一种或多种DMARD反应不足或不耐受的成年患者的活动性银屑病关节炎（PsA）。RINVOQ可用作单一疗法或与甲氨蝶呤联合使用。

Axial spondyloarthritis

轴性脊柱关节炎

Non-radiographic axial spondyloarthritis (nr-axSpA)

非影像学轴性脊柱关节炎（nr-axSpA）

RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs)..

RINVOQ适用于治疗成人活动性非放射学轴性脊柱关节炎患者，这些患者具有客观的炎症迹象，如C反应蛋白（CRP）和/或磁共振成像（MRI）升高所示，这些患者对非甾体类抗炎药（NSAIDs）反应不充分。。

Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)

强直性脊柱炎（AS，放射学轴性脊柱关节炎）

RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.

RINVOQ适用于治疗对常规治疗反应不佳的成年患者的活动性强直性脊柱炎。

RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy.

RINVOQ适用于治疗12岁及以上成人和青少年的中度至重度特应性皮炎（AD），这些患者是全身治疗的候选者。

RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

RINVOQ适用于治疗中度至重度活动性溃疡性结肠炎（UC）的成年患者，这些患者的反应不足，反应丧失或对常规疗法或生物制剂不耐受。

Crohn's disease

克罗恩病

RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

RINVOQ适用于治疗中度至重度活动性克罗恩病的成年患者，这些患者的反应不足，反应丧失或对常规疗法或生物制剂不耐受。

About AbbVie 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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

AbbVie AbbVie的使命是发现并提供创新药物和解决方案，以解决当今严重的健康问题，并应对未来的医疗挑战。我们致力于在几个关键治疗领域（免疫学、肿瘤学、神经科学和眼部护理）以及Allergan美学产品组合中的产品和服务，对人们的生活产生重大影响。