The FDA has approved Dupixent (dupilumab) for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment

美国食品药品监督管理局（FDA）已批准 Dupixent（dupilumab）用于治疗 12 岁及以上、尽管已接受组胺-1（H1）抗组胺药治疗但仍持续出现症状的慢性自发性荨麻疹（CSU）成人和青少年患者。

Kenneth Mendez, President and Chief Executive Officer at the Asthma and Allergy Foundation of America: 'People with chronic spontaneous urticaria experience sudden, unpredictable hives and severe itch that cause a significant, and often overwhelming, burden on their everyday lives. The approval of this treatment offers patients more options and the chance to control their disease.”.

美国哮喘和过敏基金会主席兼首席执行官肯尼斯·门德斯表示：“慢性自发性荨麻疹患者会突然出现无法预测的荨麻疹和严重瘙痒，这对他们的日常生活造成了显著且常常难以承受的负担。这种治疗方案的批准为患者提供了更多选择，并有机会控制他们的疾病。”

Alyssa Johnsen, M.D., Ph.D., Global Therapeutic Area Head, Immunology and Oncology Development at Sanofi: 'CSU patients with uncontrolled disease experience highly burdensome itch and hives that can significantly disrupt daily living. This FDA approval provides a new treatment option to help address the underlying drivers of these severe and recurring signs and symptoms.

赛诺菲免疫学与肿瘤学开发全球治疗领域负责人、医学博士兼哲学博士阿丽莎·约翰森表示：“病情未受控制的CSU患者会经历极其沉重的瘙痒和荨麻疹，这可能会严重扰乱日常生活。此次FDA的批准提供了一种新的治疗选择，有助于解决这些严重且反复出现的症状的根本原因。”

Dupixent has the potential to improve outcomes for CSU patients who previously had limited treatment options.”.

Dupixent 有可能改善之前治疗选择有限的 CSU 患者的预后。

The US approval is based on data from two phase III clinical studies, Study A (n=136) and Study C (n=148), which included biologic-naïve patients aged 12 years and older who were symptomatic despite the use of antihistamines and assessed Dupixent as an add-on therapy to standard-of-care antihistamines, compared to antihistamines alone.

美国的批准是基于两项 III 期临床研究（研究 A（n=136）和研究 C（n=148））的数据，这些研究纳入了 12 岁及以上、尽管使用抗组胺药但仍出现症状的生物制剂初治患者，并评估了 Dupixent 联合标准护理抗组胺药作为附加疗法的效果，与单独使用抗组胺药进行了比较。

Both studies met their primary and key secondary endpoints with Dupixent demonstrating reductions in itch severity and urticaria activity (a composite of itch and hives) compared to placebo at 24 weeks. Dupixent also increased the likelihood of well-controlled disease or complete response compared to placebo at 24 weeks.

两项研究均达到了主要终点和关键次要终点，与安慰剂相比，Dupixent 在 24 周时显示出瘙痒严重程度和荨麻疹活动度（瘙痒和风团的综合指标）的降低。与安慰剂相比，Dupixent 还增加了在 24 周时疾病得到良好控制或完全缓解的可能性。

Study B (n=108) provided additional safety data and evaluated Dupixent in patients aged 12 years and older who were inadequate responders or intolerant to anti-IgE therapy and symptomatic despite antihistamine use..

研究B（n=108）提供了额外的安全性数据，并在12岁及以上对IgE治疗反应不佳或不耐受且在使用抗组胺药后仍有症状的患者中评估了Dupixent。

Safety results from Study A, Study B, and Study C were generally consistent with the known safety profile of Dupixent in its approved indications. In pooled data from all three studies, the most common adverse event (≥2%) more frequently observed in patients on Dupixent compared to placebo was injection site reactions..

研究A、研究B和研究C的安全性结果通常与Dupixent在其获批适应症中已知的安全性特征一致。在所有三项研究的汇总数据中，与安慰剂相比，接受Dupixent治疗的患者中最常见的不良事件（≥2%）是注射部位反应。

George D. Yancopoulus, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron: “Dupixent is the first new targeted treatment for chronic spontaneous urticaria, or CSU, in over ten years, with pivotal trials demonstrating its ability to help patients significantly reduce the hallmark symptoms of intense itch and unpredictable hives associated with this disease.

再生元公司董事会联合主席、总裁兼首席科学官George D. Yancopoulus医学博士表示：“Dupixent是十多年来首个用于治疗慢性自发性荨麻疹（CSU）的新型靶向疗法，关键试验证明其能够帮助患者显著减轻与该疾病相关的剧烈瘙痒和不可预测的风团等标志性症状。”

With this FDA decision, Dupixent is now approved for seven chronic, debilitating atopic conditions driven in part by underlying type 2 inflammation, several of which have been shown to co-morbidly occur with CSU, such as atopic dermatitis and asthma – providing patients with one treatment that might help multiple atopy conditions.

随着FDA的这项决定，Dupixent现已获批用于七种由部分潜在2型炎症引起的慢性、致残性特应性疾病，其中一些已被证明与CSU（慢性自发性荨麻疹）共病，例如特应性皮炎和哮喘——为患者提供了一种可能对多种特应性疾病有帮助的治疗方案。

We look forward to bringing Dupixent to the more than 300,000 CSU patients in the US. with inadequately controlled disease on standard-of-care treatment who, until now, had limited treatment options.”.

我们期待着将Dupixent带给美国超过30万名接受标准治疗但疾病控制不佳的CSU患者，这些患者迄今为止治疗选择有限。

Dupixent is already approved for CSU in Japan, the United Arab Emirates, and Brazil. Submissions are currently under review with other regulatory authorities around the world including in the EU.

Dupixent已在日本、阿拉伯联合酋长国和巴西获准用于治疗CSU。目前，包括欧盟在内的全球其他监管机构正在审查该药物的申请。

About the Dupixent CSU phase III study program

关于Dupixent CSU三期研究计划

The LIBERTY-CUPID phase III program evaluating Dupixent for CSU consists of Study A, Study B, and Study C. These studies were randomized, double-blind, placebo-controlled clinical studies that evaluated the efficacy and safety of Dupixent as an add-on therapy to standard-of-care antihistamines compared to antihistamines alone.

LIBERTY-CUPID III期项目评估Dupixent用于治疗CSU，包括研究A、研究B和研究C。这些研究是随机、双盲、安慰剂对照的临床试验，评估了Dupixent作为标准护理抗组胺药的附加疗法相较于单独使用抗组胺药的有效性和安全性。

Studies A and C were replicate studies that assessed patients aged six years and older who remained symptomatic despite the use of antihistamines. Study B was conducted in patients aged 12 years and older who were symptomatic despite use of antihistamines and were inadequate responders or intolerant to anti-IgE therapy.

研究A和C是评估六岁及以上使用抗组胺药后仍有症状患者的重复研究。研究B针对12岁及以上使用抗组胺药后仍有症状且对抗IgE治疗反应不佳或不耐受的患者进行。

During the 24-week treatment period in all three studies, patients received an initial loading dose followed by 300 mg Dupixent every two weeks, except for pediatric patients weighing <60 kg who received 200 mg every two weeks..

在所有三项研究的24周治疗期间，患者接受初始负荷剂量，随后每两周接受300 mg Dupixent，体重小于60公斤的儿科患者除外，他们每两周接受200 mg。

In all three studies, the primary endpoint assessed the change from baseline in itch at 24 weeks (measured by the weekly itch severity score, 0-21 scale). The key secondary endpoints (also assessed at 24 weeks) included change from baseline in itch and hives (weekly urticaria activity score [UAS7], 0-42 scale).

在所有三项研究中，主要终点评估了24周时瘙痒相对于基线的变化（通过每周瘙痒严重程度评分衡量，0-21分制）。关键次要终点（同样在24周评估）包括瘙痒和荨麻疹相对于基线的变化（每周荨麻疹活动评分[UAS7]，0-42分制）。

Additional secondary endpoints assessed at 24 weeks evaluated the proportion of patients achieving well-controlled disease status (UAS7 ≤6) and the proportion of patients with complete response (UAS7=0)..

24周时评估的其他次要终点包括达到良好疾病控制状态（UAS7 ≤6）的患者比例以及完全缓解（UAS7=0）的患者比例。

The results from Studies A and B were published in The Journal of Allergy and Clinical Immunology. Study B did not meet the primary endpoint in the US of reduction in ISS7 compared to placebo at 24 weeks.

研究 A 和 B 的结果发表在《过敏与临床免疫学杂志》上。在美国，研究 B 在 24 周时未达到与安慰剂相比减少 ISS7 的主要终点。

Citation: Dupilumab in patients with chronic spontaneous urticaria (LIBERTY-CSU CUPID): Two randomized, double-blind, placebo-controlled, phase 3 trials. Authors: Marcus Maurer, MD Thomas B. Casale, MD Sarbjit S. Saini, MD et al. J Allergy Clin Immunol 2024;154:184 https://doi.org/10.1016/j.jaci.2024.01.028..

引用：Dupilumab在慢性自发性荨麻疹患者中的应用（LIBERTY-CSU CUPID）：两项随机、双盲、安慰剂对照的3期临床试验。作者：Marcus Maurer，医学博士，Thomas B. Casale，医学博士，Sarbjit S. Saini，医学博士等。《过敏与临床免疫学杂志》2024；154：184 https://doi.org/10.1016/j.jaci.2024.01.028。

Condition:

条件：

Urticaria

荨麻疹

Type:

类型：

drug

药物