Tezspire significantly reduced nasal congestion, polyp size and nearly eliminated the need for surgery in patients with chronic rhinosinusitis with nasal polyps

Tezspire显著减少了慢性鼻窦炎伴鼻息肉患者的鼻塞、息肉大小，并几乎消除了手术的需要。

WAYPOINT data published in New England Journal of Medicine and highlighted as late-breaking oral presentation at AAAAI/WAO 2025

WAYPOINT数据发表在《新英格兰医学杂志》上，并作为最新的口头报告在2025年AAAAI/WAO会议上重点展示。

Full results from the positive Phase III WAYPOINT trial showed AstraZeneca and Amgen’s

三期WAYPOINT试验的完整结果表明，阿斯利康和安进公司的

Tezspire

特泽斯派

(tezepelumab) significantly reduced nasal polyp severity, the need for subsequent surgery, and systemic corticosteroid use in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) compared to placebo.

（替泽普利单抗）显著减轻了慢性鼻窦炎伴鼻息肉（CRSwNP）患者的鼻息肉严重程度、后续手术需求以及全身性皮质类固醇的使用，与安慰剂相比。

1,2

1,2

These data were published in the

这些数据发布在

New England Journal of Medicine

新英格兰医学杂志

and presented today as a late-breaking oral presentation at the American Academy of Allergy Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress in San Diego, CA.

今天在加利福尼亚州圣地亚哥举行的美国过敏、哮喘和免疫学学会 (AAAAI)/世界过敏组织 (WAO) 联合大会上作为最新口头报告发表。

1,2

1,2

Treatment with

治疗

Tezspire

特泽斯派

significantly reduced nasal polyp severity measured by the co-primary endpoints; Nasal Polyp Score (NPS) by -2.065 (95% CI: -2.389, -1.742; p<0.0001) and nasal congestion (measured by participant-reported Nasal Congestion Score [NCS]) by -1.028 (95% CI: -1.201, -0.855; p<0.0001) at week 52 compared to placebo..

显著降低了由共同主要终点测量的鼻息肉严重程度；鼻息肉评分（NPS）减少了2.065（95%置信区间：-2.389，-1.742；p<0.0001），鼻塞（通过参与者报告的鼻塞评分[NCS]测量）减少了1.028（95%置信区间：-1.201，-0.855；p<0.0001），在第52周与安慰剂相比。

1,2

1,2

Improvements in NPS were observed as early as week four and NCS as early as week two (the first post-treatment assessment respectively) and were sustained through week 52.

在第四周时就观察到NPS的改善，第二周时就观察到NCS的改善（分别是首次治疗后评估），并且持续到第52周。

1

1

Statistically significant and clinically meaningful improvements were observed across all key secondary outcomes assessed in the overall trial population.

在整体试验人群中评估的所有关键次要结局均观察到具有统计学意义和临床意义的改善。

1

1

Importantly,

重要的是，

Tezspire

特泽斯匹韦

significantly reduced the need for subsequent nasal polyp surgery by 98% (p<0.0001) and the need for systemic corticosteroid treatment by 88% (p<0.0001) compared to placebo.

与安慰剂相比，显著减少了98%的后续鼻息肉手术需求（p<0.0001）和88%的全身性皮质类固醇治疗需求（p<0.0001）。

1

1

Dr Joseph Han, Vice Chair of Department of Otolaryngology - Head and Neck Surgery, Old Dominion University, US, and co-primary investigator in the trial, said: “Many patients living with nasal polyps are at risk of repeat surgeries and serious systemic side effects from long-term oral corticosteroids.

美国奥多明尼昂大学耳鼻喉科-头颈外科副主任、试验的共同主要研究者韩约瑟夫博士说：“许多患有鼻息肉的患者面临再次手术的风险，并且长期口服皮质类固醇会带来严重的全身性副作用。"

The WAYPOINT results are clinically meaningful and suggest that tezepelumab could greatly reduce the burden of nasal polyps for patients by nearly eliminating the need for future surgery and corticosteroid use and by significantly reducing nasal polyp size and congestion.”.

WAYPOINT研究结果具有临床意义，表明替泽普鲁单抗可大大减轻鼻息肉患者的负担，几乎消除未来手术和皮质类固醇使用的需要，并显著减小鼻息肉的大小和鼻塞症状。

Sharon Barr, Executive Vice President, BioPharmaceuticals R&D said, “The WAYPOINT results demonstrate the potential for

Sharon Barr，执行副总裁，生物制药研发部门表示：“WAYPOINT 结果展示了潜在的可能用于...

Tezspire

特泽斯普利

to provide a much-needed option for patients with chronic rhinosinusitis with nasal polyps. With its first-in-class mode of action, targeting TSLP at the top of the inflammatory cascade, the data add to the body of evidence that tezepelumab can transform care for patients with epithelial-driven inflammatory diseases.”.

为慢性鼻窦炎伴鼻息肉患者提供一个急需的治疗选择。凭借其首创的作用机制，针对炎症级联顶部的TSLP，这些数据增加了证据，表明替泽鲁单抗可以改变上皮驱动的炎症疾病患者的治疗。”

Table M1: Summary of co-primary and key secondary efficacy endpoints

表M1：共同主要和关键次要疗效终点总结

1,2

1,2

Endpoint

端点

Tezepelumab (n=203)

特泽鲁单抗 (n=203)

Placebo (n=205)

安慰剂 (n=205)

Difference vs. Placebo

与安慰剂的差异

(95% CI)

（95% 置信区间）

Co-primary endpoints

主要共同终点指标

Total nasal polyp score (range 0-8)*

总鼻息肉评分（范围0-8）*

-2.458 (0.114)

-2.458（0.114）

-0.392 (0.118)

-0.392（0.118）

-2.065 (-2.389, -1.742)

-2.065（-2.389，-1.742）

p<0.0001**

p<0.0001**

Nasal congestion score (range 0-3)*

鼻塞评分（范围0-3）*

-1.743 (0.062)

-1.743（0.062）

-0.715 (0.064)

-0.715（0.064）

-1.028 (-1.201, -0.855)

-1.028（-1.201，-0.855）

p<0.0001**

p<0.0001**

Key secondary endpoints

次要终点指标

Assessed in the overall trial population

在整体试验人群中评估

Time to first nasal polyp surgery decision

首次鼻息肉手术决策时间

(% patients)***

（% 患者）***

0.5 (0.0, 2.5)

0.5 (0.0, 2.5)

22.1 (16.4, 28.2)

22.1 (16.4, 28.2)

0.02 (0.00, 0.09)

0.02（0.00，0.09）

p<0.0001**

p<0.0001**

Time to first systemic glucocorticoid use

首次使用全身性糖皮质激素的时间

(% patients)***

（% 患者）***

5.2 (1.1, 14.7)

5.2（1.1，14.7）

18.3 (13.3, 24.1)

18.3 (13.3, 24.1)

0.12 (0.04, 0.27)

0.12（0.04，0.27）

p<0.0001**

p<0.0001**

Time to nasal polyp surgery decision and/or systemic glucocorticoid use

鼻息肉手术决策和/或全身性糖皮质激素使用的时间

(% patients)***

（% 患者）***

5.7 (1.3, 15.0)

5.7（1.3，15.0）

30.6 (24.2, 37.1)

30.6（24.2，37.1）

0.08 (0.03, 0.17)

0.08（0.03，0.17）

p<0.0001**

p<0.0001**

Loss of smell score

嗅觉丧失评分

(range 0-3)*

(范围 0-3)*

-1.26 (0.06)

-1.26（0.06）

-0.26 (0.06)

-0.26（0.06）

-1.00 (-1.18, -0.83)

-1.00（-1.18，-0.83）

p<0.0001**

p<0.0001**

Sino-Nasal Outcome Test-22 (SNOT-22) total score (range 0-110)*

鼻窦结局测试-22（SNOT-22）总分（范围0-110）*

-45.02 (1.81)

-45.02（1.81）

-17.76 (1.84)

-17.76（1.84）

-27.26 (-32.32, -22.21)

-27.26（-32.32，-22.21）

p<0.0001**

p<0.0001**

Sinus Computed Tomography Lund–Mackay (CT-LMK) score

鼻窦计算机断层扫描 Lund-Mackay (CT-LMK) 评分

(range 0-24)*

（范围 0-24）*

-6.27 (0.24)

-6.27（0.24）

-0.55 (0.24)

-0.55（0.24）

-5.72 (-6.39, -5.06)

-5.72（-6.39，-5.06）

p<0.0001**

p<0.0001**

Total Symptom Score (TSS) (range 0-24)*

总症状评分 (TSS)（范围 0-24）*

-10.39 (0.40)

-10.39（0.40）

-3.50 (0.41)

-3.50 (0.41)

-6.89 (-8.02, -5.76)

-6.89（-8.02，-5.76）

p<0.0001**

p<0.0001**

Key secondary endpoint

关键次要终点

Assessed in a subset of patients with co-morbid asthma or nonsteroidal anti-inflammatory drug exacerbated respiratory disease

在患有共病哮喘或非甾体抗炎药加重的呼吸系统疾病的患者子集中进行评估

Pre-bronchodilator forced expiratory volume in 1 second (FEV1 in liters)*

支气管扩张剂前1秒用力呼气量（FEV1，单位：升）*

0.02 (0.04)

0.02（0.04）

0.03 (0.04)

0.03（0.04）

-0.01 (-0.12, 0.11)

-0.01（-0.12，0.11）

p=0.9362

p=0.9362

*LS mean change (SE) from baseline at Week 52

*第52周时从基线的最小二乘（LS）均值变化（标准误）

**Denotes statistically significant at 0.01 level after adjustment for multiplicity. Unadjusted P-values are presented

**表示在对多重性进行调整后，在0.01水平上具有统计学显著性。未调整的P值已呈现。

*** % patients from Kaplan Meier estimate (95% confidence interval) is provided for each treatment group, hazard ratio (95% confidence interval) is presented for the difference vs placebo.

*** 每个治疗组的 Kaplan Meier 估计值（95% 置信区间）的患者百分比已提供，与安慰剂的差异以风险比（95% 置信区间）表示。

Tezspire

特泽斯匹韦

was generally well tolerated in patients with CRSwNP and had a safety profile

在伴有鼻息肉的慢性鼻窦炎（CRSwNP）患者中通常耐受性良好，并且具有安全性

consistent with its approved severe asthma indication.

与批准的重度哮喘适应症一致。

1,2

1,2

The most frequently reported adverse events for

最常报告的不良事件为

Tezspire

特泽斯普利

in the WAYPOINT trial were COVID-19, nasopharyngitis and upper respiratory tract infection.

在WAYPOINT试验中，COVID-19、鼻咽炎和上呼吸道感染是相关因素。

1

1

There were no clinically meaningful differences in safety results between the

安全性结果之间没有临床意义上的差异

Tezspire

特泽斯匹韦

and placebo group.

和安慰剂组。

1

1

Tezspire

特泽斯匹韦

is currently approved for the treatment of severe asthma in the US, EU, Japan, and over 60 countries across the globe.

目前已在美国、欧盟、日本及全球超过60个国家获批用于治疗重度哮喘。

3-5

3-5

It is approved as a single-use pre-filled syringe and auto-injector for self-administration in the US and EU.

它在美国和欧盟被批准作为一次性预充注射器和自动注射器用于自我给药。

3,4

3，4

Regulatory filings for tezepelumab in CRSwNP are currently under review by regulatory authorities in multiple regions.

Tezepelumab用于治疗CRSwNP的监管文件目前正在多个地区接受监管机构的审查。

++++

++++

Notes

笔记

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

伴有鼻息肉的慢性鼻窦炎 (CRSwNP)

CRSwNP is a complex inflammatory disorder, characterised by persistent inflammation of the nasal mucosa accompanied by benign growths, called nasal polyps.

CRSwNP是一种复杂的炎症性疾病，其特征是鼻腔黏膜持续发炎，并伴有称为鼻息肉的良性增生。

6,7

6,7

Nasal polyps and the accompanying inflammation can block nasal passages and lead to breathing problems, difficulty in sense of smell, nasal discharge, facial pain, sleep disturbance and other adverse effects on quality of life.

鼻息肉和伴随的炎症可阻塞鼻腔通道，导致呼吸问题、嗅觉困难、鼻涕流出、面部疼痛、睡眠障碍以及对生活质量的其他不良影响。

8-10

8-10

Current treatments for CRSwNP include intranasal and/or systemic corticosteroids, surgery and biologics.

目前针对CRSwNP的治疗方法包括鼻内和/或全身性皮质类固醇、手术和生物制剂。

7,10-16

7，10-16

Phase III WAYPOINT trial

III期WAYPOINT试验

WAYPOINT was a double-blind, multi-centre, randomised, placebo-controlled, parallel group trial designed to evaluate the efficacy and safety of tezepelumab in adults with severe CRSwNP.

WAYPOINT是一项双盲、多中心、随机、安慰剂对照、平行组试验，旨在评估tezepelumab在重度CRSwNP成人患者中的疗效和安全性。

1,2,17

1,2,17

Participants received tezepelumab or placebo, administered via subcutaneous injection.

参与者接受了通过皮下注射给予的替泽鲁单抗或安慰剂。

1,2,17

1,2,17

The trial also included a post-treatment follow-up period of 12-24 weeks for participants who completed the 52-week treatment period.

试验还包括一个为期12至24周的随访期，适用于完成52周治疗期的参与者。

1,17

1,17

Tezepelumab

特泽鲁单抗

Tezepelumab is being developed by AstraZeneca in collaboration with Amgen as a first-in-class human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of allergic, eosinophilic, and other types of epithelial-driven inflammation associated with severe asthma and other inflammatory diseases..

Tezepelumab是由阿斯利康与安进合作开发的一种首创新人类单克隆抗体，可抑制胸腺基质淋巴细胞生成素（TSLP）的作用。TSLP是一种关键的上皮细胞因子，位于多种炎症级联反应的顶端，对严重哮喘及其他炎症性疾病相关的过敏性、嗜酸性粒细胞及其他类型的上皮驱动炎症的启动和持续起着至关重要的作用。

18,19

18,19

TSLP is released in response to multiple epithelial triggers and insults (including allergens, viruses, bacteria, smoke, air pollution and other airborne particles) associated with asthma, CRSwNP, chronic obstructive pulmonary disease (COPD), eosinophilic esophagitis (EoE) and other diseases.

TSLP 在响应多种上皮触发因素和损伤（包括过敏原、病毒、细菌、烟雾、空气污染和其他空气颗粒物）时释放，这些因素与哮喘、CRSwNP、慢性阻塞性肺病 (COPD)、嗜酸性粒细胞性食管炎 (EoE) 和其他疾病相关。

19,20

19，20

Expression of TSLP is increased in these patients and has been correlated with disease severity.

这些患者中TSLP的表达增加，并且与疾病严重程度相关。

10,18

10，18

Blocking TSLP can prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of exacerbations and improved disease control.

阻断TSLP可以防止免疫细胞释放促炎性细胞因子，从而预防病情加重并改善疾病控制。

18,19,21

18，19，21

Tezepelumab

特泽鲁单抗

acts at the top of the inflammatory cascade and research indicates that targeting TSLP released by the airway and gastrointestinal epithelium may be a potential approach to treating other diseases in the future.

位于炎症级联反应的顶端，研究表明，靶向由呼吸道和胃肠道上皮释放的TSLP可能是未来治疗其他疾病的潜在方法。

18,22,23

18，22，23

Tezspire

特泽斯派

is approved in the US, the EU and over 60 countries for the add-on maintenance treatment of adult and paediatric patients aged 12 years and older with severe asthma.

在美国、欧盟及超过60个国家获批，用于12岁及以上重度哮喘成人和儿童患者的附加维持治疗。

3-5

3-5

Beyond CRSwNP, tezepelumab

超出CRSwNP，tezepelumab

is also in development for other potential indications including COPD and EoE.

也正在开发用于其他潜在适应症，包括慢性阻塞性肺病和嗜酸性食管炎。

24,25

24，25

In October 2021, tezepelumab was granted

2021年10月，tezepelumab 获得

Orphan Drug Designation

孤儿药认定

by the U.S. Food and Drug Administration (FDA) for the treatment of EoE. In July 2024, the U.S. FDA granted a Breakthrough Therapy Designation for tezepelumab

由美国食品和药物管理局 (FDA) 批准用于治疗 EoE。2024 年 7 月，美国 FDA 授予 tezepelumab 突破性疗法认定。

for the add-on maintenance treatment of patients with moderate to very severe COPD characterised by an eosinophilic phenotype.

用于中度至极重度COPD且具有嗜酸性粒细胞表型的患者的附加维持治疗。

Amgen collaboration

安进合作

In 2020, Amgen and AstraZeneca updated a

2020年，安进和阿斯利康更新了

2012 collaboration agreement

2012年合作协议

for

为了

Tezspire

特泽斯普利

. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid single-digit inventor royalty to Amgen. AstraZeneca continues to lead development and Amgen continues to lead manufacturing. All aspects of the collaboration are under the oversight of joint governing bodies.

双方公司将继续在阿斯利康向安进支付中个位数的发明者专利费后，平均分担成本和利润。阿斯利康继续领导开发工作，安进继续负责生产。合作的所有方面均在接受联合管理机构的监督。

Under the amended agreement, Amgen and AstraZeneca will jointly commercialise .

根据修订后的协议，安进和阿斯利康将共同实现商业化。

Tezspire

特泽斯匹韦

in North America. Amgen will record product sales in the US, with AZ recording its share of US profits as Collaboration Revenue. Outside of the US, AstraZeneca will record product sales, with Amgen recording profit share as Other/Collaboration revenue.

在北美地区，安进将记录美国市场的产品销售，阿斯利康则将其在美国利润的份额记录为合作收入。在美国以外地区，阿斯利康将记录产品销售，安进则将其利润份额记录为其他/合作收入。

AstraZeneca in Respiratory & Immunology

阿斯利康在呼吸与免疫学领域

Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals is a key disease area and growth driver to the Company.

呼吸系统和免疫学是阿斯利康生物制药公司的一个关键疾病领域和增长驱动力。

AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets.

阿斯利康在呼吸系统疾病治疗领域拥有50年的传承，是公认的领导者，并在免疫介导疾病方面拥有一系列不断增长的药物组合。公司致力于通过吸入式药物、生物制品以及针对以往难以触及的生物靶点的新型疗法，来满足这些慢性且常使人衰弱的疾病的巨大未满足需求。

Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases..

我们的目标是提供改变生命的药物，帮助消除慢性阻塞性肺病作为主要死亡原因，消除哮喘发作，并在免疫介导的疾病中实现临床缓解。

AstraZeneca

阿斯利康

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology.

阿斯利康（LSE/STO/Nasdaq：AZN）是一家全球领先的、以科学为导向的生物制药公司，专注于肿瘤学、罕见病以及包括心血管、肾脏与代谢、呼吸与免疫学在内的生物制药领域的处方药的发现、开发和商业化。

Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit .

总部位于英国剑桥的阿斯利康公司的创新药物在全球 125 多个国家销售，全世界数百万患者使用。请访问 。

astrazeneca.com

阿斯利康官网

and follow the Company on social media

关注公司在社交媒体上的动态

@AstraZeneca

@阿斯利康

Contacts

联系人

For details on how to contact the Investor Relations Team, please click

如需了解如何联系投资者关系团队的详细信息，请点击

here

这里

. For Media contacts, click

媒体联系人，请点击

here

这里

.

。

References

参考文献

Lipworth, BJ, Han JK,

利普沃斯，BJ，韩JK，

et al

等

. Tezepelumab in adults with severe, uncontrolled CRSwNP.

Tezepelumab用于治疗严重且未受控制的CRSwNP成人患者。

N Engl J Med

新英格兰医学杂志

. 2025.

. 2025.

Lipworth, BJ, Han JK,

利普沃斯，BJ，韩JK，

et al

等

. Efficacy and safety of tezepelumab in adults with severe chronic rhinosinusitis with nasal polyps: results from the Phase 3 WAYPOINT Study. [Late breaking oral presentation]. Presented at the American Academy of Allergy, Asthma & Immunology /World Allergy Organization Joint Congress 2025 (28 February – 03 March). .

Tezepelumab治疗成人重度慢性鼻窦炎伴鼻息肉的疗效与安全性：来自3期WAYPOINT研究的结果。[最新突破性口头报告]。于2025年美国过敏、哮喘与免疫学会/世界过敏组织联合大会（2月28日-3月3日）上发表。

Tezspire

特泽斯匹韦

(tezepelumab) US prescribing information. Available at: https:// www.accessdata.fda.gov/drugsatfda_docs/label/2023/761224s003lbl.pdf. [Last accessed: February 2025].

（替泽普利单抗）美国处方信息。可访问：https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761224s003lbl.pdf。[最后访问时间：2025年2月]。

Tezspire

特泽斯匹韦

(tezepelumab) Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/tezspire-epar-product-information_en.pdf. [Last accessed: February 2025].

（替泽普利单抗）产品特性摘要。可访问：https://www.ema.europa.eu/en/documents/product-information/tezspire-epar-product-information_en.pdf。[最后访问时间：2025年2月]。

AstraZeneca plc.

阿斯利康制药公司

Tezspire

特泽斯匹韦

approved in Japan for the treatment of severe asthma. Available at:

在日本被批准用于治疗重度哮喘。可用地址：

https://www.astrazeneca.com/media-centre/press-releases/2022/tezspire-approved-in-japan-for-severe-asthma.html

https://www.astrazeneca.com/media-centre/press-releases/2022/tezspire-approved-in-japan-for-severe-asthma.html

. [Last accessed: February 2025].

。[最后访问时间：2025年2月]。

Bachert C,

巴赫特 C，

et al

等

. Phenotypes and Emerging Endotypes of Chronic Rhinosinusitis.

慢性鼻窦炎的表型和新兴内型。

J Allergy Clin Immunol Pract.

《过敏与临床免疫学杂志》

2016; 4 (4): 621-628.

2016；4（4）：621-628。

Del Toro E, Portela J. Nasal Polyps. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK560746/ [Last accessed: February 2025].

德尔·托罗 E，波尔特拉 J. 鼻息肉. [更新于2023年7月31日]. 在：StatPearls [互联网]. 佛罗里达州金银岛：StatPearls 出版社；2024年1月起. 可从以下网址获取：https://www.ncbi.nlm.nih.gov/books/NBK560746/ [最后访问时间：2025年2月].

Stevens WW,

史蒂文斯 WW，

et al

等人

. Chronic Rhinosinusitis with Nasal Polyps.

慢性鼻窦炎伴鼻息肉。

J Allergy Clin Immunol Pract

《过敏与临床免疫学杂志》

. 2016; 4 (4): 565-572.

. 2016; 4 (4): 565-572.

Abdalla S,

阿卜杜拉·S，

et al

等

. Prevalence of sinonasal outcome test (SNOT-22) symptoms in patients undergoing surgery for chronic rhinosinusitis in the England and Wales National prospective audit.

英格兰和威尔士国家前瞻性审计中，接受慢性鼻窦炎手术的患者鼻窦结局测试（SNOT-22）症状的流行率。

Clin Otolaryngol

临床耳鼻喉科

. 2012; 37 (4): 276-282.

. 2012; 37 (4): 276-282.

Chen S

陈 S

et al

等

. Systematic literature review of the epidemiology and clinical burden of chronic rhinosinusitis with nasal polyposis. Curr Med Res Opin. 2020;36(11):1897-1911.

慢性鼻窦炎伴鼻息肉的流行病学和临床负担的系统文献综述。《当代医学研究与意见》，2020年；第36卷第11期：1897-1911页。

Xolair (omalizumab) Summary of Product Characteristics; Available at: https://www.ema.europa.eu/en/documents/product-information/xolair-epar-product-information_en.pdf. [Last accessed: February 2025].

Xolair（奥马珠单抗）产品特性摘要；可访问：https://www.ema.europa.eu/en/documents/product-information/xolair-epar-product-information_en.pdf。[最后访问时间：2025年2月]。

Xolair (omalizumab) US prescribing information; Available at: https://www.gene.com/download/pdf/xolair_prescribing.pdf [Last accessed: February 2025].

Xolair（奥马珠单抗）美国处方信息；可访问：https://www.gene.com/download/pdf/xolair_prescribing.pdf [最后访问时间：2025年2月]。

Nucala (mepolizumab) Summary of Product Characteristics. Available at: https:// www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf. [Last accessed: February 2025].

Nucala（美泊利单抗）产品特性摘要。可访问：https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf。[最后访问时间：2025年2月]。

Nucala (mepolizumab) US prescribing information; Available at: https:// www.accessdata.fda.gov/drugsatfda_docs/label/2021/761122s006,125526s018lbl.pdf. [Last accessed: February 2025].

Nucala（美泊利单抗）美国处方信息；可访问：https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761122s006,125526s018lbl.pdf。[最后访问时间：2025年2月]。

Dupixent (dupilumab) Summary of Product Characteristics. Available at: https:// www.ema.europa.eu/en/documents/product-information/dupixent-epar-product-information_en.pdf. [Last accessed: February 2025].

Dupixent（dupilumab）产品特性摘要。可访问：https://www.ema.europa.eu/en/documents/product-information/dupixent-epar-product-information_en.pdf。[最后访问时间：2025年2月]。

Dupixent (dupilumab) US prescribing information; Available at: https://www.regeneron.com/downloads/dupixent_fpi.pdf. [Last accessed: February 2025].

Dupixent（dupilumab）美国处方信息；可访问：https://www.regeneron.com/downloads/dupixent_fpi.pdf。[最后访问时间：2025年2月]。

Clinicaltrials.gov. Efficacy and Safety of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis (WAYPOINT). Available at: https://clinicaltrials.gov/ct2/show/NCT04851964. [Last accessed: February 2025].

Clinicaltrials.gov. Tezepelumab在伴有鼻息肉的重度慢性鼻窦炎患者中的疗效与安全性（WAYPOINT）。可访问：https://clinicaltrials.gov/ct2/show/NCT04851964。[最后访问时间：2025年2月]。

Corren J,

科伦J，

et al

等

. Tezepelumab in adults with uncontrolled asthma.

Tezepelumab 用于治疗未受控制的成人哮喘。

N Engl J Med

新英格兰医学杂志

. 2017;377:936-946.

. 2017;377:936-946.

Varricchi G,

瓦里奇 G，

et al

等

. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer.

胸腺基质淋巴细胞生成素异构体、炎症性疾病与癌症。

Front Immunol

免疫学前沿

. 2018;9:1595.

. 2018;9:1595.

Zhang M,

张 M，

et al

等人

. Hypoxia induces the production of epithelial-derived cytokines in eosinophilic chronic rhinosinusitis with nasal polyps.

低氧诱导伴有鼻息肉的嗜酸性慢性鼻窦炎中上皮源性细胞因子的产生。

Int Immunopharmacol.

国际免疫药理学。

2023;121:110559.

2023；121：110559。

Li Y,

李 Y，

et al

等

. Elevated Expression of IL-33 and TSLP in the Airways of Human Asthmatics In Vivo: A Potential Biomarker of Severe Refractory Disease.

. IL-33和TSLP在人类哮喘患者气道中的高表达：重度难治性疾病的潜在生物标志物。

J Immunol

免疫学杂志

. 2018;200: 2253–2262.

. 2018;200: 2253–2262.

Menzies-Gow A,

门齐斯-高 A，

et al

等人

. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma.

Tezepelumab用于治疗严重、未受控制的成年和青少年哮喘。

N Engl J Med

新英格兰医学杂志

. 2021;384:1800-1809.

. 2021;384:1800-1809.

Laidlaw TM

莱德劳 TM

et al

等人

. Tezepelumab Efficacy in Patients with Severe, Uncontrolled Asthma with Comorbid Nasal Polyps in NAVIGATOR.

Tezepelumab在伴有鼻息肉的重度、未控制哮喘患者中的疗效——NAVIGATOR研究。

J Asthma Allergy

哮喘与过敏杂志

. 2023 Sep 4:16:915-932.

2023年9月4日：16:915-932。

Clinicaltrials.gov. Tezepelumab COPD Exacerbation Study (COURSE) [Online]. Available at: https://clinicaltrials.gov/ct2/show/NCT04039113. [Last accessed: February 2025].

Clinicaltrials.gov. Tezepelumab 慢性阻塞性肺疾病急性加重研究 (COURSE) [在线]. 可访问网址: https://clinicaltrials.gov/ct2/show/NCT04039113. [最后访问时间：2025年2月].

Clinicaltrials.gov. Efficacy and Safety of Tezepelumab in Patients with Eosinophilic Esophagitis (CROSSING). Available at: https://clinicaltrials.gov/study/NCT05583227?rank=1. [Last accessed: February 2025].

Clinicaltrials.gov. Tezepelumab治疗嗜酸性粒细胞性食管炎患者的有效性与安全性（CROSSING）。可访问：https://clinicaltrials.gov/study/NCT05583227?rank=1。[最后访问时间：2025年2月]。