•  The one-year INFUSE study observed patient-reported migraine-related cognitive symptoms at baseline and changes over 6 months in those with at least one prior anti-calcitonin gene-related peptide (anti-CGRP) treatment failure

• 为期一年的INFUSE研究观察了患者报告的偏头痛相关认知症状在基线时的情况，以及在至少一次先前抗降钙素基因相关肽（anti-CGRP）治疗失败的患者中6个月内的变化。

VALBY, Denmark

瓦尔比，丹麦

,

，

April 19, 2026

2026年4月19日

/PRNewswire/ -- H. Lundbeck A/S (Lundbeck) today

/PRNewswire/ -- H. Lundbeck A/S（灵北）今天

presented

展示了

new real-world 6-month results from the INFUSE study at the American Academy of Neurology (AAN) 2026 Annual Meeting, underscoring the importance of evaluating the broad burden of migraine beyond headache and migraine frequency.  Despite being among the most frequently reported symptoms by people living with migraine, cognition and brain fog have rarely been systematically studied.

来自INFUSE研究的新现实世界6个月结果在美国神经病学学会（AAN）2026年年会上发布，强调了评估偏头痛的广泛负担的重要性，而不仅仅是头痛和偏头痛频率。尽管认知障碍和脑雾是偏头痛患者最常报告的症状之一，但它们很少被系统地研究。

These patient-reported outcomes data highlight the opportunity to focus on elements of migraine burden that are meaningful to individuals living with migraine and report improvement of migraine-related cognitive symptoms after eptinezumab treatment..

这些患者报告的结果数据突显了关注偏头痛负担中有意义的元素的机会，这些元素对偏头痛患者来说很重要，并且在依普奈珠单抗治疗后报告了偏头痛相关认知症状的改善。

[1]

[1]

'Migraine is a highly individualized neurological disease characterized by fluctuating symptoms, disability, and quality-of-life impairment. My patients often describe 'brain fog' associated with migraine as profoundly disruptive, hindering their ability to perform at work, engage with family, or simply enjoy daily life,' said INFUSE study author Dr.

偏头痛是一种高度个性化的神经系统疾病，其症状、残疾和生活质量受损情况各不相同。INFUSE研究的作者表示：“我的患者经常描述与偏头痛相关的‘脑雾’具有极大的破坏性，会妨碍他们正常工作、与家人互动，甚至无法享受日常生活。”

Amaal Starling, Neurologist, Mayo Clinic. 'The INFUSE study findings are meaningful as patients report improvements in cognitive symptoms associated with migraine after starting eptinezumab. These data further support more comprehensive goals with patients who have high disease burden despite prior anti-CGRP preventive treatment to better address their needs and improve outcomes.'.

梅奥诊所神经科医生阿玛尔·斯塔林表示：“INFUSE 研究结果意义重大，因为患者报告在开始使用埃普贴单抗后，偏头痛相关的认知症状有所改善。这些数据进一步支持了更全面的目标，即针对那些尽管之前接受过抗 CGRP 预防治疗但疾病负担仍然较高的患者，更好地满足他们的需求并改善治疗效果。”

Data from the 6-month interim analysis of the INFUSE study underscored the importance of real-world evidence to inform clinical practice with the aim to address the holistic burden of migraine with preventive treatments. This specific analysis focused on cognitive improvements. The study demonstrated that migraine-related cognitive symptoms are highly prevalent and bothersome among patients at baseline.

INFUSE 研究的 6 个月中期分析数据强调了真实世界证据对于指导临床实践的重要性，目的是通过预防性治疗全面减轻偏头痛的负担。该特定分析聚焦于认知改善。研究表明，在基线时，偏头痛相关的认知症状在患者中非常普遍且令人困扰。

Specific symptoms that were considered moderately to extremely bothersome, like difficulty making decisions, difficulty with reading comprehension, difficulty with complex tasks, and brain fog (difficulty concentrating/focusing, trouble finding right words/speaking, mental cloudiness) were reported by 64.7%, 60.0%, 62.6%, and 82.1% of participants, respectively. This population, characterized by a high disease impact, reported improvements following treatment with eptinezumab.

被认为中度到极度困扰的具体症状，如难以做出决定、阅读理解困难、处理复杂任务困难以及脑雾（难以集中注意力/聚焦、找不到合适的词语/说话困难、精神模糊），分别有64.7%、60.0%、62.6%和82.1%的参与者报告。这一群体疾病影响严重，在使用eptinezumab治疗后报告了改善情况。

Across individual cognitive symptoms (brain fog, difficulty making decisions, difficulty with reading comprehension and difficulty with complex tasks), more than 50% of participants reported improvements at 6 months (after 2 doses of eptinezumab) compared to baseline, with marked improvements observed as early as Day 7 post-treatment..

在个体认知症状（脑雾、难以做决定、阅读理解困难和复杂任务困难）方面，超过50%的参与者在6个月时（接受两剂eptinezumab后）报告了相比基线的改善，且治疗后早在第7天就观察到了显著改善。

[1]

[1]

'These real-world, patient-reported INFUSE data give greater insight into the management of the holistic burden of migraine – including highly prevalent cognitive symptoms – to better support optimal treatment decisions,' said Damian Fiore, Vice President, Lundbeck US Medical Affairs Neurology. 'We're excited to share new data that may help redefine expectations for preventive migraine treatment and reinforce our commitment to raising the standard of migraine care.'.

“这些来自真实世界、患者报告的INFUSE数据，为全面管理偏头痛的整体负担（包括高度普遍的认知症状）提供了更深入的见解，从而更好地支持最佳治疗决策，”灵北美国医学事务神经学副总裁达米安·菲奥雷表示。“我们很高兴分享可能有助于重新定义偏头痛预防治疗预期的新数据，并强化我们提升偏头痛护理标准的承诺。”

Additional eptinezumab data being presented at AAN are:

在AAN上展示的其他eptinezumab数据包括：

P10 15-006:

P10 15-006:

'

'

Real-World Effectiveness of Eptinezumab in Patients in Whom ≥1 Prior anti-CGRP Preventive Treatment had Failed: 6-Month Results for an Ongoing Prospective Study

在既往≥1种抗CGRP预防治疗失败的患者中，Eptinezumab的实际有效性：一项正在进行的前瞻性研究的6个月结果

'

'

P10 15-001:

P10 15-001:

'

'

Eptinezumab's Effect on Interictal Periods and Quality of Life in Participants with Migraine for Whom 2–4 Prior Preventive Treatments had Failed

Eptinezumab对2-4种先前预防性治疗失败的偏头痛患者间歇期和生活质量的影响

'

'

About VYEPTI

关于VYEPTI

VYEPTI® (eptinezumab) is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. eptinezumab was deliberately developed for administration by intravenous (IV) infusion to deliver 100 percent of the medication into the bloodstream at the end of the infusion..

VYEPTI®（eptinezumab）是一种人源化单克隆抗体，可与降钙素基因相关肽（CGRP）配体结合并阻断其与受体的结合。Eptinezumab 专门开发用于通过静脉（IV）输注给药，以在输注结束时将100%的药物递送至血液中。

The efficacy and safety of eptinezumab were demonstrated in two phase 3 clinical trials; episodic migraine in PROMISE-1 and chronic migraine in PROMISE-2. Eptinezumab met its primary endpoint of decrease in mean monthly migraine days (MMD) over months 1-3 in both episodic and chronic migraine. The safety of eptinezumab was evaluated in 2,076 patients with migraine who received at least one dose of eptinezumab.

Eptinezumab的疗效和安全性在两项第三阶段临床试验中得到了验证；PROMISE-1中的偶发性偏头痛和PROMISE-2中的慢性偏头痛。Eptinezumab在第1至3个月期间，无论是偶发性还是慢性偏头痛，都达到了减少平均每月偏头痛天数（MMD）的主要终点。Eptinezumab的安全性在2076名接受至少一剂Eptinezumab治疗的偏头痛患者中进行了评估。

The most common adverse reactions (≥2 percent and at least 2 percent or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. In PROMISE-1 and PROMISE-2, 1.9 percent of patients treated with eptinezumab discontinued treatment due to adverse reactions..

在预防性治疗偏头痛的临床试验中，最常见的不良反应（≥2％且至少比安慰剂高2％）是鼻咽炎和超敏反应。在PROMISE-1和PROMISE-2研究中，1.9％接受eptinezumab治疗的患者因不良反应停止治疗。

Eptinezumab offers patients with migraine a preventive treatment administered as one 30-minute IV infusion 4 times a year (every three months). The recommended dosage is 100 mg, and some patients may benefit from a dosage of 300 mg. Dosing should be based on the guidance in the Prescribing Information and Patient Information. .

Eptinezumab 为偏头痛患者提供预防性治疗，每年（每三个月）通过一次30分钟的静脉输注进行四次治疗。推荐剂量为100毫克，部分患者可能从300毫克的剂量中获益。剂量应根据处方信息和患者信息中的指导进行确定。

VYEPTI (eptinezumab-jjmr) was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020, and in January 2022, eptinezumab was granted marketing authorization by the European Commission (EC) for the prophylaxis of migraine in adults who have at least four migraine days per month.

VYEPTI（eptinezumab-jjmr）于2020年2月获得美国食品药品监督管理局（FDA）批准用于成人偏头痛的预防性治疗，并于2022年1月获得欧盟委员会（EC）的上市授权，用于每月至少有四天偏头痛的成人偏头痛预防。

Today, eptinezumab is launched in more than 30 markets worldwide..

今天，eptinezumab已在全世界30多个市场上市。

About Migraine Disease

关于偏头痛疾病

Migraine is a complex and disabling neurological disease that limits functionality and quality of life.

偏头痛是一种复杂且致残的神经系统疾病，会限制功能和生活质量。

[2]

[2]

,[3]

,[3]

It is characterized by moderate to severe head pain typically accompanied by an array of symptoms, including nausea, vomiting and sensitivity to light or sound.

它表现为中度至重度的头部疼痛，通常伴随一系列症状，包括恶心、呕吐以及对光或声音的敏感。

[2]

[2]

Over time, migraine disease may worsen, with attacks increasing in frequency, severity and duration.

随着时间的推移，偏头痛疾病可能会恶化，发作频率、严重程度和持续时间都会增加。

[4]

[4]

It is estimated to affect more than 40 million people in the U.S. and impacts three times as many women than men.

据估计，它在美国影响超过4000万人，并且对女性的影响是男性的三倍。

[5]

[5]

Headache disorders are a leading cause of years lived with disability (YLD) among all diseases and is a top 5 cause for 10–24-year-olds, according to the 2019 Global Burden of Disease study.

根据2019年全球疾病负担研究，头痛障碍是所有疾病中导致伤残调整生命年（YLD）的主要原因之一，也是10-24岁人群的前五大病因之一。

[6]

[6]

The impact of migraine permeates into career, home life and relationships.

偏头痛的影响渗透到职业生涯、家庭生活和人际关系中。

[7]

[7]

About INFUSE study

关于INFUSE研究

The INFUSE study is a 12-month, prospective, observational study in the US, assessing real-world effectiveness of IV eptinezumab (100 mg or 300 mg) in adults with migraine who previously failed at least one preventive anti-CGRP. Data were collected digitally at baseline, Day 7, and Months 3, 6, 9 and 12 through participant-reported surveys.

INFUSE 研究是一项为期 12 个月的前瞻性、观察性研究，在美国进行，评估静脉注射依普奈珠单抗（100 毫克或 300 毫克）在曾至少使用过一种预防性抗 CGRP 药物失败的成年偏头痛患者中的实际疗效。数据通过参与者报告的调查问卷以数字化方式在基线、第 7 天以及第 3、6、9 和 12 个月收集。

The primary outcome was percent of patients with 'much' or 'very much' improved on the 7-point PGIC scale ('very much improved,' 'much improved,' 'minimally improved,' 'no change,' 'minimally worse,' 'much worse,' or 'very much worse'). Secondary outcomes included monthly headache days and ≥50% reduction in monthly headache days (MIDAS-derived) and number of patient-defined 'good days'.

主要结局是7分PGIC量表（“显著改善”、“明显改善”、“轻微改善”、“无变化”、“轻微恶化”、“明显恶化”或“显著恶化”）中“明显改善”或“非常改善”的患者百分比。次要结局包括每月头痛天数、每月头痛天数减少≥50%（基于MIDAS得出）以及患者自定义的“良好天数”数量。

INFUSE did not collect safety data but these data are reported via the established safety reporting channels..

INFUSE没有收集安全数据，但这些数据通过既定的安全报告渠道进行报告。

Contacts

联系人

Anders Crillesen

安德斯·克里勒森

Jens Høyer

詹斯·霍伊尔

Senior Director, External & Internal Relations

高级总监，外部及内部关系

Vice President, Head of Investor Relations

副总裁，投资者关系主管

[email protected]

电子邮件地址

[email protected]

电子邮件地址

About H. Lundbeck A/S

关于H. Lundbeck A/S

Lundbeck is a biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases.

灵北是一家专注于脑健康的生物制药公司。凭借在神经科学领域70多年的经验，我们致力于改善神经和精神疾病患者的生活。

Brain disorders affect a large part of the world's population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments.

脑部疾病影响着世界大部分人口，其影响贯穿整个社会。随着对大脑生物学的迅速深入了解，我们通过积极探索治疗的新机会，致力于推动脑健康的发展。

As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology..

作为专注的创新者，我们努力使我们的研发计划应对一些最复杂的神经学挑战。我们开发变革性药物，针对那些治疗选择很少或没有的人群，从我们在精神病学和神经学领域的坚实基础上，扩展到神经专科和神经罕见病领域。

We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole.

我们致力于消除歧视，并采取行动改善健康公平。我们努力通过为患者、他们的家人以及整个社会做出积极贡献，为股东创造长期价值。

Lundbeck has more than 5,000 employees in more than 20 countries and our products are available in more than 80 countries. For additional information, we encourage you to visit our corporate site

灵北公司在20多个国家拥有超过5,000名员工，我们的产品在全球80多个国家有售。欲了解更多信息，我们鼓励您访问我们的企业网站。

www.lundbeck.com

www.lundbeck.com

and connect with us via

并通过以下方式联系我们

LinkedIn

领英

.

。

References

参考文献

[1]

[1]

Starling, A., Estemalik, E., Lipton, R., et al. Real-world Improvements in Cognitive Symptoms After Eptinezumab Treatment in Patients in Whom ≥1 Prior Anti-CGRP Preventive Treatment had Failed: 6-month Results for the Ongoing INFUSE Study. Presented at American Academy of Neurology 2026 Annual Meeting.

Starling, A., Estemalik, E., Lipton, R., 等。在既往≥1种抗CGRP预防治疗失败的患者中，依替奈珠单抗治疗后认知症状的现实世界改善：正在进行的INFUSE研究6个月结果。发表于2026年美国神经病学学会年会。

April 2026..

2026年4月

[2]

[2]

What is migraine? nids.nih.gov

什么是偏头痛？ nids.nih.gov

[3]

[3]

Law H. Z., Chung M. H., Nissan G., Janis J. E., Amirlak B. Hospital burden of migraine in United States adults: A 15-year national inpatient sample analysis. 2020.

劳 H. Z., 钟 M. H., 尼桑 G., 贾尼斯 J. E., 阿米尔拉克 B. 美国成人偏头痛的医院负担：一项15年的全国住院样本分析。2020年。

[4]

[4]

Lipton R. B., Buse D. C., Nahas S. J., et al. Risk factors for migraine disease progression: a narrative review for a patient-centered approach.

Lipton R. B., Buse D. C., Nahas S. J., 等。偏头痛疾病进展的风险因素：以患者为中心的叙述性综述。

J Neurol.

神经病学杂志。

2023;270(12):5692-5710.

2023；270（12）：5692-5710。

[5]

[5]

Cohen, F., Brooks, C. V., Sun, D., Buse, D. C., Reed, M. L., Fanning, K. M., & Lipton, R. B. (2024). Prevalence and burden of migraine in the United States: A systematic review.

科恩，F.，布鲁克斯，C. V.，孙，D.，布斯，D. C.，里德，M. L.，范宁，K. M.，& 利普顿，R. B. (2024). 美国偏头痛的流行率与负担：一项系统性综述。

Headache

头痛

,

，

64

64

(5), 516–532.

(5), 516–532。

[6]

[6]

Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019.

1990年至2019年，204个国家和地区的369种疾病和伤害的全球负担：2019年全球疾病负担研究的系统分析。

[7]

[7]

Buse D. C., Scher A. I., Dodick D. W., et al. Impact of Migraine on the family: Perspectives of people with migraine and their spouse/domestic partner in the CaMEO study.

Buse D. C., Scher A. I., Dodick D. W., 等。偏头痛对家庭的影响：CaMEO 研究中偏头痛患者及其配偶/同居伴侣的视角。

Mayo Clinic

梅奥诊所

. 2016, 91(5):596-611.

. 2016, 91(5):596-611.

CONTACT:

联系人：

H. Lundbeck A/S

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Denmark

丹麦瓦尔比奥蒂莉亚街9号，邮编2500

+45 3630 1311

+45 3630 1311

[email protected]

电子邮件地址

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全球AAN INFUSE决赛

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