2025年美国皮肤病学会（AAD）上发布的一项关于SPEVIGO®在泛发性脓疱型银屑病患者报告结果中的潜在影响的新分析-动脉网

New analyses on the potential impact of SPEVIGO® in generalized pustular psoriasis patient-reported outcomes presented at AAD 2025

CISION 等信源发布 2025-03-07 22:00

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可切换为仅中文







Improvements in Psoriasis Symptom Scale (PSS), Pain Visual Analog Scale (VAS) and Dermatology Life Quality Index (DLQI) scores were observed in post-hoc exploratory analyses of the EFFISAYIL

在对EFFISAYIL研究的事后探索性分析中，观察到银屑病症状量表（PSS）、疼痛视觉模拟量表（VAS）和皮肤病生活质量指数（DLQI）评分有所改善。

2 trial

2 次试验

Findings suggest the potential benefit of continuously treating generalized pustular psoriasis (GPP) with subcutaneous spesolimab

研究结果表明，持续使用皮下注射斯佩索利单抗治疗泛发性脓疱型银屑病（GPP）可能有益。

RIDGEFIELD, Conn.

康涅狄格州里奇菲尔德

，

March 7, 2025

2025年3月7日

/PRNewswire/ -- Today, Boehringer Ingelheim announced new analyses to be presented at the American Academy of Dermatology (AAD) annual meeting in

/PRNewswire/ -- 今日，勃林格殷格翰宣布将在美国皮肤病学会（AAD）年会上公布新的分析结果。

Orlando

奥兰多

that explore the effect that SPEVIGO

探索SPEVIGO效果的

(spesolimab-sbzo) may have on the physical symptoms and mental health burden associated with generalized pustular psoriasis (GPP). These post-hoc exploratory analyses from the EFFISAYIL

（spesolimab-sbzo）可能对与泛发性脓疱型银屑病（GPP）相关的身体症状和心理健康负担产生的影响。这些来自EFFISAYIL的后置探索性分析

2 clinical trial assessed the efficacy and safety of subcutaneous SPEVIGO in patients suffering from GPP.

2项临床试验评估了皮下注射SPEVIGO对GPP患者的疗效和安全性。

1,2

Distinct from plaque psoriasis, GPP is a serious and rare, chronic, heterogenous, inflammatory neutrophilic disease associated with painful skin manifestations and systemic symptoms, such as fever, pain, and fatigue.

不同于斑块型银屑病，GPP是一种严重且罕见的慢性异质性炎症性中性粒细胞性疾病，伴有疼痛性皮肤表现和全身症状，如发热、疼痛和疲劳。

3-6

GPP's unpredictable nature can potentially have significant long-term impacts on quality of life for people living with it and may cause fear and anxiety over the disease course.

GPP 的不可预测性可能会对患者的生活质量产生重大的长期影响，并可能引起对疾病进程的恐惧和焦虑。

5,7

'Generalized pustular psoriasis profoundly affects patients' physical and mental well-being, often disrupting their education, careers, and personal relationships. We are encouraged by the improvements observed in patient-reported outcomes with spesolimab. These studies strengthen our commitment to delivering innovative treatments for those living with severe dermatological conditions like GPP,' says .

“泛发性脓疱型银屑病严重影响患者的身体和心理健康，常常扰乱他们的教育、职业和个人关系。我们对spesolimab在患者报告结果中观察到的改善感到鼓舞。这些研究进一步坚定了我们为患有严重皮肤病（如GPP）的人群提供创新治疗方案的决心。”

Vicky Brown

维基·布朗

, Senior Vice President and Head of Immunology, Oncology, and Eye Health, Boehringer Ingelheim Pharmaceuticals, Inc.

，高级副总裁兼免疫学、肿瘤学和眼健康部门负责人，勃林格殷格翰制药公司。

In the EFFISAYIL 2 clinical trial, patients with a history of GPP were randomized to receive one of three active treatment regimens or a placebo. Participants were asked to rate their GPP symptoms – including pain, redness, itching, and burning – using the Psoriasis Symptom Scale (PSS), the Pain Visual Analog Scale (VAS), and the Dermatology Life Quality Index (DLQI).

在EFFISAYIL 2临床试验中，有GPP病史的患者被随机分配接受三种积极治疗方案之一或安慰剂。参与者被要求使用银屑病症状量表（PSS）、疼痛视觉模拟量表（VAS）和皮肤病生活质量指数（DLQI）对其GPP症状——包括疼痛、发红、瘙痒和灼烧感——进行评分。

The PSS ranges from 0 to 16, while the Pain VAS ranges from 0 to 100, with higher scores indicating more severe symptoms. Of the 30 patients randomized to receive subcutaneous spesolimab, 300 mg every four weeks after a 600mg loading dose, participants reported a reduction in mean Pain VAS scores over the course of the trial, with more than half (56.5%) of patients reporting a Pain VAS score of 0 at Week 48 and the mean PSS score decreasing from 5.34 to 2.96 by Week 48..

PSS 评分范围为 0 到 16，而疼痛 VAS 评分范围为 0 到 100，分数越高表示症状越严重。在 30 名随机分配接受皮下注射斯佩索利单抗（每四周 300 毫克，在初始负荷剂量 600 毫克后）的患者中，参与者在整个试验过程中报告了平均疼痛 VAS 评分的下降，超过一半（56.5%）的患者在第 48 周时报告疼痛 VAS 评分为 0，而平均 PSS 评分从 5.34 下降到第 48 周的 2.96。

Patients were also asked to rate the impact of GPP through a 10-item questionnaire to assess changes in quality of life using the DLQI. The results found that mean DLQI scores improved from a 'very large effect on patient's life' score (11.14) at baseline to a 'small effect on patient's life' score (4.57) at week 48 following treatment with SPEVIGO..

患者还通过一份包含 10 个条目的问卷评估了 GPP 对其生活质量的影响，该问卷使用 DLQI 来评估生活质量的变化。结果发现，平均 DLQI 评分从基线时的“对患者生活影响非常大”（11.14 分），在使用 SPEVIGO 治疗 48 周后改善为“对患者生活影响较小”（4.57 分）。

Measurable improvements in mean PSS, Pain VAS and DLQI scores were observed by the first assessment at Week 4.

在第4周的首次评估中，观察到PSS、疼痛VAS和DLQI评分的显著改善。

'The results from EFFISAYIL 2 provide valuable insights into the chronicity of generalized pustular psoriasis,' said Dr. Tina Bhutani, study author. 'The data are a pivotal step in advancing patient-centered care in GPP.'

“EFFISAYIL 2 的结果为泛发性脓疱型银屑病的慢性化提供了宝贵的见解，”研究作者 Tina Bhutani 博士表示。“这些数据是推进 GPP 患者中心化护理的关键一步。”

These findings may provide healthcare professionals with data that can help inform their choice of treatment regimens for people living with GPP.

这些发现可为医疗保健专业人员提供数据，有助于为 GPP 患者选择治疗方案。

About SPEVIGO

关于SPEVIGO

SPEVIGO

斯佩维戈

is a novel, humanized, selective antibody that specifically blocks the activation of the IL-36R, a signaling pathway within the immune system shown to be involved in the pathogenesis of several autoinflammatory diseases, including GPP. It is the first targeted therapy for the treatment of GPP and has been evaluated in the largest clinical program specifically for the treatment of patients with GPP..

是一种新型的、人源化的、选择性的抗体，可特异性阻断IL-36R的激活。IL-36R是免疫系统内的一种信号通路，已被证明参与多种自身炎症性疾病的发病机制，包括GPP。这是首个针对GPP治疗的靶向疗法，并已在专门针对GPP患者治疗的最大临床项目中进行了评估。

What is SPEVIGO

什么是SPEVIGO

？

SPEVIGO

斯佩维戈

is a prescription medicine used to treat generalized pustular psoriasis (GPP) in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg). It is not known if SPEVIGO

是一种用于治疗成人和12岁及以上、体重至少88磅（40公斤）的儿童的泛发性脓疱型银屑病（GPP）的处方药。目前尚不清楚SPEVIGO

is safe and effective in children under 12 years of age or who weigh less than 88 pounds (40kg).

在12岁以下或体重小于88磅（40公斤）的儿童中是安全有效的。

Important Safety Information

重要安全信息

Do not receive SPEVIGO

不要接受SPEVIGO

if you or your child

如果你或你的孩子

have had a severe or life-threatening allergic reaction to spesolimab-sbzo or any of the ingredients in SPEVIGO

对斯佩索利单抗或SPEVIGO中的任何成分有过严重或危及生命的过敏反应

。

What is the most important information I should know about SPEVIGO

我应该了解的关于SPEVIGO的最重要的信息是什么？

? SPEVIGO

？ SPEVIGO

may cause serious side effects, including:

可能导致严重的副作用，包括：

Infections.

感染。

SPEVIGO

斯佩维戈

may lower the ability of your or your child's immune system to fight infections and may increase your or your child's risk of infections. Your healthcare provider should check you or your child for infections and tuberculosis (TB) before starting treatment with SPEVIGO

可能会降低您或您孩子的免疫系统抵抗感染的能力，并可能增加您或您孩子感染的风险。在开始使用SPEVIGO治疗之前，您的医疗保健提供者应检查您或您的孩子是否有感染和结核病 (TB)。

and may treat you or your child for TB before you begin treatment with SPEVIGO

在开始使用SPEVIGO治疗之前，可能会对你或你的孩子进行结核病治疗。

if you have a history of TB or have active TB. Your healthcare provider should watch you or your child closely for signs and symptoms of TB during or after treatment with SPEVIGO

如果您有结核病史或患有活动性结核病。您的医疗保健提供者应在使用SPEVIGO治疗期间或之后密切观察您或您的孩子是否有结核病的体征和症状。

. Tell your healthcare provider right away if you or your child have an infection or have symptoms of an infection during or after treatment with SPEVIGO

如果在使用SPEVIGO治疗期间或之后，您或您的孩子出现感染或有感染症状，请立即告知您的医疗保健提供者。

, including:

，包括：

fevers, chills, or sweats

发烧、发冷或出汗

muscle aches

肌肉酸痛

cough

咳嗽

shortness of breath

呼吸急促

blood in your phlegm (mucus)

痰中带血（粘液）

burning when you urinate

排尿时灼痛感

urinating more often than normal

尿频

Allergic reactions and infusion-related reactions

过敏反应和输液相关反应

. Serious allergic reactions may happen during or after your or your child's SPEVIGO

. 在您或您的孩子使用SPEVIGO期间或之后，可能会发生严重的过敏反应

injection. If you or your child have a serious allergic reaction, your healthcare provider will stop treatment with SPEVIGO

注射。如果您或您的孩子有严重的过敏反应，您的医疗保健提供者将停止使用SPEVIGO进行治疗。

. If you or your child are given SPEVIGO

如果你或你的孩子被给予SPEVIGO

in a vein (intravenously) and have an infusion- related reaction, your healthcare provider will stop your or your child's SPEVIGO

静脉注射（intravenously）并且出现与输液相关的反应时，您的医疗保健提供者将停止您或您孩子的SPEVIGO治疗。

infusion and treat your or your child's symptoms and may restart SPEVIGO

输液并治疗您或您孩子的症状，并可能重新开始使用SPEVIGO。

at a slower infusion rate. Tell your healthcare provider or get emergency medical help right away if you or your child get any of the following symptoms during or after your or your child's SPEVIGO

以较慢的输注速度给药。如果您或您的孩子在您或您孩子的SPEVIGO输注期间或之后出现以下任何症状，请立即告知您的医疗保健提供者或寻求紧急医疗帮助。

injection:

注入：

feeling faint, dizzy, or lightheaded

感到虚弱、头晕或头重脚轻

swelling of your face, eyelids, lips, mouth, tongue, or throat

面部、眼睑、嘴唇、口腔、舌头或喉咙肿胀

trouble breathing or throat tightness

呼吸困难或喉咙紧缩

fever

发烧

mouth sores

口腔溃疡

chest tightness

胸闷

hives or skin rash that is different than the rash from generalized pustular psoriasis (GPP)

荨麻疹或不同于泛发性脓疱型银屑病 (GPP) 的皮疹

itching

瘙痒

swollen lymph nodes

肿大的淋巴结

Before you or your child receive SPEVIGO

在您或您的孩子接受SPEVIGO之前

, tell your healthcare provider about all of your medical conditions, including if you or your child:

`, 请告诉您的医疗保健提供者您所有的医疗状况，包括您或您的孩子：`

have an infection that does not go away or that keeps coming back.

感染一直不好或者反复发作。

have TB or have been in close contact with someone with TB.

患有结核病或与结核病患者有过密切接触。

have recently received or are scheduled to receive an immunization (vaccine). You or your child should not receive live vaccines during and for at least 16 weeks after treatment with SPEVIGO

最近已接种或计划接种疫苗（免疫）。您或您的孩子在使用SPEVIGO治疗期间及治疗后至少16周内不应接种活疫苗。

. You or your child should be brought up to date with all vaccines before starting SPEVIGO

在开始使用SPEVIGO之前，您或您的孩子应接种所有最新的疫苗。

。

are pregnant or plan to become pregnant. It is not known if SPEVIGO

怀孕或计划怀孕。尚不清楚SPEVIGO是否会对孕妇产生影响。

can harm your or your child's unborn baby.

可能伤害您或您孩子的未出生婴儿。

are breastfeeding or plan to breastfeed. It is not known if SPEVIGO

正在哺乳或计划哺乳。目前尚不清楚SPEVIGO是否

passes into your breast milk. Talk to your healthcare provider about the best way to feed your or your child's baby during treatment with SPEVIGO

会进入您的母乳。与您的医疗保健提供者讨论在使用SPEVIGO治疗期间喂养您或您的孩子时的最佳方法。

。

Tell your healthcare provider about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

告诉您的医疗保健提供者您或您的孩子服用的所有药物，包括处方药和非处方药、维生素和草药补充剂。

What are the possible side effects of SPEVIGO

SPEVIGO可能有哪些副作用

？

The most common side effects of SPEVIGO

SPEVIGO最常见的副作用

given in a vein (intravenously) for GPP flare treatment include:

静脉注射（静脉内）用于GPP发作治疗的药物包括：

feeling tired or weak

感到疲倦或虚弱

nausea and vomiting

恶心和呕吐

headache

头痛

itching or itchy bumps

瘙痒或发痒的肿块

a collection of blood under the skin at the infusion site or bruising

皮下输液部位的血液积聚或瘀伤

urinary tract infection

尿路感染

The most common side effects of SPEVIGO

SPEVIGO最常见的副作用

when given under the skin (subcutaneously) for treatment of GPP when not experiencing a flare include:

当皮下注射（用于治疗非发作期的GPP）时，包括以下情况：

redness, pain, swelling, hardening, hives, or warmth at the injection site

注射部位出现红肿、疼痛、肿胀、硬化、荨麻疹或发热现象

joint pain

关节疼痛

urinary tract infection

尿路感染

itching

瘙痒

These are not all of the possible side effects of SPEVIGO®. Call your doctor for medical advice about side effects.

这些并非 SPEVIGO® 的所有可能副作用。如需了解有关副作用的医疗建议，请咨询您的医生。

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit

我们鼓励您向 FDA 报告处方药的负面副作用。访问

www.fda.gov/medwatch

or call 1

或拨打 1

‐

800

‐

FDA

食品药品监督管理局

‐

1088.

一千零八十八。

Please see full

请查看完整内容

Prescribing Information

处方信息

，

Medication Guide,

药物指南，

and

和

Instructions for Use

使用说明

。

About the EFFISAYIL

关于EFFISAYIL

clinical trial program

临床试验计划

The

EFFISAYIL

clinical trial program evaluated the largest and broadest population of GPP patients in trials of a therapy specifically targeting the IL-36 pathway for GPP:

临床试验项目评估了针对GPP的IL-36通路疗法的试验中规模最大、最广泛的GPP患者群体：

EFFISAYIL

效率说易

: A Phase II study that demonstrated treatment with a single intravenous dose of spesolimab significantly improved signs and symptoms of GPP in patients experiencing a flare, including rapid pustular and skin clearance. These results supported the approval of spesolimab as the first specific treatment for GPP flares in adults in major markets.

：一项 II 期研究表明，单次静脉注射 spesolimab 可显著改善在病情发作期间泛发性脓疱型银屑病 (GPP) 患者的症状和体征，包括快速清除脓疱和皮肤病变。这些结果支持了 spesolimab 作为首个用于治疗成人 GPP 发作的特定疗法在主要市场获得批准。

EFFISAYIL

埃菲赛尔

A Phase IIb study that showed spesolimab significantly reduced the risk of GPP flares by 84% over 48 weeks compared to placebo. In the trial with 123 patients, no flares were observed after week 4 of spesolimab SC treatment in the high-dose group (n=30)

一项IIb期研究表明，与安慰剂相比，spesolimab在48周内显著降低了GPP发作的风险达84%。在123名患者的试验中，高剂量组（n=30）在使用spesolimab皮下注射治疗的第4周后未观察到发作。

EFFISAYIL

开启

: An open-label extension study to evaluate the long-term safety and efficacy of spesolimab in patients with GPP who have completed previous spesolimab trials

：一项开放标签延长期研究，旨在评估完成先前spesolimab试验的GPP患者中spesolimab的长期安全性和有效性

About generalized pustular psoriasis

关于泛发性脓疱型银屑病

GPP is a chronic, heterogenous, neutrophilic inflammatory disease associated with skin and systemic symptoms that is distinct from plaque psoriasis. GPP is recognized as a separate clinical entity from other forms of psoriasis, with the IL-36 pathway being a key driver of GPP and triggering response to treatment.

GPP是一种慢性、异质性、中性粒细胞性炎症性疾病，伴有皮肤和系统性症状，与斑块型银屑病不同。GPP被认为是区别于其他类型银屑病的独立临床实体，其中IL-36通路是GPP的关键驱动因素，并触发对治疗的反应。

Prevalence of GPP is low and varies considerably across geographical regions, ranging from 1.76 to 124 patients per million persons in reports from key countries, including .

泛发性脓疱型银屑病（GPP）的患病率较低，且在不同地理区域之间存在显著差异，据主要国家的报告显示，每百万人中患者数量范围为1.76至124人。

France

法国

，

Japan

日本

，

Sweden

瑞典

, and

，以及

South Korea

韩国

. GPP can become life-threatening (mortality rates ranging from 2% to 16%) due to severe complications, such as multisystem organ failure and sepsis requiring urgent hospital care; many GPP patients also suffer from various comorbidities, which contribute to the ongoing burden for the patient and healthcare systems.

由于严重并发症（如多系统器官衰竭和败血症）需要紧急住院治疗，GPP可能危及生命（死亡率在2%至16%之间）；许多GPP患者还患有各种合并症，这些合并症给患者和医疗系统带来了持续的负担。

GPP symptoms appear unpredictable and present on a continuum, which greatly impacts a patient's quality of life, and may cause fear and anxiety over the disease course, as well as long-term impacts on quality of life related to work/school, emotional health, social activities, and finances..

GPP症状表现难以预测，并且在连续的病程中出现，这极大地影响了患者的生活质量，可能引发对疾病进程的恐惧和焦虑，并对与工作/学校、情绪健康、社交活动及财务相关的生活质量造成长期影响。

About Boehringer Ingelheim

关于勃林格殷格翰

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in Research and Development, the company focuses on developing innovative therapies in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain.

勃林格殷格翰是一家活跃于人类和动物健康的生物制药公司。作为行业内在研发领域投资最多的公司之一，该公司专注于在未满足医疗需求的高需求领域开发创新疗法。自1885年成立以来，勃林格始终保持独立，并以长远眼光看待发展，将可持续性贯穿于整个价值链。

More than 53,500 employees serve over 130 markets to build a healthier, more sustainable, and equitable tomorrow. Learn more at .

超过 53,500 名员工为 130 多个市场服务，共同构建一个更健康、更可持续和更公平的明天。欲了解更多信息，请访问。

https://www.boehringer-ingelheim.com/us

。

Bhutani T, et al. Spesolimab improves quality of life as measured by Psoriasis Symptom Scale (PSS) and Pain Visual Analog Scale (VAS) in generalized pustular psoriasis (GPP) over time: Results from the EFFISAYIL® 2 trial. Poster presented at 2025 AAD Annual Meeting;

Bhutani T, 等。Spesolimab 在泛发性脓疱型银屑病 (GPP) 中通过银屑病症状评分 (PSS) 和疼痛视觉模拟评分 (VAS) 衡量，随着时间的推移改善生活质量：EFFISAYIL® 2 试验结果。海报展示于 2025 年 AAD 年会。

March 2025

2025年3月

;

；

Orlando

奥兰多

。

Gordon K, et al. Spesolimab improves quality of life as measured by Dermatology Life Quality Index (DLQI) in generalized pustular psoriasis (GPP) over time: Results from the EFFISAYIL® 2 trial. Poster presented at 2025 AAD Annual Meeting;

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