TREMFYA®（古塞库单抗）是首个也是唯一一个显著减轻活动性银屑病关节炎成人患者的症状和体征，并延缓结构性损伤进展的IL-23抑制剂-动脉网

TREMFYA® (guselkumab) is the first and only IL-23 inhibitor to significantly reduce both the signs and symptoms and the progression of structural damage in adults living with active psoriatic arthritis

强生等信源发布 2025-04-04 06:14

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可切换为仅中文

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TREMFYA

特雷姆亚

demonstrated clinically meaningful and statistically significant efficacy in patients with active psoriatic arthritis at risk for structural damage in Phase 3b study

在3b期研究中，对有结构损伤风险的活动性银屑病关节炎患者显示出具有临床意义且统计学显著的疗效

Topline results demonstrate efficacy across multiple domains at Week 24, reinforcing TREMFYA

第24周的顶线结果展示了跨多个领域的疗效，进一步巩固了TREMFYA的效果。

as a first-line treatment option for patients with active psoriatic arthritis

作为活动性银屑病关节炎患者的首选治疗方案

SPRING HOUSE, Pa.

宾夕法尼亚州斯普林豪斯

，

April 4, 2025

2025年4月4日

/PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced that the TREMFYA

/PRNewswire/ -- 强生公司（纽约证券交易所代码：JNJ）今天宣布了TREMFYA

(guselkumab) Phase 3b APEX study achieved both its primary endpoint (ACR20

（古塞库单抗）3b期APEX研究达到了其主要终点（ACR20）

) of reducing signs and symptoms and its major secondary endpoint of reducing progression of structural damage as measured by radiographic progression at 24 weeks, in adults living with active psoriatic arthritis (PsA), compared to placebo.

在成人活动性银屑病关节炎（PsA）患者中，与安慰剂相比，减少症状和体征的主要终点以及减少24周时通过X线进展测量的结构损伤进展的主要次要终点。

TREMFYA

特诺雅

is the first and only fully-human, dual-acting monoclonal antibody approved to treat PsA that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including active psoriatic arthritis..

是首个也是唯一一个获批治疗银屑病关节炎 (PsA) 的全人源、双重作用单克隆抗体，可阻断 IL-23，同时结合到产生 IL-23 的细胞上的 CD64 受体。IL-23 是由活化的单核细胞/巨噬细胞和树突状细胞分泌的细胞因子，已知是包括活动性银屑病关节炎在内的免疫介导疾病的驱动因素。

2,3,4,5,6

In the Phase 3b APEX study, TREMFYA

在3b期APEX研究中，TREMFYA

-treated patients also exhibited significantly less progression of structural damage versus patients receiving placebo at Week 24 as assessed by the PsA modified van der Heijde-Sharp (vdH-S) score, which includes joint space narrowing and erosion subscores. Data were consistent with the well-established safety profile of TREMFYA.

接受治疗的患者在第24周时，根据PsA改良的van der Heijde-Sharp（vdH-S）评分（包括关节间隙狭窄和侵蚀亚评分），其结构损伤进展也显著少于接受安慰剂的患者。数据与TREMFYA已确立的安全性特征一致。

with no new safety signals identified.

没有发现新的安全信号。

'Psoriatic arthritis can be a progressive and debilitating disease, and without early identification and treatment, patients may experience irreversible joint damage that significantly impacts their daily activities,' said Terence Rooney, Vice President, Rheumatology Disease Area Leader, Johnson & Johnson Innovative Medicine.

“银屑病关节炎可能是一种进展性和致残性疾病，如果不早期识别和治疗，患者可能会经历不可逆的关节损伤，严重影响他们的日常活动，”杨森创新药物部门风湿病领域负责人、副总裁特伦斯·鲁尼表示。

'These new topline data highlight the importance of addressing both inflammation and structural damage at the source as early as possible. As the only IL-23 treatment to show significant inhibition of structural damage, TREMFYA equips healthcare providers with critical data so their patients do not have to compromise their future joint health.'.

“这些新的总体数据显示了尽早从源头上同时解决炎症和结构性损伤的重要性。作为唯一一种显示对结构性损伤有显著抑制作用的IL-23治疗药物，TREMFYA为医疗保健提供者提供了关键数据，使他们的患者不必妥协于未来的关节健康。”

APEX is a Phase 3b study with long-term extension data through three years that will further assesses the sustained efficacy of TREMFYA

APEX 是一项为期三年的 3b 期研究，具有长期扩展数据，将进一步评估 TREMFYA 的持续疗效。

on inhibition of structural damage in patients with active PsA. Results from the APEX study are being prepared for presentation at upcoming medical congresses.

对活动性PsA患者结构损伤的抑制作用。APEX研究的结果正在准备于即将召开的医学大会上展示。

Editor's notes:

编辑注释：

a. ACR20 response is defined as both at least 20 percent improvement from baseline in the number of tender and number of swollen joints, and a 20 percent improvement from baseline in three of the following five criteria: patient GA, physician GA, functional ability measure (HAQ-DI), patient-reported pain using a visual analog scale, and erythrocyte sedimentation rate or C-reactive protein..

ACR20反应定义为以下两项同时成立：压痛关节数和肿胀关节数较基线至少改善20％，以及以下五项标准中的三项较基线改善20％：患者整体评估（GA）、医生整体评估（GA）、功能能力测量（HAQ-DI）、患者通过视觉模拟量表报告的疼痛、红细胞沉降率或C反应蛋白。

ABOUT APEX STUDY (

关于APEX研究 (

NCT04882098

)

APEX is a multicenter, randomized, double-blind, placebo-controlled study in patients with active PsA who are biologic naïve and have had an inadequate response to standard therapies (e.g., csDMARDs, apremilast, and/or NSAIDs). The treatment duration includes a 24-week, double-blind, placebo-controlled period, followed by a 24-week active treatment period, followed by a 12-week safety follow-up period.

APEX 是一项多中心、随机、双盲、安慰剂对照的研究，针对生物制剂初治且对标准疗法（如 csDMARDs、阿普斯特和/或非甾体抗炎药）反应不佳的活动性银屑病关节炎 (PsA) 患者。治疗周期包括一个 24 周的双盲安慰剂对照期，随后是一个 24 周的活性治疗期，最后是一个 12 周的安全性随访期。

For patients who agree to enter the long-term extension, an additional 2 years of active treatment period is scheduled prior to the final safety follow-up..

对于同意进入长期扩展期的患者，计划在最终安全随访之前安排额外2年的活性治疗期。

ABOUT PSORIATIC ARTHRITIS

关于银屑病关节炎

Psoriatic arthritis (PsA) is a chronic, immune-mediated, inflammatory disease characterized by peripheral joint inflammation, enthesitis (pain where the bone, tendon and ligament meet), dactylitis (a type of inflammation in the fingers and toes that can result in a swollen, sausage-like appearance), axial disease and the skin lesions associated with plaque psoriasis (PsO)..

银屑病关节炎（PsA）是一种慢性、免疫介导的炎症性疾病，其特征为外周关节炎、附着点炎（骨、肌腱和韧带相接处的疼痛）、指趾炎（手指和脚趾的一种炎症，可能导致肿胀，呈香肠状）、轴向疾病以及与斑块型银屑病（PsO）相关的皮肤病变。

9,10,11

9，10，11

The disease causes pain, stiffness and swelling in and around the joints; it commonly appears between the ages of 30 and 50, but can develop at any age.

这种疾病会导致关节及周围疼痛、僵硬和肿胀；它通常出现在30至50岁之间，但可以在任何年龄发病。

Nearly half of patients with PsA experience moderate fatigue and about one-third suffer from severe fatigue as measured by the modified fatigue severity scale.

近一半的银屑病关节炎患者经历中度疲劳，约三分之一的患者根据改良疲劳严重程度量表测量患有严重疲劳。

In patients with PsA, comorbidities such as obesity, cardiovascular disease, anxiety and depression are often present.

在PsA患者中，常伴有肥胖、心血管疾病、焦虑和抑郁等合并症。

Studies show up to 30% of people with plaque PsO also develop PsA.

研究表明，多达30%的斑块型银屑病患者也会发展为银屑病关节炎。

ABOUT TREMFYA

关于特姆萨

(guselkumab)

（古塞库单抗）

Developed by Johnson & Johnson, TREMFYA

由强生公司开发的特诺雅（TREMFYA）

is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). Findings for dual-acting are limited to

是第一个获批的全人源、双重作用的单克隆抗体，旨在通过阻断IL-23并结合CD64（一种存在于产生IL-23的细胞上的受体）来从细胞源头中和炎症。关于双重作用的发现有限。

in vitro

体外

studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known.

研究表明古塞库单抗与CD64结合，CD64在炎症性单核细胞模型中表达于产生IL-23的细胞表面。这一发现的临床意义尚不清楚。

TREMFYA

特雷姆扎

is a prescription medicine approved in the U.S. to treat:

是一种在美国获批的处方药，用于治疗：

adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light).

可能受益于注射或口服药物（全身治疗）或光疗（使用紫外线或UV光治疗）的中度至重度斑块型银屑病成人患者。

adults with active psoriatic arthritis.

患有活动性银屑病关节炎的成人。

adults with moderately to severely active ulcerative colitis.

中度至重度活动性溃疡性结肠炎的成人。

adults with moderately to severely active Crohn's disease.

中度至重度活动性克罗恩病的成人。

TREMFYA

特诺雅

is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis.

在欧洲、加拿大、日本及另外一些国家获批用于治疗中度至重度斑块型银屑病成人患者，以及活动性银屑病关节炎成人患者。

Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA

强生公司拥有TREMFYA的全球独家营销权。

. For more information, visit:

欲了解更多信息，请访问：

www.tremfya.com

。

IMPORTANT SAFETY INFORMATION

重要安全信息

What is the most important information I should know about TREMFYA

我应该知道的关于TREMFYA的最重要的信息是什么

？

TREMFYA

特雷姆扎

is a prescription medicine that may cause serious side effects, including:

是一种处方药，可能会导致严重的副作用，包括：

Serious Allergic Reactions.

严重过敏反应。

Stop using TREMFYA

停止使用TREMFYA

and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction:

如果出现以下严重过敏反应的症状，请立即寻求紧急医疗帮助：

o fainting, dizziness, feeling lightheaded (low blood pressure)

o 晕厥、头晕、感觉头重脚轻（低血压）

o 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

o trouble breathing or throat tightness

呼吸困难或喉咙紧缩感

o chest tightness

胸部紧迫感

o skin rash, hives

皮肤疹，荨麻疹

o o itching

o o 瘙痒

Infections.

感染。

TREMFYA

特诺雅

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

可能会降低免疫系统抵抗感染的能力，并可能增加感染的风险。在开始使用TREMFYA治疗之前，您的医疗保健提供者应检查您是否有感染和结核病（TB）。

and may treat you for TB before you begin treatment with TREMFYA

在你开始使用TREMFYA治疗之前，可能会对你进行结核病治疗。

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

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TREMFYA治疗期间及之后密切观察您是否有结核病的迹象和症状。

。

Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:

如果出现感染或感染症状，请立即告知您的医疗保健提供者，包括：

o fever, sweats, or chills

发热、盗汗或寒战

o muscle aches

o 肌肉疼痛

o weight loss

o 体重减轻

o cough

咳嗽

o warm, red, or painful skin or sores on your body different from your psoriasis

身体上出现与银屑病不同的温暖、红色或疼痛的皮肤或疮。

o diarrhea or stomach pain

腹泻或胃痛

o shortness of breath

o 呼吸急促

o blood in your phlegm (mucus)

o 痰（粘液）中带血

o burning when you urinate or urinating more often than normal

排尿时灼热感或比正常情况更频繁地排尿

Liver problems.

肝脏问题。

With the treatment of Crohn's disease or ulcerative colitis, your healthcare provider will do blood tests to check your liver before and during treatment with TREMFYA

在治疗克罗恩病或溃疡性结肠炎时，您的医疗保健提供者会在使用TREMFYA治疗前和治疗期间进行血液检查以检查您的肝脏情况。

. Your healthcare provider may stop treatment with TREMFYA

您的医疗保健提供者可能会停止使用TREMFYA进行治疗

if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms:

如果出现肝脏问题，请立即告知您的医疗保健提供者。如果您注意到以下任何症状，请立即告诉您的医疗保健提供者：

o unexplained rash

原因不明的皮疹

o vomiting

呕吐

o tiredness (fatigue)

疲惫（疲劳）

o yellowing of the skin or the whites of your eyes

皮肤或眼白发黄

o nausea

恶心

o stomach pain (abdominal)

o 胃痛（腹部）

o loss of appetite

o 食欲不振

o dark urine

深色尿液

Do not use TREMFYA

请勿使用TREMFYA

if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA

如果您对古塞库单抗或TREMFYA中的任何成分有过严重过敏反应，请注意。

。

Before using TREMFYA

使用TREMFYA之前

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

`, 请告诉您的医疗保健提供者您的所有医疗状况，包括如果您：`

have any of the conditions or symptoms listed in the section

拥有本节中列出的任何情况或症状

'What is the most important information I should know about TREMFYA

“关于TREMFYA，我应该知道的最重要的信息是什么？

？'

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

有持续不退或反复发作的感染。

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

患有结核病或与结核病患者密切接触。

have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA

最近已接种或计划接种疫苗（免疫）。在使用TREMFYA治疗期间，应避免接种活疫苗。

。

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

怀孕或计划怀孕。尚不清楚TREMFYA是否会影响胎儿。

can harm your unborn baby.

可能伤害你未出生的宝宝。

Pregnancy Registry

怀孕登记处

: If you become pregnant during treatment with TREMFYA

如果在使用 TREMFYA 治疗期间怀孕

, talk to your healthcare provider about registering in the pregnancy exposure registry for TREMFYA

，与您的医疗保健提供者谈论注册TREMFYA的妊娠暴露登记册。

. You can enroll by visiting

。您可以通过访问进行注册

www.mothertobaby.org/ongoing-study/tremfya-guselkumab

, by calling 1-877-311-8972, or emailing

，通过拨打1-877-311-8972，或发送电子邮件至

MotherToBaby@health.ucsd.edu

MotherToBaby@健康.ucsd.edu

. The purpose of this registry is to collect information about the safety of TREMFYA

该注册表的目的是收集有关TREMFYA安全性的信息

during pregnancy.

怀孕期间。

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

正在哺乳或计划哺乳。尚不清楚TREMFYA是否会影响哺乳。

passes into your breast milk.

会进入你的母乳。

Tell your healthcare provider about all the medicines you take,

告诉您的医疗保健提供者您所服用的所有药物，

including prescription and over-the-counter medicines, vitamins, and herbal supplements.

包括处方药和非处方药、维生素以及草本补充剂。

What are the possible side effects of TREMFYA

特润芙可能出现的副作用有哪些

？

TREMFYA

特诺雅

may cause serious side effects. See 'What is the most important information I should know about TREMFYA

可能会引起严重的副作用。参见“关于TREMFYA，我应该了解的最重要信息是什么？”

？'

The most common side effects of TREMFYA

TREMFYA最常见的副作用

include:

包含：

respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, stomach pain, and bronchitis.

呼吸道感染、头痛、注射部位反应、关节痛（关节炎）、腹泻、肠胃炎（胃流感）、真菌性皮肤感染、单纯疱疹病毒感染、胃痛和支气管炎。

These are not all the possible side effects of TREMFYA

这些并非 TREMFYA 的所有可能副作用

. Call your doctor for medical advice about side effects.

因副作用需要医疗建议时，请咨询医生。

Use TREMFYA

使用TREMFYA

exactly as your healthcare provider tells you to use it.

完全按照您的医疗保健提供者的指示使用。

Please read the full

请阅读全文

Prescribing Information

处方信息

, including

，包括

Medication Guide

药品指南

, for TREMFYA

，适用于TREMFYA

and discuss any questions that you have with your doctor.

并与您的医生讨论您遇到的任何问题。

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 1-800-FDA-1088.

，或者拨打 1-800-FDA-1088。

Dosage Forms and Strengths: TREMFYA

剂型和强度：TREMFYA

is available as 100 mg/mL and 200 mg/2mL for subcutaneous injection and as a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion.

可供皮下注射的剂型为100毫克/毫升和200毫克/2毫升，也可供静脉输注的剂型为200毫克/20毫升（10毫克/毫升）单剂量小瓶。

ABOUT JOHNSON & JOHNSON

关于强生公司

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. .

在强生，我们相信健康就是一切。我们在医疗保健创新方面的实力使我们能够构建一个世界，在这个世界里，复杂疾病得以预防、治疗和治愈，治疗方法更智能、更少侵入性，解决方案也更加个性化。凭借我们在创新药物和医疗技术方面的专业知识，我们有能力在当今全面的医疗保健解决方案领域进行创新，以提供明天的突破性成果，并对人类健康产生深远影响。

Learn more at

了解更多信息，请访问

https://www.jnj.com/

or at

或在

https://innovativemedicine.jnj.com/

关注我们

@JNJInnovMed.

Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies.

杨森研发有限责任公司和杨森生物科技有限公司是强生公司的子公司。

CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS

关于前瞻性陈述的注意事项

This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events.

本新闻稿包含《1995年私人证券诉讼改革法案》中定义的关于产品开发以及nipocalimab潜在益处和治疗影响的“前瞻性声明”。读者请注意，不要过度依赖这些前瞻性声明。这些声明基于对未来事件的当前预期。

If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment.

如果基本假设被证明不准确，或已知或未知的风险或不确定性成为现实，实际结果可能与杨森研发有限责任公司、杨森生物技术公司和/或强生公司的预期和预测大不相同。风险和不确定性包括但不限于：产品研发中的挑战和不确定性，包括临床成功的不确定性和获得监管批准的不确定性；商业成功的不确定性；生产困难和延误；竞争，包括技术进步、竞争对手的新产品和专利；专利挑战；因产品疗效或安全问题导致的产品召回或监管行动；医疗保健产品和服务购买者的行为和支出模式的变化；适用法律法规的变更，包括全球医疗改革；以及控制医疗成本的趋势。

A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission.

这些风险、不确定性和其他因素的进一步列表和描述，请参见强生公司最近的年度报告 Form 10-K，包括标题为“关于前瞻性陈述的警示说明”和“项目1A. 风险因素”的部分，以及强生公司随后的季度报告 Form 10-Q 和提交给证券交易委员会的其他文件。

Copies of these filings are available online at .

这些文件的副本可在线获取，网址为。

www.sec.gov

, www.jnj.com or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

，www.jnj.com 或者可向 Johnson & Johnson 索取。Janssen Research & Development, LLC、Janssen Biotech, Inc. 以及 Johnson & Johnson 均不承担因新信息、未来事件或发展而更新任何前瞻性声明的义务。

REFERENCES

参考文献

Data on file

文件中的数据

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阿特雷亚 R、阿布鲁 MT、克鲁格 JG 等。古塞库单抗，一种针对 IL-23p19 亚基的单克隆抗体，可结合 CD64+ 髓系细胞，并有可能中和来自相同细胞的 IL-23。海报展示于：第 18 届欧洲克罗恩病和结肠炎组织 (ECCO) 大会；2023 年 3 月 1 日至 4 日；丹麦哥本哈根。

Poster P504..

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Prescribing Information. Available at:

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Media contact:

媒体联系人：

Craig Stoltz

克雷格·斯托尔茨

cstoltz@its.jnj.com

Investor contact:

投资者联系人：

Lauren Johnson

劳伦·约翰逊

investor-relations@its.jnj.com

投资者关系@its.jnj.com

View original content to download multimedia:

查看原始内容以下载多媒体：

https://www.prnewswire.com/news-releases/tremfya-guselkumab-is-the-first-and-only-il-23-inhibitor-to-significantly-reduce-both-the-signs-and-symptoms-and-the-progression-of-structural-damage-in-adults-living-with-active-psoriatic-arthritis-302420476.html

SOURCE Johnson & Johnson

来源：强生公司

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