/PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval to include new evidence in the TREMFYA

/PRNewswire/ -- 强生公司（纽约证券交易所代码：JNJ）今天宣布已向美国食品药品监督管理局（FDA）提交了一份补充生物制品许可申请（sBLA），寻求批准在 TREMFYA 中包含新的证据。

(guselkumab) label for the inhibition of progression of structural damage in adults with active psoriatic arthritis (PsA).

（ Guselkumab ）标签用于抑制活动性银屑病关节炎（ PsA ）成人患者的结构损伤进展。

The submission is supported by the Phase 3b APEX study in patients with active PsA, which achieved both its primary endpoint of reducing joint symptoms (ACR20) and its major secondary endpoint of inhibited progression of structural damage as measured by change in the modified van der Heijde-Sharp (vdH-S) score at 24 weeks, compared to placebo in bio-naïve patients.

该提交得到了针对活动性PsA患者的3b期APEX研究的支持，该研究在生物制剂初治患者中达到了其主要终点，即减轻关节症状（ACR20），并且在24周时通过改良的van der Heijde-Sharp（vdH-S）评分测量，成功实现了抑制结构损伤进展的关键次要终点，相比安慰剂组表现更优。

These data were .

这些数据是 。

recently presented

最近提交的

at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress.

在2025年欧洲风湿病学协会联盟（EULAR）大会上。

'Psoriatic arthritis is a complex disease that can lead to severe and irreversible joint damage, which is why we are dedicated to developing innovative therapies that comprehensively address the long-term impact as well as the everyday challenges of this condition,' said Brandee Pappalardo, Ph.D., M.P.H., Vice President, Medical Affairs, Dermatology & Rheumatology, Johnson & Johnson Innovative Medicine.

“银屑病关节炎是一种复杂的疾病，可能导致严重且不可逆的关节损伤，因此我们致力于开发创新疗法，全面应对这种疾病的长期影响以及日常挑战，”强生创新制药公司皮肤病学与风湿病学医学事务副总裁布兰迪·帕帕拉多（Brandee Pappalardo）博士、公共卫生硕士表示。

'With this new evidence, TREMFYA.

“有了这个新证据，TREMFYA。

would become the first and only IL-23 inhibitor proven to provide symptom control and to significantly inhibit the progression of joint damage in patients living with active PsA.'

将成为首个且唯一一个被证明可以控制症状并显著抑制活动性银屑病关节炎（PsA）患者关节损伤进展的IL-23抑制剂。

Data from the APEX study were consistent with the well-established safety profile of TREMFYA

APEX研究的数据与TREMFYA已确立的安全性特征一致。

. Additional data will be presented at future medical meetings.

更多信息将在未来的医学会议上展示。

TREMFYA

特雷姆萨

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 PsA..

是首个且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的同时结合到CD64上，CD64是产生IL-23的细胞上的受体。IL-23是由活化的单核细胞/巨噬细胞和树突细胞分泌的一种细胞因子，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。

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..

a) 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％：患者总体评估（GA）、医生总体评估（GA）、功能能力测量（HAQ-DI）、患者报告的疼痛（使用视觉模拟量表），以及红细胞沉降率或C反应蛋白。

ABOUT THE APEX STUDY (

关于APEX研究 (

NCT04882098

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.

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。

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..

对于同意进入长期延长期的患者，计划在最终安全随访之前再进行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、肌腱端炎（骨、肌腱和韧带交汇处的疼痛）、指趾炎（手指和脚趾的一种炎症，可能导致肿胀，呈香肠状外观）、轴向疾病以及与斑块型银屑病（PsO）相关的皮肤病变。

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. 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.

这种疾病会导致关节及其周围出现疼痛、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。近一半的PsA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出患有严重疲劳。

In patients with PsA, comorbidities such as obesity, cardiovascular disease, anxiety and depression are often present. Studies show up to 30% of people with plaque PsO also develop PsA..

在PsA患者中，常存在肥胖、心血管疾病、焦虑和抑郁等合并症。研究表明，多达30%的斑块型PsO患者也会发展为PsA。

ABOUT TREMFYA

关于特雷姆萨

(guselkumab)

（古塞库单抗）

Developed by Johnson & Johnson, TREMFYA

由强生公司开发，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

是首个获批的全人源、双重作用的单克隆抗体，旨在通过阻断IL-23并结合CD64（产生IL-23的细胞上的一种受体）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

特诺雅

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).

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

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

特雷姆扎

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。

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优势使我们能够构建一个世界，在这个世界中，复杂疾病得以预防、治疗和治愈，治疗方法更加智能且侵入性更小，解决方案更加个性化。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创新各类医疗保健解决方案，实现明日的突破性进展，并对人类健康产生深远影响。