First-of-its-kind Phase 3b study shows TREMFYA® achieved statistical significance across all primary and secondary endpoints in low body surface area psoriasis with special site involvement

首次进行的3b期研究表明，TREMFYA®在低体表面积牛皮癣的所有主要和次要终点均具有统计学意义，并伴有特殊部位受累

Johnson & Johnson launches library of clinical images from Phase 3b VISIBLE study to enhance clinical decision making for people across all skin tones living with moderate to severe plaque psoriasis

强生公司推出了3b期可见研究的临床图像库，以增强患有中度至重度斑块状牛皮癣的所有肤色人群的临床决策

LAS VEGAS, Oct. 25, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that treatment with TREMFYA® (guselkumab) resulted in clear or almost clear skin in the majority of adults with low body surface area (BSA) moderate plaque psoriasis (PsO) with special site involvement who had failed topical treatment.

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Sensitive or highly visible areas affected by PsO, including the scalp, face, skin folds and genitals, are considered 'special sites' and can have significant impact on patients' daily lives, yet systemic treatment is infrequently provided and this group of patients remains largely undertreated.1 Data from the Phase 3b SPECTREM study, the first prospective, large-scale, randomized-controlled, double-blind clinical study to measure skin clearance and other treatment outcomes in low BSA moderate PsO with involvement across four special sites (scalp, face, skin folds and genitals) and previous topical treatment failure, were presented today at the 2024 Fall Clinical Dermatology Conference..

受PsO影响的敏感或高度可见的区域，包括头皮，面部，皮肤褶皱和生殖器，被认为是“特殊部位”，可能对患者的日常生活产生重大影响，但很少提供全身治疗，这组患者在很大程度上仍然得不到治疗。1b期SPECTREM研究的数据是第一项前瞻性，大规模，随机对照，双盲临床研究，用于测量低BSA中度PsO的皮肤清除率和其他治疗结果，涉及四个特殊部位（头皮，面部，皮肤褶皱和生殖器）和以前的局部治疗失败，今天在2024年秋季临床皮肤病学会议上发表。。

'People who have special site plaque psoriasis with lesions that cover a smaller total area of their body are often only prescribed topical treatments and not considered candidates for advanced therapies, as treatment decisions are often driven by body surface area coverage and not symptomatic burden,' said Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health, and SPECTREM investigator.

亨利·福特健康（Henry Ford Health）皮肤病临床研究主任、SPECTREM调查员琳达·斯坦·戈尔德（Linda Stein Gold）医学博士说：“患有特殊部位斑块型银屑病且病变覆盖全身面积较小的人通常只接受局部治疗，不被视为高级治疗的候选者，因为治疗决策通常是由体表面积覆盖而不是症状负担决定的。”。

'Results of the SPECTREM study could represent a new approach to care for patients with low body surface area psoriasis, as the majority of patients treated with TREMFYA achieved clear or almost clear skin.'.

“SPECTREM研究的结果可能代表了一种护理低体表面积牛皮癣患者的新方法，因为大多数接受TREMFYA治疗的患者皮肤都很清澈或几乎清澈。”。

SPECTREM Week 16 Results Show High Levels of Skin Clearance

SPECTREM第16周的结果显示皮肤清除率很高

A significantly greater proportion of patients who received TREMFYA® achieved the primary endpoint of an Investigator's Global Assessment (IGA) score of cleared (0) or minimal disease (1) compared to those who received placebo (74.2% versus 12.4%, respectively; p<0.001). These results were comparable irrespective of baseline BSA..

与接受安慰剂的患者相比，接受TREMFYA®治疗的患者达到研究者全球评估（IGA）评分清除（0）或轻微疾病（1）的主要终点的比例显着更高（分别为74.2%和12.4%；p<0.001）。。。

Results Demonstrate High Levels of Skin Clearance in Patients with Special Site Involvement2,3,4

结果表明，特殊部位受累患者的皮肤清除率很高2,3,4

Significant clearance (defined as site-specific IGA 0/1 response) versus placebo at Week 16: scalp (75.0% versus 14.5%), face (87.8% versus 28.6%), intertriginous (86.5% versus 28.8%) and genital (78.0% versus 37.5%) (all comparisons p<0.001).Complete clearance of each special site was consistently achieved in the majority of patients who received TREMFYA® versus placebo: scalp (60.3% versus 9.3%), face (75.7% versus 23.9%), intertriginous (76.6% versus 24.2%) and genital (72.7% versus 32.7%).Statistically significant improvements were also achieved across all major secondary endpoints, including:.

在第16周，与安慰剂相比，显着清除率（定义为位点特异性IGA 0/1反应）：头皮（75.0%对14.5%），面部（87.8%对28.6%），三叉间（86.5%对28.8%）和生殖器（78.0%对37.5%）（所有比较p＜0.001）。与安慰剂相比，大多数接受TREMFYA®治疗的患者始终能够完全清除每个特殊部位：头皮（60.3%比9.3%），面部（75.7%比23.9%），三叉间（76.6%比24.2%）和生殖器（72.7%比32.7%）。。

52.9% achieved a Psoriasis Area Severity Index (PASI) 90 response compared to 6.2% of participants who received placebo (p<0.001).The average patient saw over 80% improvement from baseline for both BSA and PASI compared to those who received placebo (80.6% versus 6.1% and 82.6% versus 13.7%, respectively; p<0.001).Participants Report Improved Quality of Life Impact After Three Doses of TREMFYA®5.

52.9%的受试者达到银屑病面积严重程度指数（PASI）90反应，而接受安慰剂的受试者为6.2%（p＜0.001）。与接受安慰剂的患者相比，BSA和PASI的平均患者比基线改善了80%以上（分别为80.6%比6.1%和82.6%比13.7%；p＜0.001）。参与者报告说，服用三剂TREMFYA®5后，生活质量得到改善。

A greater proportion of TREMFYA®-treated patients achieved:Dermatology Life Quality Index (DLQI) scores of 0/1 compared to patients receiving placebo (48.9% versus 3.5%).A 4-point greater improvement from baseline in Psoriasis Symptoms and Signs Diary (PSSD) itch compared to placebo (62.7% versus 12.5%).The overall safety in the SPECTREM study was consistent with the established TREMFYA® safety profile..

与接受安慰剂的患者相比，接受TREMFYA®治疗的患者比例更高：皮肤病生活质量指数（DLQI）评分为0/1（48.9%比3.5%）。与安慰剂相比，牛皮癣症状和体征日记（PSSD）瘙痒比基线改善4分（62.7%比12.5%）。SPECTREM研究的总体安全性与已建立的TREMFYA®安全性概况一致。。

TREMFYA® Clearance Photo Library Debuts

TREMFYA®Clearance照片库首次亮相

Beginning today, healthcare providers will have access to the TREMFYA® Clearance Photo Library, an expansive, longitudinal library of before and after treatment photographs from the Phase 3b VISIBLE study. The online resource enables patient images to be filtered based on clinical characteristics, such as disease severity, areas of involvement, and clearance outcomes across all skin tones..

从今天开始，医疗保健提供者将可以访问TREMFYA®Clearance照片库，这是一个扩展的纵向图书馆，包含3b期可见研究的治疗前后照片。在线资源使患者图像能够根据临床特征进行过滤，例如疾病严重程度，受累区域和所有肤色的清除结果。。

Currently, only 4-19% of images in dermatology textbooks show PsO on darker skin tones, which makes it challenging to recognize the disease in patients with skin of color.6 People of color living with plaque and scalp PsO also face challenges such as misdiagnosis and delayed diagnosis at much higher rates than white individuals with PsO.7 The TREMFYA® Clearance Photo Library will continue to be updated with additional images from ongoing and future studies that address underrepresented PsO patient types, with the goal of setting a new standard for inclusion in medical research..

目前，皮肤病学教科书中只有4-19%的图像显示PsO的肤色较深，这使得识别有色皮肤患者的疾病具有挑战性。6患有斑块和头皮PsO的有色人种也面临着诸如误诊和延迟诊断等挑战，其发生率远高于患有PsO的白人。7 TREMFYA®清除照片库将继续更新正在进行和未来研究的其他图像，以解决代表性不足的PsO患者类型，目标是为纳入医学研究制定新标准。。

'The results from this study are aligned with our commitment to elevate the standard of care for the millions of adults impacted by moderate-to-severe plaque psoriasis, many of whom are currently overlooked and undertreated,' said Brandee Pappalardo, PhD, MPH, Vice President of Dermatology and Rheumatology Medical Affairs, Immunology, Johnson & Johnson Innovative Medicine.

强生创新医学皮肤病和风湿病医学事务、免疫学副总裁Brandee Pappalardo博士说：“这项研究的结果与我们致力于提高数百万受中度至重度斑块状牛皮癣影响的成年人的护理标准相一致，其中许多人目前被忽视和治疗不足。”。

'The positive SPECTREM data and TREMFYA Clearance Photo Library both reinforce the significance of TREMFYA as the only biologic treatment to demonstrate robust and clinically significant data across a broad range of patients, including those with low body surface area or special site plaque psoriasis, as well as patients of color.'.

“阳性SPECTREM数据和TREMFYA清除照片库都强化了TREMFYA作为唯一一种生物治疗方法的重要性，该方法可以在广泛的患者（包括体表面积低或特殊部位斑块型牛皮癣患者）以及有色患者中显示出强大且具有临床意义的数据。”。

Editor's Notes:

编者按：

a. TREMFYA® is a biologic therapy approved for adult patients with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light), for the treatment of adult patients with active psoriatic arthritis (PsA), and for adults with moderately to severely active ulcerative colitis..

a、 TREMFYA®是一种生物疗法，适用于患有中度至重度斑块状牛皮癣的成年患者，这些患者可能受益于注射或服用药丸（全身治疗）或光疗（使用紫外线治疗），用于治疗患有活动性银屑病关节炎（PsA）的成年患者，以及患有中度至重度活动性溃疡性结肠炎的成年人。。

b. Dr. Stein Gold is a paid consultant for Johnson & Johnson. She has not been compensated for any media work.

b、 Stein Gold博士是强生公司的有偿顾问。她没有得到任何媒体工作的补偿。

About Plaque Psoriasis (PsO)Plaque PsO is an immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful.8 It is estimated that eight million Americans and more than 125 million people worldwide live with the disease. Nearly one-quarter of all people with plaque PsO have cases that are considered moderate to severe.9 Living with plaque PsO can be a challenge and impact life beyond a person's physical health, including emotional health, relationships, and handling the stressors of life.10.

关于斑块型银屑病（PsO）斑块型银屑病是一种免疫介导的疾病，导致皮肤细胞过度产生，导致发炎的鳞状斑块，可能发痒或疼痛。据估计，全世界有800万美国人和1.25亿多人患有这种疾病。近四分之一的斑块型PsO患者有中度至重度的病例[9]。患有斑块型PsO的人可能是一个挑战，并影响一个人的身体健康，包括情绪健康，人际关系和应对生活压力。

About SPECTREM (NCT06039189)11SPECTREM is a Phase 3b, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of TREMFYA® (guselkumab) versus placebo for the treatment of low body surface area (BSA) moderate plaque PsO with special site involvement. Patients (n=338) were randomized approximately 2:1 to receive TREMFYA® 100 mg subcutaneous injection at Weeks 0 and 4, then every eight weeks (q8w) or placebo at Weeks 0 and 4, followed by crossover to TREMFYA® at Week 16 and q8w.

关于SPECTREM（NCT06039189）11SPECTREM是一项3b期，多中心，随机，双盲，安慰剂对照研究，评估TREMFYA®（guselkumab）与安慰剂治疗低体表面积（BSA）中度斑块PsO的安全性和有效性，有特殊部位的参与。患者（n=338）被随机分配约2:1，在第0周和第4周接受TREMFYA®100 mg皮下注射，然后在第0周和第4周每八周（q8w）或安慰剂，然后在第16周和q8w交叉接受TREMFYA®。

The study was designed to evaluate the efficacy and safety of TREMFYA® in patients with a diagnosis of PsO, BSA 2-15% with at least one plaque outside of special sites, per Investigator's Global Assessment (IGA) 3, and involvement of at least one qualifying special site, including scalp, face, intertriginous, or genital, with at least moderate severity.

根据研究者全球评估（IGA）3，该研究旨在评估TREMFYA®在诊断为PsO，BSA 2-15%，特殊部位以外至少有一个斑块的患者中的疗效和安全性，以及至少一个符合条件的特殊部位的参与，包括头皮，面部，三叉间或生殖器，至少有中度严重程度。

The primary endpoint of the study is the percentage of patients who achieve an IGA score of cleared (0) or minimal (1) at Week 16; overall lesions are graded for induration, erythema, and scaling. The SPECTREM study is ongoing with an active treatment period from Weeks 16-48 to evaluate final efficacy and from Weeks 16-56 to evaluate final safety. .

该研究的主要终点是在第16周达到IGA评分清除（0）或最低（1）的患者百分比；总体病变分级为硬结，红斑和结垢。SPECTREM研究正在进行中，从第16-48周开始积极治疗，以评估最终疗效，从第16-56周开始评估最终安全性。。

Through Week 16, 37.8% of patients who received TREMFYA® experienced at least one adverse event (AE), compared to 39.8% who received placebo. Three patients who received TREMFYA® experienced a serious AE, compared to 1 patient who received placebo. There were no discontinuations due to an AE in patients who received TREMFYA®, while 4 patients who received placebo discontinued because of an AE..

在第16周，接受TREMFYA®的患者中有37.8%经历了至少一次不良事件（AE），而接受安慰剂的患者中有39.8%经历了不良事件（AE）。与接受安慰剂的1名患者相比，接受TREMFYA®的3名患者经历了严重的AE。接受TREMFYA®的患者没有因AE而停药，而接受安慰剂的4名患者因AE而停药。。

The study is evaluating approximately 338 patients from the U.S. and Canada, who will be treated and followed for 56 weeks. SPECTREM enrolled nearly the same number of male and female participants in both the TREMFYA® and placebo treatment groups (51.6% and 48.4% vs. 50.4% and 49.6%), which reflects the similar prevalence of the disease in both men and women..

该研究正在评估来自美国和加拿大的大约338名患者，他们将接受治疗并随访56周。SPECTREM在TREMFYA®和安慰剂治疗组中招募的男性和女性参与者人数几乎相同（分别为51.6%和48.4%，而50.4%和49.6%），这反映了该疾病在男性和女性中的患病率相似。。

About VISIBLE (NCT05272150)12VISIBLE is a Phase 3b, multicenter, randomized, double-blind, placebo-controlled (Weeks 0-16) trial in adult patients (≥18 years of age) with moderate to severe body and/or scalp PsO. Patients (n=211) were randomized to TREMFYA® 100 mg subcutaneous injection at Weeks 0, 4, and 12, then q8w; placebo at Weeks 0, 4, and 12, followed by crossover to TREMFYA® at Week 16, Week 20, and q8w.

关于VISIBLE（NCT05272150）12VISIBLE是一项针对中度至重度身体和/或头皮PsO的成年患者（≥18岁）的3b期，多中心，随机，双盲，安慰剂对照（第0-16周）试验。患者（n=211）在第0,4和12周随机接受TREMFYA®100 mg皮下注射，然后是q8w；安慰剂在第0周，第4周和第12周，然后在第16周，第20周和第8w周交叉使用TREMFYA®。

The study was designed to evaluate the efficacy and safety of TREMFYA® in skin of color patients (self-identify as non-white) across the entire spectrum of the Fitzpatrick scale (I-VI). The study consisted of 2 cohorts, Cohort A: moderate to severe plaque PsO (IGA ≥3, PASI ≥12, and BSA involvement of ≥10%) and Cohort B: moderate to severe scalp PsO (SSA ≥30%, PSSI ≥12, ss-IGA ≥3, and ≥1 plaque outside the scalp) for at least 6 months before study administration, or central photo review expert confirmed PsO diagnosis, or biopsy confirmed PsO.

该研究旨在评估TREMFYA®在整个Fitzpatrick量表（I-VI）范围内对有色皮肤患者（自我识别为非白人）的疗效和安全性。该研究由2个队列组成，队列A：中度至重度斑块PsO（IGA≥3，PASI≥12，BSA受累≥10%）和队列B：中度至重度头皮PsO（SSA≥30%，PSSI≥12，ss IGA≥3，头皮外≥1个斑块）在研究给药前至少6个月，或中央照片审查专家证实的PsO诊断，或活检证实的PsO。

The VISIBLE study is still ongoing with an active treatment period from Weeks 16-48 and long-term extension through Week 112 where patients continued receiving TREMFYA® q8w. .

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The study will evaluate approximately 211 participants from the U.S. and Canada who will be treated and followed for approximately two years.

这项研究将评估大约211名来自美国和加拿大的参与者，他们将接受大约两年的治疗和随访。

About TREMFYA® (guselkumab)Developed by Johnson & Johnson, 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 cell that produce IL-23). Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model.

关于强生公司开发的TREMFYA®（guselkumab），TREMFYA®是第一个被批准的完全人类双作用单克隆抗体，旨在通过阻断IL-23并与CD64（产生IL-23的细胞上的受体）结合来中和细胞来源的炎症。双重作用的发现仅限于体外研究，证明guselkumab与CD64结合，CD64在炎性单核细胞模型中在产生IL-23的细胞表面表达。

The clinical significance of this finding is not known..

这一发现的临床意义尚不清楚。。

TREMFYA® is approved in the U.S., 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 adult patients with active psoriatic arthritis. TREMFYA® is also now approved in the U.S. for the treatment of adults with moderately to severely active ulcerative colitis..

TREMFYA®在美国、欧洲、加拿大、日本和许多其他国家获得批准，用于治疗患有中度至重度斑块状银屑病的成年人以及治疗患有活动性银屑病关节炎的成年患者。TREMFYA®现在也被美国批准用于治疗患有中度至重度活动性溃疡性结肠炎的成年人。。

Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®.

强生公司拥有TREMFYA®的全球独家营销权。

IMPORTANT SAFETY INFORMATION

重要安全信息

What is the most important information I should know about TREMFYA® (guselkumab)?TREMFYA® is a prescription medicine that may cause serious side effects, including:

关于TREMFYA®（guselkumab），我应该知道的最重要的信息是什么？TREMFYA®是一种可能引起严重副作用的处方药，包括：

Serious Allergic Reactions. Stop using TREMFYA® and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction:

严重过敏反应。如果出现以下任何严重过敏反应症状，请停止使用TREMFYA®，并立即寻求紧急医疗帮助：

fainting, dizziness, feeling lightheaded (low blood pressure)swelling of your face, eyelids, lips, mouth, tongue, or throat

昏厥、头晕、头晕（低血压）面部、眼睑、嘴唇、嘴巴、舌头或喉咙肿胀

trouble breathing or throat tightnesschest tightnessskin rash, hivesitchingInfections. TREMFYA® 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® and may treat you for TB before you begin treatment with TREMFYA® if you have a history of TB or have active TB.

呼吸困难或喉咙紧绷胸闷皮疹、荨麻疹感染。TREMFYA®可能会降低免疫系统抵抗感染的能力，并可能增加感染风险。您的医疗保健提供者应在开始使用TREMFYA®治疗之前检查您的感染和结核病（TB），如果您有结核病病史或患有活动性结核病，则可能在开始使用TREMFYA®治疗之前对您进行结核病治疗。

Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA®.Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:.

您的医疗保健提供者应在使用TREMFYA®治疗期间和之后密切关注您的结核病体征和症状。如果您感染或有感染症状，请立即告知您的医疗保健提供者，包括：。

fever, sweats, or chillsmuscle achesweight losscoughwarm, red, or painful skin or sores on your body different from your psoriasis

发烧、出汗或发冷。与牛皮癣不同，身体上的皮肤或溃疡可能会失去温暖、红色或疼痛

diarrhea or stomach painshortness of breathblood in your phlegm (mucus)burning when you urinate or urinating more often than normalDo not take TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®.

腹泻或胃痛呼吸急促痰中有血（粘液）当您排尿或排尿频率高于正常值时，如果您对guselkumab或TREMFYA®中的任何成分有严重过敏反应，请不要服用TREMFYA®。

Before using TREMFYA®, tell your healthcare provider about all of your medical conditions, including if you:

在使用TREMFYA®之前，请告知您的医疗保健提供者您的所有医疗状况，包括您是否：

have any of the conditions or symptoms listed in the section 'What is the most important information I should know about TREMFYA®?'have an infection that does not go away or that keeps coming back.have TB or have been in close contact with someone with TB.have recently received or are scheduled to receive an immunization (vaccine).

是否有“我应该知道的关于TREMFYA®的最重要信息是什么”一节中列出的任何病症或症状感染不会消失或不断复发。患有结核病或与结核病患者密切接触。最近接受或计划接受免疫接种（疫苗）。

You should avoid receiving live vaccines during treatment with TREMFYA®.are pregnant or plan to become pregnant. It is not known if TREMFYA® can harm your unborn baby.Pregnancy Registry: If you become pregnant during treatment with TREMFYA®, talk to your healthcare provider about registering in the pregnancy exposure registry for TREMFYA®.

在使用TREMFYA®治疗期间，您应避免接种活疫苗。怀孕或计划怀孕。目前尚不清楚TREMFYA®是否会伤害未出生的婴儿。妊娠登记处：如果您在使用TREMFYA®治疗期间怀孕，请与您的医疗保健提供者联系，以登记TREMFYA®的妊娠暴露登记处。

You can enroll by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing MotherToBaby@health.ucsd.edu. The purpose of this registry is to collect information about the safety of TREMFYA® during pregnancy.are breastfeeding or plan to breastfeed. It is not known if TREMFYA® passes into your breast milk.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements..

您可以通过访问www.mothertobaby.org/increating-study/tremfya-guselkumab、致电1-877-311-8972或发送电子邮件进行注册MotherToBaby@health.ucsd.edu.本登记册的目的是收集有关怀孕期间TREMFYA®安全性的信息。是否母乳喂养或计划母乳喂养。目前尚不清楚TREMFYA®是否会进入母乳。告诉你的医疗保健提供者你服用的所有药物，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 TREMFYA®?TREMFYA® may cause serious side effects. See 'What is the most important information I should know about TREMFYA®?'

TREMFYA®可能有哪些副作用？TREMFYA®可能会导致严重的副作用。请参阅“我应该知道的关于TREMFYA®的最重要信息是什么？”

The most common side effects of TREMFYA® include: respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, and bronchitis.

TREMFYA®最常见的副作用包括：呼吸道感染、头痛、注射部位反应、关节痛（关节痛）、腹泻、胃流感（胃肠炎）、真菌皮肤感染、单纯疱疹感染和支气管炎。

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

这些并不是TREMFYA®所有可能的副作用。打电话给你的医生，询问有关副作用的医疗建议。

Use TREMFYA® exactly as your healthcare provider tells you to use it.

严格按照医疗保健提供者的指示使用TREMFYA®。

Please read the full Prescribing Information, including Medication Guide, for TREMFYA® and discuss any questions that you have with your doctor.

请阅读TREMFYA®的完整处方信息，包括药物指南，并与医生讨论您的任何问题。

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

鼓励您向FDA报告处方药的负面副作用。访问www.fda.gov/medwatch，或致电1-800-fda-1088。

Dosage Forms and Strengths: TREMFYA® is available in a 100 mg/mL prefilled syringe and One-Press patient-controlled injector for subcutaneous injection, a 200 mg/2 mL prefilled syringe and prefilled pen (TREMFYA® PEN) for subcutaneous injection, and a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion. .

剂型和强度：TREMFYA®可用于100 mg/mL预填充注射器和一个用于皮下注射的按压患者控制注射器，200 mg/2 mL预填充注射器和预填充笔（TREMFYA®笔）用于皮下注射，以及200 mg/20 mL（10 mg/mL）单剂量小瓶用于静脉输注。。

About Johnson & JohnsonAt 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..

关于强生公司在强生公司，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建立一个预防、治疗和治愈复杂疾病的世界，在这个世界上，治疗更加智能，侵入性更小，解决方案更加个性化。通过我们在创新医学和医学技术方面的专业知识，我们在今天的医疗保健解决方案的全方位创新中处于独特的地位，以实现明天的突破，并深刻影响人类的健康。。

Learn more at https://www.jnj.com/ or at https://www.innovativemedicine.jnj.com/.

Learn more at https://www.jnj.com/ or at https://www.innovativemedicine.jnj.com/.

Follow us at @JanssenUS and @JNJInnovMed.

请访问@JanssenUS和@JNJInnovMed。

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

Janssen Research&Development，LLC、Janssen Biotech，Inc.和Janssen Scientific Affairs，LLC是强生公司。

Cautions Concerning Forward-Looking StatementsThis press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding development of TREMFYA® (guselkumab). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events.

关于前瞻性声明的注意事项本新闻稿包含1995年《私人证券诉讼改革法案》中关于TREMFYA®（guselkumab）发展的“前瞻性声明”。提醒读者不要依赖这些前瞻性陈述。这些声明基于当前对未来事件的预期。

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., Janssen Scientific Affairs, LLC 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.

如果基础假设不准确或出现已知或未知的风险或不确定性，实际结果可能与Janssen Research＆Development，LLC，Janssen Biotech，Inc.，Janssen Scientific Affairs，LLC和/或Johnson＆Johnson的预期和预测有很大差异。风险和不确定性包括但不限于：产品研发固有的挑战和不确定性，包括临床成功和获得监管批准的不确定性；商业成功的不确定性；制造困难和延误；竞争，包括竞争对手取得的技术进步、新产品和专利；专利面临的挑战；导致产品召回或监管行动的产品功效或安全问题；；适用法律法规的变更，包括全球医疗保健改革；以及医疗保健成本控制的趋势。

A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2023, 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 Exchan.

有关这些风险、不确定性和其他因素的更多列表和描述，请参见强生公司截至2023年1月1日的10-K表年度报告，包括标题为“关于前瞻性声明的警示说明”和“项目1A”的章节。以及强生公司随后在10-Q表上的季度报告以及向证券和Exchan提交的其他文件。

© Johnson & Johnson, Inc. 2024. All rights reserved.

©强生公司，2024年。保留所有权利。

1 National Psoriasis Foundation. Psoriasis on High-Impact Sites. Available at: https://www.psoriasis.org/high-impact-sites/. Accessed October 23, 2024.2 Stein Gold L, Strober B, Armstrong AW, et al. SPECTREM: Guselkumab Demonstrates Consistent Significant Clearance at Week 16 Across the Full Range of Low Body Surface Area, Moderate Psoriasis with Special Sites Involvement.

1国家牛皮癣基金会。高影响部位的牛皮癣。网址：https://www.psoriasis.org/high-impact-sites/.2024年10月23日访问。2 Stein Gold L，Strober B，Armstrong AW等人。光谱：Guselkumab在第16周表现出在整个低体表面积，中度牛皮癣和特殊部位受累的持续显着清除。

Poster presented at: 2024 Fall Clinical Dermatology Conference; October 24-27, 2024; Las Vegas, NV.3 Gottlieb AB, Krueger J, Gordon KB, et al. SPECTREM: Guselkumab Demonstrates Significant Clearance at Week 16 Across Special Sites in Participants with Low Body Surface Area, Moderate Psoriasis. Poster presented at: 2024 Fall Clinical Dermatology Conference; October 24-27, 2024; Las Vegas, NV.4 Glick BP, Beecker J, Alonso-Llamazares J, et al.

海报发布于：2024年秋季临床皮肤病学会议；2024年10月24日至27日；内华达州拉斯维加斯3 Gottlieb AB，Krueger J，Gordon KB等。光谱：Guselkumab在第16周表现出在低体表面积，中度牛皮癣参与者的特殊部位显着清除。海报发布于：2024年秋季临床皮肤病学会议；2024年10月24日至27日；内华达州拉斯维加斯4 Glick BP，Beecker J，Alonso-Llamazares J等。

SPECTREM: Guselkumab Demonstrates Consistent Complete Clearance at Week 16 Across Special Sites in Participants with Low Body Surface Area, Moderate Psoriasis. Poster presented at: 2024 Fall Clinical Dermatology Conference; October 24-27, 2024; Las Vegas, NV.5 Soung J, Kelly V, Wiseman M, et al. SPECTREM: Guselkumab Significantly Improves Patient Reported Outcomes at Week 16 in Participants with Low Body Surface Area, Moderate Psoriasis with Special Sites Involvement.

SPECTREM：Guselkumab在第16周表现出在低体表面积，中度牛皮癣参与者的特殊部位持续完全清除。海报发布于：2024年秋季临床皮肤病学会议；2024年10月24日至27日；。

Poster presented at: 2024 Fall Clinical Dermatology Conference; October 24-27, 2024; Las Vegas, NV.6 Ebede T, Papier A. Disparities in dermatology educational resources. J Am Acad Dermatol. 2006;55(4):687-90. doi: 10.1016/j.jaad.2005.7 Yadav G, Yeung J, Miller-Monthrope Y, et al. Unmet Need in People with Psoriasis and Skin of Color in Canada and the United States.

海报发布于：2024年秋季临床皮肤病学会议；2024年10月24日至27日；内华达州拉斯维加斯6 Ebede T，Papier A.皮肤病学教育资源的差异。J Am Acad Dermatol。2006年；55（4）：687-90。doi:10.1016/j.jaad。2005.7 Yadav G，Yeung j，Miller-Monthrope Y等人。加拿大和美国牛皮癣和有色皮肤患者的未满足需求。

Dermatol Ther (Heidelb). 2022;12(11):2401-2413. doi: 10.1007/s13555-022-00811-0.8 National Psoriasis Foundation. About psoriasis. Availabl.

Dermatol Ther（海德堡）。2022年；12（11）：2401-2413。doi:10.1007/s13555-022-00811-0.8国家牛皮癣基金会。关于牛皮癣。可用。

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