New data for investigational nipocalimab in Sjögren's Disease (SjD) and new research on the impact of TREMFYA® (guselkumab) in psoriatic arthritis (PsA) will be highlighted across three oral sessions and a plenary session

将在三次口服会议和全体会议上重点介绍用于研究干燥综合征（SjD）的nipocalimab的新数据以及关于TREMFYA®（guselkumab）对银屑病关节炎（PsA）影响的新研究

Results from the Phase 2 DAHLIAS study of nipocalimab in SjD show nipocalimab met the primary endpoint with a reduction in ClinESSDAI score from baseline and other key efficacy endpoints at Week 24 compared with placebo, presented in a plenary session

在SjD中对nipocalimab进行的第二阶段大丽花研究的结果显示，与安慰剂相比，nipocalimab在第24周达到了主要终点，与基线和其他关键疗效终点相比，ClinESSDAI评分降低

Results from the PsABIOnd observational study highlight the patient-reported impact in psoriatic arthritis (PsA) disease burden following treatment with TREMFYA®, presented as an oral presentation

PsABIOnd观察性研究的结果突出了患者报告的TREMFYA®治疗后对银屑病关节炎（PsA）疾病负担的影响，以口服形式呈现

SPRING HOUSE, Pa., Nov. 7, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that 43 presentations showcasing the Company's rheumatology pipeline and portfolio will be featured at the American College of Rheumatology (ACR) 2024 Annual Meeting. Presentations include three oral sessions and a plenary session, highlighting new data for investigational nipocalimab in SjD and new research on the impact of TREMFYA® in PsA..

宾夕法尼亚州斯普林豪斯，2024年11月7日/PRNewswire/--强生公司（纽约证券交易所：JNJ）今天宣布，将在美国风湿病学会（ACR）2024年年会上展出43篇展示公司风湿病管道和投资组合的演讲。演讲包括三次口头会议和一次全体会议，重点介绍了SjD中nipocalimab研究的新数据以及TREMFYA®对PsA影响的新研究。。

'Johnson & Johnson is proud to share new data and analyses that demonstrate the potential of nipocalimab and support the well-established efficacy and safety profile of TREMFYA®,' said Terence Rooney, M.D., Vice President, Medical Rheumatology Disease Area Leader, Johnson & Johnson Innovative Medicine.

强生创新医学副总裁、医学风湿病领域负责人特伦斯·鲁尼（Terence Rooney，M.D.）说：“强生很荣幸分享新的数据和分析，这些数据和分析证明了nipocalimab的潜力，并支持TREMFYA®的良好疗效和安全性。”。

'This is a testament to our decades-long legacy of innovation and continued exploration of new ways to meet the needs of patients with rheumatic diseases, focusing on treatments that improve patient outcomes.'.

“这证明了我们数十年来的创新遗产，以及不断探索满足风湿性疾病患者需求的新方法，重点是改善患者预后的治疗方法。”。

Progressing research in autoantibody-driven diseasesThe plenary session will feature data from the Phase 2 DAHLIAS study presented earlier this year. The data showed that adult patients who received nipocalimab 15 mg/kg every two weeks demonstrated a greater than 70% relative average improvement on the primary endpoint compared to patients who received placebo.1 More than twice as many patients on 15 mg/kg nipocalimab compared to placebo experienced at least a 50% increase in saliva production at Week 24 in a post-hoc analysis.1.

自身抗体驱动疾病的研究进展全体会议将展示今年早些时候提出的第二阶段大丽花研究的数据。数据显示，与接受安慰剂的患者相比，每两周接受nipocalimab 15 mg/kg的成年患者在主要终点的相对平均改善率高于70%[1]。服用15 mg/kg nipocalimab的患者数量是安慰剂组的两倍以上。在事后分析中，与安慰剂组相比，第24周唾液产量至少增加了50%。

Additional nipocalimab data highlights include:

其他nipocalimab数据亮点包括：

SjD pharmacokinetics (PK), pharmacodynamics (PD), and biomarker data: Two posters will show decreases in rheumatoid factor, circulating immune complexes and all IgG subclasses, and will demonstrate through PK/PD modeling that the median for the maximum potential reduction in total IgG is greater than 77%, providing evidence of interaction of nipocalimab with FcRn and its mechanism of action (MOA) (Abstract #1427 and #2294)Assessment of nipocalimab as an immunoselective investigational therapy: Two posters will be shared showing that nipocalimab-treated study participants respond to vaccines by increasing anti-vaccine IgG levels.

SjD药代动力学（PK），药效学（PD）和生物标志物数据：两张海报将显示类风湿因子，循环免疫复合物和所有IgG亚类的减少，并将通过PK/PD建模证明总IgG最大潜在减少的中位数大于77%，提供了nipocalimab与FcRn相互作用的证据及其作用机制（MOA）（摘要#1427和#2294）评估nipocalimab作为免疫选择性研究疗法：将共享两张海报，显示nipocalimab治疗的研究参与者通过增加抗疫苗IgG水平对疫苗产生反应。

In addition, a majority of rheumatoid arthritis (RA) patients treated with nipocalimab showed anti-vaccine antibody levels consistently above protective thresholds during treatment. (Abstract #1988 and #1976)Driving leadership in IL-23 research across patient typesInterim results from the PsABIOnd study, an ongoing, prospective, observational cohort study, assessing the effect of TREMFYA® and IL-17 inhibitors on patient-perceived impact of PsA will be presented during the abstract session as an oral presentation.

此外，大多数接受nipocalimab治疗的类风湿性关节炎（RA）患者在治疗期间显示抗疫苗抗体水平始终高于保护阈值。（摘要#1988和#1976）推动IL-23研究在患者类型中的领导地位PsABIOnd研究的结果，这是一项正在进行的前瞻性观察性队列研究，评估TREMFYA®和IL-17抑制剂对患者感知的影响PsA将在抽象会议期间作为口头介绍。

The study highlights reductions in joint pain, skin symptoms, and overall disease activity, demonstrating the positive impact of TREMFYA® in PsA..

该研究强调了关节疼痛，皮肤症状和整体疾病活动的减少，证明了TREMFYA®对PsA的积极影响。。

Additional data across broad patient types and disease manifestations (domains) will highlight the benefits of treatment with TREMFYA® for moderate to severe plaque psoriasis (PsO) and active PsA.

广泛的患者类型和疾病表现（领域）的其他数据将突出使用TREMFYA®治疗中度至重度斑块型牛皮癣（PsO）和活性PsA的益处。

The full list of accepted Johnson & Johnson abstracts is below.

以下是公认的强生文摘的完整列表。

Data presentation highlights: ACR Convergence – November 14-19

数据展示亮点：ACR融合–11月14日至19日

**denotes encore

**Denotes再次

Nipocalimab

尼泊卡单抗

Presenter/Presentation Time (ET)

演示者/演示时间（ET）

Poster Number

Abstract Name

摘要名称

Oral Session

口头会议

Abstracts: Genetics, Genomics & Proteomics

Date: Monday, November 18

日期：11月18日星期一

Session Time: 1:00 PM - 2:30 PM

会议时间：下午1:00-2:30

Presentation Time: 2:00 PM - 2:15 PM

演示时间：下午2:00-下午2:15

scRNAseq SjD Predictors of Disease Progression: Sjögren's Disease and Non-Sjögren's Sicca Patient Subsets Exhibit Cell Type-specific Transcriptional Dysregulations That May Identify Early Molecular Predictors Disease Transition

scRNAseq SjD疾病进展的预测因子：Sjögren病和非Sjögren干燥综合征患者亚群表现出细胞类型特异性转录失调，可能识别早期分子预测因子疾病转变

Abstracts: RA – Diagnosis, Manifestations, & Outcomes III: Best Day (RA Subpopulations)

摘要：RA–诊断，表现和结果III：最佳日子（RA亚群）

Date: Sunday, November 17

日期：11月17日星期日

Session Time: 3:00 PM - 4:30 PM

Presentation Time: 3:00 PM - 3:15 PM

演示时间：下午3:00-下午3:15

BRASS 3 RA Remission/Pt Outcomes: What are the Benefits of Treating Rheumatoid Arthritis Patients to Remission After Achieving Low Disease Activity in Clinical Practice?

BRASS 3 RA缓解/Pt结果：在临床实践中实现低疾病活动后，治疗类风湿性关节炎患者缓解有什么益处？

Plenary Session

全体会议

#2527

#2527

Date: Monday, November 18

日期：11月18日星期一

Presentation Time: 9:00 AM - 9:15 AM

演示时间：上午9:00-上午9:15

** Nipo DAHLIAS SjD: Efficacy and Safety of Nipocalimab, an Anti-FcRn Monoclonal Antibody, in Primary Sjogren's Disease: Results From a Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study (DAHLIAS)

**

Poster Session

#1427

#1427

Date: Sunday, November 17

日期：11月17日星期日

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

DAHLIAS SjD PK/PD: Observed and Simulated Pharmacokinetics and Pharmacodynamics of Nipocalimab, a Fully Human FcRn Blocking Monoclonal Antibody, in Adults With Sjögren's Disease: Results From a Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study

大丽花SjD PK/PD：观察和模拟完全阻断人FcRn的单克隆抗体Nipocalimab在成人干燥综合征中的药代动力学和药效学：第二阶段，多中心，随机，安慰剂对照，双盲研究的结果

#2294

#2294

Date: Monday, November 18

日期：11月18日星期一

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

DAHLIAS SjD PD/Clinical Biomarkers: Pharmacodynamic Effects of Nipocalimab on Disease Biomarkers in Patients with Moderate-to-Severe Active Sjögren's Disease: Results from a Multicenter, Randomized, Double-blinded, Placebo-controlled Phase 2 Study

大丽花SjD PD/临床生物标志物：Nipocalimab对中度至重度活动性干燥综合征患者疾病生物标志物的药效学影响：多中心，随机，双盲，安慰剂对照的2期研究结果

#1509

#1509

Date: Sunday, November 17

日期：11月17日星期日

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

GLADEL Infection Score SLE: Validation of a Score for the Prediction of Serious Infection in Patients With Systemic Lupus Erythematosus: Data From a Latin American Lupus Cohort

GLADEL感染评分SLE：系统性红斑狼疮患者严重感染预测评分的验证：来自拉丁美洲狼疮队列的数据

#0639

#0639

Date: Saturday, November 16

日期：11月16日，星期六

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

GLADEL 2.0 Delayed Diagnosis SLE: Delayed Diagnosis in Systemic Lupus Erythematosus

GLADEL 2.0延迟诊断SLE：系统性红斑狼疮的延迟诊断

#1360

#1360

Date: Sunday, November 17

日期：11月17日星期日

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

BRASS 4 RA LDA/HCRU: Impact of Maintaining Low Disease Activity on Patient Outcomes and Healthcare Resource Utilization in Rheumatoid Arthritis Patients Receiving Advanced Treatment

BRASS 4 RA LDA/HCRU：维持低疾病活动对接受晚期治疗的类风湿性关节炎患者预后和医疗资源利用的影响

#0136

#0136

Date: Saturday, November 16

日期：11月16日，星期六

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

LupusNet SLE Pt Characteristics: Demographic and Clinical Characteristics of Patients With SLE Across 5 Registries – The LupusNet Federated Data Network

LupusNet SLE Pt特征：5个登记处（LupusNet联邦数据网络）SLE患者的人口统计学和临床特征

#1331

#1331

Date: Sunday, November 17

日期：11月17日星期日

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

Refractory RA Pt Global Assessment: Does Refractory Rheumatoid Arthritis Status Matter in Modeling Patient Global Assessment Trajectories Over 20 Years in a Large US Registry?

难治性RA Pt全球评估：难治性类风湿性关节炎状态在美国大型登记处模拟患者20年来的全球评估轨迹方面是否重要？

#1988

#1988

Date: Monday, November 18

日期：11月18日星期一

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

** Nipo Effect on Vaccine Response: A Randomized, Open-Label Study on the Effect of Nipocalimab on Vaccine Responses in Healthy Participants

**Nipo对疫苗反应的影响：一项关于Nipocalimab对健康参与者疫苗反应影响的随机开放标签研究

#1976

#1976

Date: Monday, November 18

日期：11月18日星期一

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

** Nipo Anti-Vaccine Ab in RA: Post-Hoc Analysis of Clinically Relevant Anti-Vaccine Antibodies in Participants With Rheumatoid Arthritis Treated With Nipocalimab

**RA中的Nipo抗疫苗抗体：用Nipocalimab治疗的类风湿性关节炎参与者的临床相关抗疫苗抗体的事后分析

#1511

#1511

Date: Sunday, November 17

日期：11月17日星期日

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

** GLADEL Lupus Nephritis Response: Lupus Nephritis and Response to Treatment in Latin America

**唐菖蒲狼疮性肾炎的反应：拉丁美洲的狼疮性肾炎和对治疗的反应

#1510

#1510

Date: Sunday, November 17

日期：11月17日星期日

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

** GLADEL Lupus Nephritis QoL: Impact of Active Lupus Nephritis on the Quality of Life of Patients From a Latin American Lupus Cohort

**GLADEL狼疮性肾炎生活质量：活动性狼疮性肾炎对拉丁美洲狼疮队列患者生活质量的影响

#2416

#2416

Date: Monday, November 18

日期：11月18日星期一

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

** GLADEL Lupus Nephritis Work Productivity: The Impact of Active Lupus Nephritis on Work Productivity in Patients From a Latin American Lupus Cohort

**GLADEL狼疮性肾炎工作效率：活动性狼疮性肾炎对拉丁美洲狼疮队列患者工作效率的影响

#1051

#1051

Date: Sunday, November 17

日期：11月17日星期日

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

** IIM MarketScan LT OC HCRU in DM/PM: Healthcare Costs and Resource Utilization Associated With Long-term Medium-to-High Dose Oral Corticosteroid Use in Patients With Dermatomyositis or Polymyositis

**IIM MarketScan LT OC HCRU在DM/PM中的应用：皮肌炎或多发性肌炎患者长期中高剂量口服皮质类固醇相关的医疗保健成本和资源利用

#2001

#2001

Date: Monday, November 18

日期：11月18日星期一

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

** IIM MarketScan LT OC Complications in DM/PM: Complications and Treatment Use Associated With Long-term Oral Corticosteroid Therapy Among Patients With Dermatomyositis or Polymyositis

**IIM MarketScan LT OC在DM/PM中的并发症：皮肌炎或多发性肌炎患者长期口服皮质类固醇治疗的并发症和治疗使用

Guselkumab

古塞尔库马布

Presenter/Presentation Time (ET)

演示者/演示时间（ET）

Poster Number

海报编号

Abstract Name

摘要名称

Oral Session

口头会议

Session: Abstracts: SpA Including PsA – Treatment II

会议：摘要：SpA，包括PsA–治疗II

PsABIOnd – 6M PSAID-12/PRO: Guselkumab and IL-17 Inhibitors Improve Patient-perceived Impact of Psoriatic Arthritis Similarly: 6-month Interim Results of the PsABIOnd Observational Cohort Study

PsABIOnd–6M PSAID-12/PRO:Guselkumab和IL-17抑制剂可改善患者对银屑病关节炎的感知影响同样：PsABIOnd观察性队列研究的6个月中期结果

Poster Session

海报会议

#0588

#0588

Date: Saturday, November 16

日期：11月16日，星期六

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

GUS Sex Disaggregation @ BL: Sex-Related Differences in Baseline Patient and Disease Characteristics: Post Hoc Analyses of Three Phase 3, Randomized, Double-blind, Placebo-Controlled Studies in Patients With Active Psoriatic Arthritis

GUS性别分类@BL：基线患者和疾病特征的性别相关差异：对活动性银屑病关节炎患者进行的三期随机，双盲，安慰剂对照研究的事后分析

#2342

#2342

Date: Monday, November 18

日期：11月18日星期一

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

GUS Sex Disaggregation – Domain Efficacy: Guselkumab Shows Similar Domain-Specific Efficacy in Females and Males With Active Psoriatic Arthritis: Post Hoc Analyses of Three Phase 3, Randomized, Double-blind, Placebo-Controlled Studies

GUS性别分解-领域功效：Guselkumab在活动性银屑病关节炎的女性和男性中显示出相似的领域特异性功效：三期随机，双盲，安慰剂对照研究的事后分析

#0583

#0583

Date: Saturday, November 16

日期：11月16日，星期六

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

GUS RCT MCII by TNFi and Disease Activity: Impact of Prior Tumor Necrosis Factor Inhibitor Treatment and Baseline Psoriatic Arthritis Disease Activity on Minimal Clinically Important Improvement Thresholds for Efficacy Outcomes: Post hoc Analysis of Three Phase 3 Studies of Guselkumab in Patients With Active Psoriatic Arthritis.

TNFi和疾病活动的GUS RCT MCII：先前的肿瘤坏死因子抑制剂治疗和基线银屑病关节炎疾病活动对疗效结果的最小临床重要改善阈值的影响：对活动性银屑病关节炎患者的Guselkumab三期研究的事后分析。

#1464

#1464

Date: Sunday, November 17

日期：11月17日星期日

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

PsABIOnd - 6M Clinical Outcomes: Guselkumab and IL-17 Inhibitors Show Comparable Treatment Persistence and Effectiveness in Psoriatic Arthritis: 6-month Interim Results of the PsABIOnd Observational Cohort Study

PsABIOnd-6M临床结果：Guselkumab和IL-17抑制剂在银屑病关节炎中显示出可比的治疗持久性和有效性：PsABIOnd观察性队列研究的6个月中期结果

#1912

#1912

Date: Monday, November 18

日期：11月18日星期一

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

PsA RISE Regional GC vs AdvTx: Greater Glucocorticoid and Less Biologic/Targeted Therapy Use in Midwest PsA Patients Despite Prevalent Comorbidity

PsA升高区域GC与AdvTx：尽管合并症普遍存在，但中西部PsA患者的糖皮质激素水平较高，生物/靶向治疗使用较少

#1458

#1458

Date: Sunday, November 17

日期：11月17日星期日

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

TIGERS – Synovial Transcriptome by Sex: Synovial Transcriptomic Sex-Specific Difference in the Response to Biologics in Psoriatic Arthritis Patients

TIGERS-按性别划分的滑膜转录组：银屑病关节炎患者对生物制剂反应的滑膜转录组性别特异性差异

#2316

#2316

Date: Monday, November 18

日期：11月18日星期一

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

TIGERS 2 – PsD Gene Expression by Sex: Gene Expression Profile is Different Between Men and Women in Psoriatic Disease

老虎2-PsD基因的性别表达：银屑病中男性和女性的基因表达谱不同

#1469

#1469

Date: Sunday, November 17

日期：11月17日星期日

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

Spain RWE 2L GUS v TNFi Persistence: Manhattan Study: Observational, Ambispective Study to Describe Persistence and Effectiveness of a Second-line Guselkumab or TNF Inhibitors After First-line TNF Inhibitors for the Treatment of Active Psoriatic Arthritis in Spain

西班牙RWE 2L GUS v TNFi持久性：曼哈顿研究：观察性，双视角研究，描述了一线TNF抑制剂治疗西班牙活动性银屑病关节炎后二线Guselkumab或TNF抑制剂的持久性和有效性

#1904

#1904

Date: Monday, November 18

日期：11月18日星期一

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

IIS Bautista Economic Burden PsA: Evaluation of the Economic Burden of Psoriatic Arthritis: Assessment of Direct and Indirect Costs Using National Administrative Databases at National Level

IIS Bautista经济负担PsA：评估银屑病关节炎的经济负担：使用国家一级的国家行政数据库评估直接和间接成本

#0082

#0082

Date: Saturday, November 16

日期：11月16日，星期六

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

IL-23 in Axial vs Peripheral Entheseal Sites: Comparative Immunology of Entheseal Anchorage Sites Between Spine, Hip and Knee Demonstrates up to 70-Fold Greater IL-23 Induction From Axial Enthesis Bone: A New Angle on the Failure of IL-23 Blockade in Ankylosing Spondylitis

轴向和外周附着点的IL-23：脊柱、髋关节和膝关节附着点的比较免疫学显示，轴向附着骨诱导的IL-23增加了70倍：强直性脊柱炎IL-23阻断失败的新角度

#1456

#1456

Date: Sunday, November 17

日期：11月17日星期日

Presentation Time: 10:30 AM – 12:30 PM

演示时间：上午10:30–下午12:30

MONITOR-PsA BL Characteristics: Real-World Treat-to-Target Strategy in Psoriatic Arthritis: Baseline Characteristics From the MONITOR-PsA Cohort

监测PsA-BL特征：银屑病关节炎的现实治疗目标策略：监测PsA队列的基线特征

#2353

#2353

Date: Monday, November 18

日期：11月18日星期一

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

** D1+D2 cDAPSA Deep Dive: Effects of Guselkumab on cDAPSA Disease Activity State and Its Association With Long-Term Radiographic Progression in a Cohort of Patients With Moderately-Highly Active Psoriatic Arthritis: Post Hoc Analyses of Phase 3 Randomized Controlled Studies

**D1+D2 cDAPSA深潜：Guselkumab对中度高度活动性银屑病关节炎患者队列中cDAPSA疾病活动状态的影响及其与长期影像学进展的关系：3期随机对照研究的事后分析

#1472

#1472

Date: Sunday, November 17

日期：11月17日星期日

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

** GUS cDAPSA Deep Dive by BL Characteristics: Achievement of Low Disease Activity/Remission in Guselkumab-Treated Patients With Moderately-Highly Active Psoriatic Arthritis Regardless of Baseline Characteristics: Pooled Post-Hoc Analysis of Two Phase 3/Randomized Studies

**通过BL特征进行GUS-cDAPSA深度研究：无论基线特征如何，在接受Guselkumab治疗的中度高度活动性银屑病关节炎患者中实现低疾病活动/缓解：两项3期/随机研究的汇总事后分析

#1478

#1478

Date: Sunday, November 17

日期：11月17日星期日

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

** STAR Screening MRI: Associations Between Clinical Characteristics and Screening MRI Findings: Exploratory Analysis of the Ongoing Phase 4, Multicenter, Randomized, Controlled STAR Study of Biologic-naïve Patients With PsA With MRI-confirmed Axial Involvement

**STAR筛查MRI：临床特征与筛查MRI结果之间的关联：对正在进行的4期多中心随机对照STAR研究进行探索性分析，该研究针对未经MRI证实轴向受累的PsA患者

#1474

#1474

Date: Sunday, November 17

日期：11月17日星期日

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

** GUS Severe PsA Disease Activity: Efficacy of Guselkumab in Bionaive Psoriatic Arthritis Patients With Severe Disease Activity:Post-hoc Analysis of a Phase 3, Randomized, Double-blind, Placebo-Controlled Study

**GUS严重PsA疾病活动：Guselkumab对具有严重疾病活动的生物天真型银屑病关节炎患者的疗效：对3期随机双盲安慰剂对照研究的事后分析

#2357

#2357

Date: Monday, November 18

日期：11月18日星期一

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

** GUS NLR CV Risk in PsD: Longitudinal Evaluation of Neutrophil-to-Lymphocyte Ratio in Guselkumab-Treated Patients With Psoriatic Disease and Levels of Systemic Inflammation Associated With Elevated Cardiovascular Risk: Post hoc Analysis of 4 Phase 3, Randomized, Controlled Studies

**PsD中的GUS NLR CV风险：Guselkumab治疗的银屑病患者中性粒细胞与淋巴细胞比率的纵向评估以及与心血管风险升高相关的全身炎症水平：4项3期随机对照研究的事后分析

#0447

#0447

Date: Saturday, November 16

日期：11月16日，星期六

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

** GUS Pooled Pregnancy: Pregnancy Outcomes in Women Exposed to Guselkumab: Review of Cases Reported to the Manufacturer's Global Safety Database

**GUS合并妊娠：暴露于Guselkumab的女性的妊娠结局：对制造商全球安全数据库报告的病例的审查

#2047

#2047

Date: Monday, November 18

日期：11月18日星期一

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

** GUS LTBI Safety Pooled PsD: Safety in Patients With Latent Tuberculosis who Received Concomitant Anti-Tuberculosis Medications: Analysis of 11 Studies of Guselkumab in Psoriatic Disease

**GUS LTBI安全性合并PsD：接受抗结核药物治疗的潜伏性结核病患者的安全性：对11项Guselkumab治疗银屑病研究的分析

#1462

#1462

Date: Sunday, November 17

日期：11月17日星期日

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

** IQVIA GUS vs SC IL-17Ai Persistence: Comparison of On-Label Treatment Persistence in Real-World Patients With Psoriatic Arthritis Receiving Guselkumab Versus Subcutaneous IL-17A Inhibitors

**IQVIA GUS与SC IL-17Ai持续性：接受Guselkumab与皮下IL-17A抑制剂的银屑病关节炎患者标签上治疗持续性的比较

#1136

#1136

Date: Sunday, November 17

日期：11月17日星期日

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

**GUS CD GALAXI 2&3: Efficacy and Safety of Guselkumab Therapy in Patients With Moderately to Severely Active Crohn's Disease: Results of the GALAXI 2 & 3 Phase 3 Studies

**GUS CD GALAXI 2和3：Guselkumab治疗中度至重度活动性克罗恩病患者的疗效和安全性：GALAXI 2和3期研究的结果

#1132

#1132

Date: Sunday, November 17Presentation Time: 10:30 AM - 12:30 PM

Date: Sunday, November 17Presentation Time: 10:30 AM - 12:30 PM

**VEGA UC MoA Wk38: Guselkumab and Golimumab Combination Induction Therapy in Ulcerative Colitis Results in Early Local Tissue Healing That is Sustained Through Guselkumab Maintenance Therapy

**

#0605

#0605

Date: Saturday, November 16

日期：11月16日，星期六

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

**GUS Molecular Differentiation Co-culture: Guselkumab Binding to CD64+ IL-23–producing Myeloid Cells Enhances Potency for Neutralizing IL-23 Signaling

**GUS分子分化共培养：Guselkumab与产生CD64+IL-23的骨髓细胞结合增强了中和IL-23信号传导的效力

Ustekinumab

Ustekinumab

Presenter/Presentation Time (ET)

演示者/演示时间（ET）

Poster Number

海报编号

Abstract Name

摘要名称

Poster Session

海报会议

#0384

#0384

Date: Saturday, November 16

日期：11月16日，星期六

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

UST PK in RWE jPsA: Pharmacokinetics of Ustekinumab in Patients With Juvenile Psoriatic Arthritis in a Real World Opportunistic Study

RWE jPsA中的UST PK:Ustekinumab在青少年银屑病关节炎患者中的药代动力学

#1496

#1496

Date: Sunday, November 17

日期：11月17日星期日

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

** SLE BL Biomarker + Clinical Features: Dysregulated Serum Cytokines in Association With Clinical Manifestations in Patients With Systemic Lupus Erythematosus

**SLE BL生物标志物+临床特征：系统性红斑狼疮患者血清细胞因子失调与临床表现的关系

JNJ-2113

JNJ-2113

Presenter/Presentation Time (ET)

演示者/演示时间（ET）

Poster Number

海报编号

Abstract Name

摘要名称

Poster Session

海报会议

#0303

#0303

Date: Saturday, November 16

日期：11月16日，星期六

Presentation Time: 10:30 AM - 12:30 PM

演示时间：上午10:30-下午12:30

** FRONTIER-2 1Y: Phase 2b, Long-term Extension, Dose-ranging Study of Oral JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis: FRONTIER-2

**FRONTIER-2 1Y：口服JNJ-77242113治疗中重度斑块状银屑病的2b期，长期延长，剂量范围研究：FRONTIER-2

About Sjögren's Disease

关于干燥综合征

Sjögren's disease (SjD) is one of the most prevalent autoantibody-driven diseases for which no therapies are currently approved that treat the underlying and systemic nature of the disease.2 It is a chronic autoimmune disease that is estimated to impact approximately four million people worldwide and is nine times more common in women than men.3,4 SjD is characterized by autoantibody production, chronic inflammation, and lymphocytic infiltration of exocrine glands.

舍格伦病（SjD）是最普遍的自身抗体驱动的疾病之一，目前尚未批准治疗该疾病的潜在和全身性质的疗法。2它是一种慢性自身免疫性疾病，估计会影响全球约400万人，女性的发病率是男性的9倍[3,4]。SjD的特征是自身抗体产生，慢性炎症和外分泌腺的淋巴细胞浸润。

Most patients are affected by mucosal dryness (eyes, mouth, vagina), joint pain and fatigue.2 More than 50% of SjD patients have a moderate to severe form of the condition, and disease burden can be as high as that of rheumatoid arthritis or systemic lupus erythematosus and is often associated with impaired quality of life and functional capacity.5, 3,6.

大多数患者受到粘膜干燥（眼睛，口腔，阴道），关节疼痛和疲劳的影响[2]。超过50%的SjD患者患有中度至重度疾病，疾病负担可能与类风湿性关节炎或系统性红斑狼疮一样高，常与生活质量和功能能力受损有关[5,3,6]。

About Rheumatoid Arthritis

关于类风湿性关节炎

Rheumatoid arthritis (RA) is a chronic, symmetric, inflammatory disease involving the synovial joints.7 RA occurs when the immune system loses its normal state of balanced control and activates sustained inflammation in the soft inner lining of joints, called synovial tissue.8 This inflammation produces joint pain, swelling, and stiffness, and can lead to permanent damage and deformity in structural joint elements like cartilage and bone.8 Significantly reduced physical function and health-related quality of life typically accompany these features.9 Antibody systems, such as rheumatoid factor (RF) and anti-citrullinated protein antibodies (ACPAs) are associated with RA, having been identified based on the antigens these antibodies bind to.10 RA is the most common inflammatory arthritis and affects an estimated 13 million people worldwide.11 It is estimated that 1.5 million people in the United States are affected by RA.8,12.

类风湿性关节炎（RA）是一种涉及滑膜关节的慢性对称性炎症性疾病。当免疫系统失去正常的平衡控制状态并激活关节软内层（称为滑膜组织）的持续炎症时，就会发生RA。这种炎症会产生关节疼痛，肿胀和僵硬，并可能导致软骨和骨骼等结构性关节元件的永久性损伤和畸形。8这些特征通常会导致身体功能和与健康相关的生活质量显着降低。9抗体系统，如类风湿因子（RF）和抗瓜氨酸蛋白抗体（ACPA）与RA相关，已根据这些抗体结合的抗原进行鉴定。10 RA是最常见的炎性关节炎，估计会影响13据估计，美国有150万人受到RA的影响[8,12]。

About Systemic Lupus Erythematosus

关于系统性红斑狼疮

Lupus is a chronic, inflammatory autoimmune disorder that can affect many different body systems, including joints, skin, heart, lungs, kidneys and brain.13 Systemic lupus erythematosus (SLE), the most common form of lupus, can range from mild to severe and is characterized by inflammation of any organ system including kidneys, nervous system, brain or brain vasculature, as well as potential hardening of the arteries or coronary artery disease.14 The disease most often affects women and disproportionately affects women of African American, Hispanic, Asian American, Native Hawaiian and Pacific Islander (AAHPI) and Native American descent compared to Caucasian women.15 Lupus is estimated to affect at least 5 million people worldwide.16.

狼疮是一种慢性炎症性自身免疫性疾病，可影响许多不同的身体系统，包括关节，皮肤，心脏，肺，肾脏和大脑。13系统性红斑狼疮（SLE）是最常见的狼疮形式，范围从轻度到重度，其特征是任何器官系统的炎症，包括肾脏，神经系统，脑或脑血管系统，以及动脉或冠状动脉疾病的潜在硬化。14与白人女性相比，该疾病最常影响女性，对非裔美国人，西班牙裔，亚裔美国人，夏威夷原住民和太平洋岛民（AAHPI）以及美洲原住民血统的女性的影响不成比例。据估计，狼疮影响全球至少500万人.16节。

About Idiopathic Inflammatory Myopathies

关于特发性炎性肌病

Idiopathic inflammatory myopathies (IIM), generally referred to as myositis, are a heterogeneous group of rare, chronic, autoimmune diseases that are characterized by progressive muscle weakness and damage to joints and major organs.17 It is thought to be caused by an overactive immune system that attacks the body's own muscles, skin and other organs, but the specific cause of the disease is unknown.17 The most common symptom of IIM is muscle weakness in the large muscles of the shoulders, neck or hips and can result in difficulty performing typical daily-life activities such as swallowing, walking, driving, climbing stairs, rising from a seated position, turning over in bed and raising arms overhead.17 It is currently estimated that 5-10 people per million are diagnosed with a type of IIM each year.17 .

特发性炎性肌病（IIM），通常被称为肌炎，是一组罕见的慢性自身免疫性疾病，其特征是进行性肌肉无力以及关节和主要器官受损。17它被认为是由过度活跃的免疫系统引起的，该免疫系统攻击人体自身的肌肉，皮肤和其他器官，但疾病的具体原因尚不清楚。17 IIM最常见的症状是肩部，颈部或臀部的大肌肉无力，可能导致难以进行典型的日常生活活动，如吞咽，行走，开车，爬楼梯，从坐姿上升，在床上翻身并在头顶举起手臂。17目前估计，5-10每年每百万人被诊断出患有IIM。

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).18,19,20 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.21 Nearly half of patients with PsA experience moderate fatigue and about 30% suffer from severe fatigue as measured by the modified fatigue severity scale.22 In patients with PsA, comorbidities such as obesity, cardiovascular disease, anxiety and depression are often present.23 Studies show up to 30% of people with plaque PsO also develop PsA.24 Although the exact cause of PsA is unknown, genes, the immune system and environmental factors are all believed to play a role in disease onset.25.

银屑病关节炎（PsA）是一种慢性，免疫介导的炎症性疾病，其特征是外周关节炎症，附着点炎（骨，肌腱和韧带相遇处的疼痛），指关节炎（手指和脚趾的一种炎症，可导致肿胀，香肠状外观），轴性疾病和与斑块状银屑病（PsO）相关的皮肤病变[18,19,20]。该疾病引起关节内和周围的疼痛，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展[21]。根据改良的疲劳严重程度量表，近一半的PsA患者经历中度疲劳，约30%患有严重疲劳[22]。在PsA患者中，经常存在肥胖，心血管疾病，焦虑和抑郁等合并症[23]。研究表明，高达30%的斑块型PsO患者也会发生PsA[24]。尽管PsA的确切原因尚不清楚，但基因，免疫系统和环境因素都被认为在疾病发作中起作用[25]。

About Ulcerative Colitis

关于溃疡性结肠炎

Ulcerative colitis (UC) is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. It is the result of the immune system's overactive response.26 Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.

溃疡性结肠炎（UC）是一种大肠慢性疾病，也称为结肠，其中结肠衬里发炎并形成微小的开放性溃疡或溃疡，产生脓液和粘液。这是免疫系统过度反应的结果。26症状各不相同，但通常可能包括排便不畅和更紧急，直肠出血或血便，持续性腹泻，腹痛，食欲不振，体重减轻和疲劳。

People with UC also have increased rates of depression.27 .

UC患者的抑郁症发病率也有所增加。

About Crohn's Disease

关于克罗恩病

Crohn's disease is one of the two main forms of inflammatory bowel disease, which affects an estimated three million Americans and an estimated four million people across Europe.28,29 Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet, or other environmental factors.30 Symptoms of Crohn's disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever..

克罗恩病是炎症性肠病的两种主要形式之一，在全欧洲约有300万美国人和400万人受到影响。28,29克罗恩病是一种胃肠道慢性炎症，病因不明，但该病与遗传易感性，饮食或其他环境因素可能引发的免疫系统异常有关。克罗恩病的30种症状可能有所不同，但通常包括腹痛和压痛，频繁腹泻，直肠出血，体重减轻和发烧。。

About Nipocalimab

关于Nipocalimab

Nipocalimab is an investigational monoclonal antibody, designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies potentially without impact on other immune functions. This includes autoantibodies and alloantibodies that underlie multiple conditions across three key segments in the autoantibody space including Rare Autoantibody diseases, Maternal Fetal diseases mediated by maternal alloantibodies and Prevalent Rheumatology.1,31,32,33,34,35,36,37,38 Blockade of IgG binding to FcRn in the placenta is also believed to limit transplacental transfer of maternal alloantibodies to the fetus.39,40.

Nipocalimab是一种研究性单克隆抗体，旨在以高亲和力结合以阻断FcRn并降低循环免疫球蛋白G（IgG）抗体的水平，而不会影响其他免疫功能。这包括自身抗体和同种抗体，它们是自身抗体空间中三个关键部分的多种条件的基础，包括罕见的自身抗体疾病，由母体同种抗体介导的母胎疾病和流行的风湿病[1,31,32,33,34,35,36,37,38]。阻断IgG与胎盘中FcRn的结合也被认为限制了母体同种抗体向胎儿的经胎盘转移[39,40]。

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including:

美国食品和药物管理局（FDA）和欧洲药品管理局（EMA）已授予nipocalimab几个关键名称，包括：

U.S. FDA Fast Track designation in hemolytic disease of the fetus and newborn (HDFN) and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021 and fetal neonatal alloimmune thrombocytopenia (FNAIT) in March 2024U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023U.S.

U、 2019年7月，美国食品和药物管理局（FDA）在胎儿和新生儿溶血病（HDFN）和温热自身免疫性溶血性贫血（wAIHA）方面的快速通道指定，2021年12月的gMG和2024U年3月的胎儿新生儿同种免疫性血小板减少症（FNAIT）。S、 2019年12月wAIHA的FDA孤儿药状态，2020年6月的HDFN，2021年2月的gMG，2021年10月的慢性炎症性脱髓鞘性多发性神经病（CIDP）和2023U年12月的FNAIT。S。

FDA Breakthrough Therapy designation for HDFN in February 2024 by the FDA EU EMA Orphan medicinal product designation for HDFN in October 2019About TREMFYA® (guselkumab).

2024年2月，FDA对HDFN进行了突破性治疗指定，2019年10月，FDA欧盟EMA对HDFN进行了孤儿药物指定，关于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.

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

TREMFYA®是美国批准用于治疗以下疾病的处方药：

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).adults with active psoriatic arthritis.adults with moderately to severely active ulcerative colitis.41TREMFYA® 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. .

患有中度至重度斑块状银屑病的成年人，可能会从注射或服用药丸（全身治疗）或光疗（使用紫外线或紫外线治疗）中受益。患有活动性银屑病关节炎的成年人。患有中度至重度活动性溃疡性结肠炎的成年人。41TREMFYA®在欧洲，加拿大，日本和许多其他国家被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人。。

Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®. For more information, visit: www.tremfya.com.

强生公司拥有TREMFYA®的全球独家营销权。有关更多信息，请访问：www.tremfya.com。

Important Safety Information for TREMFYA®

TREMFYA®的重要安全信息

What is the most important information I should know about TREMFYA® (guselkumab)?

关于TREMFYA®（guselkumab），我应该知道的最重要的信息是什么？

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

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 normal

腹泻或胃痛呼吸急促当你排尿或排尿频率高于正常水平时，痰（粘液）中的血液会燃烧

Do not take TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®.

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®可能有哪些副作用？

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

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 STELARA® (ustekinumab)

关于斯特拉拉® （乌司他尼单抗）

STELARA® (ustekinumab), a human interleukin (IL)-12 and IL-23 antagonist, is a prescription medicine approved in the United States to treat:

STELARA®（ustekinumab）是一种人白细胞介素（IL）-12和IL-23拮抗剂，是美国批准用于治疗以下疾病的处方药：

adults and children 6 years and older with moderate to severe psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).adults and children 6 years and older with active psoriatic arthritis.adults 18 years and older with moderately to severely active Crohn's disease.adults 18 years and older with moderately to severely active ulcerative colitis.42Johnson & Johnson maintains exclusive worldwide marketing rights to STELARA®..

6岁及以上患有中度至重度牛皮癣的成年人和儿童，可能会从注射或服用药丸（全身治疗）或光疗（单独使用紫外线或服用药丸治疗）中受益。6岁及以上患有活动性银屑病关节炎的成年人和儿童。18岁及以上患有中度至重度活动性克罗恩病的成年人。18岁及以上患有中度至重度活动性溃疡性结肠炎的成年人。42强生公司拥有STELARA®的全球独家营销权。。

Important Safety Information for STELARA® (Ustekinumab)

STELARA®（Ustekinumab）的重要安全信息

STELARA® is a prescription medicine that affects your immune system. STELARA® can increase your chance of having serious side effects including:

STELARA®是一种影响免疫系统的处方药。STELARA®可以增加您产生严重副作用的机会，包括：

Serious InfectionsSTELARA® may lower your ability to fight infections and may increase your risk of infections. While taking STELARA®, some people have serious infections, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.

严重感染Stelara®可能会降低您抵抗感染的能力，并可能增加您感染的风险。在服用STELARA®时，一些人患有严重感染，可能需要住院治疗，包括结核病（TB），以及由细菌，真菌或病毒引起的感染。

Your doctor should check you for TB before starting STELARA® and watch you closely for signs and symptoms of TB during treatment with STELARA®.If your doctor feels that you are at risk for TB, you may be treated for TB before and during treatment with STELARA®.You should not start taking STELARA® if you have any kind of infection unless your doctor says it is okay..

开始使用STELARA®前，医生应检查您的结核病，并在使用STELARA®治疗期间密切观察您的结核病体征和症状。如果您的医生认为您有患结核病的风险，您可能会在使用STELARA®治疗之前和期间接受结核病治疗。如果你有任何感染，除非你的医生说可以，否则你不应该开始服用STELARA®。。

Before starting STELARA®, tell your doctor if you:

在开始STELARA®之前，如果您：

think you have an infection or have symptoms of an infection such as:fever, sweats, or chillsmuscle achescoughshortness of breathblood in phlegmweight losswarm, red, or painful skin or sores on your bodydiarrhea or stomach painburning when you urinate or urinate more often than normalfeel very tiredare being treated for an infection or have any open cuts.get a lot of infections or have infections that keep coming back.have TB, or have been in close contact with someone with TB.After starting STELARA®, call your doctor right away if you have any symptoms of an infection (see above).

认为你感染了或有感染症状，例如：发烧，出汗或发冷，痰中有血气不足，体重减轻，皮肤发红或疼痛，身体上有溃疡，排尿或排尿频率高于正常水平时腹泻或胃痛，感到非常疲倦正在接受感染治疗或有任何开放性伤口。感染很多或感染不断复发。患有结核病，或与结核病患者密切接触。开始使用STELARA®后，如果您有任何感染症状，请立即致电医生（见上文）。

These may be signs of infections such as chest infections, or skin infections or shingles that could have serious complications. STELARA® can make you more likely to get infections or make an infection that you have worse. People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL–12) and interleukin 23 (IL–23) are at a higher risk for certain serious infections that can spread throughout the body and cause death.

。STELARA®会使你更容易感染或使你的感染更严重。患有遗传问题且身体不产生任何蛋白质白细胞介素12（IL-12）和白细胞介素23（IL-23）的人，患某些严重感染的风险更高，这些感染可在全身传播并导致死亡。

People who take STELARA® may also be more likely to get these infections..

服用STELARA®的人也可能更容易感染。。

Cancers

癌症

STELARA® may decrease the activity of your immune system and increase your risk for certain types of cancer. Tell your doctor if you have ever had any type of cancer. Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving STELARA®. Tell your doctor if you have any new skin growths..

STELARA®可能会降低您的免疫系统活性，并增加您患某些类型癌症的风险。告诉你的医生你是否患过任何类型的癌症。。如果你有任何新的皮肤生长，请告诉你的医生。。

Posterior Reversible Encephalopathy Syndrome (PRES)

后部可逆性脑病综合征（PRES）

PRES is a rare condition that affects the brain and can cause death. The cause of PRES is not known. If PRES is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including: headache, seizures, confusion, and vision problems.

PRES是一种罕见的疾病，会影响大脑并可能导致死亡。PRES的原因尚不清楚。如果早期发现并治疗PRES，大多数人就会康复。如果你有任何新的或恶化的医疗问题，包括头痛、癫痫发作、精神错乱和视力问题，请立即告诉你的医生。

Serious Allergic Reactions

严重过敏反应

Serious allergic reactions can occur. Stop using STELARA® and get medical help right away if you have any symptoms of a serious allergic reaction such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, or skin rash.

可能会发生严重的过敏反应。如果您有任何严重过敏反应的症状，例如：头晕、面部、眼睑、舌头或喉咙肿胀、胸闷或皮疹，请停止使用STELARA®并立即寻求医疗帮助。

Lung Inflammation

肺部炎症

Cases of lung inflammation have happened in some people who receive STELARA® and may be serious. These lung problems may need to be treated in a hospital. Tell your doctor right away if you develop shortness of breath or a cough that doesn't go away during treatment with STELARA®.

一些接受STELARA®治疗的患者发生了肺部炎症，可能很严重。这些肺部问题可能需要在医院治疗。如果您在使用STELARA®治疗期间出现呼吸急促或咳嗽并没有消失，请立即告诉您的医生。

Before receiving STELARA®, tell your doctor about all of your medical conditions, including if you:

在接受STELARA®治疗之前，请告知您的医生您的所有医疗状况，包括您是否：

have any of the conditions or symptoms listed above for serious infections, cancers, or PRES.ever had an allergic reaction to STELARA® or any of its ingredients. Ask your doctor if you are not sure.are allergic to latex. The needle cover on the prefilled syringe contains latex.have recently received or are scheduled to receive an immunization (vaccine).

患有上述严重感染、癌症或PRES的任何病症或症状。曾经对STELARA®或其任何成分产生过过敏反应。如果你不确定是否对乳胶过敏，请咨询你的医生。预充注射器上的针头盖含有乳胶。最近接受或计划接受免疫接种（疫苗）。

People who take STELARA® should not receive live vaccines. Tell your doctor if anyone in your house needs a live vaccine. The viruses used in some types of live vaccines can spread to people with a weakened immune system, and can cause serious problems. You should not receive the BCG vaccine during the one year before receiving STELARA® or one year after you stop receiving STELARA®.have any new or changing lesions within psoriasis areas or on normal skin.are receiving or have received allergy shots, especially for serious allergic reactions.receive or have received phototherapy for your psoriasis.are pregnant or plan to become pregnant.

服用STELARA®的人不应接种活疫苗。如果你家里有人需要活疫苗，请告诉你的医生。某些类型的活疫苗中使用的病毒可以传播给免疫系统较弱的人，并可能导致严重问题。在接受STELARA®之前的一年内或停止接受STELARA®之后的一年内，您不应接种卡介苗。在牛皮癣区域或正常皮肤上有任何新的或变化的病变。正在接受或已经接受过敏注射，特别是对于严重的过敏反应。接受或已经接受牛皮癣的光疗。怀孕或计划怀孕。

It is not known if STELARA® can harm your unborn baby. You and your doctor should decide if you will receive STELARA® if you are breastfeeding or plan to breastfeed. It is thought that STELARA® passes into your breast milk.talk to your doctor about the best way to feed your baby if you receive STELARA®.Tell your doctor about all the medicines you take, including prescription and over–the–counter medicines, vitamins, and herbal supplements.

目前尚不清楚STELARA®是否会伤害未出生的婴儿。如果您正在母乳喂养或计划母乳喂养，您和您的医生应该决定您是否将接受STELARA®。据认为，STELARA®会进入您的母乳。如果您接受STELARA®，请与您的医生谈谈喂养宝宝的最佳方法。告诉你的医生你服用的所有药物，包括处方药和非处方药、维生素和草药补充剂。

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine..

了解你服用的药物。保存一份清单，以便在你买新药时给你的医生和药剂师看。。

When prescribed STELARA®:

Use STELARA® exactly as your doctor tells you to.STELARA® is intended for use under the guidance and supervision of yourdoctor. In children 6 years and older, it is recommended that STELARA® be administered by a healthcare provider. If your doctor decides that you or a caregiver may give your injections of STELARA® at home, you should receive training on the right way to prepare and inject STELARA®.

严格按照医生的指示使用STELARA®。STELARA®是在医生的指导和监督下使用的。对于6岁及以上的儿童，建议由医疗保健提供者管理STELARA®。如果您的医生决定您或护理人员可以在家中注射STELARA®，您应该接受有关准备和注射STELARA®的正确方法的培训。

Your doctor will determine the right dose of STELARA® for you, the amount for each injection, and how often you should receive it. Do not try to inject STELARA® yourself until you or your caregiver have been shown how to inject STELARA® by your doctor or nurse.Common side effects of STELARA® include: nasal congestion, sore throat, and runny nose, upper respiratory infections, fever, headache, tiredness, itching, nausea and vomiting, redness at the injection site, vaginal yeast infections, urinary tract infections, sinus infection, bronchitis, diarrhea, stomach pain, and joint pain.

您的医生将为您确定STELARA®的正确剂量、每次注射的量以及您应该多久注射一次。在医生或护士向您或您的护理人员演示如何注射STELARA®之前，不要尝试自己注射STELARA®。STELARA®的常见副作用包括：鼻塞、喉咙痛和流鼻涕、上呼吸道感染、发烧、头痛、疲倦、瘙痒、恶心和呕吐、注射部位发红、阴道酵母感染、尿路感染、鼻窦感染、支气管炎、腹泻、胃痛和关节痛。

These are not all of the possible side effects with STELARA®. Tell your doctor about any side effect that you experience. Ask your doctor or pharmacist for more information..

这些并不是STELARA®可能产生的所有副作用。告诉你的医生你经历的任何副作用。向你的医生或药剂师询问更多信息。。

Please click to read the full Prescribing Information and Medication Guide for STELARA® and discuss any questions you have with your doctor.

请点击阅读STELARA®的完整处方信息和药物指南，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。

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..

在强生公司，我们相信健康就是一切。我们在医疗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，我们拥有独特的优势，可以在今天的所有医疗保健解决方案中进行创新，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 www.innovativemedicine.jnj.com\

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

Follow us at @JanssenUS and @JNJInnovMed.

请访问@JanssenUS和@JNJInnovMed。

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

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

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“前瞻性声明”，涉及产品开发以及nipocalimab的潜在益处和治疗影响。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. 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.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；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；。

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 December 31, 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 Exchange Commission.

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12月31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。“风险因素”，以及强生公司随后在10-Q表上的季度报告以及向美国证券交易委员会提交的其他文件中。

Copies of these .

这些文件的副本。

1 ClinicalTrials.gov Identifier: NCT04968912. Available at: https://clinicaltrials.gov/study/NCT04968912. Last accessed: February 2024.2 Huang H, Xie W, Geng Y, Fan Y, Zhang Z. Mortality in patients with primary Sjögren's syndrome: a systematic review and meta-analysis. Rheumatology (Oxford). 2021 Sep 1;60(9):4029-4038.

1 ClinicalTrials.gov标识符：NCT04968912。网址：https://clinicaltrials.gov/study/NCT04968912.最后访问时间：2024年2月。2 Huang H，Xie W，Geng Y，Fan Y，Zhang Z.原发性干燥综合征患者的死亡率：系统评价和荟萃分析。风湿病学（牛津）。2021年9月1日；60（9）：4029-4038。

doi: 10.1093/rheumatology/keab364. PMID: 33878179.3 Nat Rev Rheumatol 20, 158–169 (2024). https://doi.org/10.1038/s41584-023-01057-6 4 Beydon, M., McCoy, S., Nguyen, Y. et al. Epidemiology of Sjögren syndrome.5 Hackett KL, et al. Arthritis Care Res (Hoboken). 2012;64(11):1760-1764.6 Carsons SE, Patel BC.

doi:10.1093/风湿病/keab364。PMID:33878179.3 Nat Rev Rheumatol 20158-169（2024）。https://doi.org/10.1038/s41584-023-01057-64 Beydon，M.，McCoy，S.，Nguyen，Y.等人，《干燥综合征的流行病学》。5 Hackett KL等人，《关节炎护理研究》（Hoboken）。2012年；64（11）：1760-1764.6卡森SE，帕特尔BC。

Sjogren Syndrome. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK431049/7 Aletaha D, Smolen JS. Diagnosis and Management of Rheumatoid Arthritis: A Review. JAMA. 2018 Oct 2;320(13):1360-1372.

干燥综合征。[于2023年7月31日更新]。在：StatPearls[互联网]。金银岛（佛罗里达）：StatPearls出版社；2024年1月-。https://www.ncbi.nlm.nih.gov/books/NBK431049/7阿勒塔哈D，斯莫伦JS。类风湿性关节炎的诊断和治疗：综述。杰玛。2018年10月2日；320（13）：1360-1372。

doi: 10.1001/jama.2018.13103. PMID: 30285183.8 Arthritis Foundation. Rheumatoid Arthritis: Causes, Symptoms, Treatments and More. Accessed November 2023. Available at https://www.arthritis.org/diseases/rheumatoid-arthritis.9 Malm K, Bergman S, Andersson ML, Bremander A, Larsson I. Quality of life in patients with established rheumatoid arthritis: A phenomenographic study.

doi:10.1001/jama.2018.13103。PMID:30285183.8关节炎基金会。类风湿性关节炎：病因、症状、治疗等。2023年11月访问。可在https://www.arthritis.org/diseases/rheumatoid-arthritis.9Malm K，Bergman S，Andersson ML，Bremander A，Larsson I.类风湿性关节炎患者的生活质量：现象学研究。

SAGE Open Med. 2017 Jun 7;5:2050312117713647. doi: 10.1177/2050312117713647. PMID: 28611920; PMCID: PMC5466281.10 Myrthe A.M. van Delft, Tom W.J. Huizinga, An overview of autoantibodies in rheumatoid arthritis, Journal of Autoimmunity, Volume 110, 2020, 102392, ISSN 0896-8411, https://doi.org/10.1016/j.jaut.2019.102392.11 Cieza A, et al.

SAGE开放医学2017年6月7日；5： 2050312117713647年。。PMID:28611920；PMCID:PMC5466281.10 Myrthe A.M.van Delft，Tom W.J.Huizinga，《类风湿性关节炎中自身抗体的概述》，《自身免疫杂志》，第1102020、102392卷，ISSN 0896-8411，https://doi.org/10.1016/j.jaut.2019.102392.11Cieza A等人。

'Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Diseas.

“基于2019年全球疾病负担研究的全球康复需求估计：全球疾病负担的系统分析。

Media contact:

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Mobile: (215) 688-6033

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Investor contact: Lauren Johnson

投资者联系人：劳伦·约翰逊

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