首个且唯一，强生IL-23抑制剂获FDA批准，治疗中重度活动性克罗恩病成人-动脉网

U.S. FDA approves TREMFYA® (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn's disease

强生等信源发布 2025-03-20 23:12



可切换为仅中文







TREMFYA

特雷姆萨

is the only IL-23i to demonstrate clinical remission and endoscopic response, both at one year, with a fully subcutaneous induction regimen

是唯一一个在一年内通过完全皮下注射诱导方案显示出临床缓解和内镜反应的IL-23i。

Supported by data from the GALAXI study, TREMFYA

GALAXI 研究的数据支持，TREMFYA

is the only IL-23i to show superiority versus STELARA

是唯一显示优于STELARA的IL-23i

in all pooled endoscopic endpoints within a double-blinded registrational trial

在双盲注册试验的所有汇总内镜终点中

TREMFYA

特诺雅

approval in Crohn's disease builds upon recent ulcerative colitis FDA approval, marking the fourth indication for this dual-acting IL-23i in the U.S.

克罗恩病的获批是基于近期溃疡性结肠炎的FDA批准，标志着这款双重作用的IL-23i在美国的第四个适应症。

HORSHAM, Pa.

宾夕法尼亚州霍舍姆

，

March 20, 2025

2025年3月20日

/PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA

/PRNewswire/ -- 强生公司（纽约证券交易所代码：JNJ）今天宣布，美国食品药品监督管理局 (FDA) 已批准 TREMFYA

(guselkumab), the first and only IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options, for the treatment of adults with moderately to severely active Crohn's disease (CD), a chronic inflammatory condition of the gastrointestinal tract.

（古塞库单抗）是首个也是唯一一个提供皮下（SC）和静脉（IV）诱导选项的IL-23抑制剂，用于治疗中度至重度活动性克罗恩病（CD）成人患者，这是一种胃肠道的慢性炎症性疾病。

This milestone builds upon the FDA approval of TREMFYA

这一里程碑建立在TREMFYA获得FDA批准的基础之上

in moderately to severely active ulcerative colitis (UC), one of two main forms of inflammatory bowel disease (IBD),

在中度至重度活动性溃疡性结肠炎（UC）中，这是炎症性肠病（IBD）的两种主要形式之一，

which impacts the lives of nearly three million Americans.

这影响了近三百万美国人的生活。

TREMFYA

特雷姆法

is the first and only approved fully-human, dual-acting monoclonal antibody 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 CD..

是第一个也是唯一一个获批的全人源、双重作用的单克隆抗体，能够阻断IL-23的同时结合到产生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一种细胞因子，已知是包括克罗恩病在内的免疫介导疾病的一个驱动因素。

4,5,6,7,8

4，5，6，7，8

'Despite the progress in the management of Crohn's disease, many patients experience debilitating symptoms and are in need of new treatment options,' said Remo Panaccione, MD, FRCPC, Professor of Medicine and the Director of the Inflammatory Bowel Disease Unit at the University of Calgary and lead investigator of the Phase 3 GRAVITI study.

“尽管克罗恩病的管理取得了进展，但许多患者仍会出现令人虚弱的症状，并且需要新的治疗选择，”卡尔加里大学医学教授、炎症性肠病科主任、3期GRAVITI研究的首席研究员雷莫·帕纳乔内（Remo Panaccione）博士说道。

'The approval of TREMFYA offers an IL-23 inhibitor that has shown robust rates of endoscopic remission with both subcutaneous and intravenous induction regimens. Importantly, the fully subcutaneous regimen offers choice and flexibility for patients and providers that have not been available before.'.

“TREMFYA的批准提供了一种IL-23抑制剂，该抑制剂在内镜缓解率方面表现出强劲的效果，无论是皮下注射还是静脉注射诱导方案。重要的是，全皮下注射方案为患者和医生提供了前所未有的选择和灵活性。”

This approval is supported by results from multiple rigorous Phase 3 trials evaluating more than 1,300 patients with moderately to severely active CD who failed or were intolerant to conventional therapy (i.e. corticosteroids or immunomodulators) or biologics.

该批准得到了多项严格的 III 期试验结果的支持，这些试验评估了超过 1,300 名中度至重度活动性 CD 患者，这些患者对传统疗法（如皮质类固醇或免疫调节剂）或生物制剂无效或不耐受。

The GRAVITI study evaluated TREMFYA

GRAVITI 研究评估了 TREMFYA

SC induction and maintenance therapy versus placebo. Data from the GALAXI clinical program showed TREMFYA

皮下注射诱导和维持治疗与安慰剂对比。GALAXI 临床项目的数据表明 TREMFYA

was superior to STELARA

优于STELARA

in all pooled endoscopic endpoints, the only IL-23 inhibitor to achieve this in a double-blinded registrational program. The comprehensive results from these Phase 3 studies demonstrated the robust efficacy of SC or IV TREMFYA

在所有汇集的内镜终点中，是唯一一个在双盲注册研究中达到这一目标的IL-23抑制剂。这些3期研究的综合结果证明了皮下注射或静脉注射TREMFYA的显著疗效。

in achieving clinical and endoscopic endpoints. Highlights from these pivotal studies showed:

在实现临床和内镜终点方面。这些关键研究的亮点显示：

Week 12 Results

第12周结果

GRAVITI

重力

GALAXI 2

银河系 2

GALAXI 3

银河系 3

TREMFYA

特雷姆扎

400 mg SC

400毫克皮下注射

induction at Weeks 0, 4

在第0周、第4周进行诱导

and 8 vs. placebo

和8 vs. 安慰剂

TREMFYA

特润吉亚

200 mg IV

200毫克静脉注射

induction at Weeks 0, 4

第0周、第4周诱导

and 8 vs. placebo

和8对比安慰剂

TREMFYA

特诺雅

200 mg IV

200毫克静脉注射

induction at Weeks 0, 4

第0周、第4周进行诱导

and 8 vs. placebo

和8 vs. 安慰剂

Clinical remission

临床缓解

56% vs. 22% (p<0.001)

56% 对 22% （p<0.001）

47% vs. 20% (p<0.001)

47% 对比 20% （p<0.001）

47% vs. 15% (p<0.001)

47% 对比 15% （p<0.001）

Endoscopic response

内镜反应

34% vs. 15% (p<0.001)

34% 对比 15% （p<0.001）

36% vs. 9% (p<0.001)

36% 对 9% （p<0.001）

34% vs. 13% (p<0.001)

34% 对 13% （p<0.001）

Week 48 Results

第48周结果

GRAVITI

重力

TREMFYA

特诺雅

100 mg SC maintenance

100毫克皮下注射维持量

q8w starting at Week 16 vs. placebo

从第16周开始，q8w与安慰剂对比

TREMFYA

特诺雅

200 mg SC maintenance

200毫克皮下注射维持剂量

q4w starting at Week 12 vs. placebo

从第12周开始，q4w与安慰剂对比

Clinical remission

临床缓解

59% vs. 17%

59% 对 17%

65% vs. 17%

65% 对 17%

Endoscopic response

内镜反应

39% vs. 5%

39% 对 5%

48% vs. 5%

48% 对 5%

Endoscopic remission

内镜缓解

31% vs. 6%

31% 对 6%

40% vs. 6%

40% 对比 6%

Deep remission (clinical

深度缓解（临床）

& endoscopic

& 内窥镜的

remission)

缓解）

26% vs. 4%

26% 对 4%

34% vs. 4%

34% 对 4%

'TREMFYA is the first and only IL-23 inhibitor that offers a fully subcutaneous treatment option for moderately to severely active Crohn's disease. With the approval of TREMFYA, it is now possible to achieve meaningful improvements in clinical and endoscopic outcomes with the flexibility of self-administration from the start,' said Chris Gasink, MD, Vice President, Medical Affairs, Gastroenterology & Autoantibody, Johnson & Johnson Innovative Medicine.

“TREMFYA 是首个也是唯一一个为中度至重度活动性克罗恩病提供完全皮下注射治疗选择的 IL-23 抑制剂。随着 TREMFYA 的获批，现在可以在治疗开始时通过灵活的自我给药方式实现临床和内镜结果的显著改善，”杨森创新药物公司胃肠病学与自身抗体医学事务副总裁 Chris Gasink 医学博士表示。

'TREMFYA provides people living with Crohn's disease and their healthcare providers a new treatment option that is supported by data from multiple Phase 3 studies, including pooled analyses showing statistical superiority versus STELARA across four endoscopic or combined clinical and endoscopic endpoints.'.

“TREMFYA为克罗恩病患者及其医疗保健提供者提供了一种新的治疗选择，该选择得到了多项三期研究数据的支持，包括汇总分析显示在四个内镜或联合临床和内镜终点上相较于STELARA具有统计学优势。”

TREMFYA

特诺雅

dosing in the treatment of moderately to severely active CD:

在中度至重度活动性CD的治疗中给药：

The recommended SC induction dosage is 400 mg (given as two consecutive injections of 200 mg each, dispensed in one Induction Pack) at Weeks 0, 4 and 8. TREMFYA

推荐的皮下注射诱导剂量为400毫克（分为两次连续注射，每次200毫克，装在一个诱导包装中），在第0周、第4周和第8周给药。TREMFYA

is also available in a 200 mg prefilled syringe. For the IV induction option, 200 mg IV infusions are administered at Weeks 0, 4 and 8.

也可提供200毫克预填充注射器。对于静脉诱导选项，将在第0、4和8周给予200毫克静脉输注。

Recommended maintenance dosage is 100 mg administered by SC injection at Week 16, and every 8 weeks thereafter, or 200 mg administered by SC injection at Week 12, and every 4 weeks thereafter. Healthcare providers are instructed to use the lowest effective recommended dosage to maintain therapeutic response..

推荐的维持剂量为在第16周通过皮下注射给予100 mg，此后每8周一次，或在第12周通过皮下注射给予200 mg，此后每4周一次。医疗保健提供者被指示使用最低的有效推荐剂量以保持治疗反应。

Johnson & Johnson is committed to supporting access to all its treatments, including offering a patient support program called TREMFYA

强生公司致力于支持其所有治疗方案的可及性，包括提供名为TREMFYA的患者支持计划。

withMe. For commercially insured patients, adults who are prescribed TREMFYA

与我一起。对于商业保险的患者，成人被处方TREMFYA

for CD may be eligible to receive their first induction treatment in as little as 24 hours through TREMFYA

对于CD患者，可能在短短24小时内通过TREMFYA接受首次诱导治疗

withMe.

和我一起。

This approval marks the fourth indication for TREMFYA

该批准标志着TREMFYA的第四个适应症。

in the U.S., following moderate-to-severe plaque psoriasis in July 2017, active psoriatic arthritis in July 2020 and moderately to severely active UC in September 2024,

在美国，继2017年7月的中度至重度斑块型银屑病、2020年7月的活动性银屑病关节炎以及2024年9月的中度至重度活动性UC之后，

underscoring Johnson & Johnson's long-standing legacy in innovation and commitment to patients living with chronic immune-mediated diseases, including IBD. In November 2024, Johnson & Johnson

强调了强生公司在创新和致力于治疗慢性免疫介导疾病（包括IBD）患者方面的悠久传统。2024年11月，强生公司

submitted

已提交

a supplemental Biologics License Application (sBLA) to the FDA seeking approval of a SC induction regimen of TREMFYA

向FDA提交了一份补充生物制品许可申请（sBLA），寻求批准TREMFYA的皮下注射诱导方案。

for the treatment of adults with moderately to severely active UC, based on results of the Phase 3 ASTRO study.

基于3期ASTRO研究的结果，用于治疗中度至重度活动性UC的成人患者。

Editor's Notes:

编辑备注：

a) CD64+ cells are the predominant source of IL-23 in CD. Cells not expressing CD64 may also contribute to IL-23 production but to a lesser extent.

a) CD64+ 细胞是克罗恩病 (CD) 中 IL-23 的主要来源。不表达 CD64 的细胞也可能对 IL-23 的产生有贡献，但程度较低。

1,3

b) 'Only' based on approved selective IL-23 inhibitors for moderately to severely active CD as of March 2025.

b) 仅基于截至2025年3月获批的针对中度至重度活动性CD的选择性IL-23抑制剂。

6,7,8

c) Based on in vitro studies in an inflammatory monocyte model.

c) 基于炎症性单核细胞模型的体外研究。

d) Moderately to severely active CD was defined as a Crohn's Disease Activity Index (CDAI) score of ≥220 and a Simple Endoscopic Score for Crohn's Disease (SES-CD) of ≥6 (or ≥4 for subjects with isolated ileal disease).

中度至重度活动性CD定义为克罗恩病活动指数（CDAI）评分≥220，且克罗恩病简化内镜评分（SES-CD）≥6（或对于孤立性回肠疾病患者≥4）。

e) Clinical remission was defined as a CDAI score of <150.

临床缓解定义为CDAI评分<150。

，6

f) Endoscopic response is defined as >50% improvement from baseline in SES-CD score.

f) 内镜反应定义为SES-CD评分较基线改善超过50%。

g) Endoscopic remission was defined as an SES-CD score ≤4 and at least a 2-point reduction from baseline and no subscore greater than 1 in any individual component.

g) 内镜缓解定义为SES-CD评分≤4，且较基线至少减少2分，并且任何单个组成部分的子评分均不大于1。

h) q4w is defined as every four weeks.

h) q4w 定义为每四周。

i) q8w is defined as every eight weeks.

每八周一次定义为q8w。

j) Dr. Panaccione is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.

j) Panaccione 博士是 Johnson & Johnson 的付费顾问。他未因任何媒体工作获得报酬。

ABOUT THE GRAVITI STUDY (

关于GRAVITI研究（

NCT05197049

)

GRAVITI is a randomized, double-blind, placebo-controlled Phase 3 study to evaluate guselkumab SC induction therapy (400 mg at Weeks 0, 4, and 8) in patients with moderately to severely active Crohn's disease who experienced an inadequate response or failed to tolerate conventional therapy (i.e., corticosteroids or immunomodulators) or biologic therapy (TNF antagonists or vedolizumab)..

GRAVITI是一项随机、双盲、安慰剂对照的3期研究，旨在评估古塞库单抗皮下注射诱导疗法（第0、4和8周给予400毫克）在中度至重度活动性克罗恩病患者中的疗效，这些患者对传统疗法（如皮质类固醇或免疫调节剂）反应不足或无法耐受，或对生物疗法（TNF拮抗剂或维多珠单抗）无效。

Patients received guselkumab 400 mg SC q4w (x3) followed by guselkumab 200 mg SC q4w; or guselkumab 400 mg SC q4w (x3) followed by guselkumab 100 mg SC q8w; or placebo. The maintenance doses in GRAVITI (200 mg SC q4w and 100 mg SC q8w) are the same as those evaluated in the Phase 3 GALAXI 2 and GALAXI 3 studies that evaluated the efficacy and safety of IV induction followed by SC maintenance therapy in patients with moderate to severely active Crohn's disease.

患者接受400 mg皮下注射guselkumab每4周一次（共3次），随后接受200 mg皮下注射guselkumab每4周一次；或400 mg皮下注射guselkumab每4周一次（共3次），随后接受100 mg皮下注射guselkumab每8周一次；或安慰剂。GRAVITI研究中的维持剂量（200 mg皮下注射每4周一次和100 mg皮下注射每8周一次）与在中度至重度活动性克罗恩病患者中评估静脉诱导后皮下维持治疗的疗效和安全性的3期GALAXI 2和GALAXI 3研究中评估的剂量相同。

Similar to GALAXI, GRAVITI employed a treat-through design, in which patients were randomized to guselkumab at Week 0 and remained on that regimen throughout the study, regardless of clinical response status at the end of induction. Participants randomized to placebo were able to receive guselkumab (400 mg SC q4w x3 ➔ 100 mg SC q8w) if rescue criteria were met at Week 16..

与GALAXI类似，GRAVITI采用了贯穿治疗设计，患者在第0周被随机分配接受古塞库单抗，并在整个研究期间保持该方案，无论在诱导期结束时的临床反应状态如何。如果在第16周达到救援标准，被随机分配至安慰剂组的参与者可以接受古塞库单抗（400 mg SC q4w x3 ➔ 100 mg SC q8w）。

ABOUT THE GALAXI PROGRAM (

关于银河计划 (

NCT03466411

)

GALAXI is a randomized, double-blind, placebo-controlled, active-controlled (ustekinumab), global, multicenter Phase 2/3 program designed to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active Crohn's disease with inadequate response/intolerance to conventional therapies (corticosteroids or immunomodulators) and/or biologics (TNF antagonists or vedolizumab)..

GALAXI是一项随机、双盲、安慰剂对照、活性对照（ustekinumab）的全球多中心2/3期临床项目，旨在评估guselkumab在对传统疗法（皮质类固醇或免疫调节剂）和/或生物制剂（TNF拮抗剂或vedolizumab）反应不足或不耐受的中重度活动性克罗恩病患者中的疗效和安全性。

GALAXI includes a Phase 2 dose-ranging study (GALAXI 1) and two independent, identically designed confirmatory Phase 3 studies (GALAXI 2 and 3).

GALAXI 包括一项二期剂量范围研究 (GALAXI 1) 和两项独立设计相同的三期确证性研究 (GALAXI 2 和 3)。

Each GALAXI study employed a treat-through design in which participants remained on the treatment to which they were initially randomized and includes a long-term extension study that will assess clinical, endoscopic, and safety outcomes with guselkumab through a total of five years. Patients received guselkumab 200 mg intravenous induction at Weeks 0, 4 and 8 followed by guselkumab 200 mg subcutaneous maintenance every 4 weeks; or guselkumab 200 mg intravenous induction at Weeks 0, 4 and 8, followed by guselkumab 100 mg subcutaneous maintenance every 8 weeks; or a biologic active control; or placebo.

每个GALAXI研究都采用了持续治疗设计，即参与者继续接受他们最初随机分配的治疗，并包括一个长期扩展研究，该研究将通过总共五年的随访评估古塞库单抗的临床、内镜和安全性结果。患者在第0、4和8周接受200 mg静脉注射诱导剂量的古塞库单抗，随后每4周接受200 mg皮下注射维持剂量；或在第0、4和8周接受200 mg静脉注射诱导剂量，随后每8周接受100 mg皮下注射维持剂量；或接受一种生物活性对照药物；或接受安慰剂。

Participants randomized to placebo were able to receive ustekinumab if clinical response was not met at Week 12. Of the 873 individuals pooled across the GALAXI 2 & 3 dataset, 456 (52 percent) had prior history of inadequate response to biologics, 365 (42 percent) were biologic-naïve and 52 (6 percent) were biologic experienced without documented inadequate response or intolerance..

如果在第12周未达到临床反应，随机分配到安慰剂组的参与者可以接受乌司奴单抗。在GALAXI 2和3数据集中汇总的873人中，456人（52%）既往有对生物制剂反应不足的历史，365人（42%）为生物制剂初治者，52人（6%）为有生物制剂使用经验但无记录显示反应不足或不耐受的患者。

The GALAXI 2 and GALAXI 3 studies were the first-ever double-blind registrational head-to-head clinical trials to demonstrate superiority versus ustekinumab in Crohn's disease, showing guselkumab was superior to ustekinumab in all endoscopic-based endpoints when analyzed with pooled data.

GALAXI 2 和 GALAXI 3 研究是首个双盲注册头对头临床试验，证明在克罗恩病治疗中优于乌司奴单抗，汇总数据显示，在所有基于内镜的终点指标上，古塞库单抗均优于乌司奴单抗。

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.

克罗恩病是炎症性肠病的两种主要形式之一，影响着大约三百万美国人。

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.

克罗恩病是一种慢性炎症性胃肠道疾病，病因不明，但该疾病与免疫系统的异常有关，可能由遗传易感性、饮食或其他环境因素触发。

Symptoms of Crohn's disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever. Currently no cure is available for Crohn's disease.

克罗恩病的症状可能有所不同，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。目前尚无治愈克罗恩病的方法。

ABOUT TREMFYA® (guselkumab)

关于特姆瓦®（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（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表达于炎症性单核细胞模型中产生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成人患者。

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、日本及许多其他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® 的最重要信息是什么？

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

TREMFYA® 是一种处方药，可能会引起严重的副作用，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：

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

昏厥、头晕、感觉头重脚轻（低血压）

ο 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

ο trouble breathing or throat tightness

呼吸困难或喉咙紧缩感

ο chest tightness

胸闷

ο skin rash, hives

皮肤疹，荨麻疹

ο itching

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患有感染和结核病（TB）。

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

在开始使用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治疗期间及治疗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：

ο fever, sweats, or chills

发热、出汗或寒战

ο muscle aches

肌肉疼痛

ο weight loss

重量损失

ο cough

咳嗽

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

身体上出现与牛皮癣不同的温暖、红色或疼痛的皮肤或疮疡。

ο diarrhea or stomach pain

腹泻或胃痛

ο shortness of breath

呼吸急促

ο blood in your phlegm (mucus)

痰中带血（粘液）

ο 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。

. 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，请立即告诉您的医疗保健提供者，如果您注意到以下任何症状：

ο unexplained rash

无法解释的皮疹

ο vomiting

呕吐

ο tiredness (fatigue)

疲惫（疲劳）

ο yellowing of the skin or the whites of your eyes

皮肤或眼白发黄

ο nausea

恶心

ο stomach pain (abdominal)

胃痛（腹部）

ο loss of appetite

食欲不振

ο 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的过敏反应

。

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健康状况，包括：

have any of the conditions or symptoms listed in the section

拥有该章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®，我应该了解的最重要的信息是什么？”

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

感染一直不好或者反复发作。

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

患有结核病或与结核病患者有过密切接触。

have recently received or are scheduled to receive an immunization (vaccine). You 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

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

：如果您在使用 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

. 您可以通过访问以下网址进行注册

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

, by calling

，通过调用

1-877-311-8972

, or emailing

，或者发送电子邮件至

MotherToBaby@health.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。目前尚不清楚TREMFYA是否

passes into your breast milk.

传递到你的母乳中。

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®?

TREMFYA® 有哪些可能的副作用？

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

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

The most common side effects of TREMFYA® include:

TREMFYA® 最常见的副作用包括：

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 的全部可能副作用

. Call your doctor for medical advice about side effects.

因副作用需要医疗建议时，请咨询您的医生。

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告诉您的方式使用。

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® and discuss any questions that you have with your doctor.

，对于TREMFYA®，并与您的医生讨论您有的任何问题。

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

，或者致电

1-800-FDA-1088

。

Dosage Forms and Strengths

剂型和规格

: TREMFYA

：特雷姆亚

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.

可作为100毫克/毫升和200毫克/2毫升的皮下注射剂，以及200毫克/20毫升（10毫克/毫升）的单剂量静脉输注小瓶。

ABOUT STELARA® (ustekinumab)

关于STELARA®（乌司奴单抗）

STELARA

喜达诺

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

（乌司奴单抗）是一种人类白细胞介素（IL）-12 和 IL-23 拮抗剂，是美国批准的处方药，用于治疗。

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).

6岁及以上中度至重度银屑病成人和儿童，可能受益于注射或口服药物（系统治疗）或光疗（单独使用紫外线或与药物联合治疗）。

adults and children 6 years and older with active psoriatic arthritis.

6岁及以上的成人和儿童，患有活动性银屑病关节炎。

adults 18 years and older with moderately to severely active Crohn's disease.

18岁及以上的中度至重度活动性克罗恩病成人患者。

adults 18 years and older with moderately to severely active ulcerative colitis.

18岁及以上患有中度至重度活动性溃疡性结肠炎的成人。

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA

强生旗下的杨森制药公司拥有STELARA的全球独家营销权。

。

IMPORTANT SAFETY INFORMATION

重要安全信息

STELARA

乌司奴单抗

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

是一种影响免疫系统的处方药。STELARA® 可能增加出现严重副作用的几率，包括：

Serious Infections

严重感染

STELARA

喜达诺

may lower your ability to fight infections and may increase your risk of infections. While taking STELARA

可能会降低你抵抗感染的能力，并可能增加你感染的风险。在使用STELARA时

, some people have serious infections, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.

，一些人患有严重的感染，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

在开始使用STELARA之前，您的医生应为您检查结核病。

and watch you closely for signs and symptoms of TB during treatment with STELARA

在使用STELARA治疗期间，密切观察您是否有结核病的体征和症状。

。

If your doctor feels that you are at risk for TB, you may be treated for TB before and during treatment with STELARA

如果您的医生认为您有感染结核病的风险，您可能在使用STELARA治疗之前和期间接受结核病的治疗。

。

You should not start taking STELARA

您不应该开始服用STELARA

if you have any kind of infection unless your doctor says it is okay.

如果你有任何感染，除非你的医生说可以。

Before starting STELARA®, tell your doctor if you:

在开始使用STELARA®之前，如果您有以下情况，请告诉您的医生：

think you have an infection or have symptoms of an infection such as:

认为你有感染或有感染症状，例如：

fever, sweats, or chills

发烧、出汗或发冷

muscle aches

肌肉酸痛

cough

咳嗽

shortness of breath

呼吸急促

blood in phlegm

痰中带血

weight loss

减肥

warm, red, or painful skin or sores on your body

身体上出现温暖、发红、疼痛的皮肤或疮疖

diarrhea or stomach pain

腹泻或胃痛

burning when you urinate or urinate more often than normal

排尿时灼痛或比正常情况更频繁地排尿

feel very tired

感觉非常累

are being treated for an infection or have any open cuts.

正在接受感染治疗或有任何开放性伤口。

get a lot of infections or have infections that keep coming back.

感染很多或反复感染。

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

患有结核病，或与结核病患者有过密切接触。

After starting STELARA®, call your doctor right away

开始使用STELARA®后，请立即致电您的医生

if you have any symptoms of an infection (see above). These may be signs of infections such as chest infections, or skin infections or shingles that could have serious complications. STELARA

如果您有任何感染症状（见上文），这些可能是感染的迹象，例如胸部感染、皮肤感染或带状疱疹，可能会导致严重并发症。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.

会使你更容易感染或使你现有的感染更严重。那些有基因问题导致身体无法生成白细胞介素12 (IL-12) 和白细胞介素23 (IL-23) 的人，面临某些严重感染的更高风险，这些感染可能扩散至全身并导致死亡。

People who take STELARA.

使用STELARA的人。

may also be more likely to get these infections.

也可能更容易感染这些疾病。

Cancers

癌症

STELARA

乌司奴单抗

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

可能会降低您免疫系统的活性并增加您患某些类型癌症的风险。如果您曾经患有任何类型的癌症，请告诉您的医生。一些有皮肤癌风险因素的人在使用STELARA期间出现了某些类型的皮肤癌。

. Tell your doctor if you have any new skin growths.

告诉你的医生你是否有任何新的皮肤增生。

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是一种罕见的脑部疾病，可能致命。PRES的病因尚不清楚。如果早期发现并治疗PRES，大多数人能够康复。如果你有任何新的或恶化的健康问题，包括头痛、癫痫发作、意识模糊和视力问题，请立即告知你的医生。

Serious Allergic Reactions

严重过敏反应

Serious allergic reactions can occur. Stop using STELARA

可能会发生严重的过敏反应。停止使用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.

如果出现任何严重过敏反应的症状，如感到头晕、面部、眼睑、舌头或喉咙肿胀、胸闷或皮肤皮疹，请立即就医。

Lung Inflammation

肺部炎症

Cases of lung inflammation have happened in some people who receive STELARA

一些接受STELARA治疗的人发生了肺部炎症的病例。

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

并且可能很严重。这些肺部问题可能需要在医院治疗。如果在使用STELARA治疗期间出现呼吸急促或持续不愈的咳嗽，请立即告诉您的医生。

。

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

在使用STELARA®之前，请告知医生您的所有健康状况，包括：

have any of the conditions or symptoms listed above for serious infections, cancers, or PRES.

具有上述严重感染、癌症或PRES所列的任何情况或症状。

ever had an allergic reaction to STELARA

曾经对STELARA产生过过敏反应

or any of its ingredients. Ask your doctor if you are not sure.

或其任何成分。如果你不确定，请咨询你的医生。

are allergic to latex. The needle cover on the prefilled syringe contains latex.

对乳胶过敏。预装注射器的针头盖含有乳胶。

have recently received or are scheduled to receive an immunization (vaccine). People who take STELARA

最近已接种或计划接种疫苗的人。使用STELARA的人

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.

不应该接种活疫苗。如果你家里的任何人需要接种活疫苗，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，并可能导致严重的问题。

You should not receive the BCG vaccine during the one year before receiving STELARA® or one year after you stop receiving STELARA®.

您在接种STELARA®前一年或停止使用STELARA®后的一年内不应接种卡介苗（BCG）疫苗。

have any new or changing lesions within psoriasis areas or on normal skin.

在银屑病区域或正常皮肤上出现任何新的或变化的病灶。

are receiving or have received allergy shots, especially for serious allergic reactions.

正在接受或已经接受过过敏注射，尤其是针对严重过敏反应的。

receive or have received phototherapy for your psoriasis.

接受或已接受过银屑病的光疗。

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

怀孕或计划怀孕。尚不清楚STELARA是否

can harm your unborn baby. You and your doctor should decide if you will receive STELARA

可能对未出生的胎儿造成伤害。您和您的医生应决定是否接受STELARA治疗。

。

received STELARA

收到STELARA

while you were pregnant. It is important that you tell your baby's healthcare provider before any vaccinations are given to your baby.

当你怀孕时。在给宝宝接种任何疫苗之前，告诉宝宝的医疗保健提供者这一点很重要。

are breastfeeding or plan to breastfeed. STELARA

正在哺乳或计划哺乳。STELARA

can pass into your breast milk.

可以进入你的母乳。

talk to your doctor about the best way to feed your baby if you receive STELARA

如果您服用STELARA，请咨询您的医生关于喂养宝宝的最佳方法。

。

Tell your doctor about all the medicines you take

告诉你的医生你所服用的所有药物

, including prescription and over-the counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

，包括处方药和非处方药、维生素以及草药补充剂。了解你所服用的药物。当你获得新药时，保留一份清单，向医生和药剂师展示。

When prescribed STELARA®:

当开具STELARA®处方时：

Use STELARA

使用STELARA

exactly as your doctor tells you to.

完全按照医生告诉你的去做。

STELARA

乌司奴单抗

is intended for use under the guidance and supervision of your doctor. In children 6 years and older, it is recommended that STELARA

应在医生的指导和监督下使用。对于6岁及以上的儿童，建议使用STELARA。

be administered by a healthcare provider. If your doctor decides that you or a caregiver may give your injections of STELARA

由医疗保健提供者进行管理。如果你的医生决定你或护理人员可以给你注射STELARA。

at home, you should receive training on the right way to prepare and inject STELARA

在家时，您应该接受关于正确准备和注射STELARA的培训。

. Your doctor will determine the right dose of STELARA

医生将确定STELARA的正确剂量。

for you, the amount for each injection, and how often you should receive it. Do not try to inject STELARA

对于您，每次注射的剂量，以及您应该多久接受一次注射。不要尝试自行注射STELARA。

yourself until you or your caregiver have been shown how to inject STELARA

您自己，直到您或您的护理人员被展示如何注射STELARA

by your doctor or nurse.

由您的医生或护士。

Common side effects of STELARA® include:

STELARA® 的常见副作用包括：

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. These are not all of the possible side effects with.

鼻塞、喉咙痛、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、阴道酵母菌感染、尿路感染、鼻窦感染、支气管炎、腹泻、胃痛和关节痛。这些并非所有可能的副作用。

STELARA

喜达诺

. Tell your doctor about any side effect that you experience. Ask your doctor or pharmacist for more information.

告诉您的医生您所经历的任何副作用。向您的医生或药剂师咨询更多信息。

Please click to read the full

请单击以阅读全文

Prescribing Information

处方信息

and

和

Medication Guide

药品指南

for STELARA® and discuss any questions you have with your doctor.

对于STELARA®，请与您的医生讨论您拥有的任何问题。

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

https://www.fda.gov/medwatch

or call 1-800-FDA-1088

或拨打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，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，在这个世界中，复杂疾病得以预防、治疗和治愈，治疗方法更加智能且更少侵入性，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，请访问。

https://www.jnj.com/

or at

或在

www.innovativemedicine.jnj.com

。

关注我们

@JNJInnovMed

。

Janssen Research & Development, LLC, Janssen Scientific Affairs, LLC, Janssen Biotech, Inc., and Janssen-Cilag International NV are Johnson & Johnson companies.

杨森研究与发展有限责任公司、杨森科学事务有限责任公司、杨森生物技术公司以及杨森-西拉格国际公司均为强生公司旗下企业。

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 TREMFYA

本新闻稿包含《1995年私人证券诉讼改革法案》中定义的关于TREMFYA的“前瞻性声明”。

. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. 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 Scientific Affairs, LLC, Janssen Biotech, Inc., Janssen-Cilag International NV and/or Johnson & Johnson.

读者被提醒不要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。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显现，实际结果可能与Janssen Research & Development, LLC、Janssen Scientific Affairs, LLC、Janssen Biotech, Inc.、Janssen-Cilag International NV和/或Johnson & Johnson的预期和预测有重大差异。

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.

风险和不确定性包括但不限于：产品研究和开发中固有的挑战和不确定性，包括临床成功的不确定性以及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、竞争对手获得的新产品和专利；专利挑战；产品功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可以在强生公司最近的年度报告 Form 10-K 中找到，包括标题为“关于前瞻性声明的警示说明”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中。

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 Scientific Affairs, LLC, Janssen Biotech, Inc., Janssen-Cilag International NV nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments..

或应Johnson & Johnson的要求。Janssen Research & Development, LLC、Janssen Scientific Affairs, LLC、Janssen Biotech, Inc.、Janssen-Cilag International NV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责任。

Crohn's & Colitis Foundation. What is Crohn's disease? Available at:

克罗恩病和结肠炎基金会。什么是克罗恩病？引用日期：

https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes

. Accessed February 2025.

访问时间：2025年2月。

Crohn's & Colitis Foundation. What is Crohn's disease? Available at:

克罗恩病和结肠炎基金会。什么是克罗恩病？可用资源：

https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes

. Accessed February 2025.

访问时间：2025年2月。

Crohn's & Colitis Foundation. Overview of Crohn's disease. Available at:

克罗恩病与结肠炎基金会。克罗恩病概述。可用资源：

https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview

. Accessed March 2025.

. 2025年3月访问。

Atreya R, Abreu MT, Krueger JG, et al. Guselkumab, an IL-23p19 subunit-specific monoclonal antibody, binds CD64+ myeloid cells and potentially neutralizes IL-23 produced from the same cells. Poster presented at: 18th Congress of the European Crohn's and Colitis Organization (ECCO); March 1-4, 2023; Copenhagen, Denmark.

阿特雷亚 R、阿布雷乌 MT、克鲁格 JG 等。Guselkumab，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..

海报 P504。。

Kreuger JG, Eyerich K, Kuchroo VK. Il-23 past, present, and future: a roadmap to advancing IL-23 science and therapy.

克鲁格 JG，艾瑞奇 K，库奇罗 VK。IL-23 的过去、现在和未来：推进 IL-23 科学与治疗的路线图。

Front Immunol.

前免疫学。

2024; 15:1331217. doi:10.3389/fimmu.2024.1331217.

2024；15:1331217。doi:10.3389/fimmu.2024.1331217。

TREMFYA

特雷姆萨

[Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.

[处方信息]。宾夕法尼亚州霍舍姆：杨森生物技术公司

Skyrizi

[Prescribing Information]. North Chicago, IL: AbbVie, Inc.

[处方信息]。伊利诺伊州北芝加哥：AbbVie公司。

Omvoh™ [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company.

Omvoh™ [处方信息]。印第安纳波利斯，IN：礼来公司。

Panaccione, R, et al. Efficacy and Safety of Subcutaneous Guselkumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease: Results Through Week 48 From the Phase 3 GRAVITI Study. Oral presentation (OP72) at American College of Gastroenterology (ACG) 2024.

潘纳乔内，R. 等。皮下注射古塞库单抗诱导疗法在中至重度活动性克罗恩病患者中的疗效与安全性：来自3期GRAVITI研究的第48周结果。美国胃肠病学院（ACG）2024年会口头报告（OP72）。

National Institutes of Health:

国立卫生研究院：

Clinicaltrials.gov

临床试验.gov

. A study of guselkumab subcutaneous therapy in participants with moderately to severely active Crohn's disease (GRAVITI). Identifier: NCT05197049. Available at:

一项关于古塞库单抗皮下治疗中度至重度活动性克罗恩病（GRAVITI）的研究。标识符：NCT05197049。可于以下网址获取：

https://classic.clinicaltrials.gov/ct2/show/NCT05197049

. Accessed February 2025.

。引用日期：2025年2月。

National Institutes of Health:

国家卫生研究院：

Clinicaltrials.gov

临床试验.gov

. A study of the efficacy and safety of guselkumab in participants with moderately to severely active Crohn's disease (GALAXI). Identifier: NCT03466411. Available at:

. 一项评估古塞库单抗在中度至重度活动性克罗恩病患者中的疗效和安全性的研究（GALAXI）。标识符：NCT03466411。可在：

https://clinicaltrials.gov/study/NCT03466411

. Accessed February 2025.

访问时间：2025年2月。

Danese S, et al. Week 48 efficacy of guselkumab and ustekinumab in Crohn's disease based on prior response/exposure to biologic therapy: Results from the GALAXI 2 & 3 Phase 3 Studies. Poster presentation (Abstract MP672) at United European Gastroenterology Week (UEGW) 2024. October 2024.

Danese S, 等。基于先前对生物治疗的反应/暴露，guselkumab 和 ustekinumab 在克罗恩病治疗中第48周的疗效：GALAXI 2 & 3 三期研究结果。海报展示（摘要 MP672），2024年欧洲联合胃肠病学周 (UEGW)。2024年10月。

STELARA

乌司奴单抗

Prescribing information. Available at:

处方信息。可于以下网址获取：

https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf

Accessed March 2025.

访问于2025年3月。

View original content to download multimedia:

查看原始内容以下载多媒体：

https://www.prnewswire.com/news-releases/us-fda-approves-tremfya-guselkumab-the-first-and-only-il-23-inhibitor-offering-both-subcutaneous-and-intravenous-induction-options-for-adult-patients-with-moderately-to-severely-active-crohns-disease-302407565.html

https://www.prnewswire.com/news-releases/美国食品药品监督管理局批准Tremfya（古塞库单抗），这是首个也是唯一一个提供皮下和静脉注射诱导选项的IL-23抑制剂，用于治疗中度至重度活动性克罗恩病的成年患者-302407565.html

SOURCE Johnson & Johnson

来源：强生公司

全球产业链接平台

重庆市渝北区金星科技大厦A区5楼512室

联系电话：023-67139735（重庆）

关于我们

产品服务