HORSHAM, Pa., Sept. 11, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC), a chronic disease of the large intestine in which the lining of the colon becomes inflamed.

HORSHAM，Pa.，2024年9月11日/PRNewswire/--强生公司（纽约证券交易所：JNJ）今天宣布，美国食品和药物管理局（FDA）已批准TREMFYA®（guselkumab）用于治疗患有中度至重度活动性溃疡性结肠炎（UC）的成年人，UC是一种结肠衬里发炎的大肠慢性疾病。

TREMFYA® 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 UC.1,2,3,4,5.

TREMFYA®是第一个也是唯一一个被批准的完全人类双作用单克隆抗体，它可以阻断IL-23，同时还可以与产生IL-23的细胞上的受体CD64结合。IL-23是由活化的单核细胞/巨噬细胞和树突状细胞分泌的细胞因子，已知它是包括UC在内的免疫介导疾病的驱动因素。

'Treatment with TREMFYA resulted in significant improvement in the chronic symptoms of ulcerative colitis, and importantly, normalization in the endoscopic appearance of the intestinal lining,' said David T. Rubin, MD, Director, Inflammatory Bowel Disease Center, University of Chicago Medicine, and lead investigator for the QUASAR program.

芝加哥大学医学院炎症性肠病中心主任兼QUASAR项目首席研究员David T.Rubin医学博士说：“用TREMFYA治疗可以显着改善溃疡性结肠炎的慢性症状，重要的是，可以使肠内膜的内镜外观正常化。”。

'Today's approval of TREMFYA builds on the clinical and well-established safety profile of this IL-23 inhibitor and marks a significant step forward in the treatment of this chronic inflammatory disease.'.

“今天对TREMFYA的批准建立在这种IL-23抑制剂的临床和公认的安全性基础上，标志着在治疗这种慢性炎症性疾病方面迈出了重要的一步。”。

The UC approval is supported by data from the pivotal, ongoing Phase 2b/3 QUASAR study evaluating the efficacy and safety of TREMFYA® in adult patients with moderately to severely active UC who experienced an inadequate response or who demonstrate intolerance to conventional therapy, other biologics and/or JAK inhibitors.6 Highlights from QUASAR showed:.

UC的批准得到了关键的，正在进行的2b/3期QUASAR研究的数据的支持，该研究评估了TREMFYA®对中度至重度活动性UC的成年患者的疗效和安全性，这些患者的反应不足或对常规治疗，其他生物制剂和/或JAK抑制剂不耐受。QUASAR的6个亮点显示：。

50% of patients receiving TREMFYA® 200 mg subcutaneous (SC) maintenance every four weeks (q4w) and 45% of patients receiving TREMFYA® 100 mg SC every eight weeks (q8w) achieved primary endpoint of clinical remission at week 44 compared to 19% placebo-treated patients (p<0.001).34% (200 mg) and 35% (100 mg) of patients achieved endoscopic remission at one year with TREMFYA® SC maintenance therapy compared to 15% placebo-treated patients (p<0.001).'There is a significant need for new UC therapies that offer meaningful improvements in symptoms and the promise of remission, both overall clinical remission as well as delivering visible healing of the colon through endoscopic remission,' said Christopher Gasink, MD, Vice President, Medical Affairs, Gastroenterology & Autoantibody, Johnson & Johnson Innovative Medicine.

50%接受TREMFYA®200 mg皮下（SC）维持治疗的患者每四周（q4w）一次，45%接受TREMFYA®100 mg SC维持治疗的患者每八周（q8w）一次，在第44周达到临床缓解的主要终点，而安慰剂治疗的患者为19%（p＜0.001）。34%（200 mg）和35%（100 mg）的患者在接受TREMFYA®SC维持治疗的一年内达到内镜缓解，而安慰剂治疗的患者为15%（p＜0.001）。'Johnson＆Johnson Innovative Medicine负责医学事务、胃肠病学和自身抗体的副总裁克里斯托弗·加辛克（Christopher Gasink）医学博士说，迫切需要新的UC疗法，这些疗法可以显着改善症状并有望缓解，包括整体临床缓解以及通过内镜缓解提供结肠的可见愈合。

'In the QUASAR clinical program, TREMFYA demonstrated high reported rates of endoscopic remission at one year of treatment, continuing to raise the bar for efficacy in the treatment of this inflammatory bowel disease.'.

“在QUASAR临床计划中，TREMFYA在治疗一年时表现出较高的内镜缓解率，继续提高了治疗这种炎症性肠病的疗效。”。

For the treatment of UC, TREMFYA® is administered as a 200 mg induction dose intravenously at weeks zero, four and eight by a healthcare professional. The 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. The SC maintenance dose can be self-administered by the patient or administered by a caregiver using TREMFYA® after proper training.

对于UC的治疗，TREMFYA®由医疗保健专业人员在第0周，第4周和第8周静脉注射200 mg诱导剂量。推荐的维持剂量是在第16周和之后每8周通过SC注射施用100 mg，或在第12周和之后每4周通过SC注射施用200 mg。。

Use the lowest effective recommended dosage to maintain therapeutic response..

使用最低有效推荐剂量维持治疗反应。。

The QUASAR results reinforced the well-established safety profile of TREMFYA® including in the treatment of patients with UC. This FDA approval marks the third indication approved for TREMFYA®, which builds on Johnson & Johnson's nearly 30-year legacy of immunology innovation. TREMFYA® first received approval in the U.S.

QUASAR结果加强了TREMFYA®的公认安全性，包括治疗UC患者。该FDA批准标志着TREMFYA®的第三个适应症获得批准，该适应症建立在强生公司近30年的免疫学创新遗产的基础上。。

in July 2017 for the treatment of adult patients with moderate-to-severe plaque psoriasis and received subsequent approval for adults with active psoriatic arthritis in July 2020.3 In June 2024, Johnson & Johnson submitted a supplemental Biologics License Application (sBLA) to the FDA seeking approval of TREMFYA® for the treatment of adult patients with moderately to severely active Crohn's disease. .

2017年7月，用于治疗中度至重度斑块状银屑病的成年患者，并于2020年7月获得了活动性银屑病关节炎成人的后续批准.3 2024年6月，强生公司向FDA提交了补充生物制剂许可证申请（sBLA），寻求批准TREMFYA®用于治疗中度至重度活动性克罗恩病的成年患者。。

Editor's Notes:

编者按：

CD64+ cells are the predominant source of IL-23 in UC. Cells not expressing CD64 may also contribute to IL-23 production but to a lesser extent.1,2'Only' based on approved selective IL-23 inhibitors for moderately to severely active UC as of September 2024.3,4,5Based on in vitro studies in an inflammatory monocyte model.1Clinical remission was defined as a Mayo stool frequency subscore of 0 or 1 and not increased from induction baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.6Endoscopic remission (normalization) was defined as a Mayo endoscopic subscore of 0.6 Dr.

CD64+细胞是UC中IL-23的主要来源。不表达CD64的细胞也可能有助于IL-23的产生，但程度较小。1,2“仅”基于截至2024年9月批准的用于中度至重度活动性UC的选择性IL-23抑制剂。3,4,5基于炎症单核细胞模型的体外研究。1临床缓解定义为梅奥粪便频率分数为0或1，不从诱导基线增加，梅奥直肠出血分数为0，梅奥内镜检查分数为0或1，内镜检查中不存在脆性。6内镜缓解（标准化）定义为梅奥内镜分数为0.6 Dr。

Rubin is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.TREMFYA® is not approved for the treatment of adults living with Crohn's disease in the U.S.ABOUT THE QUASAR PROGRAM (NCT04033445).

鲁宾是强生公司的有偿顾问。他没有得到任何媒体工作的补偿。关于QUASAR计划（NCT04033445），TREMFYA®在美国未被批准用于治疗患有克罗恩病的成年人。

QUASAR is a randomized, double-blind, placebo-controlled, parallel group, multicenter Phase 2b/3 program designed to evaluate the efficacy and safety of TREMFYA®, a selective IL-23 inhibitor, in adult patients with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics and/or JAK inhibitors (i.e., tumor necrosis factor-alpha antagonists, vedolizumab, or tofacitinib).3 QUASAR included a Phase 2b dose-ranging induction study, a confirmatory Phase 3 induction study, and a Phase 3 maintenance study.

QUASAR是一项随机，双盲，安慰剂对照，平行组，多中心的2b/3期计划，旨在评估选择性IL-23抑制剂TREMFYA®在中度至重度活动性溃疡性结肠炎患者中的疗效和安全性，这些患者对常规治疗（如硫嘌呤或皮质类固醇），既往生物制剂和/或JAK抑制剂（即肿瘤坏死因子α拮抗剂，维多珠单抗或托法替尼）的反应不足或不耐受[3]。QUASAR包括2b期剂量范围诱导研究，验证性3期诱导研究和3期维持研究。

Efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers are assessed at specified time points.6.

在指定的时间点评估疗效，安全性，药代动力学，免疫原性和生物标志物。

The most common adverse reactions (>2%) in patients with UC who received TREMFYA® and at a higher rate of placebo in the induction study were respiratory tract infections. The most common adverse reactions (>3%) in patients with UC who received TREMFYA® and at a higher rate of placebo in the maintenance study were injection site reactions, arthralgia, and upper respiratory tract infection..

在诱导研究中，接受TREMFYA®且安慰剂使用率较高的UC患者最常见的不良反应（>2%）是呼吸道感染。在维持研究中，接受TREMFYA®且安慰剂使用率较高的UC患者最常见的不良反应（>3%）是注射部位反应，关节痛和上呼吸道感染。。

ABOUT ULCERATIVE COLITISUlcerative colitis (UC) is a form of inflammatory bowel disease (IBD) that causes inflammation in the digestive tract and can result in damage to the colon lining. It is the result of the immune system's overactive response. Patients can experience a range of unpredictable symptoms, which may include loose and more frequent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.7 Patients with UC also have increased rates of depression.8 More than one million people in the U.S.

关于溃疡性结肠炎溃疡性结肠炎（UC）是一种炎症性肠病（IBD），可引起消化道炎症，并可导致结肠衬里受损。这是免疫系统过度反应的结果。患者可能会出现一系列不可预测的症状，包括排便不畅和更频繁，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。7 UC患者的抑郁率也有所增加。8美国有100多万人。

are living with UC, making it one of the largest populations globally affected by this disease, and the prevalence continues to rise.9,10,11.

患有UC，使其成为全球受这种疾病影响最大的人群之一，患病率持续上升[9,10,11]。

ABOUT TREMFYA® (guselkumab) Developed by Johnson & Johnson, TREMFYA® is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cell that produce IL-23). Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model.

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

The clinical significance of this finding is not known..

这一发现的临床意义尚不清楚。。

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

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

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。

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。我们在医疗保健创新方面的优势使我们有能力建立一个能够预防、治疗和治愈复杂疾病的世界，在这个世界里，治疗更智能，创伤更小，解决方案更个性化。凭借我们在创新医学和医疗技术领域的专业知识，我们处于独特的地位，能够在当今医疗保健解决方案的各个领域进行创新，实现未来的突破，并对人类健康产生深远影响。