VIENNA, Austria, Oct. 10, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced TREMFYA® (guselkumab) data in both Crohn's disease (CD) and ulcerative colitis (UC) showing high rates of endoscopic remission in both biologic-naïve and biologic-refractory patients (including UC patients refractory to JAK inhibitors), indicating a normal appearance of intestinal mucosa.1,2 These subgroup analyses are from pooled data from the Phase 3 GALAXI 2 & 3 studies of TREMFYA® in adults with moderately to severely active CD and the Phase 3 QUASAR maintenance study of TREMFYA® in adults with moderately to severely active UC.

维也纳，奥地利，2024年10月10日/PRNewswire/--强生（纽约证券交易所：JNJ）今天宣布了克罗恩病（CD）和溃疡性结肠炎（UC）的TREMFYA®（guselkumab）数据，显示生物学幼稚和生物学难治性患者（包括对JAK抑制剂难治的UC患者）的内镜缓解率很高，表明肠粘膜外观正常。1,2这些亚组分析来自中度至重度活动性CD成年人TREMFYA®的3期GALAXI 2和3期研究以及中度至重度活动性成年人TREMFYA®的3期QUASAR维持研究的汇总数据坎特伯雷大学。

These findings are among 19 Johnson & Johnson abstracts being presented at the United European Gastroenterology (UEG) Week 2024. TREMFYA® is under review for the treatment of adults with moderately to severely active UC and CD by the European Medicines Agency (EMA). .

这些发现是2024年欧洲胃肠病学联合会（UEG）周上发表的19篇强生文摘之一。欧洲药品管理局（EMA）正在审查TREMFYA®治疗中度至重度活动性UC和CD的成人。。

'These results show the potential of TREMFYA to offer a differentiated treatment option for patients with CD and UC, including those starting on a biologic for the first time, and those who have failed prior biologics and traditionally have been less likely to respond to other therapies,' stated Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine.

“这些结果表明，TREMFYA有潜力为CD和UC患者提供差异化的治疗选择，包括那些首次开始使用生物制剂的患者，以及那些先前生物制剂失败且传统上不太可能对其他疗法产生反应的患者，”强生创新医学胃肠病领域负责人、免疫学副总裁Esi Lamousé-Smith博士表示。

'TREMFYA builds upon our nearly three decades of leadership in IBD therapy and focused innovation in the IL-23 pathway to address the needs of people living with ulcerative colitis and delivering meaningful improvements in symptoms and the potential for sustained remission.' .

“TREMFYA建立在我们近三十年在IBD治疗方面的领导地位和IL-23途径的重点创新基础上，以满足溃疡性结肠炎患者的需求，并在症状和持续缓解潜力方面提供有意义的改善。”。

Endoscopic remission in biologic-naïve patientsIn the pooled Phase 3 GALAXI 2 & 3 dataset, TREMFYA® demonstrated greater rates of endoscopic remission compared to ustekinumab at Week 48 in biologic-naïve patients with CD. Endoscopic remission was achieved in 44% of patients treated with TREMFYA® 100 mg every eight weeks (q8w) subcutaneous (SC) injection and 46.1% of patients treated with TREMFYA® 200 mg every four weeks (q4w) SC injection, versus 29.8% of patients treated with ustekinumab.1  .

生物学初治患者的内镜缓解在汇集的3期GALAXI 2＆3数据集中，TREMFYA®在第48周时表现出比ustekinumab更高的内镜缓解率。44%接受TREMFYA®100 mg每八周（q8w）皮下（SC）注射治疗的患者和46.1%接受TREMFYA®200 mg每四周（q4w）SC注射治疗的患者获得内镜缓解，而29.8%接受ustekinumab治疗的患者获得内镜缓解。

In the Phase 3 QUASAR study, TREMFYA® demonstrated greater rates of endoscopic remission compared to placebo at Week 44 in biologic/JAK inhibitor-naïve patients with UC. Endoscopic remission was achieved in 38.1% of patients treated with TREMFYA® 100 mg q8w SC injection and 41.7% of patients treated with TREMFYA® 200 mg q4w SC injection, versus 20.4% of patients treated with placebo.2  .

在3期QUASAR研究中，TREMFYA®在生物/JAK抑制剂初治的UC患者中，与安慰剂相比，在第44周表现出更高的内镜缓解率。38.1%接受TREMFYA®100 mg q8w SC注射治疗的患者和41.7%接受TREMFYA®200 mg q4w SC注射治疗的患者获得内镜缓解，而安慰剂治疗的患者为20.4%。

Endoscopic remission in patients with a history of inadequate response or intolerance to biologics/JAK inhibitors In the pooled Phase 3 GALAXI 2 & 3 dataset, TREMFYA® demonstrated greater rates of endoscopic remission compared to ustekinumab at Week 48 in biologic-refractory patients with CD. Endoscopic remission was achieved in 28.1% of patients treated with TREMFYA® 100 mg q8w SC injection and 28.6% of patients treated with TREMFYA® 200 mg q4w SC injection, versus 20.5% of patients treated with ustekinumab.1 .

内镜缓解对生物制剂/JAK抑制剂反应不足或不耐受史的患者在汇总的3期GALAXI 2＆3数据集中，TREMFYA®在生物难治性CD患者中，与第48周的ustekinumab相比，内镜缓解率更高。28.1%接受TREMFYA®100 mg q8w SC注射治疗的患者和28.6%接受TREMFYA®200 mg q4w SC注射治疗的患者获得内镜缓解，而20.5%接受ustekinumab治疗的患者获得内镜缓解。

In the Phase 3 QUASAR study, TREMFYA® demonstrated greater rates of endoscopic remission compared to placebo at Week 44 in biologic/JAK inhibitor-refractory patients with UC. Endoscopic remission was achieved in 31.2% of patients treated with TREMFYA® 100 mg q8w SC injection and 23.9% of patients treated with TREMFYA® 200 mg q4w SC injection, versus 8% of patients treated with placebo.2  .

在3期QUASAR研究中，与安慰剂相比，TREMFYA®在生物/JAK抑制剂难治性UC患者的第44周表现出更高的内镜缓解率。31.2%接受TREMFYA®100 mg q8w SC注射治疗的患者和23.9%接受TREMFYA®200 mg q4w SC注射治疗的患者获得内镜缓解，而安慰剂治疗的患者为8%。

Results from these studies reinforce the well-established safety profile of TREMFYA® including in the treatment of patients with UC and CD.

这些研究的结果强化了TREMFYA®的公认安全性，包括治疗UC和CD患者。

TREMFYA® received U.S. Food and Drug Administration (FDA) approval in September 2024 for the treatment of adults with moderately to severely active UC and an application for the treatment of moderately to severely active CD is currently under FDA review. Regulatory applications seeking approval of TREMFYA® for the treatment of adults with moderately to severely active UC and for the treatment of adults with moderately to severely active CD have been submitted in Europe..

TREMFYA®于2024年9月获得美国食品和药物管理局（FDA）的批准，用于治疗中度至重度活动性UC的成年人，目前正在FDA审查治疗中度至重度活动性CD的申请。欧洲已经提交了寻求TREMFYA®批准用于治疗中度至重度活动性UC成人和治疗中度至重度活动性CD成人的监管申请。。

ABOUT THE GALAXI PROGRAM (NCT03466411)

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

GALAXI是一项随机，双盲，安慰剂对照，主动对照（ustekinumab），全球，多中心2/3期计划，旨在评估guselkumab对中度至重度活动性克罗恩病患者的疗效和安全性，这些患者对常规疗法（皮质类固醇或免疫调节剂）和/或生物制剂（TNF拮抗剂或维多珠单抗）的反应/不耐受性不足。3 GALAXI包括一项2期剂量范围研究（GALAXI 1）和两项独立的，设计相同的验证性3期研究（GALAXI 2和3）。1每项GALAXI研究均采用了一种治疗通过设计，参与者继续接受最初随机分组的治疗，并包括长期长期扩展研究，将评估guselkumab在总共五年内的临床，内镜和安全性结果。

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.

患者在第0,4和8周接受guselkumab 200 mg静脉诱导，然后每4周接受guselkumab 200 mg皮下维持；或在第0、4和8周静脉注射guselkumab 200 mg，然后每8周皮下注射guselkumab 100 mg；或生物活性对照；或安慰剂。

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 (41.8 percent) were biologic-naïve and 52 (6 percent) were biologic experienced without documented inadequate response or intolerance.1 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 CD.

如果在第12周未达到临床反应，随机接受安慰剂的参与者能够接受ustekinumab。在GALAXI 2＆3数据集中汇集的873名个体中，456名（52%）有对生物制剂反应不足的既往史，365名（41.8%）为生物学幼稚，52名（6%）为生物学经历，没有记录到反应不足或不耐受。GALAXI 2和GALAXI 3研究是有史以来首次双盲注册头对头临床试验，以证明CD优于ustekinumab。

Data from GALAXI 2 & 3 showed guselkumab was superior to ustekinumab in all pooled en.

来自GALAXI 2和3的数据显示，在所有合并的en中，guselkumab优于ustekinumab。

ABOUT THE QUASAR STUDY (NCT04033445)

关于类星体研究（NCT04033445）

QUASAR is a randomized, double-blind, placebo-controlled, parallel group, multicenter, Phase 2b/3 program designed to evaluate the efficacy and safety of guselkumab in adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or JAK inhibitors (tofacitinib).4 QUASAR included a Phase 2b dose-ranging induction study, a confirmatory Phase 3 induction study, and a Phase 3 randomized withdrawal maintenance study.

QUASAR是一项随机，双盲，安慰剂对照，平行组，多中心，2b/3期计划，旨在评估guselkumab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（例如硫嘌呤或皮质类固醇），既往生物制剂（TNF拮抗剂或维多珠单抗）和/或JAK抑制剂（托法替尼）的反应不足或不耐受[4]。QUASAR包括2b期剂量范围诱导研究，验证性3期诱导研究和3期随机戒断维持研究。

In the induction study, patients received either guselkumab 200 mg or placebo by intravenous infusion at Week 0, Week 4, and Week 8. In the maintenance study, patients received a subcutaneous maintenance regimen of either TREMFYA 100 mg every 8 weeks, guselkumab 200 mg every 4 weeks, or placebo. Efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers are assessed at specified time points.

在诱导研究中，患者在第0周，第4周和第8周通过静脉输注接受guselkumab 200 mg或安慰剂。在维持研究中，患者接受皮下维持方案，每8周服用100毫克TREMFYA，每4周服用200毫克guselkumab，或服用安慰剂。在指定的时间点评估功效，安全性，药代动力学，免疫原性和生物标志物。

Of the 568 individuals included in the QUASAR maintenance study, 240 (42.3 percent) had a history of inadequate response or intolerance to biologics or JAK inhibitors, 309 (54.4 percent) were biologic/JAK inhibitor naïve, and 19 (3.3 percent) were biologic/JAK inhibitor experienced without documented inadequate response or intolerance.3.

在QUASAR维持研究中包括的568名个体中，240名（42.3%）有对生物制剂或JAK抑制剂反应不足或不耐受的病史，309名（54.4%）是生物/JAK抑制剂天真的，19名（3.3%）是生物/JAK抑制剂，没有记录到反应不足或不耐受。

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.5,6 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.7 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。5,6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。7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。。

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.8 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。8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.6 .

UC患者的抑郁率也有所增加。

ABOUT TREMFYA® (guselkumab)

关于TREMFYA® （圭亚那）

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.

TREMFYA®由强生公司开发，是第一种经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。

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。