Johnson & Johnson (NYSE: JNJ) today announced new data from the Phase 3 ASTRO study evaluating TREMFYA® (guselkumab) subcutaneous (SC) induction therapy in adults with moderately to severely active ulcerative colitis (UC). The ASTRO Week 24 data build on the Week 12 SC induction data that showed statistically significant and clinically meaningful improvements compared to placebo across all clinical and endoscopic measures consistent with the U.S. Food and Drug Administration (FDA)-approved intravenous (IV) induction regimen evaluated in this population, in the Phase 3 QUASAR study.1,2 TREMFYA® is the first and only IL-23 inhibitor to demonstrate robust results with a fully SC regimen. These findings are among 24 abstracts highlighting the Company's research being presented at Digestive Disease Week (DDW) 2025.

强生公司 (NYSE: JNJ) 今天公布了 3 期 ASTRO 研究的新数据，该研究评估了 TREMFYA® （ guselkumab）皮下 (SC) 诱导治疗对中度至重度活动性溃疡性结肠炎 (UC) 成人患者的效果。ASTRO 第 24 周的数据以第 12 周 SC 诱导数据为基础，该数据表明，与安慰剂相比，所有临床和内窥镜指标均有统计学上显著且有临床意义的改善，这与美国食品药品监督管理局 (FDA) 批准的静脉 (IV) 诱导方案在该人群中评估的结果一致，该方案是在 3 期 QUASAR 研究中实施的。1,2 TREMFYA®是第一个也是唯一一个通过完全 SC 方案证明效果显著的 IL-23 抑制剂。这些结果是该公司将在 2025 年消化疾病周 (DDW) 上展示的 24 篇研究摘要之一。

Data at Week 24 show patients treated with TREMFYA® 400 mg SC induction followed by SC maintenance dose regimens of either 100 mg every eight weeks (q8w) or 200 mg every four weeks (q4w) demonstrated statistically significant and clinically meaningful improvements across all clinical and endoscopic measures compared with patients receiving placebo.

第 24 周的数据显示，与接受安慰剂治疗的患者相比，接受 TREMFYA ® 400 毫克皮下诱导治疗，随后接受皮下维持剂量方案（每八周 100 毫克（q8w）或每四周 200 毫克（q4w））治疗的患者在所有临床和内窥镜检查指标中均表现出统计学上显着且具有临床意义的改善。

"Data from the ASTRO study demonstrate that subcutaneous induction treatment with TREMFYA provides clinically meaningful remission in patients with ulcerative colitis, similar to the effects seen with intravenous induction," said Millie Long, M.D., MPH, Professor of Gastroenterology and Hepatology at the University of North Carolina at Chapel Hill and study investigator.e "The availability of both subcutaneous and intravenous induction options would offer physicians and patients greater flexibility in their treatment approach."

北卡罗来纳大学教堂山分校胃肠病学和肝病学教授兼研究研究员 Millie Long 医学博士、公共卫生硕士表示： “ASTRO 研究的数据表明，使用 TREMFYA 进行皮下诱导治疗可为溃疡性结肠炎患者提供具有临床意义的缓解，类似于静脉诱导的效果。皮下和静脉诱导两种治疗方式的出现将为医生和患者的治疗方法提供更大的灵活性。”

Furthermore, at Week 24, in prespecified analyses of subpopulations defined by prior advanced therapy treatment status, TREMFYA® demonstrated statistically significant results across endpoints in both biologic and JAK inhibitor-naïve and biologic and JAK inhibitor-refractory patients. Safety data from the ASTRO study were consistent with the well-established safety profile of TREMFYA®.

此外，在第24周，根据既往晚期治疗状态定义的亚群预设分析中，TREMFYA®在生物制剂和JAK抑制剂初治患者以及生物制剂和JAK抑制剂难治患者中均表现出了各项终点均具有统计学意义的结果。ASTRO研究的安全性数据与TREMFYA® 已证实的安全性一致。

"These results highlight the potential of TREMFYA to redefine ulcerative colitis care with a fully subcutaneous induction and maintenance regimen that offers a convenient option with meaningful clinical and endoscopic improvements," said Esi Lamousé-Smith, MD, PhD, Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. "Our goal is to reshape UC care and empower prescribers with a differentiated and effective treatment that offers the option of patient self-administration from day one."

强生创新医学副总裁、胃肠病学领域负责人、免疫学部门负责人 Esi Lamousé-Smith 医学博士表示：“这些结果凸显了 TREMFYA 重新定义溃疡性结肠炎治疗的潜力。TREMFYA 采用完全皮下诱导和维持方案，提供了一种便捷的选择，并带来了显著的临床和内镜改善。我们的目标是重塑溃疡性结肠炎治疗，并为处方医生提供差异化​​、有效的治疗方案，让患者从第一天起就可以自行用药。”

TREMFYA® is the first and only approved, 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.

TREMFYA®是首个也是唯一获批的双效单克隆抗体，它能够阻断IL-23，同时结合产生IL-23的细胞上的受体CD64。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，已知是包括溃疡性结肠炎（UC）在内的免疫介导疾病的驱动因素。

TREMFYA® received FDA approval in September 2024 for the treatment of adult patients with moderately to severely active UC and is currently administered via an IV induction regimen, followed by a SC maintenance regimen. In November 2024, a supplemental Biologics License Application (sBLA) was submitted to the FDA seeking approval of a SC induction regimen of TREMFYA® for the treatment of adults with moderately to severely active UC. TREMFYA® was also approved by the FDA in March 2025 for SC and IV induction options for the treatment of adults with moderately to severely active Crohn's disease (CD).

TREMFYA®于 2024 年 9 月获得 FDA批准 ，用于治疗中度至重度活动性溃疡性结肠炎 (UC) 成人患者，目前通过静脉注射诱导方案给药，随后进行皮下维持治疗。2024 年 11 月，公司向 FDA 提交了一份补充生物制品许可申请 (sBLA)， 寻求 批准 TREMFYA® 皮下诱导方案用于治疗中度至重度活动性 UC 成人患者。2025 年 3 月，TREMFYA®还 获得FDA批准，用于皮下和静脉注射诱导方案治疗中度至重度活动性克罗恩病 (CD) 成人患者。