Johnson & Johnson (NYSE: JNJ) today announced new data from the TREMFYA® (guselkumab) Phase 3 QUASAR long-term extension (LTE) study in adults with moderately-to-severely active ulcerative colitis (UC). These data 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TREMFYA®（guselkumab）3期QUASAR长期扩展研究（针对中度至重度活动性溃疡性结肠炎 (UC) 成人患者）的最新数据。这些数据是该公司将在2025年消化疾病周 (DDW) 上展示的24篇研究摘要之一。

Data from the QUASAR LTE study demonstrate patients treated with TREMFYA® sustained clinical and endoscopic efficacy at Week 92:

QUASAR LTE 研究的数据显示，接受 TREMFYA ®治疗的患者在第 92 周仍具有持续的临床和内镜疗效：

72% of patients were in clinical remissionb with 99% of those patients remaining corticosteroid free for 8 or more weeks through Week 92. 43% of patients were in endoscopic remission.c Among patients achieving endoscopic improvementd at Week 44, 84% maintained endoscopic improvement through Week 92.

72% 的患者临床症状得到缓解，其中 99% 的患者在第 92 周前 8 周或更长时间没有使用皮质类固醇。 43% 的患者处于内镜缓解期。 在第 44周实现内镜改善的患者中，84% 的患者在第 92 周保持了内镜改善。

Patients treated with TREMFYA® sustained clinical and endoscopic remission regardless of prior biologic and/or JAK inhibitor treatment history.

接受 TREMFYA ®治疗的患者无论之前是否接受过生物制剂和/或 JAK 抑制剂治疗，均能维持临床和内镜缓解。

"People living with ulcerative colitis seek treatments that both address the challenging symptoms of the disease and provide durable results," said Gary R. Lichtenstein, Vice Chief, Division of Gastroenterology and Hepatology, Development and Philanthropy at the University of Pennsylvania.e "These new data show TREMFYA delivers long-term, sustained clinical and endoscopic remission, marking important progress in UC care."

宾夕法尼亚大学胃肠病学和肝病学、发展和慈善事业部副主任 Gary R. Lichtenstein 表示：“溃疡性结肠炎患者寻求既能解决该疾病棘手症状又能提供持久疗效的治疗方法。这些新数据表明，TREMFYA 可提供长期、持续的临床和内镜缓解，标志着溃疡性结肠炎治疗领域取得重要进展。”

Safety data were consistent with the well-established safety profile of TREMFYA® in inflammatory bowel disease (IBD) with no new safety concerns identified.

安全数据与 TREMFYA ®在炎症性肠病 (IBD) 中已确立的安全性概况一致，未发现新的安全问题。

"With these findings, TREMFYA shows the powerful impact it can have in achieving longer term remission in patients," said Esi Lamousé-Smith, MD, PhD, Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. "This is a significant step forward in our mission to reshape the standard of care in inflammatory bowel disease."

强生创新医学副总裁、胃肠病学领域负责人、免疫学系主任 Esi Lamousé-Smith 医学博士表示：“这些研究结果证明了 TREMFYA 对患者实现长期缓解的强大作用。这是我们重塑炎症性肠病治疗标准这一使命迈出的重要一步。”

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，被认为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。