Johnson & Johnson (NYSE: JNJ) today announced findings from the Phase 3b APEX study showing that TREMFYA® (guselkumab) significantly reduced both signs and symptoms of active psoriatic arthritis (PsA) and inhibited progression of joint structural damage at 24 weeks compared to placebo.1 These data from a late-breaking abstract are among the 30 oral and poster presentations Johnson & Johnson is highlighting at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress.

强生公司 (NYSE: JNJ) 今天公布了 3b 期 APEX 研究的结果，结果显示，与安慰剂相比，TREMFYA®（guselkumab）在 24 周时显著减轻了活动性银屑病关节炎 (PsA) 的体征和症状，并抑制了关节结构损伤的进展。1这些来自最新摘要的数据是强生公司在 2025 年欧洲风湿病学会联盟 (EULAR) 大会上重点展示的 30 场口头报告和海报展示的一部分。

In the Phase 3b APEX study, TREMFYA® significantly inhibited progression of joint structural damage, including joint erosions and space narrowing, in patients with active PsA at Week 24 as assessed by the PsA modified van der Heijde-Sharp (vdH-S) score. The mean change from baseline to Week 24 in the modified van der Heijde-Sharp (vdH-S) score was 0.55 and 0.54 for patients receiving TREMFYA® every four weeks (Q4W) and every eight weeks (Q8W) respectively, compared with 1.35 in the placebo group (p=0.002 for Q4W and p<0.001 for Q8W dosing versus placebo, respectively). In the two TREMFYA® dose groups, 67% (Q4W) and 63% (Q8W) of patients experienced no radiographic progression, versus 53% in the placebo group.

在 3b 期 APEX 研究中，TREMFYA®显著抑制了活动性银屑病关节炎 (PsA) 患者在第 24 周的关节结构损伤进展，包括关节侵蚀和间隙狭窄，并以银屑病关节炎 (PsA) 改良范德海德-夏普评分 (vdH-S) 进行评估。每四周 (Q4W) 和每八周 (Q8W) 接受 TREMFYA® 治疗的患者，其改良范德海德-夏普评分 (vdH-S) 从基线到第 24 周的平均变化量分别为 0.55 和 0.54 ，而安慰剂组为 1.35（Q4W 组与安慰剂组相比，p=0.002，Q8W 组与安慰剂组相比，p<0.001）。在两个 TREMFYA® 剂量组中， 67% (Q4W) 和 63% (Q8W) 的患者未出现放射学进展，而安慰剂组为 53%。

"In psoriatic arthritis, joint damage can begin early and progress quickly if left untreated, significantly impacting a patient's ability to move, work and maintain independence," said Philip J. Mease, MD, Director of Rheumatology Research at the Swedish Medical Center and study investigator.b "The results of the APEX study are promising as the data show guselkumab to be the only IL-23 inhibitor in its class that has inhibited the progression of structural damage in patients, providing new clinical insights for the psoriatic community and underscoring the need for safe, effective options that address the full burden of disease."

瑞典医学中心风湿病学研究主任兼研究研究员 Philip J. Mease 医学博士表示：“银屑病关节炎的关节损伤可能早期出现，如果不及时治疗，进展会非常迅速，严重影响患者的活动、工作和维持独立生活的能力。APEX研究的结果令人鼓舞，因为数据显示，guselkumab 是同类药物中唯一能够抑制患者结构性损伤进展的 IL-23 抑制剂，这为银屑病患者群体提供了新的临床见解，并强调了对安全有效的治疗方案的需求，以全面缓解疾病负担。”

TREMFYA® also improved both joint and skin symptoms in patients with active PsA. Significantly greater proportions of TREMFYA®-treated patients (67% for Q4W and 68% for Q8W) achieved American College of Rheumatology response criteria (ACR20c) at Week 24 versus 47% receiving placebo (p<0.001) More than twice as many patients treated with TREMFYA® achieved ACR50c (41% for Q4W and 42% for Q8W) versus 20% receiving placebo at Week 24.1 In assessing skin clearance, greater proportions of TREMFYA®-treated patients (73% for Q4W and 68% for Q8W) achieved an Investigator's Global Assessment (IGA) score of 0/1d (clear or almost clear skin) at Week 24 versus 31% receiving placebo.

TREMFYA ®还改善了活动性 PsA 患者的关节和皮肤症状。 在第 24 周，接受TREMFYA ®治疗的患者中，达到美国风湿病学会反应标准 (ACR20 c ) 的患者比例显著较高 (Q4W 为 67%，Q8W 为 68%)，而接受安慰剂治疗的患者比例仅为 47% (p<0.001) 在第 24 周，接受 TREMFYA ®治疗的患者达到 ACR50 c 的比例是接受安慰剂治疗的患者比例的两倍多（Q4W 为 41%，Q8W 为 42%），而接受安慰剂治疗的患者比例为 20% 。1 在评估皮肤清除情况时，接受 TREMFYA ®治疗的患者中，有更大比例（第 4 周为 73%，第 8 周为 68%）在第 24 周达到研究者总体评估 (IGA) 评分 0/1天（皮肤清除或几乎清除），而接受安慰剂治疗的患者比例为 31% 。

The data from the APEX study were consistent with the well-established safety profile of TREMFYA®, with no new safety signals identified

APEX 研究的数据与 TREMFYA ®公认的安全性一致，未发现新的安全信号。

"With these results from the APEX study, TREMFYA has set a new bar for joint preservation as the only IL-23 inhibitor proven to significantly inhibit structural damage in active psoriatic arthritis, an inflammatory arthritis that can develop in up to 30% of people living with psoriasis," said Terence Rooney, Vice President, Rheumatology Disease Area Leader, Johnson & Johnson Innovative Medicine. "The efficacy and safety profile of TREMFYA offers psoriatic healthcare providers and patients an innovative option for disease control."

强生创新医学副总裁兼风湿病领域负责人Terence Rooney表示：“凭借APEX研究的这些结果，TREMFYA为关节保护树立了新的标杆，它是唯一被证实能够显著抑制活动性银屑病关节炎结构损伤的IL-23抑制剂。银屑病关节炎是一种炎症性关节炎，多达30%的银屑病患者可能会患上这种疾病。TREMFYA的疗效和安全性为银屑病医疗保健提供者和患者提供了一种创新的疾病控制选择。”

TREMFYA® is the first and only fully-human, dual-acting monoclonal antibody approved to treat PsA 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 active psoriatic arthritis.

TREMFYA®是首个也是唯一一个获批用于治疗银屑病关节炎的全人源双效单克隆抗体，它能够阻断IL- 23，同时与产生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，已知是包括活动性银屑病关节炎在内的免疫介导疾病的驱动因素。