Janssen reports top-line Phase 3 results for TREMFYA® in adults with active psoriatic arthritis

强生成人银屑病关节炎治疗药物guselkumab III期临床试验达主要终点

2019-06-17 15:39:00 BioSpace


Data are part of the DISCOVER 1 and 2 program, the first Phase 3 studies to evaluate a selective IL-23 p19 inhibitor in the treatment of psoriatic arthritis The Janssen Pharmaceutical Companies of Johnson & Johnson today announced top-line results from the Phase 3 DISCOVER 1 and 2 studies, which evaluated the efficacy and safety of guselkumab compared to placebo in adult patients with active moderate to severe psoriatic arthritis (PsA). Both studies met their primary endpoints of American College of Rheumatology 20 percent improvement (ACR20), and the safety profiles observed for guselkumab in the DISCOVER program were consistent with previous studies of guselkumab and TREMFYA® current prescribing information. The DISCOVER program comprises the first-ever Phase 3 studies evaluating an IL-23 p19 inhibitor for the treatment of psoriatic arthritis, and data will be presented at upcoming scientific medical meetings. Data from the two DISCOVER studies will serve as the basis of submissions to the U.S. Food and Drug Administration and European Medicines Agency seeking approval of guselkumab as a treatment for psoriatic arthritis, which are anticipated for later this year. The DISCOVER program consists of DISCOVER-1 and DISCOVER-2, two randomized, double-blind, multicenter Phase 3 studies designed to evaluate efficacy and safety of subcutaneous guselkumab in patients with active PsA compared to placebo. In addition to the primary endpoint of ACR20 response at week 24, multiple secondary endpoints were assessed that included ACR50/70, resolution of soft tissue inflammation (enthesitis and dactylitis), disease activity (DAS-28 CRP), improvement in physical function (HAQ-DI), skin clearance (IGA), and quality of life (SF-36 PCS and MCS). DISCOVER-2 also assessed effect on structural damage (vdH-S) as a key secondary endpoint. DISCOVER-1 included 381 participants, including participants previously treated with anti-TNF biologics. The study continued through 52 weeks. DISCOVER-2 included 739 bio-naive participants and continued through 100 weeks.
数据是 DISCOVER 1和2计划的一部分,第一阶段3研究评估选择性 IL-23 p19抑制剂治疗银屑病关节炎 强生公司杨森(Janssen) Pharmaceutical Companies 今天公布了第三期 DISCOVER 1和2期研究的一线结果,该研究评估了 guselkumab 相对于安慰剂在成年患者积极中重度银屑病关节炎( PsA )的疗效和安全性。这两项研究都达到了美国风湿病学学会20%改进( ACR20)的主要终点, DISCOVER 计划中观察到的姜黄单抗的安全性概况与先前对姜黄和 TREMFYA ®当前处方信息的研究一致。 DISCOVER 计划包括首次评估 IL-23 p19抑制剂用于治疗银屑病关节炎的第3阶段研究,数据将在即将召开的科学医学会议上公布。来自 DISCOVER 两项研究的数据将作为向美国食品和药物管理局和欧洲药品管理局提交的申请的基础,这些申请要求批准 guselkumab 作为治疗银屑病关节炎的药物,预计将在今年晚些时候完成。 DISCOVER 方案包括 DISCOVER-1和 DISCOVER-2,两项随机、双盲、多中心3期研究,目的是评估与安慰剂相比的活性假单胞菌的疗效和安全性。除了24周 ACR20反应的主要终点外,还对多个次要终点进行了评估,包括 ACR50/70、软组织炎症(根治炎和胆道炎)、疾病活动( DAS-28 CRP )、物理功能改善( HAQ-DI )、皮肤清除率( IGA )和生活质量( SF-36 PCS 和 MCS )。DISCOVER-2还评估了结构损伤( vdH-S )作为关键的次要终点的影响。 DISCOVER-1包括381名参与者,其中包括以前用抗 TNF 生物制剂治疗的参与者。这项研究持续了52周。DISCOVER-2包括739名生物幼稚参与者,持续了100周。