New Long-Term Data from Upadacitinib Phase 3 Studies in Rheumatoid Arthritis Including Results on Clinical Remission at 48 Weeks Presented at EULAR

艾伯维SELECT III期试验结果显示upadacitinib能有效治疗类风湿性关节炎

2019-06-13 12:39:00 PR Newswire


Data from SELECT-EARLY and SELECT-COMPARE show a significantly higher proportion of patients treated with upadacitinib monotherapy or in combination with methotrexate maintaining clinical remission compared with MTX or adalimumab plus MTX, respectively, at 48 weeks1,2 Findings from an integrated safety analysis across five studies in the SELECT Phase 3 clinical program support the well-characterized safety profile of upadacitinib in patients with moderately to severely active rheumatoid arthritis. Upadacitinib, an investigational oral agent engineered by AbbVie to selectively inhibit JAK1, is being studied as a once-daily therapy in moderately to severely active rheumatoid arthritis and across multiple other immune-mediated inflammatory diseases4-17 NORTH CHICAGO, Ill., June 12, 2019 /PRNewswire/ -- AbbVie (ABBV), a research-based global biopharmaceutical company, today announced new results from the Phase 3 clinical trials SELECT-EARLY and SELECT-COMPARE showing that patients receiving upadacitinib once-daily (15 mg or 30 mg, SELECT-EARLY; 15 mg plus methotrexate (MTX), SELECT-COMPARE) through 48 weeks continue to demonstrate improved signs and symptoms of rheumatoid arthritis, as measured by ACR20/50, and clinical remission based on Disease Activity Score 28 C-Reactive Protein (DAS28-CRP)<2.6.1,2 The studies evaluate upadacitinib, an investigational, once-daily JAK1-selective inhibitor, in patients with moderately to severely active rheumatoid arthritis.1,2 Additionally, data from an integrated safety analysis across five Phase 3 SELECT clinical trials show that treatment with upadacitinib in patients with moderately to severely active rheumatoid arthritis demonstrates a consistent safety profile.3 These results are being presented at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology, June 12-15, in Madrid. "These data continue to support the potential of upadacitinib to help maintain consistent disease control for patients living with moderately to severely active rheumatoid arthritis," said Professor Ronald van Vollenhoven, M.D., Ph.D., Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands. "While remission is the primary treatment goal, in accordance with the American College of Rheumatology and the European League Against Rheumatism recommendations, a majority of patients do not achieve clinical remission today, despite currently available treatment options." Rheumatoid arthritis is a chronic and debilitating disease that affects an estimated 23.7 million people worldwide.18 Many patients with rheumatoid arthritis still do not achieve clinical remission or low disease activity targets.19-21 "Over the past decade, important advances have been made in the understanding of rheumatoid arthritis and its management, looking beyond treating symptoms to achieving remission," said Marek Honczarenko, M.D., Ph.D., vice president, immunology development, AbbVie. "As data continue to emerge from the SELECT program, we look forward to deepening our understanding of the benefits and risks of JAK inhibition on treatment outcomes in different patient populations with moderately to severely active rheumatoid arthritis." Upadacitinib is an investigational oral agent and has not been approved by any regulatory authorities.
SELECT-EARLY 和 SELECT-COMPARE 的数据显示,与 MTX 或阿达木单抗联合 MTX 治疗48周的患者相比,接受 upadacitinib 单药治疗或与维持临床缓解的甲氨蝶呤联合治疗的患者比例要高得多。 SELECT 第3期临床方案五项研究的综合安全性分析结果支持中度至严重活动性类风湿关节炎患者 upadacitinib 的特征良好的安全性概况。 Upadacitinib 是艾伯维(AbbVie)公司为选择性抑制 JAK1而设计的一种研究口服剂,目前正在研究中至重度活动性类风湿关节炎和其他多种免疫介导的炎性疾病的每日一次治疗 伊利诺伊州,芝加哥北部。全球生物制药公司艾伯维(AbbVie)( ABBV )今天宣布了 SELECT-EARLY 和 SELECT-COMPAARE 三期临床试验的新结果,显示每天接受 upadacitinib 的患者(15毫克或30毫克, SELECT-EARLY ,15毫克加上甲氨蝶呤( MTX ))。SELECT-COMPAARE )在48周内继续显示类风湿性关节炎的症状和体征改善,以 ACR20/50为标准,根据疾病活动评分28 C 反应蛋白( DAS28-CRP )进行临床缓解。1,2该研究评估了中度至严重活动性类风湿关节炎患者每天一次的 JAK1选择性抑制剂 upadacitinib 。1,2此外,五个 SELECT 临床试验的综合安全性分析数据显示,对于中度至严重活动性类风湿关节炎患者, upadacitinib 治疗显示出一致的安全性。3. 这些结果将在6月12-15日在马德里举行的欧洲风湿病学会年会上公布。 荷兰阿姆斯特丹阿姆斯特丹阿姆斯特丹风湿病学和免疫学中心的 Ronald van Vollenhoven 教授说:“这些数据继续支持 upadacitinib 的潜力,有助于对中度至严重活动性类风湿关节炎患者保持一致的疾病控制。”虽然缓解是主要的治疗目标,但根据美国风湿病学学会和欧洲抗风湿病联盟的建议,大多数病人今天不能达到临床缓解,尽管目前有治疗选择。 类风湿性关节炎是一种慢性的、使人衰弱的疾病,全世界估计有2,370万人受到影响。18.许多类风湿关节炎患者仍未达到临床缓解或低疾病活动指标。19-21 “在过去的十年里,在了解类风湿关节炎及其管理方面取得了重要进展,从治疗症状到达到缓解,”艾伯维(AbbVie)免疫学发展副总裁 Marek Honczanko 博士说。随着 SELECT 项目的数据不断出现,我们期待着加深我们对 JAK 抑制对中度至严重活动性类风湿关节炎不同患者治疗结果的益处和风险的理解。 Upadacitinib 为调查口服剂,未经任何监管部门批准。