期刊
INTERNATIONAL JOURNAL OF RHEUMATIC DISEASES
卷 19, 期 11, 页码 1143-1156出版社
WILEY
DOI: 10.1111/1756-185X.12723
关键词
anti-tumor necrosis factor; Asian; biologics; rheumatoid arthritis
类别
资金
- Janssen Research & Development, LLC
AimThe efficacy and safety of golimumab+methotrexate (MTX) were evaluated in Chinese patients with active rheumatoid arthritis (RA) despite MTX therapy. MethodsChinese patients (n=264) were randomly assigned (1:1) to receive subcutaneous injections of placebo+MTX with crossover to golimumab 50mg+MTX at week 24 (Group 1) or to golimumab 50mg+MTX (Group 2) every 4weeks. Group 1 patients with inadequate response entered blinded early escape to golimumab 50mg+MTX at week 16. At least a 20% improvement in the American College of Rheumatology (ACR20) criteria at week 14 was the primary endpoint. Other assessments included the 28-joint count Disease Activity Score using C-reactive protein (DAS28-CRP) and Health Assessment Questionnaire-Disability Index (HAQ-DI) through week 52. Adverse events (AEs) were monitored through week 56. ResultsACR20 response at week 14 was significantly higher in Group 2 (40.9% [54/132]) compared with Group 1 (15.9% [21/132]; P<0.001). Greater proportions of patients in Group 2 compared with Group 1 had a DAS28-CRP response at week 14 (65.2% vs. 30.3%, P<0.001) or ACR20 response at week 24 (42.4% vs. 15.9%, P<0.001), and Group 2 had a significantly greater change in HAQ-DI at week 24 (-0.26 vs. 0.15, P<0.001). After week 24, the proportion of patients achieving ACR20 in Group 1 approached that in Group 2. Through week 16, 23.5% of Group 1 and 26.7% of Group 2 patients reported AEs. Among golimumab+MTX-treated patients, 50.2% and 4.2% had 1 AE or serious AE, respectively, through week 56. No unexpected safety signals were observed. ConclusionAmong MTX-experienced Chinese patients with active RA, a significantly greater proportion of patients receiving golimumab+MTX had improvements in the signs and symptoms of RA compared with MTX monotherapy. Safety findings were consistent with previous studies of golimumab in patients with RA.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据