Golimumab公司
医学
类风湿性关节炎
甲氨蝶呤
安慰剂
内科学
痹症科
不利影响
关节炎
外科
阿达木单抗
病理
替代医学
作者
Edward Keystone,Mark C. Genovese,Lars Klareskog,Elizabeth C. Hsia,Stephen Hall,Pedro Miranda,J Pazdur,Sang Cheol Bae,William Palmer,Stephen Xu,Mahboob U. Rahman
标识
DOI:10.1136/ard.2009.116319
摘要
Objective To evaluate the efficacy and safety of golimumab to 52 weeks in patients with active rheumatoid arthritis despite methotrexate. Methods Patients were randomly assigned to receive placebo plus methotrexate (group 1), golimumab 100 mg plus placebo (group 2), golimumab 50 mg plus methotrexate (group 3) and golimumab 100 mg plus methotrexate (group 4). At week 16, patients in groups 1, 2 and 3 who had less than 20% improvement in tender and swollen joints entered early escape. At week 24, patients in group 1 who had not entered early escape crossed over to 50 mg golimumab plus methotrexate. Results At week 16, 31%, 27% and 17% of patients in groups 1, 2 and 3, respectively, entered early escape. At week 52, 44%, 45%, 64% and 58% of patients in groups 1, 2, 3 and 4, respectively, achieved 20% improvement in the American College of Rheumatology criteria; and 34%, 31%, 42% and 53%, respectively, achieved low disease activity (≤3.2) according to the 28-joint disease activity score. Patients in group 4 appeared to have an increased risk of serious adverse events and serious infections. Conclusion The results of various outcome measures showed that the response rates achieved by patients receiving golimumab to 24 weeks were sustained to 52 weeks. The safety profile appeared to be consistent with the known safety profile of tumour necrosis factor inhibitors.
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