托珠单抗单药治疗对初治或已停用甲氨蝶呤6个月的类风湿关节炎患者的5年疗效及安全性：AMBITION研究
Five-year Efficacy and Safety of Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Methotrexate- and Biologic-naive or Free of Methotrexate for 6 Months: the AMBITION Study.
作者信息
Jones Graeme, Wallace Thomas, McIntosh Matthew J, Brockwell Laura, Gómez-Reino Juan J, Sebba Anthony
机构信息
From the Menzies Research Institute, University of Tasmania, Hobart, Australia; Genentech, South San Francisco, California; University of South Florida, Tampa, Florida, USA; Roche Products Ltd., Welwyn Garden City, UK; Hospital Clínico Universitario, Universidad de Santiago de Compostela, Santiago, Spain.
Dr. A. Sebba has received research and consulting fees from Jansen and Jansen, Novartis, Genentech, Pfizer, Lilly, Amgen, Sandoz, and Sanofi. Dr. T. Wallace is an employee of and owns stock options in Genentech. Dr. M. McIntosh is an employee of Genentech. Dr. L. Brockwell is an employee of Roche Products Ltd.
出版信息
J Rheumatol. 2017 Feb;44(2):142-146. doi: 10.3899/jrheum.160287. Epub 2016 Dec 1.
OBJECTIVE
To report on the 5-year efficacy and safety results of the AMBITION (Actemra versus Methotrexate double-Blind Investigative Trial In mONotherapy) monotherapy study (ClinicalTrials.gov: NCT00109408, NCT00720798).
METHODS
Patients with rheumatoid arthritis for whom biologics had not failed or who did not discontinue methotrexate because of lack of efficacy or tolerability were followed up for 5 years to assess the efficacy and serious adverse events (SAE) of tocilizumab (TCZ) monotherapy.
RESULTS
Longterm efficacy results showed that efficacy was maintained or improved for up to 264 weeks in patients receiving TCZ monotherapy. Serious infection was the most frequent SAE; no new safety signals were reported.
CONCLUSION
Longterm monotherapy with TCZ demonstrated continuing efficacy and safety.
目的
报告AMBITION（托珠单抗与甲氨蝶呤单药治疗双盲研究）单药治疗研究（ClinicalTrials.gov：NCT00109408，NCT00720798）的5年疗效和安全性结果。
方法
对生物制剂未失效或未因疗效不佳或耐受性差而停用甲氨蝶呤的类风湿性关节炎患者进行5年随访，以评估托珠单抗（TCZ）单药治疗的疗效和严重不良事件（SAE）。
结果
长期疗效结果显示，接受TCZ单药治疗的患者疗效维持或改善长达264周。严重感染是最常见的SAE；未报告新的安全信号。
结论
TCZ长期单药治疗显示出持续的疗效和安全性。
Zotero 插件