作者
Josef S Smolen, Andre Beaulieu, Andrea Rubbert-Roth, Cesar Ramos-Remus, Josef Rovensky, Emma Alecock, Thasia Woodworth, Rieke Alten
发表日期
2008/3/22
期刊
The Lancet
卷号
371
期号
9617
页码范围
987-997
出版商
Elsevier
简介
Background
Interleukin 6 is involved in the pathogenesis of rheumatoid arthritis via its broad effects on immune and inflammatory responses. Our aim was to assess the therapeutic effects of blocking interleukin 6 by inhibition of the interleukin-6 receptor with tocilizumab in patients with rheumatoid arthritis.
Methods
In this double-blind, randomised, placebo-controlled, parallel group phase III study, 623 patients with moderate to severe active rheumatoid arthritis were randomly assigned with an interactive voice response system, stratified by site with a randomisation list provided by the study sponsor, to receive tocilizumab 8 mg/kg (n=205), tocilizumab 4 mg/kg (214), or placebo (204) intravenously every 4 weeks, with methotrexate at stable pre-study doses (10–25 mg/week). Rescue therapy with tocilizumab 8 mg/kg was offered at week 16 to patients with less than 20% improvement in both swollen and tender joint …
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