作者
Yoshikazu Nakaoka, Mitsuaki Isobe, Syuji Takei, Yoshiya Tanaka, Tomonori Ishii, Shumpei Yokota, Akira Nomura, Seitaro Yoshida, Norihiro Nishimoto
发表日期
2018/3/1
期刊
Annals of the rheumatic diseases
卷号
77
期号
3
页码范围
348-354
出版商
BMJ Publishing Group Ltd
简介
Objective
To investigate the efficacy and safety of the interleukin-6 receptor antibody tocilizumab in patients with Takayasu arteritis (TAK).
Methods
Patients with TAK who had relapsed within the previous 12 weeks were induced into remission with oral glucocorticoid therapy. In this double-blind, placebo-controlled trial, patients were randomly assigned 1:1 to receive weekly tocilizumab 162 mg or placebo subcutaneously, and oral glucocorticoids were tapered 10 %/week from week 4 to a minimum of 0.1 mg/kg/day until 19 patients relapsed. The primary endpoint was time to relapse of TAK, defined as ≥2 of the following: objective systemic symptoms, subjective systemic symptoms, elevated inflammation markers, vascular signs and symptoms or ischaemic symptoms.
Results
The intent-to-treat and safety populations included 18 tocilizumab-treated and 18 placebo-treated patients. The per-protocol set (PPS …
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