A randomized, double-blind, parallel-group, phase III study of shortening the dosing interval of subcutaneous tocilizumab monotherapy in patients with rheumatoid arthritis and an inadequate response to subcutaneous tocilizumab every other week: Results of
A randomized, double-blind, parallel-group, phase III study of shortening the dosing interval of subcutaneous tocilizumab monotherapy in patients with rheumatoid arthritis and an inadequate response to subcutaneous tocilizumab every other week: Results of
复制标题
一项随机、双盲、平行组、III 期研究，旨在缩短类风湿性关节炎患者皮下注射托珠单抗单药治疗的给药间隔，并且每隔一周对托珠单抗皮下注射治疗反应不足：结果
DOI：
10.1080/14397595.2017.1332507
复制
发表时间：
2018
期刊：
影响因子：
2.2
通讯作者：
Ohsawa S; SHINOBI study group.
中科院分区：
文献类型：
--
作者：
Ogata A1,2;Tanaka Y;Ishii T;Kaneko M;Miwa H;Ohsawa S; SHINOBI study group.
目的：比较每周一次皮下注射托珠单抗（TCZ-SC）与每隔一周一次皮下注射托珠单抗（TCZ-SC）治疗对TCZ-SC q2w疗效不佳的类风湿关节炎患者的疗效和安全性。方法：将日本对TCZ-SC q2w疗效不佳的成人患者随机分为TCZ-SC 162 mg qw单药治疗组和TCZ-SC 162 mg q2w单药治疗组，治疗12周（双盲）。主要终点是第12周时校正的疾病活动性评分28-红细胞沉降率（DAS 28-ESR）较基线的变化。结果：TCZ-SC qw在DAS 28-ESR从基线至第12周的校正平均变化方面优于TCZ-SC q2w，差异有上级。TCZ-SC qw和q2w之间DAS 28-ESR变化的差异为− 1.21（95%CI：− 2.13，− 0.30，p =.0108）。接受TCZ-SC qw治疗的患者达到DAS 28-ESR缓解/疾病活动度低的比例高于接受TCZ-SC q2w治疗的患者。TCZ-SC qw和q2w的不良事件分别为71.4%和66.7%，感染是最常见的事件，一个致命的情况下与TCZ-SC qw.Conclusions：在患者TCZ-SC q2w反应不足，缩短给药间隔qw提高疗效与可接受的耐受性。TCZ q2w和qw感染的发生是重要的，需要仔细注意。
Objective:To determine the efficacy and safety of subcutaneous tocilizumab (TCZ-SC) monotherapy every week (qw) versus every other week (q2w) in patients with rheumatoid arthritis who had an inadequate response to TCZ-SC q2w.Methods:Adult patients in Japan with inadequate response to TCZ-SC q2w were randomized to either TCZ-SC 162 mg qw monotherapy or TCZ-SC 162 mg q2w monotherapy for 12 weeks (double-blind). The primary endpoint was the change from baseline in adjusted Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) at week 12. Efficacy, safety and pharmacokinetics were assessed.Results:TCZ-SC qw was superior to TCZ-SC q2w for adjusted mean change in DAS28-ESR from baseline to week 12. The difference in the change in DAS28-ESR between TCZ-SC qw and q2w was −1.21 (95%CI: −2.13, −0.30,p= .0108). A higher proportion of patients receiving TCZ-SC qw achieved DAS28-ESR remission/low disease activity than TCZ-SC q2w. Adverse events were 71.4% and 66.7% for TCZ-SC qw and q2w, respectively; infection was the most common event with one fatal case with TCZ-SC qw.Conclusions:In patients with inadequate response to TCZ-SC q2w, shortening the dosing interval to qw improved efficacy with acceptable tolerability. Occurrence of infection for both TCZ q2w and qw is important and needs careful attention.