Lindegaard H M, Johansen P, Gröndal G, Jensen E C, Juul L, Schlemmer A M, Agular B, Hansen Imj
a Department of Rheumatology , Odense University Hospital , Odense , Denmark.
b Holbaek Hospital , Holbaek , Denmark.
Scand J Rheumatol. 2016 Jul;45(4):262-6. doi: 10.3109/03009742.2015.1112030. Epub 2016 Jan 4.
To investigate the impact of enhanced infusion rate of tocilizumab on the occurrence of infusion reactions, overall safety, and efficacy in rheumatoid arthritis (RA).
We conducted a 24-week multicentre, open-label, randomized parallel group study comparing adverse event (AE) and effect profiles following tocilizumab IV 8 mg/kg every 4 weeks over 31 min vs. standard 60-min infusions in patients with RA and an inadequate clinical response to disease-modifying anti-rheumatic drugs (DMARDs) and/or tumour necrosis factor (TNF)-α inhibitors.
A total of 47 patients were enrolled in the study and randomized to fast infusions (n = 25) and controls (n = 22). Incidences of infusion reactions were similar between the two groups, neither of them leading to withdrawal. Likewise, the incidence of additional AEs did not differ between the treatment arms. Two serious adverse events (SAEs) were reported, in the control group. Four patients withdrew due to AEs, two from each arm. Efficacy at week 24 was comparable between groups.
In RA, monthly tocilizumab infusions of 8 mg/kg provided over 31 or 60 min during 24 weeks did not differ concerning safety or efficacy.
探讨托珠单抗输注速率加快对类风湿关节炎(RA)患者输注反应的发生情况、总体安全性及疗效的影响。
我们开展了一项为期24周的多中心、开放标签、随机平行组研究,比较类风湿关节炎患者每4周静脉注射8 mg/kg托珠单抗,分别在31分钟内输注与标准60分钟输注后的不良事件(AE)和疗效情况,这些患者对改善病情抗风湿药(DMARDs)和/或肿瘤坏死因子(TNF)-α抑制剂临床反应不足。
共有47例患者入组本研究并随机分为快速输注组(n = 25)和对照组(n = 22)。两组输注反应发生率相似,均未导致停药。同样,治疗组间其他不良事件的发生率也无差异。对照组报告了2例严重不良事件(SAEs)。4例患者因不良事件退出,每组各2例。两组在第24周时的疗效相当。
在类风湿关节炎中,24周内每月31分钟或60分钟输注8 mg/kg托珠单抗,在安全性或疗效方面并无差异。