Plasencia Chamaida, Wolbink Gertjan, Krieckaert Charlotte L M, Kneepkens Eva L, Turk Samina, Jurado Teresa, Martínez-Feito Ana, Navarro-Compán Victoria, Bonilla Gema, Villalba Alejandro, Peiteado Diana, Nuño Laura, Martín-Mola Emilio, Nurmohamed Michael T, van der Kleij Desiree, Rispens Theo, Pascual-Salcedo Dora, Balsa Alejandro
Department of Rheumatology, La Paz University Hospital-Idipaz, Madrid, Spain.
Jan van Breemen Research Institute/Reade, Amsterdam; and Department of Rheumatology, V.U. University Medical Centre, Amsterdam, The Netherlands.
Clin Exp Rheumatol. 2016 Jul-Aug;34(4):655-62. Epub 2016 May 19.
The aim of this study is to compare clinical outcomes, incidence of flares and administered drug reduction between rheumatoid arthritis (RA) patients under TNF inhibitors (TNFi) tapering strategy and RA patients on standard regimen.
Two groups of RA patients on TNFi with DAS28<3.2 were compared: the tapering group (TG: 67 pts from Spain) and the control group with standard therapy regimen (CG: 77 pts from the Netherlands). DAS28 was measured at different time points: visit 0 (prior starting TNFi), visit 1 (prior to start tapering in TG and with DAS28<3.2 in TG and CG), visit 2 (6 months after visit 1), visit 3 (1 year after visit 1), visit 4 (the last visit available after visit 1) and visit-flare (visit with the worst flare between visit 1 and visit 4).
Despite the reduction of administered drug at visit 4 in the TG (interval elongation of 32.8% in infliximab, 52.9% in adalimumab and 52.6% in etanercept), the DAS28 remained similar between groups at the end of the study (DAS28: 2.7±0.9 in TG vs. 2.5±1 in CG, p=0.1). No differences were seen in the number of patients with flares [26/67 (38.9%) in the TG vs. 30/77 (39%) in the CG, p=0.324] and only nineteen out of 136 patients (14%) had anti-drug antibodies at the end of the study.
The tapering strategy of TNFi in RA patients result in a reduction of the drug administered, while the disease control is not worse than patients on the standard regimen.
本研究旨在比较采用肿瘤坏死因子抑制剂(TNFi)减量策略的类风湿关节炎(RA)患者与采用标准治疗方案的RA患者的临床结局、病情复发率及药物减量情况。
比较两组接受TNFi治疗且疾病活动度评分28(DAS28)<3.2的RA患者:减量组(TG:来自西班牙的67例患者)和采用标准治疗方案的对照组(CG:来自荷兰的77例患者)。在不同时间点测量DAS28:访视0(开始使用TNFi之前)、访视1(TG开始减量前以及TG和CG中DAS28<3.2时)、访视2(访视1后6个月)、访视3(访视1后1年)、访视4(访视1后的最后一次可用访视)以及复发访视(访视1至访视4期间病情最严重复发时的访视)。
尽管TG在访视4时药物用量减少(英夫利昔单抗间隔延长32.8%,阿达木单抗延长52.9%,依那西普延长52.6%),但研究结束时两组间DAS28仍相似(TG组DAS28:2.7±0.9,CG组2.5±1,p=0.1)。病情复发患者数量无差异[TG组26/67(38.9%),CG组30/77(39%),p=0.324],且研究结束时136例患者中只有19例(14%)产生抗药抗体。
RA患者中TNFi减量策略可减少药物用量,同时疾病控制情况并不比采用标准治疗方案的患者差。