Naredo Esperanza, Hinojosa Michelle, Valor Lara, Hernández-Flórez Diana, Mata-Martínez Carmen, Serrano-Benavente Belén, Del Río Tamara, Bello Natalia, Montoro María, Nieto-González Juan Carlos, González Carlos M, López-Longo Francisco Javier, Monteagudo Indalecio, Carreño Luis
Department of Rheumatology, Hospital General Universitario Gregorio Marañón, Faculty of Medicine, Complutense University, Madrid, Spain.
Rheumatology (Oxford). 2014 Nov;53(11):2088-94. doi: 10.1093/rheumatology/keu248. Epub 2014 Jun 17.
The aim of this study was to investigate the influence of the pharmacokinetics of s.c. anti-TNF agents on the grade of US-detected synovitis in RA patients.
Fifty RA patients were prospectively recruited from the Biologic Therapy Unit of our hospital. Inclusion criteria were being in treatment with s.c. anti-TNF agents and having had neither changes in therapy nor local corticosteroid injections in the previous 3 months. Patients underwent clinical, laboratory [28-joint DAS (DAS28) and Simplified Disease Activity Index (SDAI)] and US assessment at two time points, i.e. at peak plasma drug concentration and at trough plasma drug concentration. US assessments were performed blindly to the anti-TNF agent, the administration time and the clinical and laboratory data. Twenty-eight joints were investigated for the presence and grade (0-3) of B-mode synovitis and synovial power Doppler signal. Global indices for B-mode synovitis (BSI) and Doppler synovitis (DSI) were calculated for 12 joints and for wrist-hand-ankle-foot joints. B-mode US remission was defined as a BSI <1 and Doppler US remission as a DSI <1.
There were no significant differences between the clinical, laboratory and B-mode and Doppler US parameters at peak time and trough time (P = 0.132-0.986). There were no significant differences between the proportion of patients with active disease and those in remission according to DAS28, SDAI, B-mode US and Doppler US at peak time and trough time assessments (P = 0.070-1).
Our results suggested that s.c. anti-TNF pharmacokinetics do not significantly influence US-scored synovitis in RA patients.
本研究旨在探讨皮下注射抗TNF药物的药代动力学对类风湿关节炎（RA）患者经超声检测的滑膜炎分级的影响。
从我院生物治疗科前瞻性招募了50例RA患者。纳入标准为正在接受皮下注射抗TNF药物治疗，且在过去3个月内治疗未改变且未进行局部皮质类固醇注射。患者在两个时间点接受临床、实验室检查[28个关节的疾病活动度评分（DAS28）和简化疾病活动指数（SDAI）]以及超声评估，即血浆药物浓度峰值时和血浆药物浓度谷值时。超声评估对所用抗TNF药物、给药时间以及临床和实验室数据均采用盲法。对28个关节进行B型滑膜炎和滑膜能量多普勒信号的存在情况及分级（0 - 3级）调查。计算12个关节以及腕 - 手 - 踝 - 足关节的B型滑膜炎总体指数（BSI）和多普勒滑膜炎总体指数（DSI）。B型超声缓解定义为BSI <1，多普勒超声缓解定义为DSI <1。
峰值时间和谷值时间的临床、实验室以及B型和多普勒超声参数之间无显著差异（P = 0.132 - 0.986）。根据DAS28、SDAI、B型超声和多普勒超声在峰值时间和谷值时间评估时，疾病活动患者与缓解患者的比例之间无显著差异（P = 0.070 - 1）。
我们的结果表明，皮下注射抗TNF药物的药代动力学对RA患者超声评分的滑膜炎无显著影响。
