Fernández-Nebro Antonio, Irigoyen María V, Ureña Inmaculada, Belmonte-López María A, Coret Virginia, Jiménez-Núñez Francisco G, Díaz-Cordovés Gisela, López-Lasanta María A, Ponce Antonio, Rodríguez-Pérez Manuel, Calero Enrique, González-Santos Pedro
Servicio de Reumatología, Hospital Regional Universitario Carlos Haya, Facultad de Medicina de Málaga, Málaga, Spain.
J Rheumatol. 2007 Dec;34(12):2334-42. Epub 2007 Nov 1.
To evaluate the effectiveness and safety of anti-tumor necrosis factor (anti-TNF) therapies in rheumatoid arthritis (RA), and to identify the factors involved in this response.
Dynamic prospective cohort study of patients with RA treated with anti-TNF under clinical practice conditions. Effectiveness was evaluated using Disease Activity Score (DAS) 28, European League Against Rheumatism (EULAR) response, Health Assessment Questionnaire (HAQ), and time to treatment failure. Prior adherence was evaluated retrospectively and safety was evaluated by adverse events (AE). The analysis was restricted to anti-TNF-naive patients.
The study included 161 patients treated for RA during 6 years (60 infliximab, 79 etanercept, and 22 adalimumab). At 6 months, 15% reached a good EULAR response and 38% a moderate response. A mean decrease of -1.5 (p < 0.0001) was observed in the DAS28 and of -0.34 in the HAQ (p < 0.0001); however, women showed poorer progress in terms of DAS and HAQ. In the first year, 64.3% did not experience treatment failure and this figure was 50.5% after 2 years. In one-third, glucocorticoids were withdrawn and in the remainder the dose was reduced by 50%. Adherence to treatment, selection of etanercept, and intensification of infliximab were associated with a lower probability of premature failure in the multivariate model. AE were similar to other those in studies and no outstanding differences in safety were found between the 3 anti-TNF therapies.
Anti-TNF treatments are effective and safe, reducing the activity of the disease, disability, and the need for corticosteroids. Patients who displayed good adherence prior to the anti-TNF treatment and were treated with etanercept or with increasing doses of infliximab had the best chance of displaying a response.
评估抗肿瘤坏死因子(抗TNF)疗法治疗类风湿关节炎(RA)的有效性和安全性,并确定与该反应相关的因素。
在临床实践条件下,对接受抗TNF治疗的RA患者进行动态前瞻性队列研究。使用疾病活动评分(DAS)28、欧洲抗风湿病联盟(EULAR)反应、健康评估问卷(HAQ)以及治疗失败时间来评估有效性。回顾性评估既往依从性,并通过不良事件(AE)评估安全性。分析仅限于初治抗TNF患者。
该研究纳入了161例在6年期间接受RA治疗的患者(60例英夫利昔单抗、79例依那西普和22例阿达木单抗)。6个月时,15%的患者达到良好的EULAR反应,38%达到中度反应。DAS28平均下降了-1.5(p < 0.0001),HAQ平均下降了-0.34(p < 0.0001);然而,女性在DAS和HAQ方面进展较差。第一年,64.3%的患者未出现治疗失败,2年后这一数字为50.5%。三分之一的患者停用了糖皮质激素,其余患者剂量减少了50%。在多变量模型中,治疗依从性、依那西普的选择以及英夫利昔单抗的强化治疗与过早失败的可能性较低相关。AE与其他研究中的情况相似,3种抗TNF疗法在安全性方面未发现显著差异。
抗TNF治疗有效且安全,可降低疾病活动度、残疾程度以及对糖皮质激素的需求。在抗TNF治疗前表现出良好依从性且接受依那西普治疗或使用递增剂量英夫利昔单抗治疗的患者最有可能出现反应。