Duclos Muriel, Gossec Laure, Ruyssen-Witrand Adeline, Salliot Carine, Luc Mathieu, Guignard Sandra, Dougados Maxime
Rene Descartes University, Faculty of Medicine, Paris, France.
J Rheumatol. 2006 Dec;33(12):2433-8. Epub 2006 Oct 1.
Tumor necrosis factor (TNF) blockers are efficacious in clinical trials in rheumatic diseases. However, their efficacy in daily practice, depending on the specific diagnosis or the use of concomitant therapy, remains to be confirmed. Our objective was to evaluate TNF blocker retention rates and their predisposing factors in daily practice.
Retrospective evaluation of all TNF blocker therapies in one center. Retention rate was evaluated using a Kaplan-Meier survival data analysis technique in which the event was discontinuation of the drug due to inefficacy or toxicity with log-rank tests and a Cox proportional-hazards regression model.
From 1997 to 2004, 770 patients with inflammatory rheumatism received at least one TNF blocker; 142 received more than one agent (975 treatment courses: 493 etanercept, 335 infliximab, 147 adalimumab). The underlying disease was mainly rheumatoid arthritis (RA), found in 57.1% of patients, and spondyloarthropathies (SpA) in 37.7%. The percentage of patients receiving the same treatment at Month 12, 24, and 36 was 64.0%, 50.3%, and 39.4%, respectively. No difference between the 3 TNF blockers was found (p = 0.48). The retention rate was longer for the first treatment course [hazard ratio (HR) 2.17, 95% confidence interval (95% CI) 1.82-2.58, p < 0.0001]; longer for patients with SpA (HR 1.60, 95% CI 1.20-2.13, p = 0.001); and longer without concomitant DMARD (HR 0.70, 95% CI 0.51-0.97, p = 0.03).
Our results indicate a lower retention rate of TNF blockers in daily practice compared with clinical trials, with no difference between the 3 currently available agents. Moreover, results suggest greater benefit in SpA. The role of concomitant DMARD remains to be confirmed.
肿瘤坏死因子（TNF）阻滞剂在风湿病的临床试验中疗效显著。然而，其在日常临床实践中的疗效，取决于具体诊断或联合治疗的使用情况，仍有待证实。我们的目的是评估TNF阻滞剂在日常临床实践中的持续使用率及其相关影响因素。
对某中心所有使用TNF阻滞剂的治疗进行回顾性评估。采用Kaplan-Meier生存数据分析技术评估持续使用率，其中事件定义为因疗效不佳或毒性而停药，并使用对数秩检验和Cox比例风险回归模型。
1997年至2004年，770例炎性风湿病患者至少接受过一次TNF阻滞剂治疗；142例患者接受过不止一种药物治疗（共975个疗程：493个依那西普疗程、335个英夫利昔单抗疗程、147个阿达木单抗疗程）。基础疾病主要为类风湿关节炎（RA），占患者总数的57.1%，脊柱关节病（SpA）占37.7%。在第12个月、24个月和36个月仍接受相同治疗的患者比例分别为64.0%、50.3%和39.4%。三种TNF阻滞剂之间未发现差异（p = 0.48）。第一个疗程的持续使用率更高[风险比（HR）2.17，95%置信区间（CI）1.82 - 2.58，p < 0.0001]；SpA患者的持续使用率更高（HR 1.60，95% CI 1.20 - 2.13，p = 0.001）；未联合使用改善病情抗风湿药（DMARD）的患者持续使用率更高（HR 0.70，95% CI 0.51 - 0.97，p = 0.03）。
我们的结果表明，与临床试验相比，TNF阻滞剂在日常临床实践中的持续使用率较低，目前可用的三种药物之间无差异。此外，结果表明SpA患者获益更大。联合使用DMARD的作用仍有待证实。
