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首页> 外文期刊>Rheumatology >Efficacy and safety of leflunomide in DMARD-na?ve patients with early rheumatoid arthritis: Comparison of a loading and a fixed-dose regimen
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Efficacy and safety of leflunomide in DMARD-na?ve patients with early rheumatoid arthritis: Comparison of a loading and a fixed-dose regimen

机译：来氟米特对初发DMARD的类风湿关节炎患者的疗效和安全性：负荷和固定剂量方案的比较

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Objective. To assess the efficacy of LEF administered with or without a loading dose in DMARD-na?ve patients with early RA. Methods. This multicentre, double-blind, randomized clinical trial included adults with RA diagnosed within 6 months (ACR criteria). Patients were randomly selected to receive either a 100mg loading dose or a 20mg fixed dose of LEF for 3 days, followed by a 3-month open-label maintenance period of 20mg LEF qd. The primary outcome criterion was ACR20 response rate at study end in the intent-to-treat population. Secondary criteria were ACR20, ACR50, ACR70 and DAS28 response rates at 1 and 3 months and safety. Results. The intent-to-treat population included 120 patients (median time since diagnosis 0.95 months). The ACR20 response rate at study end was 69.0% (95%CI 60.5%, 77.4%). Response rates were significantly lower (P= 0.025) in the loading-dose group [58.5% (45.2%, 71.8%)] than in the fixed-dose group [77.8% (67.5%, 88.0%)]. Three-month ACR50, ACR70 and DAS28 response rates were 41.4%, 17.7% and 81.7%, respectively, with no significant differences between groups. Adverse events occurred in 53.7% (loading-dose group) and 49.3% (fixed-dose group) of patients, most frequently diarrhoea and elevated hepatic enzymes; these occurred more frequently and earlier in treatment when the loading dose was used. Conclusion. LEF was effective in DMARD-na?ve patients with early disease. No incremental benefit was observed with the use of a loading dose, which may be associated with an increased initial rate of adverse events. The advantage of LEF initiation with a loading dose is not confirmed in this population. Trial Registration. ClinicalTrials.gov, http://clinicaltrials.gov/, NCT00596206.
机译：目的。评估在未使用DMARD的RA早期患者中，不论是否使用负荷剂量LEF的疗效。方法。这项多中心，双盲，随机临床试验包括在6个月内被诊断为RA的成人（ACR标准）。随机选择患者接受100毫克负荷剂量或20毫克固定剂量的LEF，持续3天，然后进行3个月的开放标签维持期20毫克LEF qd。主要结果标准是研究目的人群中研究结束时的ACR20反应率。次要标准是1个月和3个月时的ACR20，ACR50，ACR70和DAS28反应率以及安全性。结果。意向性治疗人群包括120例患者（自诊断以来的平均时间为0.95个月）。研究结束时的ACR20响应率为69.0％（95％CI 60.5％，77.4％）。负荷剂量组的反应率[58.5％（45.2％，71.8％）]显着低于固定剂量组的[77.8％（67.5％，88.0％）]（P = 0.025）。三个月的ACR50，ACR70和DAS28应答率分别为41.4％，17.7％和81.7％，两组之间无显着差异。不良事件发生在53.7％（负荷剂量组）和49.3％（固定剂量组）患者中，最常见的是腹泻和肝酶升高;当使用负荷剂量时，这些发生的频率更高，治疗更早。结论。 LEF对初发DMARD的初发患者有效。使用负荷剂量未观察到增加的益处，这可能与不良事件的初始发生率增加有关。在该人群中未证实以负荷剂量开始LEF的优势。试用注册。 ClinicalTrials.gov，http：//clinicaltrials.gov/，NCT00596206。

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