Dougados Maxime, Emery Paul, Lemmel Ernst-Martin, de la Serna Rodriguez, Zerbini Cristiano A, Brin Sylvie, van Riel Piet
René Descartes University, Hôpital Cochin, 27 rue du Faubourg Saint-Jacques, 75679 Paris Cedex 14, France.
J Rheumatol. 2003 Dec;30(12):2572-9.
The RELIEF investigation was a 48-week, multicenter, international study comprising 2 phases. Results from the first phase, a 24-week open-label cohort study that evaluated the safety and efficacy of leflunomide, as well as predisposing factors to treatment response, are reported here.
Patients received leflunomide 100 mg once daily for 3 days, followed by 20 mg once daily thereafter. All adverse events were documented. Efficacy variables were the European League Against Rheumatism (EULAR) response criteria using the Disease Activity Score (DAS 28) responder rate and the response rate according to American College of Rheumatology (ACR) criteria. At Week 24, baseline data were analyzed to determine predictive factors for treatment response.
A total of 969 patients were entered in the trial. No adverse events that have not previously been seen with leflunomide were reported. Among 968 evaluable patients, 673 (69.6%) completed 24 weeks of treatment and were responders according to DAS 28 response rate, and 587 (60.6%) completed 24 weeks of treatment and were responders according to ACR 20%. Thus, there was a high correlation between the EULAR and ACR criteria in determining treatment response. In addition, 240 (24.8%) patients had a low DAS 28 (< or = 3.2) and 123 (12.7%) patients fulfilled the disease remission criteria (DAS 28 < 2.6) at the end of the study.
This study demonstrates that leflunomide is well tolerated, with a safety profile similar to that seen previously in Phase III studies, and confirms the efficacy of leflunomide across a range of patient categories.
RELIEF研究是一项为期48周的多中心国际研究，包括两个阶段。本文报告了第一阶段的结果，这是一项为期24周的开放标签队列研究，评估了来氟米特的安全性和有效性以及治疗反应的易感因素。
患者接受来氟米特100mg每日一次，共3天，之后每日20mg。记录所有不良事件。疗效变量采用欧洲抗风湿病联盟（EULAR）反应标准，使用疾病活动评分（DAS 28）反应率和根据美国风湿病学会（ACR）标准的反应率。在第24周时，分析基线数据以确定治疗反应的预测因素。
共有969例患者进入试验。未报告来氟米特以前未出现过的不良事件。在968例可评估患者中，673例（69.6%）完成了24周治疗，根据DAS 28反应率为反应者，587例（60.6%）完成了24周治疗，根据ACR 20%为反应者。因此，在确定治疗反应方面，EULAR和ACR标准之间存在高度相关性。此外，240例（24.8%）患者在研究结束时DAS 28较低（≤3.2），123例（12.7%）患者达到疾病缓解标准（DAS 28<2.6）。
本研究表明，来氟米特耐受性良好，安全性与先前III期研究相似，并证实了来氟米特在一系列患者类别中的疗效。
