Becciolini Andrea, Biggioggero Martina, Favalli Ennio Giulio
Department of Clinical Sciences and Community Health, University of Milan, Division of Rheumatology, Gaetano Pini Institute, Milan, Italy.
Department of Rheumatology, Gaetano Pini Institute, Milan, Italy
J Int Med Res. 2016 Sep;44(1 suppl):113-118. doi: 10.1177/0300060515593261.
In a real-life setting, to analyse retrospectively the effects of different methotrexate regimens on etanercept efficacy during the first year of treatment for rheumatoid arthritis (RA).
Demographic characteristics, clinical parameters and treatment data from patients with RA receiving the first-line biological disease-modifying antirheumatic drug, etanercept, as monotherapy or in combination with methotrexate were analysed at baseline and after 6 and 12 months. The study population was stratified into three groups according to the level of concomitant methotrexate therapy: no methotrexate, low-dose methotrexate (≤ 10 mg/week) or high-dose methotrexate (>10 mg/week).
Clinical response at 6 and 12 months and clinical outcome at 12 months were significantly better in patients concomitantly treated with high-dose methotrexate. Furthermore, this regimen was associated with the lowest discontinuation rate, suggesting a favourable safety profile.
These data confirm, in a real-life setting, the importance of methotrexate as a combination therapy with etanercept and suggest that the minimal effective dose of methotrexate is >10 mg/week.
在实际临床环境中，回顾性分析类风湿关节炎（RA）治疗第一年中不同甲氨蝶呤治疗方案对依那西普疗效的影响。
对接受一线生物改善病情抗风湿药依那西普单药治疗或与甲氨蝶呤联合治疗的RA患者的人口统计学特征、临床参数和治疗数据在基线、6个月和12个月后进行分析。根据同时使用甲氨蝶呤治疗的水平将研究人群分为三组：不使用甲氨蝶呤、低剂量甲氨蝶呤（≤10毫克/周）或高剂量甲氨蝶呤（>10毫克/周）。
高剂量甲氨蝶呤联合治疗的患者在6个月和12个月时的临床反应以及12个月时的临床结局明显更好。此外，该方案的停药率最低，表明安全性良好。
这些数据在实际临床环境中证实了甲氨蝶呤作为依那西普联合治疗药物的重要性，并表明甲氨蝶呤的最小有效剂量>10毫克/周。
