Institute of Health, Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada Department of Medicine, University of Calgary, Calgary, Alberta, Canada McCaig Institute for Bone and Joint Health, University of Calgary, Calgary, Alberta, Canada.
Southlake Regional Health Centre, Newmarket, Ontario, Canada.
Ann Rheum Dis. 2016 Jun;75(6):1003-8. doi: 10.1136/annrheumdis-2014-206504. Epub 2015 May 15.
To determine the comparative effectiveness of oral versus subcutaneous methotrexate (MTX) as initial therapy for patients with early rheumatoid arthritis (ERA).
Patients with ERA (symptoms ≤1 year) initiating MTX therapy were included from a multicentre, prospective cohort study. We compared the effectiveness between starting with oral versus subcutaneous MTX over the first year. Longitudinal multivariable models, adjusted for potential baseline and time-varying confounders, were used to compare treatment changes due to inefficacy or toxicity and treatment efficacy (Disease Activity Score-28 (DAS-28), DAS-28 remission and Health Assessment Questionnaire-Disability Index (HAQ-DI)).
666 patients were included (417 oral MTX, 249 subcutaneous MTX). Patients prescribed subcutaneous MTX were prescribed a higher dose of MTX (mean dose over first three months 22.3 mg vs 17.2 mg/week). At 1 year, 49% of patients initially treated with subcutaneous MTX had changed treatment compared with 77% treated with oral MTX. After adjusting for potential confounders, subcutaneous MTX was associated with a lower rate of treatment failure ((HR (95% CI) 0.55 (0.39 to 0.79)). Most treatment failures were due to inefficacy with no difference in failure due to toxicity. In multivariable models, subcutaneous MTX was also associated with lower average DAS-28 scores (mean difference (-0.38 (95% CI -0.64 to -0.10)) and a small difference in DAS-28 remission (OR 1.2 (95% CI 1.1 to 1.3)). There was no significant difference in sustained remission or HAQ-DI (p values 0.43 and 0.75).
Initial treatment with subcutaneous MTX was associated with lower rates of treatment changes, no difference in toxicity and some improvements in disease control versus oral MTX over the first year in patients with ERA.
确定口服与皮下注射甲氨蝶呤（MTX）作为早期类风湿关节炎（ERA）患者初始治疗的比较效果。
本研究纳入了一项多中心前瞻性队列研究中起始 MTX 治疗的 ERA（症状≤1 年）患者。我们比较了起始口服与皮下 MTX 治疗在第一年的效果。使用纵向多变量模型，根据潜在的基线和时变混杂因素进行调整，比较了因无效或毒性而改变治疗以及治疗效果（28 关节疾病活动度评分（DAS-28）、DAS-28 缓解和健康评估问卷残疾指数（HAQ-DI））的治疗变化。
共纳入 666 例患者（口服 MTX 417 例，皮下 MTX 249 例）。起始皮下 MTX 治疗的患者 MTX 剂量更高（前三个月的平均剂量为 22.3mg vs 17.2mg/周）。1 年后，49%初始接受皮下 MTX 治疗的患者与 77%接受口服 MTX 治疗的患者相比，治疗方案发生了改变。在调整潜在混杂因素后，皮下 MTX 与较低的治疗失败率相关（HR（95%CI）为 0.55（0.39 至 0.79））。大多数治疗失败是由于无效，而因毒性导致的失败没有差异。在多变量模型中，皮下 MTX 也与较低的平均 DAS-28 评分相关（平均差值（-0.38（95%CI-0.64 至-0.10））和 DAS-28 缓解率略有差异（OR 1.2（95%CI 1.1 至 1.3））。持续缓解或 HAQ-DI 无显著差异（p 值分别为 0.43 和 0.75）。
与口服 MTX 相比，在 ERA 患者中，初始皮下 MTX 治疗在第一年与治疗方案改变率较低、毒性无差异和疾病控制方面的一些改善相关。
