Methotrexate (MTX) Plus Hydroxychloroquine versus MTX Plus Leflunomide in Patients with MTX-Resistant Active Rheumatoid Arthritis: A 2-Year Cohort Study in Real World
Methotrexate (MTX) Plus Hydroxychloroquine versus MTX Plus Leflunomide in Patients with MTX-Resistant Active Rheumatoid Arthritis: A 2-Year Cohort Study in Real World
复制标题
甲氨蝶呤 (MTX) 加羟氯喹与 MTX 加来氟米特治疗 MTX 耐药的活动性类风湿关节炎患者：现实世界中的 2 年队列研究
DOI：
10.2147/jir.s282249
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发表时间：
2020-12-18
影响因子：
4.5
通讯作者：
Ye S
中科院分区：
文献类型：
--
作者：
Zhang L;Chen F;Geng S;Wang X;Gu L;Lang Y;Li T;Ye S
比较甲氨蝶呤（MTX）联合羟氯喹（HCQ）与MTX联合来氟米特（LEF）治疗MTX单药治疗疗效不佳的类风湿关节炎（RA）的疗效、安全性和成本效益。前瞻性RA队列（n=549）筛选了对初始MTX单一疗法反应不足（使用红细胞沉降率在28个关节中进行疾病活动性评分，DAS 28-ESR>3.2）并且随后接受MTX+HCQ或MTX+LEF的合格患者。采用倾向评分匹配（PSM）校正两组间可能的基线混杂因素。主要结果是通过对数秩检验在随访期间实现首次缓解（DAS 28-ESR<2.6）的患者比例。次要结局是24个月随访后DAS 28、糖皮质激素（GC）暴露、安全性、成本效益、持续缓解和低疾病活动（LDA）率的变化。总体而言，222名合格患者接受了上述两种治疗方案（MTX+HCQ，n=102; MTX+LEF，n=120）。调整PSM后，每组97例患者进行分析。MTX+HCQ组的缓解率高于MTX+LEF组（70.1%vs56.7%，P=0.048）。两组的中位缓解时间分别为11个月和16个月。在终点时，HCQ组中更多的患者达到缓解（46.8% vs 32.5%，P=0.063）并维持持续LDA（53.2% vs 38.6%，P=0.062），并且该组中更多的患者撤回GC（32% vs 16.7%，P=0.053）。安全性特征不令人担忧，两组之间无显著差异。MTX+HCQ相对于MTX+LEF产生的增量成本效益比为每质量调整生命年（QALY）1，111.8美元，在中国人均国内生产总值（GDP）设定的成本效益阈值范围内。在甲氨蝶呤单药治疗疗效不佳的中国RA患者的真实队列中，MTX+HCQ联合治疗的疗效和成本-效果似乎上级于MTX+LEF。
To compare the efficacy, safety, and cost-effectiveness of methotrexate (MTX) plus hydroxychloroquine (HCQ) vs MTX plus leflunomide (LEF) in established rheumatoid arthritis (RA) with inadequate response to MTX monotherapy in a real-world Chinese cohort. A prospective RA cohort (n=549) was screened with eligible patients who had inadequate response (disease activity score in 28 joints using erythrocyte sedimentation rate, DAS28-ESR>3.2) to initial MTX monotherapy and subsequently received either MTX+HCQ or MTX+LEF. Propensity score matching (PSM) was applied to adjust the possible baseline confounders between two groups. The primary outcome was the proportion of patients achieving first remission (DAS28-ESR<2.6) during follow-up by log rank test. Secondary outcomes were changes of DAS28, glucocorticoids (GCs) exposure, safety, cost-effectiveness, sustained remission, and low disease activity (LDA) rate after 24-month follow-up. Overall, 222 eligible patients were subjected to the aforementioned two treatment protocols (MTX+HCQ, n=102; MTX+LEF, n=120). After PSM adjustment, 97 patients in each group were analyzed. A higher remission rate was observed in the MTX+HCQ group than in the MTX+LEF group (70.1% vs 56.7%, P=0.048). The median time to remission was 11 and 16 months in the two groups, respectively. At the endpoint, more patients achieved remission (46.8% vs 32.5%, P=0.063) and maintained sustained LDA in the HCQ group (53.2% vs 38.6%, P=0.062) and also more patients withdrew GCs in this group (32% vs 16.7%, P=0.053) than those in the LEF group. Safety profiles were non-alarming, with no significant difference between the two groups. The incremental cost-effectiveness ratio yielded by MTX+HCQ over MTX+LEF was $1,111.8 per quality-adjusted life-year (QALY), within the cost-effective threshold set as the per capita gross domestic product (GDP) of China. The MTX+HCQ combination was seemingly superior to MTX+LEF in a real-world cohort of Chinese RA patients with inadequate response to methotrexate monotherapy in respect of the efficacy and cost-effectiveness.