Abstract：
The search for new glucocorticoid-sparing disease-modifying anti-rheumatic drugs continues to be an unmet need in large vessel vasculitis (LVV). This report aims to assess the effectiveness and safety of leflunomide (LEF) in Takayasu arteritis (TA) and giant cell arteritis (GCA).
We systematically reviewed the literature, searching for studies evaluating the efficacy of LEF in LVV. A meta-analysis was conducted using the random-effects method.
The literature search identified eight studies that assessed LEF in TAK and seven in GCA. All were uncontrolled observational studies with a high risk of bias, implying a low or very-low certainty of evidence. In TAK, the pooled proportion of patients achieving at least a partial remission was 75% (95% CI: 0.64-0.84), angiographic stabilization was observed in 86% (0.77-0.94) and relapses in 12% (0.05-0.21). The mean reduction in the prednisolone dose (MRPD) after LEF treatment was 15.7 mg/d (10.28-21.16). Adverse events were observed in 8% of patients (0.02-0.16). Comparison of LEF with methotrexate (MTX) or cyclophosphamide revealed LEF to be superior in terms of remission induction, relapse prevention, and tolerance. When compared with tofacitinib, both drugs demonstrated comparable efficacy. In GCA, the pooled proportion of patients achieving at least a partial remission was 60% (0.17-0.95). The MRPD after LEF treatment was 15.63 mg/d (1.29-32.55) and 53% of the patients were able to discontinue glucocorticoids (0.25 - 0.80). Relapses were observed in 21% of cases (0.14- 0.28) and adverse events in 28% (0.12-0.46). Comparison of LEF with MTX showed similar efficacy and tolerance.
LEF is well tolerated and might be effective for patients with TAK and GCA.
We systematically reviewed the literature, searching for studies evaluating the efficacy of LEF in LVV. A meta-analysis was conducted using the random-effects method.
The literature search identified eight studies that assessed LEF in TAK and seven in GCA. All were uncontrolled observational studies with a high risk of bias, implying a low or very-low certainty of evidence. In TAK, the pooled proportion of patients achieving at least a partial remission was 75% (95% CI: 0.64-0.84), angiographic stabilization was observed in 86% (0.77-0.94) and relapses in 12% (0.05-0.21). The mean reduction in the prednisolone dose (MRPD) after LEF treatment was 15.7 mg/d (10.28-21.16). Adverse events were observed in 8% of patients (0.02-0.16). Comparison of LEF with methotrexate (MTX) or cyclophosphamide revealed LEF to be superior in terms of remission induction, relapse prevention, and tolerance. When compared with tofacitinib, both drugs demonstrated comparable efficacy. In GCA, the pooled proportion of patients achieving at least a partial remission was 60% (0.17-0.95). The MRPD after LEF treatment was 15.63 mg/d (1.29-32.55) and 53% of the patients were able to discontinue glucocorticoids (0.25 - 0.80). Relapses were observed in 21% of cases (0.14- 0.28) and adverse events in 28% (0.12-0.46). Comparison of LEF with MTX showed similar efficacy and tolerance.
LEF is well tolerated and might be effective for patients with TAK and GCA.
摘要：
目的：在大血管血管炎（LVV）中，寻找新的保留糖皮质激素的疾病缓解性抗风湿药仍未满足。本报告旨在评估来氟米特（LEF）治疗大动脉炎（TA）和巨细胞动脉炎（GCA）的有效性和安全性。
方法：我们系统回顾了文献，寻找评估LEF在LVV中疗效的研究。使用随机效应方法进行荟萃分析。
结果：文献检索确定了8项在TAK中评估LEF的研究和7项在GCA中评估LEF的研究。所有都是不受控制的观察性研究，有很高的偏倚风险，暗示证据的确定性低或极低。InTAK,达到至少部分缓解的患者的合并比例为75％（95％CI：0.64-0.84），在86％（0.77-0.94）中观察到血管造影稳定，在12％（0.05-0.21）中观察到复发。LEF治疗后泼尼松龙剂量（MRPD）的平均减少为15.7mg/d（10.28-21.16）。8％的患者出现不良事件（0.02-0.16）。LEF与甲氨蝶呤（MTX）或环磷酰胺的比较显示，LEF在诱导缓解方面具有优势，预防复发,和宽容。与托法替尼相比，两种药物表现出相当的疗效。在GCA,达到至少部分缓解的患者的合并比例为60%(0.17~0.95).LEF治疗后的MRPD为15.63mg/d（1.29-32.55），53％的患者能够停止糖皮质激素（0.25-0.80）。在21%的病例中观察到复发(0.14-0.28),在28%中观察到不良事件(0.12-0.46)。LEF与MTX的比较显示出相似的功效和耐受性。
结论：LEF对TAK和GCA患者耐受性良好，可能有效。
方法：我们系统回顾了文献，寻找评估LEF在LVV中疗效的研究。使用随机效应方法进行荟萃分析。
结果：文献检索确定了8项在TAK中评估LEF的研究和7项在GCA中评估LEF的研究。所有都是不受控制的观察性研究，有很高的偏倚风险，暗示证据的确定性低或极低。InTAK,达到至少部分缓解的患者的合并比例为75％（95％CI：0.64-0.84），在86％（0.77-0.94）中观察到血管造影稳定，在12％（0.05-0.21）中观察到复发。LEF治疗后泼尼松龙剂量（MRPD）的平均减少为15.7mg/d（10.28-21.16）。8％的患者出现不良事件（0.02-0.16）。LEF与甲氨蝶呤（MTX）或环磷酰胺的比较显示，LEF在诱导缓解方面具有优势，预防复发,和宽容。与托法替尼相比，两种药物表现出相当的疗效。在GCA,达到至少部分缓解的患者的合并比例为60%(0.17~0.95).LEF治疗后的MRPD为15.63mg/d（1.29-32.55），53％的患者能够停止糖皮质激素（0.25-0.80）。在21%的病例中观察到复发(0.14-0.28),在28%中观察到不良事件(0.12-0.46)。LEF与MTX的比较显示出相似的功效和耐受性。
结论：LEF对TAK和GCA患者耐受性良好，可能有效。
