Department of Rheumatology. Hospital Universitario de Bellvitge. Barcelona, Spain.
Servicio de Reumatología. Hospital de Sant Joan Despí - Moisés Broggi. Barcelona, Spain.
Semin Arthritis Rheum. 2023 Apr;59:152166. doi: 10.1016/j.semarthrit.2023.152166. Epub 2023 Jan 11.
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.
寻找新的糖皮质激素节约型疾病修饰抗风湿药物仍然是大血管血管炎（LVV）未满足的需求。本报告旨在评估来氟米特（LEF）在大动脉炎（TA）和巨细胞动脉炎（GCA）中的疗效和安全性。
我们系统地检索了文献，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。
文献检索确定了八项评估 LEF 在 TAK 中应用的研究和七项评估 LEF 在 GCA 中应用的研究。所有研究均为偏倚风险高的非对照观察性研究，提示证据确定性为低或极低。在 TAK 中，至少部分缓解的患者比例为 75%（95%CI：0.64-0.84），血管造影稳定率为 86%（0.77-0.94），复发率为 12%（0.05-0.21）。LEF 治疗后泼尼松剂量的平均减少量（MRPD）为 15.7mg/d（10.28-21.16）。8%的患者出现不良反应（0.02-0.16）。LEF 与甲氨蝶呤（MTX）或环磷酰胺的比较表明，LEF 在诱导缓解、预防复发和耐受性方面更具优势。与托法替尼相比，两种药物均具有相似的疗效。在 GCA 中，至少部分缓解的患者比例为 60%（0.17-0.95）。LEF 治疗后 MRPD 为 15.63mg/d（1.29-32.55），53%的患者能够停用糖皮质激素（0.25-0.80）。复发率为 21%（0.14-0.28），不良反应发生率为 28%（0.12-0.46）。LEF 与 MTX 的比较表明，疗效和耐受性相似。
LEF 耐受性良好，可能对 TA 和 GCA 患者有效。
