Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, National Clinical Research Center for Dermatologic and Immunologic Diseases, Ministry of Science and Technology, State Key Laboratory of Complex Severe and Rare Diseases, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, Beijing, China.
Department of Nephrology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.
Front Immunol. 2023 Mar 17;14:1133183. doi: 10.3389/fimmu.2023.1133183. eCollection 2023.
The condition of refractory lupus nephritis (LN) negatively affects the prognosis and life expectancy of the patients, posing a challenge to manage in clinical. This interventional study evaluated the efficacy as well as safety of leflunomide in patients with refractory LN.
Twenty patients with refractory LN were enrolled in this study. A daily dose of 20-40 mg of leflunomide was given to the patients orally. Meanwhile, immunosuppressives were withdrawn, and corticosteroids were gradually tapered. There was an average follow-up period of 3, 6, and 12 months for most patients while some were observed for as long as 24 months. We recorded biochemical parameters and side effects. We calculated the response rate using intention-to-treat analysis.
Eighteen patients (90%) completed the study. At 3 months, 80% (16/20) of the patients achieved more than a 25% decrease in 24-hour urine protein quantity. At 6 months, three patients (15%) achieved a partial response, and five patients (25%) achieved a complete response. However, by 12 months and 24 months, the complete response rate dropped to 15% and 20%, respectively. The objective responses were 30% (6/20), 40% (8/20), 40% (8/20), and 30% (6/20) at 3, 6, 12, and 24 months, respectively. Two patients withdrew from the study due to developing cytopenia and leucopenia.
In patients diagnosed with refractory LN, our study shows that leflunomide could be a promising treatment option owing to its response rate and safety profile.
难治性狼疮肾炎（LN）的状况对患者的预后和预期寿命产生负面影响，在临床上难以治疗。这项干预性研究评估了来氟米特治疗难治性 LN 的疗效和安全性。
本研究纳入了 20 例难治性 LN 患者。患者每天口服 20-40mg 来氟米特。同时，停用免疫抑制剂，逐渐减少皮质类固醇的用量。大多数患者的平均随访时间为 3、6 和 12 个月，部分患者观察时间长达 24 个月。我们记录了生化参数和不良反应。我们通过意向治疗分析计算了反应率。
18 例患者（90%）完成了研究。3 个月时，80%（16/20）的患者 24 小时尿蛋白量减少了 25%以上。6 个月时，3 名患者（15%）部分缓解，5 名患者（25%）完全缓解。然而，12 个月和 24 个月时，完全缓解率分别降至 15%和 20%。3、6、12 和 24 个月时的客观缓解率分别为 30%（6/20）、40%（8/20）、40%（8/20）和 30%（6/20）。2 名患者因出现血细胞减少和白细胞减少而退出研究。
在诊断为难治性 LN 的患者中，我们的研究表明来氟米特可能是一种有前途的治疗选择，因为它具有较高的反应率和安全性。
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