Neves Ana, Viveiros Luísa, Venturelli Veronica, Isenberg David A
Internal Medicine Department, Centro Hospitalar Universitário de São João, Oporto, Portugal.
Internal Medicine Department, Centro Hospitalar Universitário de Santo António, Oporto, Portugal.
Res Rep Urol. 2023 Jul 10;15:333-353. doi: 10.2147/RRU.S385836. eCollection 2023.
Lupus nephritis (LN) is a frequent and serious complication of systemic lupus erythematosus (SLE), impairing patients' quality of life and significantly increasing mortality. Despite optimizing the use of conventional immunosuppressants and other biological drugs, its management remains unsatisfactory. This is mainly due to the heterogeneity of SLE, but also to insufficiently effective treatment regimens and clinical trial limitations (strict criteria, low number of patients included, and side effects). Most clinical trials of new biological therapies have failed to meet their primary endpoints in both general SLE and LN, with only two biological drugs (belimumab and anifrolumab) being approved by the Food and Drug Administration (FDA) for the treatment of SLE. Recently, several Phase II randomized controlled trials have evaluated the efficacy and safety of new biologics in LN, and some of them have demonstrated an improvement in clinical and laboratory measures. Multi-target therapies are also being successfully developed and encourage a belief that there will be an improvement in LN outcomes.
狼疮性肾炎(LN)是系统性红斑狼疮(SLE)常见且严重的并发症,会损害患者的生活质量并显著增加死亡率。尽管优化了传统免疫抑制剂和其他生物药物的使用,但其治疗效果仍不尽人意。这主要是由于SLE的异质性,也由于治疗方案效果不佳以及临床试验存在局限性(标准严格、纳入患者数量少和有副作用)。大多数新型生物疗法的临床试验在普通SLE和LN中均未达到其主要终点,仅有两种生物药物(贝利尤单抗和阿尼鲁单抗)获得美国食品药品监督管理局(FDA)批准用于治疗SLE。最近,几项II期随机对照试验评估了新型生物制剂在LN中的疗效和安全性,其中一些试验已证明在临床和实验室指标方面有所改善。多靶点疗法也在成功研发中,这让人相信LN的治疗结果将会得到改善。