Division of Rheumatology, Northwell Health; Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York, USA.
Curr Opin Rheumatol. 2020 Nov;32(6):609-616. doi: 10.1097/BOR.0000000000000754.
It is an understatement to say that drug approvals in systemic lupus erythematosus (SLE), lupus nephritis, and Sjogren's syndrome have lagged far behind those in other autoimmune diseases, such as rheumatoid arthritis and psoriatic arthritis. Reasons for this are multiple and include the molecular and clinical heterogeneity of these conditions; confounding by background medications, especially corticosteroids; and clinical trial endpoints. However, the tides are changing, and there have been several bright spots in our attempts to bring more efficacious drugs to our patients.
Several positive phase II and phase III trials in SLE and lupus nephritis with drugs such as anifrolumab, voclosporin, belimumab, and obinutuzumab will no doubt eventually generate regulatory approvals for most, if not all, of these drugs. Although early in development, the promising results in Sjogren's syndrome with iscalimab and ianalumab should make the Sjogren's syndrome community quite hopeful of future drug approvals.
In this review, we highlight recent study results in Sjogren's syndrome, SLE, and lupus nephritis, emphasizing investigational therapies in late stage development, but we also provide a glimpse into drugs of the future.
目的综述：系统性红斑狼疮 (SLE)、狼疮性肾炎和干燥综合征的药物批准情况远远落后于类风湿关节炎和银屑病关节炎等其他自身免疫性疾病，这一点毫不夸张。造成这种情况的原因有很多，包括这些疾病的分子和临床异质性；背景药物（尤其是皮质类固醇）的混杂作用；以及临床试验终点。然而，形势正在发生变化，我们在为患者带来更有效药物方面取得了一些显著进展。
最新发现：在 SLE 和狼疮性肾炎中，一些针对 anifrolumab、voclosporin、belimumab 和 obinutuzumab 等药物的 II 期和 III 期阳性试验无疑将最终为这些药物中的大多数（如果不是全部）获得监管批准。尽管处于早期开发阶段，但 iscalimab 和 ianalumab 在干燥综合征中令人鼓舞的结果应使干燥综合征社区对未来的药物批准充满希望。
总结：在这篇综述中，我们重点介绍了干燥综合征、SLE 和狼疮性肾炎的最新研究结果，强调了处于后期开发阶段的研究性治疗方法，但我们也展望了未来的药物。
