系统性红斑狼疮生物制剂的最新进展。
完整摘要 · 中文译文
综述目的：直到最近，系统性红斑狼疮（SLE）的生物制剂治疗选择仍然有限。近期研究已大幅拓展了治疗格局。我们总结该领域目前所处的阶段以及哪些进展可能塑造下一步的临床实践。 近期发现：Obinutuzumab是一种II型抗CD20抗体，在REGENCY研究中改善了完全肾脏缓解，已在美国和欧盟获批用于狼疮性肾炎，并被纳入2025年EULAR推荐；在非肾脏SLE中，ALLEGORY达到了主要终点和所有关键次要终点。I型干扰素受体拮抗剂anifrolumab的每周皮下注射制剂在TULIP-SC研究后获批。双重BLyS/APRIL抑制剂泰它西普在一项中国3期试验中有效，CD40配体抑制剂dapirolizumab pegol在PHOENYCS GO中达到了主要终点。Ianalumab、litifilimab和nipocalimab正在推进3期开发。 总结：SLE目前拥有不断扩展的后期治疗管线。当前的主要挑战是患者选择、药物的序贯与联合、长期安全性以及可及性。
完整摘要 · 英文原文
PURPOSE OF REVIEW: Until recently, biologic treatment options for systemic lupus erythematosus (SLE) remained limited. Recent studies have substantially expanded the therapeutic landscape. We summarize where the field currently stands and which developments are likely to shape practice next. RECENT FINDINGS: Obinutuzumab, a type II anti-CD20 antibody, improved complete renal response in REGENCY, was approved for lupus nephritis in the United States and European Union, and was incorporated into the 2025 EULAR recommendations; in nonrenal SLE, ALLEGORY met its primary and all key secondary endpoints. A weekly subcutaneous formulation of the type I interferon receptor antagonist anifrolumab was approved after TULIP-SC. The dual BLyS/APRIL inhibitor telitacicept was effective in a Chinese phase 3 trial, and the CD40 ligand inhibitor dapirolizumab pegol met its primary endpoint in PHOENYCS GO. Ianalumab, litifilimab, and nipocalimab are advancing through phase 3 development. SUMMARY: SLE now has an expanding late-stage therapeutic pipeline. The principal challenges are now patient selection, sequencing and combination of agents, long-term safety and access.