Update on biologics in SLE

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.

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.

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.