systemic lupus erythematosus

Systemic lupus erythematosus (SLE) is a prototypic autoimmune disease with diverse clinical manifestations including nephritis, arthritis, serositis, cytopenias, and central nervous system involvement. Despite decades of off-label use of hydroxychloroquine and immunosuppressants, only three drugs have been specifically approved for SLE in the past 60 years — belimumab, anifrolumab, and voclosporin (for lupus nephritis) — reflecting the extraordinary challenge of conducting trials in a heterogeneous, relapsing-remitting condition.

Active trials investigate obinutuzumab (anti-CD20) for lupus nephritis, dapirolizumab pegol (anti-CD40L), deucravacitinib (TYK2 inhibitor), iberdomide (CELMoD agent), telitacicept (TACI-Fc fusion targeting BLyS and APRIL), and CAR-T cell therapy for severe refractory SLE. Patient selection using type I interferon gene expression signatures, anti-dsDNA titers, and complement levels guides both eligibility and endpoint assessment.

SLE trials use SLEDAI or BILAG disease activity scores at baseline; lupus nephritis trials typically require kidney biopsy confirmation of Class III/IV or V nephritis.

Frequently Asked Questions — systemic lupus erythematosus Clinical Trials