New biological agents in systemic lupus erythematosus
Abstract
INTRODUCTION: The approval in 2011 of belimumab, the first biologic approved for systemic lupus erythematosus (SLE), paved the way for testing additional biologic agents to expand treatment options for SLE. We discuss new biologic therapies that show promising results and discuss some of the barriers that must be considered in SLE clinical trials. AREAS COVERED: This review focuses on established and novel biologics targeting the BAFF/APRIL, type-I IFN, CD20, and CD40/CD40 ligand pathways and on CAR-T therapy. We review the relevant clinical trials, focusing on safety and efficacy. A literature search was conducted in PubMed/MEDLINE. Keywords used were "Lupus Erythematosus, Systemic' OR (("Lupus* AND ("Biological Products' OR Biologics*)). These search results were filtered to include only clinical trials. In addition, literature from the authors' personal collections were considered. EXPERT OPINION: Several novel therapies have shown promising results. The treatment approach for SLE is shifting toward a balanced and targeted immunosuppression tailored to key drivers of SLE pathophysiology and diverse phenotypes. Given the number of agents already or soon-to-be approved, the appropriate therapy for a given patient must be a shared patient-physician decision.
Fields of Study & Subjects
Systemic Lupus Erythematosus Research
Systemic Sclerosis and Related Diseases
Natural Compounds in Disease Treatment
Publication details
- Journal / source
- Expert Opinion on Biological Therapy
- Volume
- 26
- Issue
- 2
- Pages
- 133–147
- Publication date
- 30 January 2026
- Language
- EN