Lupus clinical development: will belimumab's approval catalyse a new paradigm for SLE drug development?

INTRODUCTION: Systemic lupus erythematosus (SLE) is a diverse autoimmune disease affecting many different organ systems. Although disease manifestations are varied across the lupus population, the widespread presence of autoantibodies indicates that SLE immunopathology involves B-cell dysregulation. Belimumab, a human anti-B-cell activating factor (BLyS) monoclonal antibody, was invented by Human Genome Sciences and co-developed with GlaxoSmithKline and became, in 2011, the first new therapy approved for SLE patients in over 50 years. AREAS COVERED: Belimumab approval represents a milestone as a new treatment for a subset of SLE patients and also a window onto the continued unmet need for many patients suffering from this diverse disease. This paper analyses the drugs and clinical trials of industry-sponsored development programs to profile the current SLE landscape and to consider how belimumab is shaping the future of SLE drug development. EXPERT OPINION: Our analysis demonstrates that the belimumab clinical program created a model for improvements in study designs that is reflected in ongoing clinical trials sponsored by a broad range of companies. Additional BLyS inhibitors, with distinctive targeting characteristics, are now in late stage development. A broad range of drugs with other mechanisms of action are also under investigation in Phase II - III trials, some of which are focused on the underserved lupus nephritis population.