Belimumab therapy in systemic lupus erythematosus – the clinical expectations and burdens

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with serious organ involvement and unpredictable outcome. In 1990s B-cell activating factor (BAFF), which induces B cell maturation, survival, switch-class recombination and high-affinity antibodies production was discovered. The intensive research proven the importance of BAFF in SLE pathogenesis in both murine models and humans. In 2011 belimumab, human monoclonal antibody specific for soluble BLyS (B-lymphocyte stimulator) was approved for active, seropositive SLE treatment in add to standard of care therapy. Belimumab is the first target, biologic therapy formally approved for SLE. To overcome the complexity and heterogeneity of SLE the new rules in clinical trial design were done: restrict inclusion criteria involving only seropositive patients with active disease and implementation of a novel, composed responder index. Despite the success, new medication rises some efficacy concerns: modest clinical effect, no data provided for treatment of lupus nephritis or central nervous system involvement and very high cost.