• autoimmune disease;
  • belimumab;
  • Benlysta;
  • B lymphocyte stimulator;
  • lupus;
  • systemic lupus erythematosus


Systemic lupus erythematosus (SLE), a complex autoimmune disease with multisystem involvement, is characterised by recurring flares and remissions throughout the course of illness. The agents currently being used for management include corticosteroids, antimalarials and various immunosuppressants. Belimumab, a B lymphocyte stimulator (BLyS) inhibitor has been recently approved for the treatment of SLE. This review aims to discuss the role of belimumab in the treatment of SLE and the trials leading to its FDA approval. Belimumab demonstrated high degree of activity in patients with autoantibody-positive active SLE disease on a stable treatment regimen. There was a significantly greater response compared to placebo as assessed with the SLE Responder Index (SRI) in two randomized, double-blind, phase III trials (BLISS-52 and BLISS-76). The treatment was well tolerated. Additional studies are required to evaluate belimumab in special populations and assess its long-term safety. This therapy could change the focus of management from symptomatic treatment to targeting an important step in the disease pathogenesis. It could enable development of treatment which could halt long-term progression, minimize target organ damage and thus provide a better quality of life for these patients.