Belimumab for the management of systemic lupus erythematosus.

摘要

INTRODUCTION: In 2011, Belimumab , a fully humanized monoclonal antibody against B lymphocyte stimulator, became the first biological agent to be licensed by the United States Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA) for the use in auto-antibody positive adult Systemic Lupus Erythematosus (SLE). AREAS COVERED: An overview of the clinical trial data, review of the medical and scientific literature following a MEDLINE search forms the basis of this expert opinion on biological therapy review. The Belimumab International SLE Study Phase III randomized placebo-controlled trials, BLISS-52 and BLISS-76, met the primary endpoint based on the SLE responder index (SRI) at week 52. The trials reported that belimumab 10 mg/kg infusions with standard therapy significantly reduced SLE disease activity compared with placebo with standard therapy. EXPERT OPINION: The clinical efficacy, safety and tolerability of belimumab indicates a potential role for this drug in achieving disease control, reducing severity of recurrent flares, reducing morbidity and in the long-term achieving a positive long-term impact on quality of life. Belimumab is now being introduced in clinical practice and over the next 5 years data on its use outside the clinical trials will determine its place in SLE management.