Biologicals for the treatment of systemic lupus erythematosus: current status and emerging therapies.

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease resulting from the dysregulation of various immunological pathways. There has been major progress in recent years in the understanding of the pathogenesis of SLE, which has led to an emergence of a new class of drugs designed to target specific components of the disease process.Evidence from a number of open-label, uncontrolled studies has supported the use of rituximab (an anti-CD20 monoclonal antibody) in SLE for more than one decade. However, these promising results are in clear contrast with the poor results of the completed Efficacy and Safety of Rituximab in Patients with Severe SLE (EXPLORER) and Efficacy and Safety of Rituximab in Subjects with class III or IV Lupus Nephritis (LUNAR) randomized controlled trials. In contrast to EXPLORER and LUNAR results, controlled trials for belimumab (a fully humanized monoclonal antibody against B lymphocyte stimulator) showed positive results and subsequently, belimumab was the first drug approved for the treatment of SLE patients. This has paved the way for the development of further biological agents, potentially revolutionizing the treatment of SLE. In this study, the potential benefits of novel biological agents are explored, obstacles to the development of a treatment target in SLE are identified, and possible strategies to achieve this goal are discussed.