Abstract
Systemic lupus erythematosus (SLE) is a complex, multisystem disease that is characterized by variable and unpredictable manifestations that are often life-threatening. Although the prognosis has improved dramatically over the past 50 years, individuals with SLE still experience considerable morbidity and undue mortality. Furthermore, since SLE affects a predominantly young population at a critical time in their lives when they are establishing careers and starting families, the economic burden to society can be immense. Only three medications have ever received US FDA approval for use in the treatment of SLE and none have received FDA approval for over 25 years. Currently used therapies may have improved the prognosis but often have undesirable side effects, such as infertility, bone-marrow suppression and infection. Recent advances in our understanding of the disease pathogenesis, coupled with progress in drug development, have led to new therapeutic strategies that will potentially offer an improved side-effect profile and improved efficacy, but will almost certainly be much more expensive than current treatments.