Systemic lupus erythematosus (SLE): Trials and issues

Extract: Systemic lupus erythematosus (SLE or lupus) is an autoimmune disorder in which antibodies to self are found in the bloodstream, and tends to develop in cycles or "flares" and "remissions." It is a complex disease, and investigators designing clinical trials are faced with an array of disease manifestations and difficult-to-measure responses to treatment. Ideally, the protocols for clinical trials and the ultimate therapeutic decisions should be guided by evidence-based medicine, considering both the pathophysiologic mechanisms and the epidemiologic principles, which influence the clinical course of the disease. Few large-scale prospective randomized studies have been published, most of them addressing lupus nephritis (autoimmune inflammation of the kidneys), as the disease manifestation with better defined end-points such as changes in serum creatinine (a waste product of protein degradation that signifies kidney damage when found in high concentrations in the bloodstream), urine protein excretion, development of end-stage renal disease, and death. Our goal is to provide an overview of the clinical trials and relevant case series in SLE published in the past 2 years, outlining the important developments and reinforcing some of the most significant issues that arise.