Pitfalls and opportunities in measuring patient outcomes in lupus.

Health outcomes and their measures used as end points in systemic lupus erythematosus (SLE) patient care and clinical trials have been varied and are still evolving. Although significant reductions in morbidity and mortality in SLE have been achieved, the medications approved for SLE have remained the same during the past 50 years. Despite the pressing need, aggressive advocacy in the community, and advances in drug development and testing in SLE, no medications have met US Food and Drug Administration guidelines for a new indication claim approval for SLE. This may be attributable to its multisystemic, remitting, and relapsing nature, and difficulty in identifying useful end points and appropriate tools to measure them. Thus, it is pivotal to identify and validate appropriate global, disease-specific, and perhaps organ-specific health outcomes for clinical research. This article reviews recent physician- and patient-generated health outcomes in SLE.