One of the major challenges in rheumatology is to overcome the classification criteria that previously defined systemic lupus erythematosis, since the heterogeneity of the disease(s) appears to represent a complexity that probably substantially contributed to the failure of a number of recent trials. For those engaged in clinical trials, validated disease activity biomarkers that respond rapidly to treatment and are predictive of clinical response would greatly facilitate early decision-making around futility and dose selection. Likewise, use of validated patient stratification biomarkers possibly in conjunction with autoantibody profiles and disease manifestations will result in the recruitment of more homogeneous patient populations during later stage clinical studies, thereby decreasing size, costs, and risks in pivotal studies.
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