In recent years, biomarkers have shown significant promise in helping 
decision-making in drug development. Systemic lupus erythematosus (SLE) is a 
complicated and highly heterogeneous disease that involves all organs. Only one 
drug, belimumab, has been approved by the US Food and Drug Administration to 
treat SLE during the last 50 years and there remains a high unmet medical need 
to develop new and effective therapies to benefit different patient populations 
in SLE. Due to the extreme heterogeneity of the disease and the complex and 
rigorous process to validate individual biomarkers, there is currently a very 
limited number of consensus biomarkers to aid the treatment decision-making in 
SLE. This review provides a snapshot of some biomarkers in the field that have 
the potential to make a big impact on drug development and/or treatment 
decisions by physicians. These include: type I interferon (IFN) gene signature 
as a pharmacodynamic marker and potential predictive marker for anti-type I IFN 
therapy; anti-double stranded DNA as a disease marker and potential predictive 
marker for flares; the complements and neutrophil signatures as disease marker 
of SLE; and TWEAK (a tumor necrosis factor family member produced by 
macrophages) and MCP-1 as potential markers to predict renal flares. Most of 
these markers need carefully planned and prospective studies with high 
statistical power to confirm their respective utilities. With the development 
and application of powerful new technologies, more successful biomarkers will 
emerge in SLE. This could improve the management of patients in the clinic and 
facilitate the development of novel and more effective therapeutics for this 
difficult-to-treat disease.