Renal Activity Index in Lupus (RAIL) Urinary Biomarkers Predict Treatment Response
Summary
Noninvasive measures to accurately gauge lupus nephritis status activity and forecast response to therapy
Overview
Systemic lupus erythematosus (SLE) is a multisystem inflammatory autoimmune disease, and lupus nephritis (LN) is a main determinant of poor prognosis. Currently, accurate assessment of LN activity and response to therapy requires repeat kidney biopsy. Cincinnati Children’s investigators have developed noninvasive measures to accurately gauge LN status activity and response to therapy. They have identified a panel of urinary biomarkers that can be used to calculate the Renal Activity Index in Lupus (RAIL), which has excellent accuracy in estimating LN activity in both children and adults. In addition, RAIL biomarkers in combination with a few others can accurately predict LN response to therapy as early as 3 months. These “early” biomarkers are invaluable for the identification of patients at risk for poor LN outcomes owing to their resistance to standard therapies, and can assist in personalizing and optimizing LN care.
Applications
* Diagnostic for SLE nephritis and LN flare
* Treatment response detection, refractory SLE identification
Value Proposition
* Noninvasive
* Early prediction of LN course
* Combined biomarkers identify disease with 84-85% accuracy, individual biomarkers identify with 68-81% accuracy
Market Overview
SLE affects ~52:100K in the US, and up to 65% of those patients will develop LN. The proportion of SLE patients with LN is higher among those with childhood-onset SLE.
Investigator
Prasad Devarajan, MD and Hermine Brunner, MD, MSc, MBA
