Study Validates LFA-REAL Disease Activity Measurement Tool for Lupus Disease Severity Measurement

Data from a post-hoc analysis of the Phase 3 clinical trial of Stelara® (ustekinumab) for treatment of people with moderate-to-severe lupus further validates the value of the Lupus Foundation of America's REAL™ (Rapid Evaluation of Activity in Lupus). The instrument helps measure disease activity in people with lupus from both the physician’s and the patient’s perspectives. The ability to accurately measure lupus disease activity is challenging, yet critical in lupus research and to determine drug efficacy. Although the Stelara® trial did not meet its endpoint and was stopped early, the trial offered the opportunity to compare the LFA-REAL system with other lupus activity measures.

The LFA-REAL was evaluated in 516 study participants across the globe. The LFA-REAL showed moderate-strong correlations with other commonly used tools that measure lupus disease activity, such as the Physician Global Assessment, British Isles Lupus Assessment Group Index, and the SLE Disease Activity Index. Disease activity was tracked over time and measured at baseline, week 24 and 52 of the trial.

“One of the goals of developing the LFA-REAL is to provide a simple, user-friendly system that can provide both an accurate global disease activity score and reliable individual organ scores from the physician and patient perspective,” shared Anca D. Askanase, MD, MPH, Lupus Foundation of America, Medical-Scientific Advisory Council member.

The LFA-REAL clinician-reported outcome (ClinRO) correlated well with active joint and skin disease measurement tools (Cutaneous Lupus Erythematosus Disease Area and Severity Index). Additionally, ClinRO showed moderate correlation with LFA-REAL’s patient-reported outcome (PRO), suggesting that it could help more accurately capture the patients’ perspective on skin, muscle, joint, and bone lupus activity.

LFA-REAL’s ClinRO and PRO effectively evaluate lupus disease activity, and the researchers suggest further studies to understand similarities and differences between ClinRO and PRO conclusions. Learn more about the LFA-REAL lupus measurement tool.

Read the study