Comparative Performance of LFA-REAL, SLEDAI, and BILAG for Detecting Clinically Meaningful Changes in Lupus Activity.

OBJECTIVE

This study aimed to compare the performance of the Lupus Foundation of America Rapid Evaluation of Activity in Lupus (LFA-REAL), British Isles Lupus Assessment Group Index (BILAG), and Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) in detecting the clinician's perception of improvement and worsening disease and identifying patients requiring treatment escalation.

METHODS

This was a prospective, observational study conducted at four centers. Adults with systemic lupus erythematosus were evaluated at a baseline and follow-up visit. Disease activity was assessed using SLEDAI, BILAG, and LFA-REAL at both visits by the same physician. At the follow-up visit, the Clinician Global Impression of Change (CGIC) was recorded to classify patients as improved, worsened, or unchanged. Receiver operating characteristic curve analysis was used to evaluate each instrument in detecting clinician-rated change gauged by CGIC with optimal cut-off points determined using the Youden Index.

RESULTS

Of the 163 patients enrolled, 145 (89%) completed a follow-up visit. Based on CGIC, 23% improved, 16% worsened, and 61% remained stable. For detecting CGIC-defined improvement, LFA-REAL had an area under the curve (AUC) of 0.85 (95% confidence interval [CI] 0.77-0.92), compared to 0.75 (95% CI 0.66-0.85) for BILAG and 0.74 (95% CI 0.64-0.84) for SLEDAI. For CGIC-defined worsening, AUCs were 0.86 (95% CI 0.77-0.96), 0.79 (95% CI 0.67-0.90), and 0.76 (95% CI 0.66-0.87). Of those with CGIC-defined worsening, eight (35%) required treatment escalation. LFA-REAL identified a difference of ≥10 mm in all eight of these patients, compared to four by BILAG and two by SLEDAI.

CONCLUSION

LFA-REAL showed comparable performance relative to SLEDAI and BILAG in detecting clinician-rated change. There was a statistically significant advantage over SLEDAI for detection of improvement. These findings support its utility as a metric for disease activity in clinical practice and research.