Do lupus disease activity measures detect clinically important change?

Objective. New scales for the clinical assessment of patients with systemic lupus erythematosus (SLE) are valid and reliable, and quantitate disease a ctivity. We assessed the responsiveness to change of 2 widely used standard ized multi-item lupus activity measures, the revised Systemic Lupus Activit y Measure (SLAM-R) and the Systemic Lupus Erythematosus Disease Activity In dex (SLEDAI), and their ability to detect clinically relevant changes. Methods. Ninety-six (96) patients with definite SLE participated in this st udy. The group mean age was 45.0 (13.7) years, 91% were female, and the mea n disease duration was 14.9 (7.5) years. Sociodemographic information, lupu s activity (SLAM-R, SLEDAI), and damage were recorded at baseline. At each of the 5 monthly followup visits, the activity measures were repeated and a transition scale asked the physician if their patient's lupus activity had changed. Five different methods were used to compare the responsiveness of the activity measures studied: 1. the effect size; 2. the standardized res ponse mean; 3. the control standardized response mean; 4. the area under th e curve of a receiver operating characteristic (ROC) curve; and 5. a new mu ltiple response modeling approach. Results. Both SLAM-R and SLEDAI are responsive. SLAM-R is consistently, alt hough moderately, more responsive than SLEDAI. All 5 methods of evaluating responsiveness yielded a consistent ranking of disease activity measures. Conclusion. SLAM-R and SLEDAI are responsive measures of lupus activity. SL AM-R appears to be more responsive than SLEDAI.