THE RELATIONSHIP BETWEEN DISEASE-ACTIVITY AND EXPERT PHYSICIANS DECISION TO START MAJOR TREATMENT IN ACTIVE SYSTEMIC LUPUS-ERYTHEMATOSUS - A DECISION AID FOR DEVELOPMENT OF ENTRY CRITERIA FOR CLINICAL-TRIALS

Objective. To explore the relationship between patients' systemic lupu s erythematosus (SLE) activity and physicians' decision to treat with steroids or alternative medication, Methods, Baseline information and clinical status was extracted from case histories of 30 patients with lupus and represented in clinical vignettes. These vignettes were then mailed to 60 physicians (rheumatologists and immunologists with exper ience in the treatment of lupus), asking them in each case whether the y would initiate treatment or not. The relationship between the 38 com plete responses and the SLE Activity Measure (SLAM-R) and SLE Disease Activity Index (SLEDAI) lupus activity scores was analyzed using a gen eral additive model. Results, SLE disease activity measured by SLAM-R or SLEDAI is a significant predictor (p < 0.0001) of physicians' decis ion to initiate treatment for patients with lupus, Variation between p hysicians was observed but was mostly due to a few outliers. Some othe r variations remained unexplained by patients' SLE disease activity, d amage, or by specific organ involvement. Conclusion. We present refere nce tables and curves for research that may be used as a basis to deri ve standardized quantitative criteria for entry in clinical trials. Mo re research is needed on how these tools can be used by clinicians to guide them in their decision to treat or not.