The use of Systemic Lupus Erythematosus Disease Activity Index-2000 to define active disease and minimal clinically meaningful change based on data from a large cohort of systemic lupus erythematosus patients

• Published in: Rheumatology (Oxford, England) England), 2011-05, Vol.50 (5), p.982-988
• Main Authors: YEE, Chee-Seng, FAREWELL, Vernon T, MCHUGH, Neil, EDWARDS, Christopher, D'CRUZ, David, KHAMASHTA, Munther A, GORDON, Caroline, ISENBERG, David A, GRIFIFITHS, Bridget, TEH, Lee-Suan, BRUCE, Ian N, AHMAD, Yasmeen, RAHMAN, Anisur, PRABU, Athiveeraramapandian, AKIL, Mohammed
• Format: Article
• Language: English
• Subjects: Adult; Biological and medical sciences; Clinical Science; Cohort Studies; Cross-Sectional Studies; Disease Progression; Diseases of the osteoarticular system; Female; Humans; Longitudinal Studies; Lupus Erythematosus, Systemic - diagnosis; Lupus Erythematosus, Systemic - physiopathology; Male; Medical sciences; Middle Aged; ROC Curve; Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis; Sensitivity and Specificity; Severity of Illness Index; United Kingdom
• ISSN: 1462-0324; 1462-0332
• DOI: 10.1093/rheumatology/keq376

To examine SLEDAI-2000 cut-off scores for definition of active SLE and to determine the sensitivity to change of SLEDAI-2000 for the assessment of SLE disease activity and minimal clinically meaningful changes in score. Data from two multi-centre studies were used in the analysis: in a cross-sectional and a longitudinal fashion. At every assessment, data were collected on SLEDAI-2000 and treatment. The cross-sectional analysis with receiver operating characteristic (ROC) curves was used to examine the appropriate SLEDAI-2000 score to define active disease and increase in therapy was the reference standard. In the longitudinal analysis, sensitivity to change of SLEDAI-2000 was assessed with multinomial logistic regression. ROC curves analysis was used to examine possible cut-points in score changes associated with change in therapy, and mean changes were estimated. In the cross-sectional analysis, the most appropriate cut-off scores for active disease were 3 or 4. In the longitudinal analysis, the best model for predicting treatment increase was with the change in SLEDAI-2000 score and the score from the previous visit as continuous variables. The use of cut-points was less predictive of treatment change than the use of continuous score. The mean difference in the change in SLEDAI-2000 scores, adjusted for prior score, between patients with treatment increase and those without was 2.64 (95% CI 2.16, 3.14). An appropriate SLEDAI-2000 score to define active disease is 3 or 4. SLEDAI-2000 index is sensitive to change. The use of SLEDAI-2000 as a continuous outcome is recommended for comparative purposes.