Journal
RHEUMATOLOGY
Volume 50, Issue 5, Pages 982-988Publisher
OXFORD UNIV PRESS
DOI: 10.1093/rheumatology/keq376
Keywords
SLEDAI-2000; SLE; Sensitivity to change; Disease activity; Minimal clinically meaningful change
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Funding
- Wellcome Trust Clinical Research Facility (Birmingham), Lupus UK
- Manchester Academic Health Sciences Centre, Manchester NIHR Biomedical Research Centre and Arthritis Research Campaign
- Arthritis Research Campaign [16081]
- Arthritis Research UK
- Vifor Pharma/Aspreva
- Roche Pharmaceuticals
- Merck Serono
- Genentech
- Amgen
- Bristol Myers Squibb
- Vifor Pharma/Aspreva Pharmaceuticals
- MRC [MC_U105261167] Funding Source: UKRI
- Medical Research Council [MC_U105261167] Funding Source: researchfish
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Methods. 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. Results. 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). Conclusions. 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.
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