Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) enables accurate and user-friendly definitions of clinical remission and categories of disease activity (original) (raw)
Systemic lupus erythematosus
Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) enables accurate and user-friendly definitions of clinical remission and categories of disease activity
- http://orcid.org/0000-0003-3136-0722Diogo Jesus1,2,
- http://orcid.org/0000-0002-1398-5967Maddalena Larosa3,
- Carla Henriques4,5,
- Ana Matos4,6,
- Margherita Zen3,
- Paulo Tomé4,
- Valter Alves4,6,
- Nuno Costa4,
- Véronique Le Guern7,
- Luca Iaccarino3,
- http://orcid.org/0000-0002-1555-9021Nathalie Costedoat-Chalumeau7,
- http://orcid.org/0000-0003-0548-4983Andrea Doria3,
- Luís Sousa Inês2,8
- 1 Rheumatology Department, Centro Hospitalar de Leiria, Leiria, Portugal
- 2 Faculty of Health Sciences, University of Beira Interior, Covilhã, Portugal
- 3 Rheumatology Unit, Department of Medicine, University of Padova, Padova, Italy
- 4 School of Technology and Management, Polytechnic Institute of Viseu, Viseu, Portugal
- 5 Centre for Mathematics, University of Coimbra, Coimbra, Portugal
- 6 Research Centre in Digital Services, CISeD, Viseu, Portugal
- 7 Internal Medicine Department, Cochin Hospital, Paris, France
- 8 CHUC Lupus Clinic, Rheumatology Department, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal
- Correspondence to Dr Luís Sousa Inês, Rheumatology Department, Centro Hospitalar e Universitário de Coimbra EPE, Coimbra, Portugal; luisines{at}gmail.com
Abstract
Objectives There is an unmet need for accurate and user-friendly definitions of systemic lupus erythematosus (SLE) disease activity and remission. We aimed to derive and validate the SLE Disease Activity Score (SLE-DAS) definitions for disease activity categories and clinical remission state.
Methods Derivation was conducted at Padova Lupus Clinic (Italy). Validation was prospectively performed at Cochin Lupus Clinic (France) and by post hoc analysis of BLISS-76 trial. At each clinic, an expert classified patients in three categories: remission, mild or moderate/severe activity. The SLE-DAS cut-offs were derived using the receiver operating characteristic curve analysis in Padova cohort; its performance was assessed against expert classification in Cochin cohort and British Isles Lupus Assessment Group (BILAG) index in BLISS-76. Gold standard for clinical remission state was the fulfilment of Definition Of Remission In SLE. A Boolean and an index-based definitions of remission were sustained by chi-square automatic interaction detection algorithm. An SLE-DAS online calculator was developed and tested.
Results We included 1190 patients with SLE: 221 in the derivation cohort and 969 in the validation cohorts (150 from Cochin; 819 from BLISS-76). Derived cut-offs were: remission, SLE-DAS ≤2.08; mild activity, 2.08<SLE-DAS≤7.64; moderate/severe activity, SLE-DAS >7.64. Regarding validation in Cochin cohort, sensitivity and specificity are above 90%, 82% and 95% for remission, mild and moderate/severe activity, respectively. The SLE-DAS Boolean-based and index-based remission showed sensitivity of 100% and specificity above 97%.
Conclusion The SLE-DAS is an accurate and easy-to-use tool for defining SLE clinical remission state and disease activity categories, validated against expert assessment and BILAG.
- systemic lupus erythematosus
- disease activity
- outcomes research
- autoimmune diseases
Data availability statement
Data are available on reasonable request. All data relevant to the study are included in the article or uploaded as online supplemental information. Data are available on reasonable request from AD (ORCID 0000-0003-0548-4983). Reuse of data is not permitted by a third party without authorisation.
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