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Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) enables accurate and user-friendly definitions of clinical remission and categories of disease activity
  1. Diogo Jesus1,2,
  2. Maddalena Larosa3,
  3. Carla Henriques4,5,
  4. Ana Matos4,6,
  5. Margherita Zen3,
  6. Paulo Tomé4,
  7. Valter Alves4,6,
  8. Nuno Costa4,
  9. Véronique Le Guern7,
  10. Luca Iaccarino3,
  11. Nathalie Costedoat-Chalumeau7,
  12. Andrea Doria3,
  13. Luís Sousa Inês2,8
  1. 1 Rheumatology Department, Centro Hospitalar de Leiria, Leiria, Portugal
  2. 2 Faculty of Health Sciences, University of Beira Interior, Covilhã, Portugal
  3. 3 Rheumatology Unit, Department of Medicine, University of Padova, Padova, Italy
  4. 4 School of Technology and Management, Polytechnic Institute of Viseu, Viseu, Portugal
  5. 5 Centre for Mathematics, University of Coimbra, Coimbra, Portugal
  6. 6 Research Centre in Digital Services, CISeD, Viseu, Portugal
  7. 7 Internal Medicine Department, Cochin Hospital, Paris, France
  8. 8 CHUC Lupus Clinic, Rheumatology Department, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal
  1. 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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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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Footnotes

  • Handling editor Josef S Smolen

  • AD and LSI contributed equally.

  • Presented at These results were presented, in part, at the Annual European Congress of Rheumatology 2021 and published as a conference abstract (Jesus D, et al. Ann Rheum Dis 2021;80[Suppl1]:182-3).

  • Contributors DJ, AD and LSI contributed to the conception and design of the project, analysis and interpretation of data, drafting and critical revision of the manuscript; AM and CH contributed to the design of the project, statistical analysis, interpretation of data and critically revised the manuscript; PT, VA and NC developed the SLE-DAS online calculator and contributed to the analysis and interpretation of data and critically reviewed the manuscript; MZ, ML and LI contributed to patients follow-up in the Padova Lupus Clinic, analysis and interpretation of data and critically revised the manuscript; LI scored the SLE disease activity categories in Padova Lupus Cohort; ML, VLG and NC-C contributed to patients follow-up in the Cochin Lupus Clinic and contributed to the analysis and interpretation of data and critically revised the manuscript; NC-C also scored the SLE disease activity categories in the Cochin Lupus Clinic; all the authors approved the final version of the manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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