Article Text

Download PDFPDF

Remission in systemic lupus erythematosus: testing different definitions in a large multicentre cohort
  1. Francesca Saccon1,
  2. Margherita Zen1,
  3. Mariele Gatto1,
  4. Domenico Paolo Emanuele Margiotta2,
  5. Antonella Afeltra2,
  6. Fulvia Ceccarelli3,
  7. Fabrizio Conti4,
  8. Alessandra Bortoluzzi5,
  9. Marcello Govoni5,
  10. Giulia Frontini6,
  11. Gabriella Moroni6,
  12. Francesca Dall'Ara7,
  13. Angela Tincani7,
  14. Viola Signorini8,
  15. Marta Mosca8,
  16. Anna Chiara Frigo9,
  17. Luca Iaccarino1,
  18. Andrea Doria1
  1. 1 Department of Medicine, Division of Rheumatology, University of Padua, Padova, Italy
  2. 2 Unit of Allergology, Immunolgy, Rheumatology, Department of Medicine, Universita Campus Bio-Medico di Roma, Roma, Italy
  3. 3 Dipartimento di Medicina Interna e Specialità Mediche, Reumatologia, Sapienza University of Rome, Roma, Lazio, Italy
  4. 4 Department of Clinical, Internal, Anesthesiological and Cardiovascular Sciences, Rheumatology Unit, Sapienza University of Rome, Roma, Lazio, Italy
  5. 5 University Hospital Arcispedale Sant'Anna, Department of Medical Sciences, Division of Rheumatology, University of Ferrara, Ferrara, Emilia-Romagna, Italy
  6. 6 Nephrology Unit, La Fondazione IRCCS Ca' Granda Ospedale Maggiore di Milano Policlinico, Milano, Lombardia, Italy
  7. 7 ASST-Spedali Civili, Rheumatology and Clinical Immunology, University of Brescia, Brescia, Lombardia, Italy
  8. 8 Department of Clinical and Experimental Medicine, Rheumatology Unit, University of Pisa, Pisa, Toscana, Italy
  9. 9 Department of Cardiac-Thoracic-Vascular Sciences and Public Health, Biostatistics, Epidemiology and Public Health Unit, University of Padua, Padova, Veneto, Italy
  1. Correspondence to Professor Andrea Doria, Department of Medicine, Division of Rheumatology, University of Padua, Padova 35128, Italy; adoria{at}unipd.it

Abstract

Objectives Remission in systemic lupus erythematosus (SLE) is defined through a combination of ‘clinical SLE Disease Activity Index (cSLEDAI)=0’, ‘physician's global assessment (PGA) <0.5’ and ‘prednisone (PDN) ≤5 mg/day’. We investigated the performance of these items, alone or in combination, in defining remission and in predicting SLICC/ACR Damage Index.

Methods We tested seven potential definitions of remission in SLE patients followed-up for ≥5 years: PDN ≤5 mg/day; PGA <0.5; cSLEDAI=0; PGA <0.5 plus PDN ≤5 mg/day; cSLEDAI=0 plus PGA <0.5; cSLEDAI=0 plus PDN ≤5 mg/day; cSLEDAI=0 plus PDN ≤5 mg/day plus PGA <0.5. The effect of these definitions on damage was evaluated by Poisson regression analysis; the best performance was identified as the lowest Akaike and Bayesian information criterion (AIC and BIC). Positive and negative predictive values in identifying no damage increase were calculated.

Results We included 646 patients (mean±SD disease duration 9.2±6.9 years). At multivariate analysis, ≥2 consecutive year remission according to all definitions protected against damage (OR, 95% CI: PGA <0.5 0.631, 0.444 to 0.896; cSLEDAI=0 0.531, 0.371 to 0.759; PGA <0.5 plus PDN ≤5 mg/day 0.554, 0.381 to 0.805; cSLEDAI=0 plus PGA <0.5 0.574, 0.400 to 0.826; cSLEDAI=0 plus PDN ≤5 mg/day 0.543, 0.376 to 0.785; cSLEDAI=0 plus PDN ≤5 mg/day plus PGA <0.5 0.532, 0.363 to 0.781, p<0.01 for all), except PDN ≤5 mg/day, which required four consecutive years (OR 0.534, 95% CI 0.325 to 0.877, p=0.013). Positive and negative predictive values were similar; however, cSLEDAI=0 showed the best performance (AIC 1082.90, BIC 1109.72, p<0.0001). Adding PGA <0.5 and/or PDN ≤5 mg/day to cSLEDAI=0 decreased remission duration (−1.8 and −1.5 year/patient, respectively) without increasing cSLEDAI=0 performance in predicting damage accrual.

Conclusions cSLEDAI=0 is the most attainable definition of remission, while displaying the best performance in predicting damage progression in the short-to-mid-term follow-up.

  • disease activity
  • systemic lupus erythematosus
  • outcomes research
View Full Text

Statistics from Altmetric.com

Footnotes

  • Handling editor Josef S Smolen

  • Contributors FS contributed to the conception and design of the work, the follow-up of patients, acquisition, analysis and interpretation of data, and mostly drafted the work; MZ and MGa followed up patients, contributed to the acquisition of data and helped in drafting and revising the paper; FCo, AA, GM, MGo, AT, MM and LI followed up patients and revised the manuscript; FCe, DPEM, GF, FD, VS and AB followed up patients and contributed to the acquisition of data; ACF contributed to and revised the analysis of data; AD designed the work, interpreted the data and revised the manuscript for important intellectual content. All the authors approved the final version of the manuscript and gave their agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

  • 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.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Patient consent for publication Not required.

  • Ethics approval The study was approved by the Ethics committee of Padova University (3806/AO16).

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

  • Data availability statement All data relevant to the study are included in the article or uploaded as online supplementary information. Data are available on reasonable request from Prof A Doria (ORCID 0000-0003-0548-4983). Reuse of data is not permitted by a third party without authorisation.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.