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An assessment of disease flare in patients with systemic lupus erythematosus: a comparison of BILAG 2004 and the flare version of SELENA
  1. D A Isenberg1,
  2. E Allen2,
  3. V Farewell3,
  4. D D'Cruz4,
  5. G S Alarcón5,
  6. C Aranow6,
  7. I N Bruce7,
  8. M A Dooley8,
  9. P R Fortin9,
  10. E M Ginzler10,
  11. D D Gladman9,
  12. J G Hanly11,
  13. M Inanc12,
  14. K Kalunian13,
  15. M Khamashta4,
  16. J T Merrill14,
  17. O Nived15,
  18. M Petri16,
  19. R Ramsey-Goldman17,
  20. G Sturfelt15,
  21. M Urowitz9,
  22. D J Wallace18,
  23. C Gordon19,
  24. A Rahman1
  1. 1Centre for Rheumatology, University College London, London, UK
  2. 2London School of Hygiene and Tropical Medicine, London, UK
  3. 3MRC Biostatistics Unit, University of Cambridge, Cambridge, UK
  4. 4The Rayne Institute, St Thomas' Hospital, London, UK
  5. 5Oakland, California, USA
  6. 6Feinstein Institute of Medical Research, New York, New York, USA
  7. 7Manchester Academic Health Sciences Centre, The University of Manchester, Manchester, UK
  8. 8University of North Carolina, Chapel Hill, North Carolina, USA
  9. 9Toronto Western Hospital, Toronto, Canada
  10. 10Downstate Medical Center, New York, New York, USA
  11. 11Dalhousie University and Capital Health, Halifax, Nova Scotia, Canada
  12. 12Istanbul University, Istanbul, Turkey
  13. 13University of California, San Diego, California, USA
  14. 14Oklahoma Medical Research Foundation, Oklahoma, USA
  15. 15University Hospital, Lund, Sweden
  16. 16John Hopkins University of School of Medicine, Baltimore, Maryland, USA
  17. 17Northwestern University, Chicago, Illinois, USA
  18. 18West Hollywood, California, USA
  19. 19University of Birmingham, Birmingham, UK
  1. Correspondence to Professor D A Isenberg, Centre for Rheumatology, UCL Division of Medicine, Room 331, 3rd Floor, Windeyer Building, 46 Cleveland Street, London W1T 4JF, UK; d.isenberg{at}ucl.ac.uk

Abstract

Aims To compare the British Isles Lupus Assessment Group (BILAG) 2004, the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) flare index (SFI) and physician's global assessment (PGA) in assessing flares of disease activity in patients with systemic lupus erythematosus (SLE).

Methods Sixteen patients with active SLE were assessed by a panel of 16 rheumatologists. The order in which the patients were seen was randomised using a 4×4 Latin square design. Each patient's flare status was determined at each assessment using the BILAG 2004 activity index; the SFI and a PGA. A group of five specialists designated each patient into severe, moderate, mild or no flare categories.

Results The rate of complete agreement (95% CI) of the four individual examining physicians for any flare versus no flare was 81% (55% to 94%), 75% (49% to 90%) and 75% (49% to 90%) for the BILAG 2004 index, SELENA flare instrument and PGA, respectively. The overall agreement between flare defined by BILAG 2004 and the SFI was 81% and when type of flare was considered was 52%. Intraclass correlation coefficients (95% CI), as a measure of internal reliability, were 0.54 (0.32 to 0.78) for BILAG 2004 flare compared with 0.21 (0.08 to 0.48) for SELENA flare and 0.18 (0.06 to 0.45) for PGA. Severe flare was associated with good agreement between the indices but mild/moderate flare was much less consistent.

Conclusions The assessment of flare in patients with SLE is challenging. No flare and severe flare are identifiable but further work is needed to optimise the accurate ‘capture’ of mild and moderate flares.

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Footnotes

  • Funding This study was funded by the Lupus Foundation of America, Merck Serono, Roche, Wyeth and Novo Nordisk. INB is supported by the Manchester Academic Health Sciences Centre and the Manchester NIHR Biomedical Research Centre.

  • Competing interests None.

  • Ethics approval This study was conducted with the approval of the University College Hospital Medical Ethics Committee.

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

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