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Definition and initial validation of a Lupus Low Disease Activity State (LLDAS)
  1. Kate Franklyn1,
  2. Chak Sing Lau2,
  3. Sandra V Navarra3,
  4. Worawit Louthrenoo4,
  5. Aisha Lateef5,
  6. Laniyati Hamijoyo6,
  7. C Singgih Wahono7,
  8. Shun Le Chen8,
  9. Ou Jin9,
  10. Susan Morton10,
  11. Alberta Hoi1,
  12. Molla Huq11,
  13. Mandana Nikpour11,
  14. Eric F Morand1
  15. for the Asia-Pacific Lupus Collaboration
  1. 1School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia
  2. 2University of Hong Kong, Hong Kong, Hong Kong
  3. 3University of Santo Tomas, Manila, Philippines
  4. 4Chang Mai University, Chang Mai, Thailand
  5. 5National University Hospital, Singapore, Singapore
  6. 6Padjadjaran University, Bandung, Indonesia
  7. 7Brawijaya University, Malang, Indonesia
  8. 8Shanghai Jiaotong University, Shanghai, China
  9. 9Division of Rheumatology, Affiliated 3rd Hospital of Sun Yat-san University, Guangzhou, China
  10. 10Monash Health, Monash University, Melbourne, Victoria, Australia
  11. 11Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia
  1. Correspondence to Professor Eric F Morand, School of Clinical Sciences at Monash Health, Monash University, Level 5, Block E, Monash Medical Centre, 246 Clayton Road, Clayton, Melbourne, VIC 3168, Australia; eric.morand{at}monash.edu

Abstract

Aims Treating to low disease activity is routine in rheumatoid arthritis, but no comparable goal has been defined for systemic lupus erythematosus (SLE). We sought to define and validate a Lupus Low Disease Activity State (LLDAS).

Methods A consensus definition of LLDAS was generated using Delphi and nominal group techniques. Criterion validity was determined by measuring the ability of LLDAS attainment, in a single-centre SLE cohort, to predict non-accrual of irreversible organ damage, measured using the Systemic Lupus International Collaborating Clinics Damage Index (SDI).

Results Consensus methodology led to the following definition of LLDAS: (1) SLE Disease Activity Index (SLEDAI)-2K ≤4, with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever) and no haemolytic anaemia or gastrointestinal activity; (2) no new lupus disease activity compared with the previous assessment; (3) a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI physician global assessment (scale 0–3) ≤1; (4) a current prednisolone (or equivalent) dose ≤7.5 mg daily; and (5) well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents. Achievement of LLDAS was determined in 191 patients followed for a mean of 3.9 years. Patients who spent greater than 50% of their observed time in LLDAS had significantly reduced organ damage accrual compared with patients who spent less than 50% of their time in LLDAS (p=0.0007) and were significantly less likely to have an increase in SDI of ≥1 (relative risk 0.47, 95% CI 0.28 to 0.79, p=0.005).

Conclusions A definition of LLDAS has been generated, and preliminary validation demonstrates its attainment to be associated with improved outcomes in SLE.

  • Systemic Lupus Erythematosus
  • Disease Activity
  • Outcomes research

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