title: Definition and initial validation of a Lupus Low Disease Activity State (LLDAS).
abstract: OBJECTIVE
  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.
authors.affiliation: School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia.
authors.forename: Kate
authors.initials: K
authors.lastname: Franklyn
authors.affiliation: University of Hong Kong, Hong Kong, Hong Kong.
authors.forename: Chak Sing
authors.initials: CS
authors.lastname: Lau
authors.affiliation: University of Santo Tomas, Manila, Philippines.
authors.forename: Sandra V
authors.initials: SV
authors.lastname: Navarra
authors.affiliation: Chang Mai University, Chang Mai, Thailand.
authors.forename: Worawit
authors.initials: W
authors.lastname: Louthrenoo
authors.affiliation: National University Hospital, Singapore, Singapore.
authors.forename: Aisha
authors.initials: A
authors.lastname: Lateef
authors.affiliation: Padjadjaran University, Bandung, Indonesia.
authors.forename: Laniyati
authors.initials: L
authors.lastname: Hamijoyo
authors.affiliation: Brawijaya University, Malang, Indonesia.
authors.forename: C Singgih
authors.initials: CS
authors.lastname: Wahono
authors.affiliation: Shanghai Jiaotong University, Shanghai, China.
authors.forename: Shun Le
authors.initials: SL
authors.lastname: Chen
authors.affiliation: Division of Rheumatology, Affiliated 3rd Hospital of Sun Yat-san University, Guangzhou, China.
authors.forename: Ou
authors.initials: O
authors.lastname: Jin
authors.affiliation: Monash Health, Monash University, Melbourne, Victoria, Australia.
authors.forename: Susan
authors.initials: S
authors.lastname: Morton
authors.affiliation: School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia.
authors.forename: Alberta
authors.initials: A
authors.lastname: Hoi
authors.affiliation: Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: Molla
authors.initials: M
authors.lastname: Huq
authors.affiliation: Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: Mandana
authors.initials: M
authors.lastname: Nikpour
authors.affiliation: School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia.
authors.forename: Eric F
authors.initials: EF
authors.lastname: Morand
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000175:diagnosis* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D015203:Reproducibility of Results; D012306:Risk; D018570:Risk Assessment / Q000379:methods; D012720:Severity of Illness Index; D013997:Time Factors
keywords: Disease Activity; Outcomes research; Systemic Lupus Erythematosus