Definition and initial validation of a Lupus Low Disease Activity State (LLDAS)

2015 ◽  
Vol 75 (9) ◽  
pp. 1615-1621 ◽  
Author(s):  
Kate Franklyn ◽  
Chak Sing Lau ◽  
Sandra V Navarra ◽  
Worawit Louthrenoo ◽  
Aisha Lateef ◽  
...  

AimsTreating 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).MethodsA 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).ResultsConsensus 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).ConclusionsA definition of LLDAS has been generated, and preliminary validation demonstrates its attainment to be associated with improved outcomes in SLE.

2013 ◽  
Vol 72 (Suppl 3) ◽  
pp. A267.1-A267 ◽  
Author(s):  
C. S. Lau ◽  
M. Nikpour ◽  
S. V. Navarra ◽  
W. Louthrenoo ◽  
A. Lateef ◽  
...  

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1488-1489
Author(s):  
Y. Hao ◽  
L. Ji ◽  
D. Gao ◽  
Y. Fan ◽  
E. F. Morand ◽  
...  

Background:The concept of treat to target in systemic lupus erythematosus has moved forward in recent years. The Lupus low disease activity state (LLDAS) defined by the Asia-Pacific Lupus Collaboration (APLC) in 2016 has been validated prospectively in the APLC cohort itself and retrospectively in multiple other cohorts.Objectives:The concept of treat to target in systemic lupus erythematosus has moved forward in recent years. The Lupus low disease activity state (LLDAS) defined by the Asia-Pacific Lupus Collaboration (APLC) in 2016 has been validated prospectively in the APLC cohort itself and retrospectively in multiple other cohorts. The aim of this study was to investigate the frequency and determinants of achieving LLDAS, and the influence of LLDAS on short term outcomes including disease flare and damage accrual in Chinese lupus patients.Methods:The baseline and follow-up data of all consecutive patients in a longitudinal lupus cohort from January 2017 to December 2018 were collected prospectively. SLEDAI-2K, PGA and disease flare were assessed at each follow-up visit, and further compared to the previous routine clinical visits. Irreversible disease damage was captured using the SLICC damage index and the short form (36) health survey for health-related quality of life was completed annually.Results:One hundred and forty-nine patients were enrolled, with the median disease duration at recruitment of 2.4 (0.9–8.2) years, and median follow-up of 15.4 (10.1-18.2) months. By the end of the study, 104 (69.8%) patients achieved LLDAS at least once; 59 patients achieved LLDAS for≥50% of observations. Multivariate logistic regression analysis showed that age at disease onset< 30 years (OR=0.05, 95%CI [0.01-0.59], p=0.017), 24-hour urine total protein (UTP) level at recruitment (OR=0.9992, 95%CI [0.9987-0.9998], p=0.007), and C3 level (OR=1.004, 95%CI [1.001-1.008], p=0.024) had independent associations with achieving LLDAS for≥50% of all observations (Table 1). During follow-up, 56 (37.6%) patients experienced disease flare including 14 (9.4%) patients with severe flare. Kaplan-Meier analyses showed significant differences in flare rates according to whether LLDAS was achieved and the percentage follow-up time in LLDAS (Figure 1). Multivariate cox analysis revealed that the percentage time of time in LLDAS was an independent negative determinant of disease flare (HR=0.18, 95% CI [0.07-0.48], p=0.001) (Table 2). There were 16 (15.0%)/107 patients who had damage accrual after one year of follow-up. Multivariate logistic analysis showed a tendency for achieving LLDAS during follow-up being protective for damage accrual (OR=0.27, 95%CI [0.07-1.00], p=0.050).Conclusion:In this Chinese early disease cohort, LLDAS was an attainable goal in clinical practice. Age at onset, UTP and C3 level at recruitment influenced achievement of LLDAS. LLDAS was negatively associated with disease flare and damage accrual; this needs to be confirmed by future longer follow-up.Acknowledgments:The data in this cohort was collected and recorded using the framework of the lupus low disease activity status (LLDAS) study from the Asia-Pacific Lupus Collaboration (APLC).Disclosure of Interests:Yanjie Hao: None declared, Lanlan Ji: None declared, Dai Gao: None declared, Yong Fan: None declared, Eric F. Morand Grant/research support from: AstraZeneca, Consultant of: AstraZeneca, Speakers bureau: AstraZeneca, Mandana Nikpour: None declared, Zhuoli Zhang: None declared


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1522.2-1522
Author(s):  
S. Shkireeva ◽  
E. Zotkin ◽  
O. Lesnyak

Background:Although the survival of patients with systemic lupus erythematosus (SLE) has improved, irreversible organ damage remains a critical concern. Long-standing inflammation, drug-related side effects and comorbidities may eventually cause permanent organ damage even in remission[1].Objectives:To describe irreversible organ damage in peri- and postmenopausal women with SLE in remission and low disease activity, to find predictors of damage progression.Methods:234 peri- and postmenopausal women with SLE were included (mean age 49,94±9,1 years) in our study. All women were under outpatient observation in St.Petersburg State Clinical Rheumatology Hospital #25 (Russia). Mean disease duration was 8,9±7,5 years. We analyzed treatment regimens and doses of glucocorticoids (GC) based on source medical documents. To assess disease activity, we used SLEDAI-2K and LLDAS. To assess organ damage, we used SLICC damage index (SDI).Results:94,3% of women have been taking GC during our study. Median of maintenance dose was 12,5 mg per day. Almost a half of all women (44,8%, n=105) in our study were postmenopausal (mean duration of menopause was 11,1±7,1 years). A half of all patients had low disease activity (44,4%, n=111) or were in remission (18,8%, n=44) according to SLEDAI-2K. 26,5% (n=65) of patients had all 5 criteria and 45,1 % (n=115) of patients had 4 of 5 criteria according to LLDAS. Critical organ damage (SDI>4) was observed in 68,8% (n=161) of women with SLE. Moderate (1≤SDI≤4) and low (SDI=1) damage had 25,6% (n=60) and 6,4% (n=15) of patients respectively. Musculoskeletal damage was on the first place among others: 37,6% (n=88) of patients had osteoporosis with fractures and 34,2% (n=80) had muscle weakness. In 75 women with SLE of osteoporotic fractures occurred in remission or low disease activity (LLDAS). Progression of irreversible organ damage in remission or low disease activity (LLDAS) had 62% (n=145) of women with SLE. Multifactorial logistic regression analysis of factors associated with organ damage in SLE showed that only patients age (р=0.013215), cumulative dose of GC (р=0.000047) and therapy with cyclophosphamide (р=0.041505) were statistically significant.Conclusion:Progression of irreversible organ damage in peri- and postmenopausal women with SLE may occur despite remission or low disease activity. There are no doubts that organ damage accrual is associated with CG therapy. Correction of GC dose or discontinuation of GC treatment in remission can predict organ damage accrual in SLE including osteoporosis and osteoporotic fractures.References:[1]Frodlund M, Reid S, Wetterö J, Dahlström Ö, Sjöwall C, Leonard D. The majority of Swedish systemic lupus erythematosus patients are still affected by irreversible organ impairment: factors related to damage accrual in two regional cohorts. Lupus. 2019;28(10):1261–1272. doi:10.1177/0961203319860198Disclosure of Interests:None declared


Lupus ◽  
2019 ◽  
Vol 28 (3) ◽  
pp. 423-426 ◽  
Author(s):  
G.S. Alarcón ◽  
M.F. Ugarte-Gil ◽  
G. Pons-Estel ◽  
L.M. Vilá ◽  
J.D. Reveille ◽  
...  

Objective The objective of this report is to determine the impact of remission and low disease activity state (LDAS) on damage accrual and mortality in systemic lupus erythematosus (SLE) patients. Patients and methods Visits from the Lupus in Minority populations: Nature vs. Nurture (LUMINA) cohort were categorized into remission (Systemic Lupus Activity Measure (SLAM) score = 0 and prednisone ≤ 5 mg/day and no immunosuppressants), LDAS ((not on remission), SLAM score ≤ 3, prednisone ≤ 7.5 mg/day, no immunosuppressants), or neither: active. Remission and LDAS visits were combined because of the relatively small number of remission visits. Their impact on damage accrual and mortality were examined by Poisson and logistic multivariable regressions adjusting for variables known to affect these outcomes. Results A total of 3879 visits for 558 patients (28% Caucasian, 37% African descent, 35% Hispanic) were studied. These visits corresponded to 71 in remission, 585 in LDAS, and 3223 active. The longer the percentage of time the patients were in remission/LDAS, the less damage accrual observed (rate ratio 0.1773 (95% confidence interval (CI) 0.1216 to 0.2584) p < 0.0001). A trend was observed in terms of mortality although statistical significance was not reached (odds ratio 0.303 (95% CI 0.063 to 1.456), p = 0.1360). Conclusions The longer the patient's state on Remission/LDAS, the less damage accrual that occurs. The protective effect on mortality was not statistically significant.


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