ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2786

Prospective Multicenter Validation Study of the Lupus Low Disease Activity State – a Treatment Target for Systemic Lupus Erythematosus

Vera Golder1, Rangi Kandane-Rathnayake2, Molla Huq3, Worawit Louthrenoo4, Shue-Fen Luo5, Yeong-Jian Wu6, Aisha Lateef7, Sargunan Sockalingam8, Susan Morton9, Sandra V. Navarra10, Leonid Zamora11, Laniyati Hamijoyo12, Yasuhiro Katsumata13, Masayoshi Harigai14, Madelynn Chan15, Sean O'Neill16, Fiona Goldblatt17, Chak Sing Lau18, Zhan-Guo Li19, Alberta Y. Hoi2, Mandana Nikpour20 and Eric Morand21, 1School of Clinical Sciences at Monash Health, School of Clinical Sciences at Monash Health, Monash University, Melbourne, Australia, 2School of Clinical Sciences at Monash Health, Monash University, Melbourne, Australia, 3The University of Melbourne at St Vincent's Hospital, Melbourne, Australia, 4Division of Rheumatology, Department of Internal Medicine, Chiang Mai University, Chiang Mai, Thailand, 5Division of Rheumatology, Allergy and Immunology, Chang Gung Memorial Hospital, Taoyuan, Taiwan, 6Chang Gung University, Taoyuan County, Taiwan, 7Medicine, Division of Rheumatology, National University Hospital of Singapore, Singapore, Singapore, 8University of Malaya, Kuala Lumpur, Malaysia, 9Monash Health, Melbourne, Australia, 10University of Santo Tomas Hospital, Manila, Philippines, 11Rheumatology, University of Santo Tomas Hospital, Manila, Philippines, 12University of Padjadjaran, Bandung, Indonesia, 13Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan, 14Tokyo Women's Medical University, Division of Epidemiology and Pharmacoepidemiology of Rheumatic Diseases, Institute of Rheumatology, Tokyo, Japan, 15Tan Tock Seng Hospital, Singapore, Singapore, 16University of New South Wales, Sydney, Australia, 17Rheumatology, Royal Adelaide Hospital, Adelaide, Australia, 18Medicine, The University of Hong Kong, Hong Kong, Hong Kong, 19Department of Rheumatology and Immunology, People’s Hospital, Peking University Health Science Center,, Beijing, China, 20The University of Melbourne, Melbourne, Australia, Melbourne, Australia, 21Medicine, School of Clinical Sciences at Monash Health, Monash University, Melbourne, Australia

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords:

Session Information

Date: Tuesday, October 23, 2018

Title: 5T046 ACR Abstract: Plenary Session III (2785–2790)

Session Type: ACR Plenary Session

Session Time: 11:00AM-12:30PM

Background/Purpose: The adoption of treat to target approaches for Systemic Lupus Erythematosus (SLE) requires the definition of a target state validated for improved patient outcomes. The Lupus Low Disease Activity State (LLDAS) has been shown in multiple retrospective and cross-sectional studies to have face, content, construct and criterion validity and be associated with better quality of life. We report on a multinational prospective study undertaken to determine whether LLDAS attainment is associated with protection from flare and damage accrual.

Methods: A prospective multicenter cohort study was undertaken in 13 centres between 2013-2017. Patients with SLE (ACR or SLICC criteria) were recruited, SLEDAI-2k, SELENA flare index, PGA, and medication data collected at every visit, and damage (SLICC-ACR damage index (SDI)) collected annually. Time-dependent Cox proportional hazards models were used to assess the association of LLDAS at any time point, as well as the effect of the proportion of time spent in LLDAS, with disease flare and damage accrual (increase in SDI).

Results: 1735 patients (93% female, 77.7% anti-dsDNA positive, mean baseline SLEDAI-2k 4.3 ± 4.4) were followed for (mean ± SD) 2.2 ± 0.9 years, totalling 12,534 visits (mean interval 0.34 ± 0.17y). LLDAS was achieved in 54.6% of observed visits. Attainment of LLDAS at any timepoint was highly significantly protective against subsequent flare and damage accrual (Table 1).

Table 1: Association of LLDAS with subsequent flare and damage accrual

Time-dependent proportional hazards model (independent variable: in LLDAS (Yes/No))

Outcome

HR

95% CI

p value

Flare (any) at subsequent visits

0.65

0.56 – 0.76

<0.001

Flare (mild-moderate) at subsequent visits

0.74

0.63 – 0.87

<0.001

Flare (severe) at subsequent visits

0.41

0.34 – 0.51

<0.001

Damage accrual (Increase in SDI ≥1)

0.55

0.43 – 0.70

<0.001

Similarly, patients who spent ≥50% of their observed time in LLDAS had a two-fold reduction in risk of flare and damage accrual (flare: HR 0.49, 95% CI 0.42-0.58, p<0.001; damage accrual HR 0.53, 95% CI 0.41-0.68, p<0.001), compared to those with <50% of observed time in LLDAS.

Conclusion: In this large prospective multicenter study, we demonstrate that LLDAS attainment provides significant protection against disease flares and damage accrual. Our findings support the use of LLDAS as a treatment target for SLE, and as an outcome measure for clinical trials and treat-to-target strategies.

Disclosure: V. Golder, None; R. Kandane-Rathnayake, None; M. Huq, None; W. Louthrenoo, None; S. F. Luo, None; Y. J. Wu, None; A. Lateef, None; S. Sockalingam, None; S. Morton, None; S. V. Navarra, None; L. Zamora, None; L. Hamijoyo, None; Y. Katsumata, None; M. Harigai, None; M. Chan, None; S. O'Neill, None; F. Goldblatt, None; C. S. Lau, None; Z. G. Li, None; A. Y. Hoi, None; M. Nikpour, Actelion, GSK, Pfizer, BMS, Eli Lilly, UCB, Astra Zeneca, Janssen, 2, 5; E. Morand, None.

To cite this abstract in AMA style:

Golder V, Kandane-Rathnayake R, Huq M, Louthrenoo W, Luo SF, Wu YJ, Lateef A, Sockalingam S, Morton S, Navarra SV, Zamora L, Hamijoyo L, Katsumata Y, Harigai M, Chan M, O'Neill S, Goldblatt F, Lau CS, Li ZG, Hoi AY, Nikpour M, Morand E. Prospective Multicenter Validation Study of the Lupus Low Disease Activity State – a Treatment Target for Systemic Lupus Erythematosus [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/prospective-multicenter-validation-study-of-the-lupus-low-disease-activity-state-a-treatment-target-for-systemic-lupus-erythematosus/. Accessed .

« Back to 2018 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/prospective-multicenter-validation-study-of-the-lupus-low-disease-activity-state-a-treatment-target-for-systemic-lupus-erythematosus/