Prospective Comparison of Remission and Lupus Low Disease Activity State - Effect on Disease Outcomes in 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, ¹⁷Royal Adelaide Hospital, Adelaide, Australia, ¹⁸Medicine, The University of Hong Kong, Hong Kong, Hong Kong, ¹⁹Rheum/Immunology, Peking University People's Hospital, 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: outcome measures and systemic lupus erythematosus (SLE)

Session Information

Date: Wednesday, October 24, 2018

Title: 6W010 ACR Abstract: SLE–Clinical V: Biomarkers, Criteria, & Outcomes (2928–2933)

Session Type: ACR Concurrent Abstract Session

Session Time: 9:00AM-10:30AM

Background/Purpose: The Definitions of Remission in SLE (DORIS) group has proposed multiple definitions of remission, but these are infrequently attained and have not previously been evaluated in relation to protection from damage accrual in a prospective study. In contrast, the Lupus Low Disease Activity State (LLDAS) is potentially more attainable, and has been shown to be associated with improved patient outcomes. The objective of this study was to compare the attainability and effect of LLDAS and remission on outcomes in a prospective multicenter study.

Methods: A prospective multinational cohort study was undertaken in 13 centres between 2013-2017. Time dependent Cox proportional hazards models were used to compare LLDAS and DORIS definitions of remission in terms of impact on disease flares and damage accrual. All eight DORIS remission definitions include a clinical SLEDAI-2K of 0, and PGA (0-3) <0.5, whilst varying in allowing for serological activity, prednisolone and immunosuppressants.

Results: 1735 SLE patients (meeting ACR or SLICC criteria) were recruited, and followed for (mean ± SD) 2.2 ± 0.9 years, totalling 12,534 visits. LLDAS was achieved in 6922 visits (54.6%). In contrast, remission was achieved in 140 (1.1%) to 1952 (15.4%) visits depending on definition. LLDAS attainment at any visit was associated with significantly reduced subsequent flare (HR 0.65, 95%CI 0.56-0.76, p<0.001) and damage accrual (HR 0.55, 95%CI 0.43-0.70, p<0.001). In contrast, considering every visit, only the least stringent remission definition (allowing serology, prednisolone ≤5mg, and immunosuppression) could be demonstrated to be associated with significantly reduced subsequent damage accrual (HR 0.58, 95%CI 0.39-0.88, p 0.01). Only remission definitions including serological remission were significantly associated with reduction in subsequent flares. Using a cut off of ≥50% of observed time meeting a given definition, LLDAS resulted in a two-fold reduction in risk of flare and damage accrual (HR 0.49, 95%CI 0.42-0.58, p<0.001; HR 0.53, 95% CI 0.41-0.68, p<0.001, respectively), while only the least stringent remission definition, or the related definition excluding serology (13.6% visits), were significantly protective against damage (HR 0.59, 95% CI 0.42-0.83, p 0.003; HR 0.69, 95% CI 0.48-0.99, p 0.05, respectively). When attained for ≥50% of observed time, all but one remission definition was significantly associated with reduced flares.

Conclusion: In this first-ever prospective study, LLDAS was markedly more attainable than any remission definition, whilst still conferring significant protection against flares and damage accrual. Among the remission definitions only the least stringent could be shown to be associated with significant reduction in damage accrual, likely reflecting a low frequency of remission attainment overall, and normal serology was required for protection from subsequent flare. LLDAS is a valid treatment target for SLE which is more achievable than remission.

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 Comparison of Remission and Lupus Low Disease Activity State – Effect on Disease Outcomes in Systemic Lupus Erythematosus [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/prospective-comparison-of-remission-and-lupus-low-disease-activity-state-effect-on-disease-outcomes-in-systemic-lupus-erythematosus/. Accessed .

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