www.thelancet.com/rheumatology Vol 1 October 2019 e103
Articles
Lancet Rheumatol 2019;
1: e103–10
See Comment page e77
*Contributed equally
School of Clinical Sciences,
Monash University, Melbourne,
VIC, Australia (V Golder MBBS,
R Kandane-Rathnayake PhD,
A Hoi MBBS,
Prof E F Morand MBBS);
Department of Rheumatology,
The University of Melbourne,
Melbourne, VIC, Australia
(M Huq MSc, M Nikpour MBBS);
Department of Internal
Medicine, Chiang Mai
University, Chiang Mai,
Thailand
(Prof W Louthrenoo MD);
Department of Rheumatology,
Allergy and Immunology,
Chang Gung Memorial
Hospital, Guishan Township,
Taiwan (Prof S F Luo MD,
Y-J J Wu MD); Rheumatology
Division, National University
Hospital, Singapore
(A Lateef MBBS); Department of
Medicine, University of Malaya,
Kuala Lumpur, Malaysia
(S Sockalingam MD); Joint and
Bone Center, University of
Santo Tomas Hospital, Manila,
Philippines
(Prof S V Navarra MD,
L Zamora MD); Department of
Internal Medicine, University
of Padjadjaran, Bandung,
Indonesia (L Hamijoyo MD);
Institute of Rheumatology,
Tokyo Women’s Medical
University, Tokyo, Japan
(Y Katsumata MD,
Prof M Harigai MD);
Department of Rheumatology,
Allergy and Immunology, Tan
Tock Seng Hospital, Singapore
(M Chan MD); South Western
Sydney Clinical School,
University of New South Wales,
Sydney, NSW, Australia
(S O’Neill BMed); Ingham
Institute of Applied Medical
Research, Liverpool,
NSW, Australia (S O’Neill);
Department of Rheumatology,
Royal Adelaide Hospital,
Evaluation of remission definitions for systemic lupus
erythematosus: a prospective cohort study
Vera Golder, Rangi Kandane-Rathnayake, Molla Huq, Worawit Louthrenoo, Shue Fen Luo, Yeong-Jian Jan Wu, Aisha Lateef,
Sargunan Sockalingam, Sandra V Navarra, Leonid Zamora, Laniyati Hamijoyo, Yasuhiro Katsumata, Masayoshi Harigai, Madelynn Chan,
Sean O’Neill, Fiona Goldblatt, Chak Sing Lau, Zhan Guo Li, Alberta Hoi, Mandana Nikpour*, Eric F Morand*, for the Asia Pacific Lupus
Collaboration
Summary
Background Validated outcome measures are needed from which to derive treatment strategies for systemic lupus
erythematosus (SLE). However, no defnition of remission for SLE has been widely adopted. The Defnitions of
Remission in Systemic Lupus Erythematosus (DORIS) group has proposed a framework with multiple potential
defnitions of remission. In this study, we aimed to assess the attainability and efect on disease outcomes of the
DORIS defnitions of remission, compared with the lupus low disease activity state (LLDAS), in patients with SLE.
Methods In this prospective cohort study, we enrolled patients with SLE from 13 international centres that are part of
the Asia Pacifc Lupus Collaboration. Eligible patients were older than 18 years and fulflled one of two classifcation
criteria for SLE (1997 American College of Rheumatology criteria or the 2012 Systemic Lupus International
Collaborating Clinics criteria). Visits were according to clinical need, with a minimum frequency of one visit per
6 months. We assessed attainment of remission on the basis of the eight DORIS defnitions of remission, which
varied in terms of serological activity, glucocorticoid use, and use of immunosuppresive agents; attainment of
LLDAS; and disease fares at each visit. Irreversible organ damage accrual was recorded annually. Our primary aim
was to assess exposure of patients to each of the remission defnitions or LLDAS, and the respective association of
these states with accrual of irreversible organ damage as the primary outcome measure. Occurrence of disease fares
was the key secondary outcome. We used time-dependent Cox proportional hazards models and generalised linear
models to assess DORIS defnitions of remission and LLDAS in terms of their association with damage accrual and
disease fares.
Findings Between May 1, 2013, and Dec 31, 2016, 1707 patients with SLE were recruited and followed for a mean of
2·2 years (SD 0·9), totalling 12 689 visits. Remission, depending on DORIS defnition, was achieved in 581 (4·6%) to
4546 (35·8%) of 12 689 visits. Spending 50% or more of observed time in any remission state was associated with a
signifcant reduction in damage accrual, except for the two most stringent remission defnitions, for which the
frequency of attainment was lowest. Remission defnitions disallowing serological activity were associated with the
greatest reductions in disease fares. LLDAS was more attainable than any remission defnition and was associated
with a similar magnitude of protection from damage accrual and disease fares. Sustained remission and LLDAS
were associated with a wider spread of efect sizes for reduction in risk of damage. By analysing patients who met the
defnition for LLDAS but not remission, we found that LLDAS was signifcantly associated with reduction in damage
accrual, independent of all defnitions of remission, except the least stringent.
Interpretation Attainment of remission was associated with signifcant reductions in damage accrual and disease
fares. LLDAS was more achievable than remission based on the DORIS criteria, but was similarly protective.
Remission defnitions with less stringency might be insufciently distinct from LLDAS to substantially afect outcome
measures, and further studies are needed to distinguish the protective efects of the various remission defnitions.
Funding UCB, GlaxoSmithKline, Janssen, Bristol-Myers Squibb, and AstraZeneca.
Copyright © 2019 Elsevier Ltd. All rights reserved.
Introduction
The use of treat-to-target approaches based on validated
outcome measures has transformed clinical trials and
practice for chronic diseases such as diabetes and hyper-
tension.
1
Treat-to-target became the standard of care in
rheumatoid arthritis after it was shown that achievement
of the treatment targets of remission or low disease activity
was associated with signifcant reduction in structural
joint damage.
2
In 2014, an international working group
highlighted as an urgent priority the need for valid-
ated outcome measures from which to derive treatment
strategies for systemic lupus erythematosus (SLE).
3
Mort-
ality in patients with SLE is strongly associated with
damage accrual, with causative factors including poorly
controlled disease activity, glucocorticoid use, and com-
plications of long-term immunosuppression.
4,5
Therefore,