An international task force has, after a six-year process, reached a consensus on the definition of remission in systemic lupus erythematosus (SLE).
The DORIS (Definitions Of Remission In SLE) Task Force, which included Professor Eric Morand, Head of Rheumatology at Monash Health, convened in 2015 and the following year published a framework for reaching a definition.
The group subsequently undertook comprehensive systematic literature reviews (SLRs) and specific topical analyses to create general statements relating to remission that were then refined and ultimately voted on.
A single definition of remission in SLE, based on clinical SLE disease activity index (SLEDAI)=0, Evaluator’s Global Assessment <0.5 (0–3), prednisolone 5 mg/day or less, and stable antimalarials, immunosuppressives and biologics, was recommended.
In reaching this definition, which is published in the BMJ’s Lupus Science & Medicine, the group achieved consensus (with more than 90% in agreement) on five new general recommendations that helped shape the final version.
The first concerned the inclusion of serology in the DORIS definition of remission on-treatment, which the task force elected not to incorporate “because the preponderance of the data suggests that this does not meaningfully alter the construct validity of a definition of remission”.
The second dealt with duration – here the group agreed that this should not be included in the definition, because while sustained remission is the ultimate goal, a definition of remission “should be able to be met at any point in time”.
The third was to include the SLEDAI-based definition of remission, as these have been investigated in research studies “considerably more extensively than BILAG-based on European consensus lupus activity measure (ECLAM)-based definitions”.
The fourth considered ‘remission off-treatment’, which the group noted is very rarely achieved. “In clinical research and as an outcome in clinical trials, practical considerations must be weighed in, and therefore the definition for remission on-treatment is recommended,” they said.
The fifth recommended that the lupus low disease activity state (LLDAS) definition for low disease activity and the DORIS definition of remission on-treatment “serve unique important purposes” and “both should be used in clinical practice and research settings including clinical trials”.
“It is expected that the 2021 DORIS definition of remission in SLE will be used as an aspirational goal in clinical care, in addition to being valuable in education and research,” the group concluded.
The DORIS Initiative was backed by unrestricted educational grants from GlaxoSmithKline and UCB Pharma.