Article Text
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Abstract
The deployment of treat-to-target approaches requires the identification of feasible, attainable endpoints, that are empirically associated with improved patient outcomes. While remission is the goal of care, the AsiaPacific Lupus Collaboration set itself the task in 2013 of developing and validating a measure of low disease activity (LDA) for SLE, on the basis that remission as defined at that time was rarely attained, with the aspiration that a less stringent goal might still be associated with improved outcomes despite higher attainability. The use of careful consensus methodology yielded the Lupus Low Disease Activity State (LLDAS), which has now been shown in multiple independent cohorts to be attainable, but also highly protective from flare, damage accrual, low quality of life, and mortality. Validation studies include a multicentre prospective study, which confirmed that most definitions of remission were much less attainable but no more protective.
Attainability is important, and the combination of strong protection and good attainability has seen LLDAS deployed in many clinical trials, both post hoc and a priori, where it has discriminated active treatment from placebo in at least five trials.
Learning Objectives
Discuss why, while remission is the goal of care for systemic lupus erythematosus, low disease activity may be more attainable and more pragmatic
Describe how LLDAS is a thoroughly validated treat-to-target endpoint for SLE
Explain why, compared with remission, the greater attainability of LLDAS enhances its performance as a clinical trial endpoint
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