SLE-DAS remission, low disease activity show promise as treat-to-target measures
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Key takeaways:
- SLE-DAS remission and low disease activity discriminated between patients taking active drug vs. placebo.
- Both measures were linked to health-related quality of life outcomes, including fatigue.
Remission and low disease activity can discriminate between patients taking active drug vs. placebo in clinical trials and are linked to health-related quality of life, according to data in Arthritis Care & Research.
“Remission and low disease activity (LDA) are recommended targets for the management of systemic lupus erythematosus,” Diogo Jesus, MD, of the Centro Hospitalar de Leiria in Portugal, and colleagues wrote. “However, a unified definition of remission and LDA is yet to be universally agreed-upon. These universal definitions would be crucial to facilitate comparing the results from different studies.”
To help arrive at universal definitions, Jesus and colleagues assessed the value of the systemic lupus erythematosus Disease Activity Score (SLE-DAS), which covers remission, LDA and is easily accessible through an online calculator. They evaluated the ability of SLE-DAS remission and LDA measures to discriminate between patients taking active drug or placebo, as well as between their health-related quality of life outcomes, in a clinical trial setting.
In a post-hoc analysis of pooled data from two clinical trials, the researchers compared the self-reported outcomes of patients with SLE who attained SLE-DAS remission or LDA vs. those who did not. The analysis included 1,684 patients randomly assigned to receive either belimumab 1 mg/kg (n = 559), belimumab 10 mg/kg (n = 563) or placebo (n = 562).
At week 52, SLE-DAS LDA registered among significantly more patients taking belimumab 1 mg/kg (OR = 1.459; 95% CI, 1.052-2.025) or 10 mg/kg (OR = 1.853; 95% CI, 1.349-2.545) than those on placebo. SLE-DAS remission was more common in both the low-dose belimumab group (OR = 1.289; 95% CI, 0.89-1.866) and the high-dose group (OR = 1.532; 95% CI, 1.069-2.195) vs. placebo.
Patients attaining SLE-DAS remission had significantly greater mean improvement in both the physical and mental components of SF-36, as did patients who attained SLE-DAS LDA (P < .005 for all). Attainment of either measure was also associated with improved fatigue, according to mean change in Functional Assessment of Chronic Illness Therapy-Fatigue score (P < .001 for both).
“Our findings contribute for the SLE-DAS content validity and support the adoption of SLE-DAS remission and [low disease activity] as [treat-to-target] measures in daily clinical practice and their use as endpoints in clinical trials,” Jesus and colleagues wrote.
They added that “future work with other SLE populations will focus on the development of predictive models using SLE-DAS as a continuous score through discriminant analysis methodology and on the assessment of treatment response based on a change in disease activity using the SLE-DAS.”
Perspective
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Whether child or adult, systemic lupus erythematous impacts every aspect of a patient’s life. Rheumatology providers are constantly balancing objective data with their patient’s perspective in determining how well their SLE is controlled. Researchers involved with SLE related randomized clinical trials face the same dilemma when analyzing data to determine how effective a new treatment regime — often a new medication — is in achieving SLE remission or low disease activity (LDA).
What constitutes remission or LDA is frequently debated among rheumatology providers, with each bringing a unique perspective to the discussion. Adopting validated definitions of SLE remission and LDA is crucial not only to shape future research endeavors into SLE treatments, but also to assist providers in treatment decisions that ultimately lead to improved outcomes and quality of life for their patients.
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