Lupus & antiphospholipid syndrome

Systemic Lupus Erythematosus Disease Activity Score Remission and Low Disease Activity States Discriminate Drug From Placebo and Better Health‐Related Quality of Life

Arthritis Care Res (Hoboken)Published Secondary analysis of the BLISS-52 and BLISS-76 randomised trials

Authors' conclusion

SLE-DAS remission and LDA showed discriminant ability for identifying patients receiving active drug in SLE clinical trials. Attainment of these SLE-DAS targets are associated with better HR-QoL.

Study context

Population
Patients with SLE in the pooled BLISS-52 and BLISS-76 trials
Comparison
Belimumab 1 mg/kg and 10 mg/kg vs placebo
Primary endpoint
SLE-DAS remission and LDA attainment and discrimination between belimumab and placebo
Follow-up
52 weeks
Methodological detailspost hoc analysis, pooled data
  • Post hoc analysis
  • Pooled data

Primary result

As reported in the abstract

SLE-DAS LDA attainment · week 52

Odds ratio

1.459

P = 0.023

Belimumab 1 mg/kg · RR 1.377; NNT 20.4

Odds ratio

1.853

P < 0.001

Belimumab 10 mg/kg · RR 1.668; NNT 11.5

Further findings

OutcomeBelimumab 10 mg/kgPlaceboOR for attaining SLE-DAS remissionP value
SLE-DAS remission attainment · week 52Belimumab 10 mg/kg vs Placebo · RR for attaining SLE-DAS remission 1.454; NNT 21.714.7%10.1%1.532P = 0.019

HR-QoL (SF-36 domain and summary scores; Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F)) in Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) remission and low disease activity (LDA) attainers vs non-attainers · week 52

Higher SF-36 domain and summary scores in patients attaining SLE-DAS remission and LDA
all P < 0.001
Higher FACIT-F scores in patients attaining SLE-DAS remission and LDA
both P < 0.001
Mean improvements from baseline in SF-36 and FACIT-F scores significantly higher in patients achieving SLE-DAS remission and LDA

Original publication

Systemic Lupus Erythematosus Disease Activity Score Remission and Low Disease Activity States Discriminate Drug From Placebo and Better Health‐Related Quality of Life. Arthritis Care Res (Hoboken). Published 29 February 2024. doi:10.1002/acr.25305

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