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
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
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
| Outcome | Belimumab 10 mg/kg | Placebo | OR for attaining SLE-DAS remission | P value |
|---|---|---|---|---|
| SLE-DAS remission attainment · week 52Belimumab 10 mg/kg vs Placebo · RR for attaining SLE-DAS remission 1.454; NNT 21.7 | 14.7% | 10.1% | 1.532 | P = 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
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