Lupus & antiphospholipid syndrome
Sensitivity analysis of EQ-5D-3L index scores in terms of discriminative and known-groups validity in SLE: introducing Adequate Health State
Authors' conclusion
Overall, higher EQ-5D index scores were associated with increasing ability to discriminate between belimumab and placebo, and between responders and non-responders.
Study context
- Population
- Patients with SLE in two phase III belimumab trials (BLISS-52 and BLISS-76)BLISS-52 and BLISS-76
- Participants
- 1,684 patients
- Comparison
- EQ-5D-3L index score thresholds: belimumab vs placebo, and SRI-4 responders vs non-responders
- Primary endpoint
- Discriminant validity (belimumab vs placebo) and known-groups validity (SRI-4 responders vs non-responders) of EQ-5D-3L index scores
- Follow-up
- Week 52
Methodological detailspooled data from two phase III trials, logistic regression adjusted for confounders
- Pooled data from two phase III trials
- Logistic regression adjusted for confounders
Primary result
As reported in the abstract
Full health state (FHS; EQ-5D index score 1)
Adjusted odds ratio (95% CI)P value
Belimumabvs Placebodiscriminant validity
1.47(1.11–1.96)
P = 0.008SRI-4 respondersvs Non-respondersknown-groups validity
3.47(1.29–10.98)
P = 0.020Further findings
| Outcome | Adjusted OR (95% CI) | P value | |
|---|---|---|---|
| EQ-5D index score 0.800 or moreBelimumabvs PlaceboDiscriminant validity | 1.29 (1.02–1.63) | P = 0.036 | |
| EQ-5D index score 0.800 or moreSRI-4 respondersvs Non-respondersKnown-groups validity | 3.08 (1.16–9.69) | P = 0.034 | |
| 0.10.31310Adjusted odds ratio (log scale) |
Original publication
Sensitivity analysis of EQ-5D-3L index scores in terms of discriminative and known-groups validity in SLE: introducing Adequate Health State. Rheumatology (Oxford). Published 22 March 2023. doi:10. 1093/ rheumatology/ kead140
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