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

Rheumatology (Oxford)Published Post hoc analysis of the BLISS-52 and BLISS-76 randomised trials

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 = 0.008
SRI-4 respondersvs Non-respondersknown-groups validity
3.47(1.29–10.98)
P = 0.020

Further findings

OutcomeAdjusted OR (95% CI)P value
EQ-5D index score 0.800 or moreBelimumabvs PlaceboDiscriminant validity1.29 (1.02–1.63)P = 0.036
EQ-5D index score 0.800 or moreSRI-4 respondersvs Non-respondersKnown-groups validity3.08 (1.16–9.69)P = 0.034

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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