Lupus & antiphospholipid syndrome

SF-36v2 and FACIT-Fatigue quality of life improvements with organ-specific SELENA-SLEDAI response and belimumab treatment in patients with systemic lupus erythematosus

Lupus Sci MedPublished Post hoc pooled analysis of four phase III randomised trials

Authors' conclusion

SLE disease burden differs with the organ system(s) involved.

Study context

Population
Patients with SLE with baseline organ system involvement in four phase III belimumab trials (BLISS-52, BLISS-76, BLISS-SC, EMBRACE)4 phase III trials pooled
Comparison
SELENA-SLEDAI organ system responders vs non-responders; and, among responders, belimumab vs placebo
Outcome
Changes in health-related quality of life (HRQoL) (SF-36v2) and fatigue (FACIT-Fatigue)
Follow-up
Over 52 weeks
Methodological detailsanalysis of variance, published group-level minimal important difference (MID)
  • Analysis of variance
  • Published group-level MID

Pooled result

As reported in the abstract

SF-36v2 and FACIT-Fatigue changes by organ system response and treatment · 52 weeks
  • Musculoskeletal and mucocutaneous responders had greater SF-36v2 improvements than non-responders across most domains, but differences largely <MID
  • Most organ system responders had improved FACIT-Fatigue vs non-responders; cardiovascular and respiratory responders ≥MID
  • Musculoskeletal and renal responders on belimumab had greater improvements in several SF-36v2 domains than responders on placebo (>MID)
  • FACIT-Fatigue improved >MID for renal responders on belimumab
  • Post hoc analyses

Original publication

SF-36v2 and FACIT-Fatigue quality of life improvements with organ-specific SELENA-SLEDAI response and belimumab treatment in patients with systemic lupus erythematosus. Lupus Sci Med. Published 8 May 2024. doi:10.1136/lupus-2023-001118

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