Lupus & antiphospholipid syndrome

Poor health-related quality of life despite Lupus Low Disease Activity State or Definitions of Remission in systemic lupus erythematosus (SLE) remission in patients with SLE: results from a clinical trial setting

RMD OpenPublished Post hoc analysis of four phase III randomised trials

Authors' conclusion

Despite LLDAS or DORIS remission, notable proportions of SLE patients report poor HRQoL

Study context

Population
Patients with SLE in phase III trials of belimumab
Participants
2,406 patients4 phase III trials
Comparison
Lupus Low Disease Activity State (LLDAS) vs Remission vs Sustained LLDAS vs Sustained remission
Primary endpoint
Prevalence of poor HRQoL (SF-36 PCS/MCS and domain scores ≤ normative fifth percentile; FACIT-F <30; EQ-5D problems) in LLDAS, DORIS remission, sustained LLDAS or sustained remission
Follow-up
Week 52
Methodological detailspooled analysis, BLISS-52, BLISS-76, BLISS-SC, EMBRACE
  • Pooled analysis
  • BLISS-52, BLISS-76, BLISS-SC, EMBRACE

Primary result

As reported in the abstract

Poor SF-36 PCS

Further findings

Poor SF-36 MCS · week 52

Poor SF-36 physical functioning domain (highest frequencies) · week 52

Range across groups
24.0%-26.3%

Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scores <30 · week 52

Range across groups
18.5%-26.2%

EQ-5D pain/discomfort problems (greatest frequencies among EQ-5D dimensions) · week 52

Range across groups
27.9%-28.7%

Change in health-related quality of life (HRQoL) over 52 weeks among patients achieving treatment goals

Significant improvements in all HRQoL outcomes; PCS scores remained below population norms

Original publication

Poor health-related quality of life despite Lupus Low Disease Activity State or Definitions of Remission in systemic lupus erythematosus (SLE) remission in patients with SLE: results from a clinical trial setting. RMD Open. Published 31 October 2025. doi:10.1136/rmdopen-2025-006061

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