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OBJECTIVE: To determine the prevalence of poor health-related quality of life (HRQoL) in patients with systemic lupus erythematosus (SLE) in Lupus Low Disease Activity State (LLDAS) or Definitions of Remission in SLE (DORIS) remission and sustained LLDAS or sustained DORIS remission, after a 52-week therapeutic intervention. METHODS: We analysed data from four phase III trials of belimumab in SLE (BLISS-52, BLISS-76, BLISS-SC, EMBRACE; n=2406). Sustained LLDAS/remission was defined as persistent LLDAS/remission for at least two visits, maintained through week 52. Poor HRQoL was defined as Short Form-36 (SF-36) physical/mental component summary (PCS/MCS) and domain scores ≤the normative fifth percentile, Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scores <30 and responses of 'some/moderate problems' or 'extreme/major problems' in any of the five dimensions of the three-level version of EuroQol 5-Dimension (EQ-5D) health questionnaire. RESULTS: At week 52, among patients in LLDAS, remission, sustained LLDAS and sustained remission, 15.7%, 13.6%, 14.3% and 9.0% reported poor SF-36 PCS, and 12.5%, 11.4%, 12.9% and 14.0% reported poor SF-36 MCS scores, respectively. The highest frequencies were reported in the physical functioning domain (24.0%-26.3%), while 18.5%-26.2% reported FACIT-F scores 30. Among EQ-5D dimensions, pain/discomfort yielded the greatest frequencies of poor HRQoL experience (27.9%-28.7%). While significant improvements were observed among patients achieving the treatment goals in all HRQoL outcomes over the 52-week study period, PCS scores remained below population norms. CONCLUSIONS: Despite LLDAS or DORIS remission, notable proportions of SLE patients report poor HRQoL, indicating that current therapeutic goal definitions do not fully capture patients' perspectives of health.
Parodis et al. (Wed,) studied this question.