Till Örebro universitet

Background: Patients with systemic lupus erythematosus (SLE) experience poor health-related quality of life (HRQoL), even despite attaining responses by the SLE Responder Index (SRI)-4.

Objectives: We herein aimed to determine the prevalence of poor HRQoL in SLE patients who had attained low disease activity (LDA) or remission and sustained LDA or sustained remission after a 52-week therapeutic intervention in a clinical trial setting.

Methods: A post-hoc analysis was conducted using data from four trials: BLISS-52, BLISS-76, BLISS-SC, and EMBRACE. We defined LDA according to the Lupus LDA State (LLDAS) criteria, i.e., SLEDAI-2K ≤4 excluding major organ activity or fever or new activity since the previous assessment, Physician Global Assessment (PGA) ≤1 (scale 0–3), and prednisone ≤7.5 mg/day. We defined remission according to the Definitions of Remission in SLE (DORIS) criteria i.e., clinical (c)SLEDAI-2K=0, PGA <0.5, and prednisone ≤5 mg/day. Sustained LLDAS/remission were defined as persistent LLDAS/remission for at least two visits, four weeks apart, 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, i.e., the worst 5% of scores reported from US population-based age- and sex-matched individuals, Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) scores <30, and responses of “some/moderate problems” or “extreme/major problems” in each one of the five EQ-5D dimensions of the three-level version of EQ-5D (EQ-5D-3L).

Results: Of 480, 239, 363, and 177 patients who attained LLDAS, DORIS remission, sustained LLDAS, and sustained DORIS remission at week 52, respectively, 16%, 14%, 15%, and 9% reported poor SF-36 PCS and 12%, 12%, 13%, and 14% reported poor SF-36 MCS scores, respectively. The greatest percentages were reported in the physical functioning domain (23–26%), followed by the general health domain (16–26%), while 19–26% reported FACIT-F scores ≤30. Lastly, pain/discomfort was the EQ-5D dimension that yielded the greatest frequencies of poor experience (28–29%) (Figure 1).

Conclusion: Despite attainment of LLDAS or remission, substantial proportions of SLE patients experience poor HRQoL, indicating that current LDA and remission definitions fail to capture important aspects of patients’ well-being.