Abstract
Objective Patients with systemic lupus erythematosus (SLE) experience poor health-related quality of life (HRQoL), despite attaining responses by the SLE Responder Index (SRI)-4.1 We aimed to determine the prevalence of poor HRQoL in SLE patients who had attained low disease activity (LDA) or remission and sustained LDA or 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 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.
Reference
Gomez A, et al. Front Med (Lausanne) 2021.
Conflicts of Interest IP has received research funding and/or honoraria from Amgen, AstraZeneca, Aurinia, Bristol Myers Squibb (BMS), Elli Lilly, Gilead, GlaxoSmithKline (GSK), Janssen, Novartis, Otsuka, and Roche. MN has received research grant support from Janssen and Boehringer Ingelheim; received honoraria from Janssen, GSK, AstraZeneca, Pfizer, and Boehringer Ingelheim. AL reports employment with BMS outside the submitted work. VS has received consulting fees from AbbVie, Alpine, Alumis, Amgen, Aria, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Celltrion, Ermium, Genentech/Roche, GSK, Horizon, Inmedix, Janssen, Kiniksa, Lilly, Merck, MiMedx, Novartis, Omeros, Pfizer, RAPT, Regeneron, R-Pharm, Samsung, Sandoz, Sanofi, Scipher, Setpoint, Sorrento, Spherix, Tonix, and Urica. The other authors declare that they have no conflicts of interest related to this work. The funders had no role in the design of the study, the analyses or interpretation of data, or the writing of the manuscript.
Poor HRQoL despite (sustained) LLDAS or DORIS remission. Bars (A–B) and radar charts (C–D) depicting proportions of patients who reported poor HRQoL among patients who attained LLDAS (in dark pink), DORIS remission (in dark blue), sustained LLDAS (in dark pink), and sustained DORIS remission (in dark blue).
