Abstract
INTRODUCTION: Preserving kidney function and limiting renal flares are important treatment goals for patients with lupus nephritis (LN). The relationship between renal flares and health-related quality of life (HRQOL) was assessed in patients with LN receiving standard therapy in the LUNAR phase 3 clinical trial. METHODS: A post hoc analysis was conducted on data collected from patients with biopsy-confirmed class III/IV ± V LN randomized to the control arm of the phase 3 LUNAR (NCT00282347) trial. Relationships between renal flare(s) (estimated glomerular filtration rate decrease > 20% and urine-to-creatinine ratio [UPCR] > 1 g/g; increase in UPCR > 1 if UPCR < 0.2 g/g or UPCR > 2 if UPCR ≥ 0.2 g/g; or receipt of rescue therapy compared with week 16 when steroid tapering occurred) and mean change in HRQOL score across eight 36-Item Short Form Health Survey (SF-36) domains and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) were assessed using multivariate analysis of covariance (ANCOVA) modeling. RESULTS: Among 72 patients receiving standard therapy, renal flare occurred in 24 patients (33%) (flare rate 3.18 per 1000 person days). Domain-specific mean SF-36 HRQOL scores and FACIT-Fatigue scores improved over time among study participants receiving standard therapy. Multivariate analyses identified a significant impact of experiencing one or more renal flares on mean change in FACIT-Fatigue score as well as the following SF-36 domains: physical functioning, role physical, bodily pain, vitality, and social functioning. CONCLUSIONS: Renal flares in patients with LN significantly impact their HRQOL as measured by the SF-36 and the FACIT-Fatigue, highlighting the importance of preserving kidney function from the patient perspective among those with LN.