Background/Purpose Patient-Reported Outcomes (PROs) allow us to know how the disease could affect patients, and maybe could not be detected by clinical measures. Among these, PROs of health-related quality of life (PRO-QL) represents patient evaluation of its health status. In systemic lupus erythematosus (SLE) patients, the heterogeneous inflammatory symptoms can affect the health-related quality of life in different ways.

We aimed to measure the PRO-QL in SLE patients and correlate them with the clinical activity of the disease.

Methods A cross-sectional observational study with SLE patients diagnosed according to SLICC 2012 criteria was performed. SLEDAI score was carried out, and patients full-filled questionnaires of fatigue (FACIT-FATIGUE), quality of life (EQ-5D-5L), disability (HAQ) and a Global Health Status Scale (GHS) (0–100). Biostatistical analysis was performed using the multivariate analysis of variance by Pillai test.

Results 54 SLE patients (91.84% female) with a mean age at diagnosis of 27.55±13.21 years and a mean time of disease evolution of 20.45±9.7 years were included. Mean SLEDAI score was 6.63±6.89, with a 37.04% of patients with SLEDAI>6. The 64.66% of patients were under glucocorticoid treatment, 38.77% under immunosuppressants (methotrexate, azatioprine or mycophenolate) and 51.02% under antimalarials.

Patients showed a mean score of 34.02±12.38 in FACIT-FATIGUE, 0.72±0.26 in EQ-5D-5L, 0.62±0.71 in HAQ and 64.02±25.93 in GHS.

Statistical analysis showed correlation among high SLEDAI scores and low scores of EQ-5D-5L, FACIT-FATIGUE and GHS, and an increment in HAQ, considering as correcting factors the age, years of disease evolution, glucocorticoid treatment, antimalarials and immunosuppressants (P=0.0107).

Conclusions We observed a correlation between PROs-QL full-filled by SLE patients with the clinical activity of the disease, independently of glucocorticoid treatment, antimalarials and immunosuppressants, the age and the disease evolution.