CO:01:3 | Which PRO reflects remission best? Bridging the gap between patient and physician in systemic lupus erythematosus

Elena Ragusa¹, Elisabetta Chessa², Marta Paola Pireddu¹, Fabio Congiu¹, Giulia Rizzo¹, Marianna Salis¹, Alessandra Oliva¹, Mattia Congia², Alberto Cauli^1|2, Matteo Piga^1|2. | ¹SC Reumatologia, Dipartimento di Scienze Mediche e Salute Pubblica, Università di Cagliari; ²SC Reumatologia, AOU Cagliari, Italy

Objective. Systemic lupus erythematosus (SLE) exerts a substantial burden on patients’ quality of life (QoL). Even if in SLE the goal is represented by the achievement of remission, in order to minimize damage accrual, many patients still report a reduced QoL. Currently the definition of remission does not include patient’s perspective. This study aims to identify which patient reported outcomes (PROs) may be the most suitable to be integrated into the definition of remission, in order to reflect the patient's viewpoint.

Materials and Methods. A 10-year retrospective analysis of SLE patients was conducted. Demographics, clinical (disease duration, fibromyalgia, anxiety and depression, death), clinimetrics (SLEDAI-2k, SLICC/Damage Index (SDI), and therapeutic data were collected. The following PROs: Short Form Health Survey (SF)-36, Health Assessment Questionnaire (HAQ), The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Visual Analogue scale (VAS)-pain scale and VAS- global health (GH) were recorded. A heatmap based on a correlation matrix (R >=|0.6| moderate, >0.4-<0.6 acceptable) between PROs and clinimetric indices and between different PROs was built. Then we analyzed correlation between PROs and patients in remission (REM), in lupus low disease activity (LLDAS) and with active disease, also integrating PROs in the definition of clinical status of REM and LLDAS.

Results. Out of 111 patients (mean age 47.3±13.7 years; disease duration 15.1±7.4 years), 6 (5.4%) were male (see Table1). FACIT-F , found <34 in 55 patients (49.5%), showed weak correlation with SLEDAI (R=-0.25; p=0.01) and SDI (R=-0.25 p=0.01);VAS-pain >=4 was found in 54 patients (48.6%) and weakly correlated with SLEDAI (R=0.21; p=0.02) (Fig. A). HAQ , altered (>=0.5) in 46 patients (41.4%), weakly correlated with SLEDAI (R=0.19; p=0.04) while VAS-GH and SF-36 did not correlate significantly with SLEDAI. FACIT-F demonstrated a moderate inverse correlation with HAQ (R=-0.60; p<0.0001), acceptable with VAS-pain (R=-0.54) and VAS-GH (R=-0.45) (p<0.0001), a substantial positive correlation with the SF-36 physical domains (R=0.70; p<0.0001) and with Mental component Summary (R=0.62; p<0.0001). None of the PROs evaluated correlated with prednisone daily dose. Adding FACIT>=34 to the definition of REM and LLDAS, both REM + FACIT>=34 group (Figures B and C) and LLDAS + FACIT-F>=34 group (Figures D and E) showed lower scores of VAS-pain, VAS-GH, HAQ (p<0.05) and higher SF-36 scores (p>0.05) than REM, LLDAS and active disease groups not including the definition of FACIT>=34.

Conclusions: The weak correlation between PROs and SLEDAI or SDI highlights the limitation of relying solely on clinical indices. Nevertheless FACIT-F emerged as a suitable PRO among those tested to complement the definition of remission or LLDAS, as when added to clinical definition status it captures disease burden not reflected by traditional measures.