Annual direct medical cost of active systemic lupus erythematosus in five European countries.

OBJECTIVES: To evaluate the annual direct medical cost of managing adult systemic lupus erythematosus (SLE) patients with active autoantibody positive disease in Europe. METHODS: A 2-year, retrospective, multicentre, observational study was conducted in five countries (France, Germany, Italy, Spain and the UK). Data included patients' characteristics, disease activity and severity, flare assessments and health resource use (eg, laboratory tests, medications, specialist visits and hospitalisations). Costs were assessed from the public payers' perspective. Cost predictors were estimated by multivariate regression models. RESULTS: Thirty-one centres enrolled 427 consecutive eligible patients stratified equally by disease severity. At baseline, mean (SD) age was 44.5 (13.8) years, 90.5% were women and mean (SD) SLE duration was 10.7 (8.0) years. The SELENA-SLEDAI (11.2 vs 5.3) and SLICC/ACR index (1.0 vs 0.7) scores were higher in severe patients. Over the study period, patients experienced on average 1.02 (0.71) flares/year. The mean annual direct medical cost was higher in severe compared to non-severe patients (€4748 vs €2650, p<0.001). Medication costs were €2518 in severe versus €1251 in non-severe patients (p<0.001). Medications represented 53% and 47% of the total cost for severe and non-severe patients, respectively, primarily due to immunosuppressants and biologics. Flares, especially severe flares, were identified as the major cost predictor, with each flare increasing the annual total cost by about €1002 (p<0.001). CONCLUSIONS: The annual direct medical cost of SLE patients in Europe is related to disease severity and flares. Medical treatments were the main cost drivers. Severe flares and major organ involvement were identified as important cost predictors.

Adaptación y validación de la versión española de una medida específica de la calidad de vida en los pacientes con lupus eritematoso sistémico: el Lupus Quality of Life / Adaptation and validation of the Spanish version of a disease-specific quality of life measure in patients with systemic lupus erythematosus: The Lupus Quality of Life

Fundamento y objetivo: El lupus eritematoso sistémico (LES) es una enfermedad autoinmunitaria que afecta la calidad de vida. Hay varios instrumentos específicos que miden la calidad de vida relacionada con la salud (CVRS), pero ninguno se ha adaptado al español. El objetivo de este trabajo fue adaptar y validar en la población española una medida específica de la CVRS en los pacientes con LES. Pacientes y métodos: La adaptación se basó en el método de traducción y retrotraducción de la versión inglesa del LupusQoL (Lupus Quality of Life) y su aplicación en 115 adultos con LES. Resultados: El análisis factorial identificó 5 dominios del LupusQoL; la fiabilidad evidenció un alto coeficiente en el alfa de Cronbach de 0,977 y en el método de las 2 mitades de Guttman de 0,936; las correlaciones significativas del LupusQoL con el Medical Outcome Survey muestran alta validez convergente del cuestionario, mientras que las correlaciones con el Systemic Lupus Erythematosus Disease Activity Index y el System Lupus International Collaborating Clinics fueron bajas, lo que evidencia su validez discriminante. Conclusión. La versión española del LupusQoL cuenta con estables propiedades psicométricas para medir la CVRS en las personas con LES en ámbitos clínicos y de investigación en la población hispanoparlante (AU)

Background and objective: Systemic Lupus Erythematosus (SLE) is an auto-immune disease that seriously affects quality of life. There are various specific instruments that measure health-related quality of life (HRQOL), but none of them has been adapted to Spanish. We intended to adapt and validate in a Spanish population a specific HRQOL measure in patients with SLE. Patients and methods: The adaptation was carried out using the translation and back-translation method of the English version of the LupusQoL, with its subsequent application to 115 adults with SLE. Results: The factorial analysis identified 5 domains of the LupusQoL; the reliability tests showed a high Cronbach α coefficient of 0.977 and a high Guttman two-halves coefficient of 0.936; the significant correlations of the LupusQoL with the SF-36 showed a high convergent validity of the questionnaire; in addition, the correlations with the SLEDAI and SLICC were low, which showed its discriminated validity. Conclusion: The Spanish version of the LupusQoL has stable psychometric properties to measure HRQOL in people with SLE in clinical and research settings in a Spanish-speaking population (AU)