7Ĭlinical manifestations of SLE, its course and prognosis are highly heterogeneous and, given its low prevalence, multicenter observational studies are needed with a high degree of standardization and sufficient number of patients, to advance the understanding of this complex disease.
5,6 In addition, SLE has important direct and indirect health costs. 2,3 Although the prognosis has improved in recent years, the quality of life of patients with SLE is clearly lower than in the general population 4 and the risk of death is 2–3 times higher. 1 In Spain, the prevalence is estimated at 9 per 10 000 population. Systemic lupus erythematosus (SLE) is one of the most common systemic rheumatic diseases, with an increasing incidence. RELESSER se constituye como herramienta de gran potencialidad para la investigación clínica multicéntrica en el LES. RELESSER representa el registro de LES europeo con mayor número de pacientes construido hasta la fecha, disponiendo de abundante información actualizada y fiable sobre manifestaciones del LES, situación de enfermedad, comorbilidad y tratamientos en condiciones de práctica clínica real. Un total de 211 pacientes (6%) han fallecido. Las medianas del índice de actividad SELENA-SLEDAI, índice de daño de SLICC/ACR y de gravedad de Katz han sido 2, 1 y 2, respectivamente. Se encuentran en seguimiento activo 3.222 pacientes (81%) y 591 (14%) han sido perdidos para seguimiento. El 90% son mujeres y el 93% caucásicos, con una mediana de edad al diagnóstico de 33 años mediana de duración de la enfermedad: 120 meses seguimiento medio: 104 meses. Han participado 45 centros e incluido 4024 pacientes con LES o LES incompleto (91% con ≥ 4 criterios ACR). Se ha realizado un análisis descriptivo preliminar de los datos. Incluye datos demográficos, manifestaciones clínicas frecuentes e infrecuentes (< 1%), actividad, daño, gravedad, comorbilidad, tratamientos y mortalidad, totalizando 359 variables por paciente, con definiciones altamente estandarizadas. Registro multicéntrico, de base hospitalaria, con recogida retrospectiva de datos de una amplia muestra representativa de adultos con LES (criterios ACR 1997) procedentes de servicios de reumatología españoles. RELESSER is constituted as a tool of great potential for multicenter clinical research in SLE.ĭescribir en detalle los objetivos y aspectos metodológicos del registro de lupus eritematoso sistémico (LES) de la Sociedad Española de Reumatología (RELESSER). RELESSER represents the largest European SLE registry built to date, providing comprehensive and reliable information on SLE manifestations, disease status, comorbid conditions and treatments in daily clinical practice. The median values of the SELENA-SLEDAI score, SLICC/ACR damage index and Katz severity index have been 2, 1 and 2, respectively. Resultsįorty-five centers were involved and 4024 SLE patients (91% with ≥4 ACR criteria) have been included 90% are women and 93% Caucasians, with a median age at diagnosis of 33 years, median disease duration: 120 months, median follow-up duration: 104 months 3222 (81%) of the patients are in active follow-up and 591 (14%) were lost to follow-up. We performed a preliminary descriptive analysis of the data. The registry includes demographic data, frequent and infrequent (<1%) clinical manifestations, information about activity, damage, severity, comorbidity, treatments and mortality, collecting 359 variables per patient, with highly standardized definitions. Multicenter, hospital-based registry, with retrospective collection of data from a large representative sample of adult patients with SLE (1997 ACR criteria) attending Spanish rheumatology services. To describe the objectives, design and methods of the Spanish Society of Rheumatology systemic lupus erythematosus (SLE) registry (RELESSER).