Active lupus in Argentina: Results of a multicenter and national registry.

OBJECTIVE: To evaluate the association between patients' characteristics and disease activity in an Argentine lupus registry. METHODS: Cross-sectional study. Disease activity was stratified into: Remission off-treatment: SLEDAI = 0, without prednisone and immunosuppressive drugs. Low disease activity Toronto Cohort (LDA-TC): SLEDAI ≤2, without prednisone or immunosuppressive drugs. Modified lupus low disease activity (mLLDAS): SLEDAI score of ≤4, with no activity in major organ systems and no new features, prednisone of ≤10 mg/day and/or immunosuppressive drugs (maintenance dose) and Active disease: SLEDAI score of >4 and prednisone >10 mg/day and immunosuppressive drugs. A descriptive analysis and logistic regression model were performed. RESULTS: A total of 1346 patients were included. Of them, 1.6% achieved remission off steroids, 0.8% LDA-TC, 12.1% mLLDAS and the remaining 85.4% had active disease. Active disease was associated with younger age (p ≤ 0.001), a shorter time to diagnosis (p ≤ 0.001), higher frequency of hospitalizations (p ≤ 0.001), seizures (p = 0.022), serosal disease (p ≤ 0.001), nephritis (p ≤ 0.001), higher SDI (p ≤ 0.001), greater use of immunosuppressive therapies and higher doses of prednisone compared to those on mLLDAS. In the multivariable analysis, the variables associated with active disease were the presence of pleuritis (OR 2.1, 95% CI 1.2-3.9; p = 0.007), persistent proteinuria (OR 2.5, 95% CI 1.2-5.5; p ≤ 0.011), nephritis (OR 2.5, 95% CI 1.2-5.6; p = .018) and hospitalizations (OR 8.9, 95% CI 5.3-16.0; p ≤ 0.001) whereas age at entry into the registry was negatively associated with it (OR 0.9, 95% CI 0.9-1.0; p = 0.029). CONCLUSION: Active disease was associated with shorter time to diagnosis, worse outcomes (SDI and hospitalizations) and renal, neurological and serosal disease.

Frecuencia de eventos cardiovasculares en pacientes con lupus eritematoso sistémico / Frequency of cardiovascular events in patients with systemic lupus erythematosus

Resumen Introducción: el progreso en los tratamientos para el lupus eritematoso sistémico (LES) resultó en una disminución de la mortalidad; sin embargo, la enfermedad cardiovascular y las complicaciones infecciosas aún son las principales causas de muerte. La evidencia apoya la participación del sistema inmunológico en la generación de la placa aterosclerótica, así como su conexión con las enfermedades autoinmunes. Objetivos: describir la frecuencia de eventos cardiovasculares (ECV) en el Registro de Lupus Eritematoso Sistémico de la Sociedad Argentina de Reumatología (RELESSAR) transversal, así como sus principales factores de riesgo asociados. Materiales y métodos: estudio descriptivo y transversal para el cual se tomaron los pacientes ingresados en el registro RELESSAR transversal. Se describieron las variables sociodemográficas y clínicas, las comorbilidades, score de actividad y daño. ECV se definió como la presencia de al menos una de las siguientes patologías: enfermedad arterial periférica, cardiopatía isquémica o accidente cerebrovascular. El evento clasificado para el análisis fue aquel posterior al diagnóstico del LES. Se conformaron dos grupos macheados por edad y sexo 1:2. Resultados: 1515 pacientes mayores de 18 años participaron del registro. Se describieron 80 pacientes con ECV (5,3%). En este análisis se incluyeron 240 pacientes conformando dos grupos. La edad media fue de 47,8 (14,4) y 47,6 (14,2) en el grupo con y sin ECV respectivamente. Los pacientes con ECV tuvieron mayor duración del LES en meses, mayor índice de Charlson, mayor SLICC (Systemic Lupus International Collaborating Clinics/American College of Rheumatology), mayor frecuencia de manifestaciones neurológicas, síndrome antifosfolípido, hospitalizaciones y uso de ciclofosfamida. Las únicas variables asociadas en el análisis multivariado fueron el índice de Charlson (p=0,004) y el SLICC (p<0,001). Conclusiones: los ECV influyen significativamente en nuestros pacientes, y se asocian a mayor posibilidad de daño irreversible y comorbilidades.

Abstract Introduction: progress in treatments for systemic lupus erythematosus (SLE) has resulted in a decrease in mortality; however, cardiovascular and infectious diseases remain the leading causes of death. Evidence supports the involvement of the immune system in the generation of atherosclerotic plaque, as well as its connection to autoimmune diseases. Objectives: to describe the frequency of cardiovascular disease (CVD) in the cross-sectional RELESSAR registry, as well as its associated variables. Materials and methods: a descriptive and cross-sectional study was performed using patients admitted to the cross-sectional RELESSAR registry. Sociodemographic variables, clinical variables, comorbidities, activity and damage scores were described. CVD was defined as at least one of the following: peripheral arterial disease, ischemic heart disease, or cerebrovascular accident. All patients with at least one CVD were included in our analysis (heart attack, central nervous system vascular disease, and peripheral arteries atherosclerotic disease). The event classified for the analysis was that after the diagnosis of SLE. SLE diagnosis was previous to CVD. Two groups matched by age and sex, 1:2 were formed. Results: a total of 1515 patients older than 18 years participated in the registry. Eighty patients with CVD (5.3%) were described in the registry. Two-hundred and forty patients were included, according to two groups. The mean age was 47.8 (SD 14.4) and 47.6 (SD 14.2) in patients with and without CVD, respectively. Patients with CVD had a longer duration of SLE in months, a higher Charlson index, a higher SLICC, increased frequency of neurological manifestations, antiphospholipid syndrome, hospitalizations, and use of cyclophosphamide. The associated variables in the multivariate were the Charlson Index (p=0.004) and the SLICC (p<0.001). Conclusions: CVDs have a significant influence on our patients, being associated with a greater possibility of damage and comorbidities.

Multicenter lupus register from Argentina, the RELESSAR database: Influence of ethnicity on disease phenotype.

OBJECTIVE: The objective is to describe the main characteristics of patients with systemic lupus erythematosus (SLE) in Argentina and to examine the influence of ethnicity on the expression of the disease. PATIENTS AND METHODS: RELESSAR is a multicentre register carried out by 106 researchers from 67 rheumatologic Argentine centres. It is a cross-sectional study of SLE (1982/1997 ACR) patients. RELESSAR electronic database includes demographic, cumulative SLE manifestations, SELENA-SLEDAI, SLICC-SDI, Katz's severity and Charlson's comorbidity indexes and treatment patterns. RESULTS: We included 1,610 patients, 91.7% were female with a median age at diagnosis of 28.1 ± 12.8; 96.2% met ≥4 ACR 1982/97 criteria. Frequent manifestations were arthritis (83.5%), malar rash (79.5%), photosensitivity (75.3%), haematological (63.8%) and renal disease (47.4%), antinuclear antibodies (96%), anti-dsDNA (66.5%) and anti-Smith antibodies (29%). The mean Selena-SLEDAI score at last visit was 3.18 (SD 4.3) and mean SDI was 1 (SD 1.3). The accumulated treatments most frequently used were antimalarials (90.4%), corticosteroids (90%), azathioprine (31.8%), intravenous cyclophosphamide (30.2%), mycophenolate mofetil or mycophenolic acid (24.5%), methotrexate (19.3%), belimumab 5.3% and rituximab 5.1%. Refractory lupus was diagnosed in 9.3% of the cases. The main causes of death were lupus activity (25.0%), activity and concomitant infections (25.0%), infections (18.2%), vascular disease (13.6%) and cancer (4.5%). Mortality was associated with higher SLEDAI, Katz, damage indexes and comorbidities. Of the 1610 patients included, 44.6% were Caucasian, 44.5% Mestizo, 8.1% Amerindian and 1.2% Afro-Latin American. Mestizo patients had higher male representation, low socioeconomic status, more inadequate medical coverage, fewer formal years of education and shorter disease duration. Polyadenopathies and Raynaud's phenomenon were more frequent in Caucasians. In the logistic regression analysis higher damage index (OR 1.28, CI 95% 1.02-1.61, p = 0.03) remained associated to mestizo ethnicity. CONCLUSIONS: This study represents the largest number of adult patients with SLE studied in Argentina. Caucasian patients were differentiated by having Raynaud's phenomenon and polyadenopathy more frequently, while patients of Mestizo origin had higher damage indexes.

Lupus en Argentina. Pacientes no respondedores al tratamiento estándar y belimumab como posible opción. Datos del registro RELESSAR / Lupus in Argentina. Non-responders to standard treatment and belimumab as a possible option. RELESSAR record data

Introducción: el lupus es una enfermedad compleja y varias veces de difícil abordaje. Alcanzar la remisión es uno de los objetivos, incorporando opciones terapéuticas. Objetivos: describir las características generales de los pacientes según el estado de la enfermedad y el uso de belimumab. Materiales y métodos: estudio de corte transversal, registro RELESSAR. Se definió el estado de la enfermedad como: remisión: SLEDAI=0 y sin corticoides; baja actividad de la enfermedad: SLEDAI >0 y ≤4 y sin corticoides; control no óptimo: SLEDAI >4 y cualquier dosis de corticoides. Resultados: se incluyeron 1.277 pacientes, 23,4% en remisión, 12,6% en baja actividad y 63,8% con control no óptimo. En este último grupo eran más jóvenes y con menor duración de la enfermedad; presentaban mayores índices de actividad y cronicidad, y mayor empleo de inmunosupresores. Solo el 22,3% de los pacientes con criterio potencial de uso de belimumab (lupus eritematoso sistémico activo a pesar del tratamiento estándar) lo recibía en ese momento. Las variables asociadas a hospitalizaciones fueron: terapia con corticoides, ciclofosfamida y mayor SLICC. Conclusiones: se refleja la complejidad del manejo de estos pacientes y se visualizan aspectos estructurales como la desigualdad. El uso del belimumab resultaría beneficioso en los pacientes seleccionados.

Introduction: lupus is a complex disease and often difficult to approach. Achieving remission is one of the objectives, incorporating therapeutic options. Objectives: to describe the characteristics of the patients and the use of belimumab, according to the status of the disease. Materials and methods: cross-sectional study. Patients of the RELESSAR registry. Stratification: Remission: SLEDAI=0 and without corticosteroids. Low disease activity SLEDAI> 0 and ≤4 and without corticosteroids and non-optimal control: SLEDAI> 4 and any dose of corticosteroids. Results: a total of 1,277 patients were included, 23.4% in remission, 12.6% in low disease activity and 63.8% in non-optimal control. The last group was younger and had a shorter duration of the disease. They had higher activity and chronicity indices and greater use of immunosuppressants. Only 22.3% of the patients with potential criteria for the use of belimumab (activity disease despite standard treatment) were receiving it. The variables associated with hospitalizations were: corticosteroids, cyclophosphamide and higher SLICC. Those associated with severe infection: mycophenolate mofetil, azathioprine, corticosteroids, and higher SLICC. Conclusions: the complexity of the management of these patients is reflected, visualizing structural aspects such as inequality. The use of belimumab could be beneficial in selected patients.

Lupus en Argentina. Pacientes no respondedores al tratamiento estándar y belimumab como posible opción. Datos del registro RELESSAR / Lupus in Argentina. Non-responders to standard treatment and belimumab as a possible option. RELESSAR record data

Introducción: el lupus es una enfermedad compleja y varias veces de difícil abordaje. Alcanzar la remisión es uno de los objetivos, incorporando opciones terapéuticas. Objetivos: describir las características generales de los pacientes según el estado de la enfermedad y el uso de belimumab. Materiales y métodos: estudio de corte transversal, registro RELESSAR. Se definió el estado de la enfermedad como: remisión: SLEDAI=0 y sin corticoides; baja actividad de la enfermedad: SLEDAI >0 y ≤4 y sin corticoides; control no óptimo: SLEDAI >4 y cualquier dosis de corticoides. Resultados: se incluyeron 1.277 pacientes, 23,4% en remisión, 12,6% en baja actividad y 63,8% con control no óptimo. En este último grupo eran más jóvenes y con menor duración de la enfermedad; presentaban mayores índices de actividad y cronicidad, y mayor empleo de inmunosupresores. Solo el 22,3% de los pacientes con criterio potencial de uso de belimumab (lupus eritematoso sistémico activo a pesar del tratamiento estándar) lo recibía en ese momento. Las variables asociadas a hospitalizaciones fueron: terapia con corticoides, ciclofosfamida y mayor SLICC. Conclusiones: se refleja la complejidad del manejo de estos pacientes y se visualizan aspectos estructurales como la desigualdad. El uso del belimumab resultaría beneficioso en los pacientes seleccionados.

Introduction: lupus is a complex disease and often difficult to approach. Achieving remission is one of the objectives, incorporating therapeutic options. Objectives: to describe the characteristics of the patients and the use of belimumab, according to the status of the disease. Materials and methods: cross-sectional study. Patients of the RELESSAR registry. Stratification: Remission: SLEDAI=0 and without corticosteroids. Low disease activity SLEDAI> 0 and ≤4 and without corticosteroids and non-optimal control: SLEDAI> 4 and any dose of corticosteroids. Results: a total of 1,277 patients were included, 23.4% in remission, 12.6% in low disease activity and 63.8% in non-optimal control. The last group was younger and had a shorter duration of the disease. They had higher activity and chronicity indices and greater use of immunosuppressants. Only 22.3% of the patients with potential criteria for the use of belimumab (activity disease despite standard treatment) were receiving it. The variables associated with hospitalizations were: corticosteroids, cyclophosphamide and higher SLICC. Those associated with severe infection: mycophenolate mofetil, azathioprine, corticosteroids, and higher SLICC. Conclusions: the complexity of the management of these patients is reflected, visualizing structural aspects such as inequality. The use of belimumab could be beneficial in selected patients.

Validation and adaptation of the Spanish version of the systemic lupus activity questionnaire (S-SLAQ) in an Argentinean population.

OBJECTIVES: To validate the systemic lupus activity questionnaire (SLAQ) in Spanish language. METHODS: The SLAQ questionnaire was translated and adapted in Spanish. Consecutive SLE patients from 8 centers in Argentina were included. A rheumatologist completed a Systemic Lupus Activity Measure (SLAM), Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K, and a physician's assessment. Reliability was assessed by internal consistency (Cronbach's alpha), stability by test-retest reliability (intraclass correlation coefficient), and construct validity by evaluating the correlation with clinically relevant scores. Sensitivity and specificity for clinically significant disease activity (SLEDAI ≥6) of different S-SLAQ cut-off points were evaluated. RESULTS: We included 97 patients ((93% female, mean age: 40 years (SD14.7)). Internal consistency was excellent (Cronbach's alpha = 0.84, p < 0.001), and the intraclass correlation coefficient was 0.95 (p < 0.001). Mean score of S-SLAQ was 8.2 (SD 7.31). Correlation of S-SLAQ was moderate with Patient NRS (r= 0.63 p< 0.001), weak with SLAM-no lab (r = 0.42, p <0.001) and SLAM (r = 0.38, p < 0.0001), and very weak with SLEDAI-2K (r = 0.15, p =0.1394). Using the S-SLAQ cutoff of five points, the sensitivity was 72.2% and specificity was 37.9%, for clinically significant disease activity. CONCLUSIONS: The S-SLAQ showed good validity and reliability. A good correlation, similar to the original instrument, was observed with patient´s global disease activity. No correlation was found between S-SLAQ and gold standard disease activity measures like SLEDAI-2K and SLAM. The S-SLAQ cutoff point of 5 showed a good sensitivity to identify the active SLE population and therefore could be an appropriate screening instrument for disease activity in clinical and epidemiological studies.

Disfunción sexual en mujeres con lupus eritematoso sistémico / Sexual dysfunction in women with systemic lupus erythematosus

Introducción: la disfunción sexual (DS) es la alteración en una o varias de las fases de la actividad sexual. Puede culminar en frustración, dolor y disminución de la frecuencia de las relaciones sexuales. Objetivos: determinar la frecuencia de DS y analizar los factores asociados en pacientes con lupus eritematoso sistémico (LES). Materiales y métodos: se realizó un estudio de corte transversal. Se incluyeron pacientes femeninas con LES, entre 18 y 50 años, se excluyeron aquellas con síndrome de Sjögren, menopausia, depresión severa y analfabetas. Se evaluaron variables demográficas y de la enfermedad. Se aplicó la escala Depression Anxiety Stress Scale (DASS-21) y el Índice de Función Sexual Femenina (Female Sexual Function Index, FSFI). Se comparó con un grupo control sano. Resultados: se evaluaron 60 mujeres con LES y 63 controles. La prevalencia de DS en LES fue de 71,7% y hubo diferencias significativas en todos los dominios de la función sexual. El score total del FSFI en pacientes con LES fue menor al comparar con los controles. Según la escala DASS-21, estrés, ansiedad y depresión se observaron en al menos la mitad de mujeres lúpicas, sin embargo, no se encontró asociación entre estas variables y DS. Conclusiones: la prevalencia de DS en pacientes con LES fue elevada. Depresión, ansiedad y estrés no fueron determinantes en la presencia de DS.

Introduction: sexual dysfunction is the alteration in one or several phases of sexual activity. It can culminate in frustration, pain and a decrease in the frequency of sexual intercourse. Objectives: determine the frequency of sexual dysfunction and analyze associated factors in patients with SLE. Materials and methods: a descriptive cross-sectional study was conducted. We included patients with SLE, between 18 and 50 years of age, Secondary Sjogren's syndrome, menopause, severe depression and illiterate patients were excluded. Demographic and disease-related variables were studied. The Depression Anxiety Stress Scale (DASS-21), and the Female Sexual Function Index (FSFI) were applied. Results: sixty women with SLE and 63 controls were evaluated. The prevalence of SD in SLE was 71.7% and there were significant differences in all domains of sexual function. The total FSFI score in patients with SLE was lower when compared to controls. According to the DASS-21 scale, stress, anxiety and depression were observed in at least half of lupus women, however no association was found between these variables and SD. Conclusions: the prevalence of SD in patients with SLE was high. Depression, Anxiety, and Stress were not determinants in the presence of SD.

Prevalence and incidence of systemic lupus erythematosus in Tucumán, Argentina.

The aim of this study was to determine the prevalence and incidence of Systemic Lupus Erythematosus (SLE) in Tucumán, Argentina. METHODS: The study included inpatient and outpatient charts from four public hospitals and private practice rheumatology clinics, all of them members of the Tucumán Rheumatology Society. Patients older than 16 years with diagnosis of SLE between January 2005 and December 2012 were included. Prevalence and annual incidence were calculated as the number of cases per 100.000 inhabitants during the period 2005 to 2012. RESULTS: Three hundred fifty-three patients were identified. The mean age at diagnosis was 30.5 ± 11.7 years, 93.5% women, 83% mestizos. Prevalence was 24.3 cases/100.000 inhabitants (CI 95% 22.6-28.8) and age-adjusted (≥16 years) of 34.9 cases/100.000 inhabitants (CI 95% 32.8-41.1). The annual incidence in 2005 was 1.8 cases/100.000 inhabitants (95% CI 1-2.9) and 2012 of 4.2 cases/100.000 inhabitants (95% CI 2.9-5.8). Mortality was 9.1%, with infections being the most frequent cause (14/32). CONCLUSION: The prevalence of SLE in the province of Tucumán was 34.9 cases/100.000 inhabitants.

La depresión es un determinante mayor de la capacidad funcional en pacientes con artritis reumatoidea, independientemente de la actividad de la enfermedad / Depression is a major driver of functional capacity in patients with rheumatoid arthritis regardless of disease activity

La depresión es una de las comorbilidades más frecuentemente reportadas en pacientes con Artritis Reumatoidea (AR). Su presencia se asocia a mayores costos de salud, mayor mortalidad y reduce las probabilidades de alcanzar una buena respuesta al tratamiento. Objetivo: Evaluar la prevalencia de depresión en pacientes argentinos con AR y establecer su relación con diferentes factores sociodemográficos y clínicos. Material y métodos: Se incluyeron pacientes ≥18 años de edad, con diagnóstico de AR según criterios ACR-EULAR 2010. Se consignaron datos sociodemográficos, comorbilidades, características clínicas, actividad de la enfermedad y tratamiento actual. Se administraron los cuestionarios EQ-5D-3L, QOL-RA, HAQ-A y PHQ-9. Los valores de PHQ-9 de 5-9, 10-14, 15-19 y ≥20 determinan la presencia de depresión leve, moderada, moderada/severa y severa, respectivamente y un valor de corte ≥10, depresión mayor. Análisis estadístico: Test T de Student, ANOVA y Chi². Regresión lineal múltiple. Resultados: Se incluyeron 258 pacientes, con un tiempo mediano (m) de evolución de la enfermedad de 9 años (RIC 3,6-16,7). La m de depresión valorada por PHQ-9 de 6 (RIC 2-12,5). La prevalencia de depresión mayor fue de 33,8%. Sesenta y seis (25,6%), 42 (16,3%), 27 (10,5%) y 18 (7%) pacientes presentaron depresión leve, moderada, moderada/severa y severa, respectivamente. Los pacientes con depresión mayor mostraron menor capacidad funcional (HAQ-A X1,6±0,8 vs X0,7±0,7, p <0,0001), peor calidad de vida (QOL-RA X5,4±1,8 vs X7,3±1,6, p <0,0001), más dolor (EVN X56,2±27,5 mm vs X33,4±25,7 mm, p <0,0001), mayor actividad de la enfermedad (DAS28-ERS X4,3±1,4 vs X3,3±1,3, p <0,0001), mayor frecuencia de desempleo (71% vs 29%, p=0,015 ) y de comorbilidades (67% vs 33%, p=0,017) y menor frecuencia de actividad física (22% vs 35%, p=0,032). En el análisis multivariado, peor capacidad funcional (OR: 2,1, IC 95%: 1,6-4,3, p <0,0001) y calidad de vida (OR: 0,7, IC 95%: 0,5-0,8, p <0,0001) se asociaron independientemente a la presencia de depresión mayor. Conclusiones: La prevalencia de depresión mayor medida por PHQ-9 en esta cohorte argentina de pacientes con AR fue de 33,8%. La presencia de depresión tiene un impacto negativo sobre la capacidad funcional y la calidad de vida de estos pacientes, independientemente de la actividad de la enfermedad.

Depression is one of the most frequent comorbidity in patients with Rheumatoid Arthritis (RA). It's presence is associated with higher healthcare costs, mortality rate and reduced odds of achieving a good treatment response. Objective: To determine the prevalence of depression in Argentinean patients with RA and to establish its relationship with different sociodemographic and clinical factors. Material and methods: Consecutive patients ≥18 years old, with a diagnosis of RA according to ACR-EULAR 2010 criteria were included. Sociodemographic data, comorbidities, RA characteristics, disease activity and current treatment were registered. Questionnaires were administered: EQ-5D-3L, QOL-RA, HAQ-A and PHQ-9. PHQ-9 scores of 5-9, 10-14, 15-19, ≥20 represent mild, moderate, moderate/severe and severe depression, respectively and a cut-off value ≥10, major depression. Statistical analysis: Student's T, ANOVA and Chi² tests. Multiple logistic regression. Results: 258 patients were included, with a median (m) disease duration of 9 years (IQR 3.6-16.7). The m PHQ-9 score was 6 (IQR 2-12.3). The prevalence of major depression was 33.8%. 66 (25.6%), 42 (16.3%), 27 (10.5%) and 18 (7%) patients presented mild, moderate, moderate/severe and severe depression, respectively. Patients with mayor depression had worse functional capacity (HAQ-A X 1.6±0.8 vs X 0.7±0.7, p <0.0001), poorer quality of life (QOL-RA X 5.4±1.8 vs X 7.3±1.6, p <0.0001), greater pain (NVS X 56.2±27.5 mm vs X 33.4±25.7 mm, p <0.0001), higher disease activity (DAS28-ESR X 4.3±1.4 vs X 3.3±1.3, p <0.0001), higher frequency of unemployment (71% vs 29%, p=0.015 ) and comorbidities (67% vs 33%, p=0.017) and lower frequency of physical activity (22% vs 35%, p=0.032). In the multivariate analysis, patients with moderate and severe depression had worse functional capacity (OR: 2.1, 95% CI: 1.6-4.3, p <0.0001) and quality of life (OR: 0.7, 95% CI: 0.5-0.8, p <0.0001), independently of disease activity. Conclusion: The prevalence of mayor depression in this Argentinean cohort of patients with RA was 33.8%. The presence of depression had a negative impact on functional capacity and quality of life regardless of disease activity.

Una nueva herramienta para valorar la calidad de vida de pacientes con artritis reumatoidea que no requiere licencia: el cuestionario QOL-RA II (Quality of Life-Rheumatoid Arthritis Scale-II) / A new tool to assess quality of life in patients with rheumatoid arthritis that does not require a license: QOL-RA II (Quality of Life-Rheumatoid Arthritis Scale-II)

Recientemente, validamos el cuestionario Quality of Life-Rheumatoid Arthritis Scale (QOL-RA) y detectamos la presencia de algunas limitaciones. Por esta razón, con la autorización de la autora, cambiamos dos preguntas y desarrollamos una nueva versión en español: el QOL-RA II. Objetivo: Validar el QOL-RA II en una cohorte argentina de pacientes con Artritis Reumatoidea (AR). Material y métodos: Estudio de corte transversal. Se incluyeron pacientes ≥18 años de edad, con diagnóstico de AR según criterios ACR-EULAR 2010. Se consignaron datos sociodemográficos, comorbilidades, características clínicas y actividad de la enfermedad. Se administraron los cuestionarios EQ-5D-3L, QOL-RA II, HAQ-A y PHQ-9. A 20 pacientes se les re-administró el cuestionario a los 7 días de haber completado el primero para evaluar reproducibilidad. Análisis estadístico: Test T de Student, ANOVA, Chi². Correlación de Spearman. Alpha de Cronbach. Coeficiente de correlación intraclase. Regresión Logística Multinomial con modelo factorial completo. Regresión lineal múltiple. Resultados: Se incluyeron 430 pacientes, con un tiempo mediano (m) de evolución de 9 años (RIC: 4-16). La m del QOL-RA II fue 6,7 (RIC: 5,3-8). El tiempo promedio para completarlo fue de 1,7±0,57 minutos y para su cálculo de 12±1,7 segundos. Solo 9 (2,1%) pacientes no contestaron alguna pregunta. El cuestionario presentó excelente confiabilidad (α de Cronbach 0,97), reproducibilidad (CCI: 0,96) y buena correlación entre los diferentes ítems y el cuestionario total, sin evidencia de redundancia. QOL-RA II presentó además, buena correlación con EQ-5D-3L (Rho: 0,6), HAQ-A (Rho: 0,55) y PHQ-9 (Rho: 0,56) y moderada con los índices de actividad de la enfermedad DAS28-ERS (Rho: 0,38) y CDAI (Rho: 0,46). Se evidenció peor calidad de vida en aquellos pacientes que no realizaban actividad física (X 6,4±1,9 vs. 7±1,8, p <0,0001), en los desocupados (X 6,1±1,9 vs. 7±1,8, p <0,0001) y en los tabaquistas (X 6,2±1,7 vs. 6,7±1,9, p=0,03). Se observó una tendencia significativa a empeorar la calidad de vida a mayor actividad de la enfermedad. Ajustando por edad, sexo y tiempo de evolución de la enfermedad, las variables que se asociaron significativamente a peor calidad de vida fueron la desocupación, la mayor actividad de la enfermedad, la discapacidad funcional y la presencia de depresión. Conclusión: El QOL-RA II demostró buena validez de constructo, reproducibilidad. Fue fácil de completar y calcular. No se observó redundancia entre las preguntas ni influencia por la edad ni el tiempo de evolución de la enfermedad.

We have recently validated the Quality of Life-Rheumatoid Arthritis Scale (QOL-RA). We have found some limitations, that is why, with the author's permission, we have changed two questions and developed a new Spanish version, QOL-RA II. Objective: To validate the QOL-RA II in an Argentinean cohort of patients with Rheumatoid Arthritis (RA). Material and methods: Cross-sectional study. Patients ≥18 years old, with a diagnosis of RA according to ACR-EULAR 2010 criteria were included. Sociodemographic data, comorbidities, RA characteristics, disease activity current treatment were registered. Questionnaires were administered: EQ-5D-3L, QOL-RA, HAQ-A and PHQ-9. The QOL-RA II was re-administered in 20 patients to evaluate reproducibility. Statistical analysis: Student's T, ANOVA and Chi² tests. Spearman correlation. Cronbach's alpha. Reproducibility using ICC. Multinomial logistic regression with completed factorial model. Multiple linear regression. Results: 430 patients were included, with a median (m) disease duration of 8.9 years (IQR: 4-16). QOL-RA was m 6.6 (IQR: 5.3-8). Mean time to complete it was 1.7±0.57 minutes and to calculate it 12±17 seconds. Only 2.1% of the questionnaires presented missing answers. It showed very good reliability (Cronbach's alpha 0.97), reproducibility (ICC: 0.96) and good correlation between the different items and the total questionnaire, without evidence of redundancy. Besides, QOL-RA II presented good correlation with EQ-5D-3L (Rho: 0.6), HAQ-A (Rho: 0.55) and PHQ-9 (Rho: 0.56) and moderate with DAS28-ESR (Rho: 0.38) and CDAI (Rho: 0.46). Worse quality of life was observed in patients not doing physical activity (X 6.4±1.9 vs. 7±1.8, p <0.0001), unemployed (X 6.1±1.9 vs. 7±1.8, p <0.0001) and current smokers (X 6.2±1.7 vs. 6.7±1.9, p=0.03). Patients with higher disease activity had a significant poorer quality of life. Adjusting by age, sex and disease duration, unemployment, higher disease activity, disability and the presence of depression were independently associated to worse quality of life. Conclusions: QOL-RA II demonstrated good construct validity, reproducibility and reliability. It was easy to complete and calculate. There were no redundancy between questions and it was not influenced by age and disease duration.

Validación del índice QOL-RA (Quality of Life-RheumatoidArthritis) en una cohorte argentina de pacientes con artritis reumatoidea / Validation of the Quality of Life-Rheumatoid Arthritis Scale (QOL-RA) in argentinean cohort of patients with rheumatoid arthritis

El autocuestionario QOL-RA es una herramienta diseñada para valorar la calidad de vida de los pacientes con Artritis Reumatoidea (AR). No requiere licencia para su uso. Objetivo: Validar el cuestionario QOL-RA en una cohorte de pacientes con AR en Argentina. Material y métodos: Estudio de corte transversal. Se incluyeron pacientes ≥18 años de edad con diagnóstico de AR según criterios ACR-EuLAR 2010. Se consignaron datos sociodemográficos, comorbilidades, características de la enfermedad. Se completaron los cuestionarios QOL-RA, EQ 5D-3L, HAQ-A, PHQ-9. Se midió el tiempo para completar y calcular el QOL-RA. Análisis estadístico: Estadística descriptiva. Test T de Student, ANOvA, Chi2. Correlación de Spearman. Alpha de Cronbach. Coeficiente de correlación intraclase. Regresión Logística multinomial con modelo factorial completo. Regresión Lineal múltiple. Resultados: Se incluyeron 258 pacientes, 85,7% eran mujeres, con una edad mediana de 54 años (RIC 45-62). La mediana del QOL-RA fue 6,75 (RIC 5,4-8,1), presentando buena correlación con EQ 5D-3L (Rho: 0,63), HAQ-A (Rho: -0,56), PHQ9 (Rho: -0,54), SDAI (Rho: -0,45) y DAS28-ERS (Rho: -0,44). Peor calidad de vida se asoció con la presencia de comorbilidades (x6,4 ± 2 vs 7 ± 1,7, p=0,01) y no realizar actividad física (x6,7 ± 1,9 vs 7,1 ± 1,7, p=0,004). El tiempo para completar el cuestionario fue de x1,7 ± 0,42 minutos y para calcularlo de x12± 2,1 segundos. La confiabilidad y la reproducibilidad fueron buenas. Sin embargo, 4,3% de los cuestionarios presentaban alguna pregunta faltante y se observó redundancia entre las preguntas 3 y 6. En el análisis de regresión lineal múltiple usando QOL-RA como variable dependiente y ajustando para edad y tiempo de evolución, las variables que se asociaron independientemente a peor calidad de vida fueron: la discapacidad funcional, la actividad de la enfermedad y la presencia de depresión y comorbilidades. Conclusión: El cuestionario QOL-RA demostró buena validez de constructo, reproducibilidad y confiabilidad. Es fácil de completar y calcular. Sin embargo, dada la redundancia entre dos preguntas proyectamos cambiar una de ellas y re-testearlo