Efficacy, Safety, and Immunogenicity of Biosimilar Etanercept (Enerceptan) Versus Its Original Form in Combination With Methotrexate in Patients With Rheumatoid Arthritis: A Randomized, Multicenter, Evaluator-Blinded, Noninferiority Study.

BACKGROUND: Enerceptan (EtaBS) has been developed as a proposed biosimilar of etanercept. METHODS: This randomized, multicenter, evaluator-blinded, noninferiority study conducted in Argentina included adults with active, moderate, and severe rheumatoid arthritis with inadequate response to methotrexate. Subjects were randomly assigned to 32 weeks treatment with EtaBS (n = 99) or etanercept (n = 51) at a weekly 50-mg dose administered subcutaneously. Patients were categorized according to prior use of biologic disease-modifying antirheumatic drugs and concomitant use of steroids. The primary efficacy endpoint was ACR20 response rate at week 32. Safety, immunogenicity, and steady-state concentration of both drugs were evaluated. The noninferiority margin for ACR20 was estimated at 12%. RESULTS: In the per-protocol population, 85 subjects (92.4%) treated with EtaBS and 44 subjects (93.6%) treated with etanercept achieved ACR20 (difference, -1.2%; 95% confidence interval, -10.1% to 7.6%). Frequent adverse drug reactions occurred in 34.3% and 38% of subjects treated with EtaBS and etanercept, respectively. The most common reaction was upper respiratory tract infection. Six and 3 serious adverse events occurred in 4 and 3 subjects treated with EtaBS and etanercept, respectively. Injection site reactions occurred in 67.7% and 66.0% of subjects treated with EtaBS and etanercept, respectively. Two subjects treated with EtaBS and 1 subject treated with etanercept developed antibodies by week 32. CONCLUSIONS: Efficacy outcomes for EtaBS were noninferior to original etanercept in patients with moderate-to-severe rheumatoid arthritis with inadequate response to methotrexate. Safety and immunogenicity results were comparable between the two. This study is a major step toward improving access to biologics in Latin America.

Prediction of remission and low disease activity in disease-modifying anti-rheumatic drug-refractory patients with rheumatoid arthritis treated with golimumab.

OBJECTIVE: To create a tool to predict probability of remission and low disease activity (LDA) in patients with RA being considered for anti-TNF treatment in clinical practice. METHODS: We analysed data from GO-MORE, an open-label, multinational, prospective study in biologic-naïve patients with active RA (DAS28-ESR ⩾3.2) despite DMARD therapy. Patients received 50 mg s.c. golimumab (GLM) once monthly for 6 months. In secondary analyses, regression models were used to determine the best set of baseline factors to predict remission (DAS28-ESR <2.6) at month 6 and LDA (DAS28-ESR ⩽3.2) at month 1. RESULTS: In 3280 efficacy-evaluable patients, of 12 factors included in initial regression models predicting remission or LDA, six were retained in final multivariable models. Greater likelihood of LDA and remission was associated with being male; younger age; lower HAQ, ESR (or CRP) and tender joint count (or swollen joint count) scores; and absence of comorbidities. In models predicting 1-, 3- and 6-month LDA or remission, area under the receiver operating curve was 0.648-0.809 (R(2) = 0.0397-0.1078). The models also predicted 6-month HAQ and EuroQoL-5-dimension scores. A series of matrices were developed to easily show predicted rates of remission and LDA. CONCLUSION: A matrix tool was developed to show predicted GLM treatment outcomes in patients with RA, based on a combination of six baseline characteristics. The tool could help provide practical guidance in selection of candidates for anti-TNF therapy.

Changing rate of serious infections in biologic-exposed rheumatoid arthritis patients. Data from South American registries BIOBADABRASIL and BIOBADASAR.

OBJECTIVE: Most reports on serious infections (SI) in rheumatoid arthritis (RA) patients treated with biological disease-modifying antirheumatic drugs (bDMARDs) are from the USA and Western Europe. Data from other regions are largely missing. We report data from South American countries with different backgrounds and health-care systems but similar registries. METHODS: We merged 2010-2016 data from two registries, BIOBADABRASIL (Brazil) and BIOBADASAR (Argentina), which share the same protocol, online platform and data monitoring process. Patients with active RA were included when they began the first bDMARD or a conventional synthetic DMARD (csDMARD, control group). The SI incidence rate (IR) per 1000 patient/years and adjusted IR ratio (aIRR) were estimated for bDMARDs and csDMARDs. RESULTS: Data were analysed for 3717 RA patients with an exposure of 13,380 patient/years. The 2591 patients treated with bDMARDs (64% tumour necrosis factor-α inhibitors (TNFi)) had a follow-up of 9300 years, and the 1126 treated with csDMARDs had an exposure of 4081 patient/years. The SI IR was 30.54 (CI 27.18-34.30) for all bDMARDs and 5.15 (CI 3.36-7.89) for csDMARDs. The aIRR between the two groups was 2.03 ([1.05, 3.9] p = 0.034) for the first 6 months of treatment but subsequently increased to 8.26 ([4.32, 15.76] p < 0.001). The SI IR for bDMARDs decreased over time in both registries, dropping from 36.59 (28.41-47.12) in 2012 to 7.27 (4.79-11.05) in 2016. CONCLUSION: While SI remains a major concern in South American patients with RA treated with bDMARDs, a favourable trend toward a reduction was observed in the last years.Key Points• New comprehensive data on biologic drugs safety from international collaboration in South America.• First proposal for national registries data merging in South America.• Serious infections remain a major concern in RA patients treated with biologics.• A significant reduction of serious infections in RA patients exposed to biologics was observed over a 7 years period.

Correction to: Regional differences in baseline disease activity and remission rates following golimumab treatment for RA: results from the GO-MORE trial.

The original publication contains two areas which require correcting. None of these errors change the results or conclusions of the article, but the authors wish to highlight the areas of change to the reader.

Regional differences in baseline disease activity and remission rates following golimumab treatment for RA: results from the GO-MORE trial.

GO-MORE (NCT00975130) was a large open-label, multinational, multicenter, prospective phase 3 trial evaluating add-on therapy with golimumab in biologic-naïve patients with active rheumatoid arthritis (RA). The objective of this post hoc analysis was to examine regional differences in baseline disease activity and remission rates following golimumab treatment for RA. This was a planned, descriptive post hoc analysis of data from the GO-MORE trial. Baseline disease activity and remission were defined as moderate or severe based on EULAR criteria. This analysis included 3280 participants from the GO-MORE trial. All participants included in this analysis had high or moderate disease activity at baseline. At baseline, high disease activity was least common in Europe (71.0%), Canada (77.0%), and the Middle East (78.2%) and most common in Latin America (90.7%), South Africa (91.5%), and Asia (92.5%). Month 6 remission rates were highest in South Africa (29.1%), Europe (27.9%), and the Middle East (27.3%) and lowest in Canada (19.7%), Latin America (17.2%), and Asia (15.0%). Higher rates of remission in each geographical region generally corresponded with lower baseline disease activity. We suspect that access to care and implementation of the treat-to-target strategy were the most important determinants, but this apparent relationship needs to be confirmed in further studies that include a statistical analysis of prognostic indicators.

Consenso de inmunizaciones en adultos con enfermedades reumáticas inflamatorias crónicas autoinmunes / Consensus on immunizations in adults with autoimmune chronic inflammatory rheumatic diseases

Aumento del riesgo de infecciones prevenibles y sus complicaciones en pacientes con enfermedades reumáticas inflamatorias crónicas (ERICA), con y sin tratamiento con inmunosupresores (IS), y beneficios de la vacunación.

Características clínicas y evolución de la infección por SARS-CoV-2 en pacientes con lupus eritematoso sistémico en Argentina: datos del registro nacional SAR-COVID / Clinical characteristics and course of SARS-CoV-2 infection in patients with systemic lupus erythematosus in Argentina: data from the SAR-COVID national registry

Introducción: el lupus eritematoso sistémico (LES) es una enfermedad sistémica que se ha asociado a mayor severidad con la infección por SARS-CoV-2. Particularmente la alta actividad de la enfermedad y algunos inmunosupresores se han vinculado a peores desenlaces. Objetivos: describir las características por SARS-CoV-2 en pacientes con LES en Argentina del registro SAR-COVID y establecer los factores asociados a peor desenlace de la misma. Materiales y métodos: estudio observacional. Se incluyeron pacientes con diagnóstico de LES con infección confirmada por SARS-CoV-2 (RT-PCR y/o serología positiva) del registro SAR-COVID. Los datos se recolectaron desde agosto de 2020 hasta marzo de 2022. El desenlace de la infección se midió mediante la escala ordinal de la Organización Mundial de la Salud (EO-OMS). Se definió COVID-19 severo con un valor EO-OMS ≥5. Análisis descriptivo, test T de Student, test de Mann Whitney U, ANOVA, chi2 y Fisher. Regresión logística múltiple. Resultados: se incluyeron 399 pacientes, el 93% de sexo femenino, con una edad media de 40,9 años (DE 12,2). El 39,6% tenía al menos una comorbilidad. Al momento de la infección, el 54,9% recibía glucocorticoides, el 30,8% inmunosupresores y el 3,3% agentes biológicos. La infección por SARS-CoV-2 fue leve en la mayoría de los casos, mientras que un 4,6% tuvo curso severo y/o falleció. Estos últimos presentaban comorbilidades, usaban glucocorticoides y tenían síndrome antifosfolipídico (SAF) con mayor frecuencia y mayor actividad de la enfermedad al momento de la infección. En el análisis multivariado, la hipertensión arterial, el diagnóstico de SAF y el uso de glucocorticoides se asociaron a hospitalización severa y/o muerte por COVID-19 (EO-OMS ≥5). Conclusiones: en esta cohorte de pacientes con LES con infección por SARS-CoV-2 confirmada, la mayoría cursó de manera sintomática, un 22,1% fue hospitalizado y un 5% requirió ventilación mecánica. La mortalidad fue cercana al 3%. El diagnóstico de SAF, tener hipertensión arterial y el uso de glucocorticoides se asociaron significativamente con COVID-19 severo.

Introduction: systemic lupus erythematosus (SLE) is a systemic disease that has been associated with greater severity with SARS-CoV-2 infection. Particularly high disease activity and some immunosuppressants have been linked to worse outcomes. Objectives: to describe the characteristics due to SARS-CoV-2 in patients with SLE in Argentina from the SAR-COVID registry and to establish the factors associated with a worse outcome of the same. Materials and methods: observational study. Patients diagnosed with SLE with confirmed SARS-CoV-2 infection (RT-PCR and/or positive serology) from the SAR-COVID registry were included. Data was collected from August 2020 to March 2022. The outcome of the infection was measured using the World Health Organization - ordinal scale (WHO-OS). Severe COVID-19 was defined as an WHO-OS value ≥5. Descriptive analysis, Student's T test, Mann Whitney U, ANOVA, chi2 and Fisher. Multiple logistic regression. Results: a total of 399 patients were included, 93% female, with a mean age of 40.9 years (SD 12.2), 39.6% had at least one comorbidity. At the time of infection, 54.9% were receiving glucocorticoids, 30.8% immunosuppressants, and 3.3% biological agents. SARS-CoV-2 infection was mild in most cases, while 4.6% had a severe course and/or died. The latter had comorbidities, used glucocorticoids and had antiphospholipid syndrome (APS) more frequently and higher disease activity at the time of infection. In the multivariate analysis, high blood pressure, the diagnosis of APS, and the use of glucocorticoids were associated with severe hospitalization and/or death from COVID-19 (WHO-EO ≥5). Conclusions: in this cohort of SLE patients with confirmed SARS-CoV-2 infection, most had a symptomatic course, 22.1% were hospitalized, and 5% required mechanical ventilation. Mortality was close to 3%. The diagnosis of APS, having high blood pressure, and the use of glucocorticoids were significantly associated with severe COVID-19.

Métodos de diagnóstico en el estudio de las Miopatías Inflamatorias Autoinmunes: Datos del Registro Argentino de Miopatías Inflamatorias de la Sociedad Argentina de Reumatología / Diagnostic methods in the study of myopathies Inflammatory Autoimmune: Data from the Argentine Registry of Inflammatory Myopathies of the Argentine Society of Rheumatology

Las Miopatías Inflamatorias Autoinmunes (MI) comprenden un grupo de enfermedades heterogéneas con presentación y características clínicas variables. Se distinguen subtipos clínicos como Polimiositis (PM), Dermatomiositis (DM), Miositis por cuerpos de Inclusión (MCI), Miopatía Necrotizante Inmunomediada (MNIM), Miositis de los Síndromes de Superposición, formas juveniles de MI (DMJ), Síndrome Antisintetasa (SAS) y Miopatía Asociada a Cáncer (MAC).La presencia de anticuerpos séricos y el infiltrado inflamatorio en la biopsia de músculo sugiere que se trata de una condición autoinmune. Realizar el diagnóstico de las MI suele ser un desafío y las herramientas diagnósticas no siempre están disponibles en la práctica diaria. Se obtuvo información sobre la disponibilidad de estos métodos del Registro Argentino de Miopatías Inflamatorias. El estudio de enzimas musculares, Anticuerpos Antinucleares (ANA), anticuerpo anti-Jo-1 y la tomografía computada de tórax, estuvieron disponibles para la mayoría de los pacientes mientras que la Resonancia Magnética de musculo (RM), el estudio de difusión de monóxido de carbono (DLco) y la biopsia muscular se realizaron en menos del 50% de los casos. La determinación de otros anticuerpos específicos de miositis, de importancia en el diagnóstico y pronóstico de la enfermedad se realizó, en mayor parte, a través de un subsidio de la SAR.

The Idiopathic Inflammatory Myopathies (IIM) comprise a heterogeneous group of acquired muscle diseases classified as polymyositis (PM), dermatomyositis (DM), Inclusion Body Myositis(IBM), ImmunoMediated Necrotizing Myopathies, (IMNM), Overlap Myositis(OM), juvenile myositis, Antisynthethase Syndrome (ASS) and cancer related myositis(CAM).The presence of myositis specific antibodies in the serum and autoantibodies against target antigens and inflammatory infiltrates in muscle tissue suggests the autoimmune condition of the disease. The diagnosis of inflammatory myopathies is often a challenge and the disposal of diagnostic tools are not always available in daily practice. Information on the accessibility of these methods was obtained from the Argentine Register of Myopathies. The study of muscle enzymes, ANA, anti-Jo-1 antibodies and chest tomography were easy to get to most patients while muscle MRI, lung diffusion capacity for carbon monoxide (DLco%) and muscle biopsy were performed in less than 50% of cases. Other myositis specific antibodies, necessary for disease diagnosis and prognosis, were mostly done through a subsidy from the Argentine Rheumatology Society.

Métodos de diagnóstico en el estudio de las Miopatías Inflamatorias Autoinmunes: Datos del Registro Argentino de Miopatías Inflamatorias de la Sociedad Argentina de Reumatología / Diagnostic methods in the study of Inflammatory Myopathies. Data from the Argentine Register: Argentine Rheumatology Society

Las Miopatías Inflamatorias Autoinmunes (MI) comprenden un grupo de enfermedades heterogéneas con presentación y características clínicas variables. Se distinguen subtipos clínicos como Polimiositis (PM), Dermatomiositis (DM), Miositis por cuerpos de Inclusión (MCI), Miopatía Necrotizante Inmunomediada (MNIM), Miositis de los Síndromes de Superposición, formas juveniles de MI (DMJ), Síndrome Antisintetasa (SAS) y Miopatía Asociada a Cáncer (MAC). La presencia de anticuerpos séricos y el infiltrado inflamatorio en la biopsia de músculo sugiere que se trata de una condición autoinmune. Realizar el diagnóstico de las MI suele ser un desafío y las herramientas diagnósticas no siempre están disponibles en la práctica diaria. Se obtuvo información sobre la disponibilidad de estos métodos del Registro Argentino de Miopatías Inflamatorias. El estudio de enzimas musculares, Anticuerpos Antinucleares (ANA), anticuerpo anti-Jo-1 y la tomografía computada de tórax, estuvieron disponibles para la mayoría de los pacientes mientras que la Resonancia Magnética de musculo (RM), el estudio de difusión de monóxido de carbono (DLco) y la biopsia muscular se realizaron en menos del 50% de los casos. La determinación de otros anticuerpos específicos de miositis, de importancia en el diagnóstico y pronóstico de la enfermedad se realizó, en mayor parte, a través de un subsidio de la SAR.

The Idiopathic Inflammatory Myopathies (IIM) comprise a heterogeneous group of acquired muscle diseases classified as polymyositis (PM), dermatomyositis (DM), Inclusion Body Myositis (IBM), Immuno Mediated Necrotizing Myopathies (IMNM), Overlap Myositis (OM), juvenile myositis, Antisynthethase Syndrome (ASS) and cancer related myositis (CAM). The presence of myositis specific antibodies in the serum and autoantibodies against target antigens and inflammatory infiltrates in muscle tissue suggests the autoimmune condition of the disease. The diagnosis of inflammatory myopathies is often a challenge and the disposal of diagnostic tools are not always available in daily practice. Information on the accessibility of these methods was obtained from the Argentine Register of Myopathies. The study of muscle enzymes, ANA, anti-Jo-1 antibodies and chest tomography were easy to get to most patients while muscle MRI, lung diffusion capacity for carbon monoxide (DLco) and muscle biopsy were performed in less than 50% of cases. Other myositis specific antibodies, necessary for disease diagnosis and prognosis, were mostly done through a subsidy from the Argentine Rheumatology Society.

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.

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