Sociodemographic and clinical factors associated with poor COVID-19 outcomes in patients with rheumatic diseases: data from the SAR-COVID Registry.

BACKGROUND/OBJECTIVE: This study aims to describe the course and to identify poor prognostic factors of SARS-CoV-2 infection in patients with rheumatic diseases. METHODS: Patients ≥ 18 years of age, with a rheumatic disease, who had confirmed SARS-CoV-2 infection were consecutively included by major rheumatology centers from Argentina, in the national, observational SAR-COVID registry between August 13, 2020 and July 31, 2021. Hospitalization, oxygen requirement, and death were considered poor COVID-19 outcomes. RESULTS: A total of 1915 patients were included. The most frequent rheumatic diseases were rheumatoid arthritis (42%) and systemic lupus erythematosus (16%). Comorbidities were reported in half of them (48%). Symptoms were reported by 95% of the patients, 28% were hospitalized, 8% were admitted to the intensive care unit (ICU), and 4% died due to COVID-19. During hospitalization, 9% required non-invasive mechanical ventilation (NIMV) or high flow oxygen devices and 17% invasive mechanical ventilation (IMV). In multivariate analysis models, using poor COVID-19 outcomes as dependent variables, older age, male gender, higher disease activity, treatment with glucocorticoids or rituximab, and the presence of at least one comorbidity and a greater number of them were associated with worse prognosis. In addition, patients with public health insurance and Mestizos were more likely to require hospitalization. CONCLUSIONS: In addition to the known poor prognostic factors, in this cohort of patients with rheumatic diseases, high disease activity, and treatment with glucocorticoids and rituximab were associated with worse COVID-19 outcomes. Furthermore, patients with public health insurance and Mestizos were 44% and 39% more likely to be hospitalized, respectively. STUDY REGISTRATION: This study has been registered in ClinicalTrials.gov under the number NCT04568421. Key Points • High disease activity, and treatment with glucocorticoids and rituximab were associated with poor COVID-19 outcome in patients with rheumatic diseases. • Some socioeconomic factors related to social inequality, including non-Caucasian ethnicity and public health insurance, were associated with hospitalization due to COVID-19.

Characteristics associated with poor COVID-19 outcomes in individuals with systemic lupus erythematosus: data from the COVID-19 Global Rheumatology Alliance.

AIM: To determine characteristics associated with more severe outcomes in a global registry of people with systemic lupus erythematosus (SLE) and COVID-19. METHODS: People with SLE and COVID-19 reported in the COVID-19 Global Rheumatology Alliance registry from March 2020 to June 2021 were included. The ordinal outcome was defined as: (1) not hospitalised, (2) hospitalised with no oxygenation, (3) hospitalised with any ventilation or oxygenation and (4) death. A multivariable ordinal logistic regression model was constructed to assess the relationship between COVID-19 severity and demographic characteristics, comorbidities, medications and disease activity. RESULTS: A total of 1606 people with SLE were included. In the multivariable model, older age (OR 1.03, 95% CI 1.02 to 1.04), male sex (1.50, 1.01 to 2.23), prednisone dose (1-5 mg/day 1.86, 1.20 to 2.66, 6-9 mg/day 2.47, 1.24 to 4.86 and ≥10 mg/day 1.95, 1.27 to 2.99), no current treatment (1.80, 1.17 to 2.75), comorbidities (eg, kidney disease 3.51, 2.42 to 5.09, cardiovascular disease/hypertension 1.69, 1.25 to 2.29) and moderate or high SLE disease activity (vs remission; 1.61, 1.02 to 2.54 and 3.94, 2.11 to 7.34, respectively) were associated with more severe outcomes. In age-adjusted and sex-adjusted models, mycophenolate, rituximab and cyclophosphamide were associated with worse outcomes compared with hydroxychloroquine; outcomes were more favourable with methotrexate and belimumab. CONCLUSIONS: More severe COVID-19 outcomes in individuals with SLE are largely driven by demographic factors, comorbidities and untreated or active SLE. Patients using glucocorticoids also experienced more severe outcomes.

Sobrevida, eficacia y seguridad de Golimumab en pacientes con Artritis Reumatoidea y Espondiloartritis: Datos de una cohorte argentina / Survival, efficacy and safety of Golimumab in patients with Rheumatoid Arthritis and Spondyloarthritis: Data from an Argentine cohort

Objetivos: Golimumab ha sido aprobado para el tratamiento de pacientes con artritis reumatoidea (AR), artritis psoriásica (APs) y espondiloartritis axial. Sin embargo, los datos provenientes de nuestra región son escasos. El objetivo de este estudio fue evaluar la eficacia, seguridad y sobrevida acumulada de golimumab en pacientes de la vida real con AR, APs y espondilitis anquilosante (EA) de diferentes centros de Argentina. Material y métodos: Se llevó a cabo un estudio longitudinal, en el que se incluyeron pacientes consecutivos mayores de 18 años con diagnóstico de AR (criterios ACR/EULAR 2010), APs (criterios CASPAR) y Espax (criterios ASAS 2009), que hayan iniciado tratamiento con golimumab de acuerdo a la indicación médica. Se obtuvieron los datos por revisión de historias clínicas. Se consignaron características sociodemográficas, clínicas, comorbilidades y tratamientos previos. Con respecto al golimumab, se registraron fecha de inicio, vía de administración y tratamientos concomitantes. Se determinó la actividad de la enfermedad mediante DAS28 en el caso de la AR, por DAPSA y MDA para APs y por BASDAI en el caso de Espax. Se consignó la presencia de eventos adversos (EA). En el caso de suspensión del tratamiento, se identificaron la fecha y motivo del mismo. Los pacientes fueron seguidos hasta la suspensión del golimumab, pérdida de seguimiento, muerte, o finalización del estudio (30 de noviembre de 2020). Resultados: Se incluyeron 182 pacientes, 116 con diagnóstico de AR, 30 con APs y 36 con Espax. La mayoría de ellos (70.9%) eran mujeres con una edad mediana (m) de 55 años (RIC 43.8-64) y una duración de la enfermedad m de 7 años (RIC 4-12.7) al inicio del tratamiento. El 34.6% de los mismos habían recibido al menos una droga modificadora de la enfermedad (DME) biológica (-b) o sintética dirigida (-sd) previamente. El seguimiento total fue de 318.1 pacientes/año. El tratamiento con golimumab mostró mejoría clínica en los tres grupos de pacientes. La incidencia de eventos adversos fue de 6.6 por 100 pacientes/año, siendo las infecciones las más frecuentes. Durante el seguimiento, 50 pacientes (27.5%) suspendieron golimumab, la causa más frecuente fue el fracaso del tratamiento (68%), seguida de la falta de cobertura (16%) y el desarrollo de eventos adversos (10%). La persistencia de golimumab fue del 76% y 68% a los 12 y 24 meses, respectivamente. Se registró una sobrevida de 50.2 meses (IC 95% 44.4-55.9). Los pacientes que habían recibido tratamiento previo con DME-b y/o -sd mostraron una menor sobrevida (HR 2.4, IC 95% 1.3-4.4). Conclusiones: El tratamiento con golimumab en pacientes de la vida real en Argentina ha demostrado una buena eficacia y seguridad. La sobrevida del fármaco fue de más de 4 años y casi el 80% seguía usando golimumab después de un año. El tratamiento previo con otros DME-b o -sd se asoció con una menor sobrevida al tratamiento.

Objectives: Golimumab is approved for patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis. However, data from our region are scarce. The aim of this study was to evaluate the efficacy, safety, and cumulative survival of golimumab in real-life patients with RA, PsA and axial spondyloarthritis (axSpa) from different rheumatology centers in Argentina. Material and methods: We performed a longitudinal study of consecutive adults with RA (ACR/EULAR 2010 criteria), PsA (CASPAR criteria) and axSpa (ASAS 2009 criteria), who have started treatment with golimumab according to medical indication. Data was obtained by review of medical records. Sociodemographic and clinical data, musculoskeletal manifestations, comorbidities and previous treatments were recorded. In reference to golimumab treatment, start date, route of administration and concomitant treatments were identified. Disease activity was assessed using DAS28 for RA patients, DAPSA and MDA for PsA and BASDAI for axSpa. The presence of adverse events was recorded. If golimumab was stopped, date and cause was documented. Patients were followed up until golimumab discontinuation, loss of follow-up, death, or study completion (November 30, 2020). Results: In total 182 patients were included, 116 with a diagnosis of RA, 30 with PsA and 36 with axSpa. Most of them (70.9%) were female with a median (m) age of 55 years (IQR 43.8-64) and m disease duration of 7 years (IQR 4-12.7) at treatment initiation. Al least one prior biological (-b) and/or targeted synthetic (-ts) disease modifying antirheumatic drug (DMARD) was received by 63 patients (34.6%). Total follow-up was 318.1 patients/year. Golimumab treatment showed clinical improvement in all three groups of patients. The incidence of AE was 6.6 per 100 patients/year, being infections the most frequents ones. During follow-up, 50 patients (27.5%) discontinued golimumab, the most frequent cause was treatment failure (68%), followed by lack of health insurance (16%) and adverse events (10%). Golimumab persistence was 76% and 68% at 12 and 24 months, respectively. Treatment survival was 50.2 months (95% CI 44.4-55.9). Patients who had received prior treatment with b- or ts-DMARDs showed lower survival (HR 2.41, 95% CI 1.3-4.4). Conclusions: Golimumab treatment in real life patients in Argentina has shown good efficacy and safety. Drug survival was over 4 years and almost 80% were still using golimumab after one year. Prior treatment with other b- or ts-DMARDs was associated with lower treatment survival.

Asociación entre Artritis Reumatoidea y otras enfermedades autoinmunes / Association between Rheumatoid Arthritis and other autoimmune diseases

Objetivos: Determinar la frecuencia de enfermedades autoinmunes (EAI) en pacientes con Artritis Reumatoidea (AR) y comparar la frecuencia de EAI entre pacientes con AR y sin AR ni otra EAI reumatológica. Material y Métodos: Estudio multicéntrico, observacional, analítico, retrospectivo. Se incluyeron pacientes consecutivos con AR (ACR/EULAR 2010) y como grupo control pacientes con diagnóstico inicial de Osteoartritis primaria (OA). Resultados: Se incluyeron 1549 pacientes: 831 con AR (84% mujeres, edad media 55.2 años [DE 13.6]) y 718 con OA (82% mujeres, edad media 67 años [DE 11.1]). La frecuencia de EAI en el grupo AR fue del 22% (n=183). Estos presentaron mayor frecuencia de EAI reumatológicas (9.4 vs 3.3%, p< 0.001), y menor frecuencia de EAI no reumatológicas que aquellos con OA (15.3 vs 20.5, p=0.007). La EAI reumatológica más prevalente fue el Síndrome de Sjögren, el cual fue más frecuente en el grupo AR (87.2 vs 29.2%, p< 0,001). La frecuencia de EAI reumatológicas en los pacientes con AR fue mayor en la forma erosiva (11 vs 6.8%, p=0.048). Conclusión: La frecuencia de EAI en los pacientes con AR fue del 22%, en quienes predominaron las de etiología reumatológica mientras que, las no reumatológicas predominaron en pacientes con OA.

Objectives: To determine the frequency of autoimmune diseases (AID) in Rheumatoid Arthritis (RA) patients and to compare this frequency between patients with and without RA or other rheumatologic AID. Methods: Multicenter, observational, analytical, retrospective study. Consecutive patients with diagnosis of RA (ACR/EULAR 2010) were included. Patients with initial diagnosis of primary ostearthritis (OA) were used as control group. Results: A total of 1549 patients were included: 831 RA (84% women, mean age 55.2 [±13.6]) and 718 OA (82% women, mean age 67 [± 11.1]). The frequency of AID in the RA group was 22% (n=183). RA patients showed higher frequency of rheumatologic AID (9.4 vs 3.3%, p< 0.001), and lower frequency of non-rheumatologic AID than OA patients (15.3 vs 20.5%, p= 0.007). The most prevalent rheumatic AID was Sjögren's Syndrome, which was more frequent in the AR group (87.2 vs 29.2%, p<0.001). The frequency of rheumatologic AID in RA patients was higher in those with erosive RA (11 vs 6.8%, p=0.048). Conclusion: The frequency of AID in RA patients was 22%. Rheumatologic AID were more frequent in RA patients, whereas non-rheumatologic AID prevailed in OA patients.

Evaluation of the Educational Needs in Argentine Patients with Rheumatoid Arthritis Using the SpENAT Questionnaire. / Evaluación de las necesidades educacionales de los pacientes con artritis reumatoide mediante el cuestionario SpENAT.

BACKGROUND: The SpENAT, a Spanish version of the Educational Needs Assessment Tool, is a self-completed questionnaire that assesses educational needs (ENs) with the purpose of providing tailored and patient-centered information. It consists of 39 questions grouped into the 7 following domains: Pain management, Movement, Feelings, Arthritic process, Treatments, Self-help measures and Support system. OBJECTIVES: The objective of the study was to describe the ENs of rheumatoid arthritis (RA) patients using the SpENAT and to determine the main sources of information consulted by these patients. MATERIAL AND METHODS: Multicenter, observational, cross-sectional study. We included consecutive patients≥18 years with diagnosis of RA (ACR 87/ACR-EULAR 2010). Sociodemographic data, disease characteristics and clinimetric properties were recorded. All patients completed the SpENAT and were asked about the sources employed to obtain information about their disease. STATISTICAL ANALYSIS: Population characteristics were described. ENs were determined as percentages of the highest possible score for each domain. Needs for each domain according to sex, years of education, disease duration, use of biologicals and functional capacity were analyzed by means of ANOVA, and bivariate comparisons were made with Student's t-test and the Bonferroni correction. Correlation between domains was determined with the Spearman correlation coefficient. We compared patients' age by source of information with Student's t-test. RESULTS: We included 496 patients from 20 centers across the country. More ENs were observed in the domains of Movement, Feelings and the Arthritic process. Patients with higher educational level (>7 years) reported more ENs in the Arthritic process and Self-help measure domains. A higher functional impairment (HAQ-A≥0.87) was associated with more ENs in every domain. Patients with high activity showed more ENs than those in remission in the domains of Pain management, Movement, Feelings, Treatments and Support system, as well as those with low activity in Self-help measures and Support system domains. All SpENAT domains showed positive correlations among each other (P<.0001), the most important being Pain management/Movement and Treatments/Arthritic process (r≥0.7). The source of information most frequently consulted was the rheumatologist (93.95%); those who made use of Internet were on average younger (P=.0004). CONCLUSION: RA patients were very interested about knowing more about their disease. High functional impairment was associated with more ENs. Patients with high disease activity had higher EN levels in almost every domain. The rheumatologist was the main source of information for the patient with RA.

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.

Spanish Validation of the GEPARD Questionnaire for the Detection of Psoriatic Arthritis in Argentinian Patients with Psoriasis.

BACKGROUND/OBJECTIVE: Psoriatic arthritis (PsA) is preceded by psoriasis in approximately 80% of cases. Dermatologists are pivotal for early detection. It is important to have simple tools that allow the detection of PsA in patients with skin psoriasis. The aim of our study was to evaluate the performance of an adapted version of the GEPARD Questionnaire in Spanish in Argentinian patients with psoriasis. METHODS: This is a cross-sectional study. A new Spanish (Argentinian) (GEPARDa) translated version of the original questionnaire (German) was developed and then tested as a diagnostic tool in patients with psoriasis, PsA, osteoarthritis associated to psoriasis, and osteoarthritis, all evaluated by rheumatologists who used the CASPAR criteria. RESULTS: Eighty-three patients were included (55 [66.3%] women with a mean age of 50.7 years [SD 6.3]). Forty-four patients had PsA (29 [34.9%] patients had previous diagnosis of PsA, and 15 [18%] were newly diagnosed after referral by their dermatologists), and 39 patients were without PsA (18 [21.6%] patients had psoriasis without articular involvement, 6 [7.22%] had psoriasis associated with osteoarthritis, and 15 [18%] had osteoarthritis). An area under the curve of 0.9554 (SD 0.01; 95% CI 0.91-0.99) was calculated considering the CASPAR criteria as the gold standard. With a cutoff of ≥6 the questionnaire showed a sensitivity of 88.64%, a specificity of 89.74%, a positive likelihood ratio of 8.6, and a negative likelihood ratio of 0.12. CONCLUSIONS: The GEPARDa version has proven to be a diagnostic tool with excellent performance so that it can be considered a valid tool for the detection of PsA in Argentinian patients.

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

Secukinumab: a promising therapeutic option in spondyloarthritis.

Psoriatic arthritis (PsA) is the second most common chronic inflammatory joint disease. Ankylosing spondylitis (AS) is another less common but equally chronic and disabling spondyloarthritis (SpA). Therapeutic agents for the treatment of these diseases have been somewhat lacking as compared with those available for rheumatoid arthritis, which represents a significant challenge for both the treating physician and the pharmaceutical industry. A promising development for our understanding of the physiopathology of PsA and AS involves new targets to interrupt IL-17 and IL-12/IL-23 pathways. Up to 30-40 % of SpA patients have inadequate or poor response, or are intolerant to anti-TNF therapies. Therefore, there has been a clear unmet medical need in an important group of these patients. As a result, new therapeutic targets have emerged for the treatment of both axial and peripheral SpA. Interleukin 17 (IL-17) is a pro-inflammatory cytokine that is increased in psoriatic lesions as well as in the synovial fluid of patients with PsA and in sites of enthesitis in SpA. IL-23 has been shown to play an important role in the polarization of CD4+ T-cells to become IL-17 producers. Based on these evidences, blockade of the cytokine IL-17 or its receptors was considered to have therapeutic implications for the treatment of psoriasis, as well as PsA and AS.This article presents a thorough review of an IL-17 A blocking agent, its mechanism of action, its clinical efficacy and its therapeutic safety.

Rheumatic manifestations in inflammatory bowel diseases: a link between GI and rheumatology.

Musculoskeletal symptoms are the most frequent extra-intestinal manifestations of inflammatory bowel disease (IBD), ranging between 10 and 40 % of cases. Pathogenesis is still unclear, although several factors have been associated (genetic, environmental, and immunologic pathways). Rheumatic manifestations in IBD patients are heterogeneous, including axial and peripheral involvement, dactylitis, enthesitis, uveitis, as well as skin involvement. Currently, magnetic resonance imaging and ultrasonography are important tools for detecting early pathological changes in IBD patients with suspected rheumatic disease. New advances into the genetics and pathophysiology have provided more effective and targeted therapy for IBD patients with rheumatic manifestations. Given the high prevalence, awareness of the musculoskeletal symptoms is essential to avoid a misdiagnosis. Finally, an interdisciplinary approach of IBD patients, including rheumatologist and gastroenterologist, will improve the quality of life these patients.

Effects of cigarette smoking on early arthritis: a cross-sectional study-data from the Argentine Consortium for Early Arthritis (CONAART).

Our objective was to analyze the effects of cigarette smoking on disease activity, functional capacity, radiographic damage, serology and presence of extraarticular manifestations in patients with rheumatoid arthritis and undifferentiated arthritis. This is a cross-sectional study of 1,305 patients (729 with rheumatoid arthritis and 576 with undifferentiated arthritis) from CONAART, the Argentine Consortium for Early Arthritis that includes patients older than 16 years with <2 years of disease. Sociodemographic data, clinical characteristics of the disease and smoking history were collected. In patients with rheumatoid arthritis the disease activity score of 28 joints was 5.4 ± 1.3 in current smokers, 5.2 ± 1.4 in former smokers and 5.1 ± 1.4 in never smokers (p = 0.011). The simple erosion narrowing score was higher in current smokers and former smokers than in never smokers (M 14.0, R Q 6.0-21.0; M 15.0, R Q 7.0-24.0; M 10.0, R Q 5.0-17.0; p = 0.006). Current smokers had higher rheumatoid factor titer (M 160.0, R Q 80.0-341.0) than former smokers (M 146.8, R Q 6.03-255.5) and never smokers (M 15.0, R Q 9.0-80.0) (p = 0.004). The variable independently associated with tobacco exposure was simple erosion narrowing score (OR = 1.03, 95 % CI 1.00-1.05; p = 0.012). In patients with undifferentiated arthritis, an association between smoking status and parameters of activity or radiographic damage was not observed. Neither was tobacco exposure related to the presence of extraarticular manifestations or to the degree of disability in any of the two groups of patients. No relation was found between disease activity and severity, and number of packs smoked per year. Tobacco.

Prevalence of psoriatic arthritis in psoriasis patients according to newer classification criteria.

The aim of this study is to determine the prevalence of psoriatic arthritis (PsA) according to CASPAR criteria, ASAS peripheral and axial SpA criteria, and New York criteria for AS. The first 100 patients consecutively attending a psoriasis dermatology clinic were assessed. Demographic and clinical data were collected; all patients were questioned and examined for joint manifestations. Rheumatoid factor and radiographies of hands, feet, cervical spine, and pelvis for sacroiliac joints were obtained. X-rays were read independently by two experienced observers in blind fashion. Patients with objective joint manifestations, both axial and peripheral, were evaluated for fulfillment of CASPAR, ASAS peripheral and axial, and New York criteria. Median age 48 years; 93 % of patients had psoriasis vulgaris and 56 % nail involvement. Seventeen patients had peripheral arthritis as follows: nine mono/oligoarticular and eight polyarthritis. Median arthritis duration was 8 years. Seventeen percent of patients fulfilled CASPAR and ASAS peripheral criteria, 6 % New York, and 5 % ASAS axial criteria. Patients who met CASPAR criteria showed a significantly higher psoriasis duration compared to those without arthritis (M 16 vs. 10 years, p = 0.02), and a higher frequency of nail involvement (88.2 vs. 49.4 %, p = 0.003). Five patients (29.4 %) fulfilled ASAS axial criteria; all of them had peripheral involvement as follows: mono/oligoarticular in three patients and polyarticular in two. Patients with peripheral and axial involvement presented a significantly higher frequency of erythrodermic psoriasis compared to the other patients (35.3 vs. 1.2 %, p = 0.0006 and 80 vs. 16.7 %, p = 0.02). Prevalence of PsA, for CASPAR and ASAS peripheral criteria, was of 17 %. Five percent of patients met ASAS axial criteria, while 6 % met New York criteria. Worth noting, few patients without signs or symptoms of arthritis had radiological changes, both axial and peripheral, precluding a proper classification.

Validación del cuestionario Rheumatoid Arthritis Impact of Disease (RAID) en pacientes argentinos con artritis reumatoidea temprana y establecida / Validation o fan Argentine version f the Rheumatoid Arthritis impact of Disease (RAID) in patients with early and established rheumatoid arthritis

Introducción: El RAID es un autocuestionario que evalúa el status global de los pacientes y mide siete dimensiones o dominios de salud. Objetivo: Validar el cuestionario RAID en una población de pacientes argentinos con diagnóstico de Artritis Reumatoidea establecida (AR) y Artritis Reumatoidea Temprana (ART). Determinar sus principales variables asociadas y establecer qué tipo de cálculo es más conveniente. Métodos: Se incluyeron pacientes con diagnóstico de ART (≤2 años de evolución) y AR establecida (>2 años de evolución) según criterios ACR ‘87. Todos los pacientes completaron los cuestionarios RAID, RAPID3, HAQ-A, y RAQoL. Se consignó la evaluación global de la enfermedad por el paciente y por el médico por Escala Visual Análoga (EVA). Se determinó Eritrosedimentación (ERS) dentro de los 10 días de la visita. Se calcularon los índices compuestos DAS28, IAS y CDAI. Resultados: Se incluyeron 99 pacientes. Un 88,9% de sexo femenino, con una edad mediana de 53 años y un tiempo mediano de evolución de 12 años. El RAID presentó buena correlación con el RAQoL (r = 0,71), HAQ-A (r = 0,62), también con los índices de actividad DAS28 (r = 0,55), RAPID3 (r = 0,90), IAS (r = 0,62), CDAI (r = 0,66). El resultado final del RAID mostró una excelente correlación entre el cálculo ponderado y el promediado (r = 0,99). El tiempo en completar el cuestionario fue de 131 segundos (RIC 122-151), el tiempo mediano de cálculo del ponderado fue de 44 segundos (RIC 40-47) y del promediado fue de 11 segundos (RIC 9,5-12,5). Discusión: El RAID es un cuestionario válido y confiable. Presentó una muy buena correlación con otras medidas de evaluación y constituye una herramienta simple para determinar en forma global el status general del paciente.

Validación del cuestionario Rheumatoid Arthritis Impact of Disease (RAID) en pacientes argentinos con artritis reumatoidea temprana y establecida / Validation o fan Argentine version f the Rheumatoid Arthritis impact of Disease (RAID) in patients with early and established rheumatoid arthritis

Introducción: El RAID es un autocuestionario que evalúa el status global de los pacientes y mide siete dimensiones o dominios de salud. Objetivo: Validar el cuestionario RAID en una población de pacientes argentinos con diagnóstico de Artritis Reumatoidea establecida (AR) y Artritis Reumatoidea Temprana (ART). Determinar sus principales variables asociadas y establecer qué tipo de cálculo es más conveniente. Métodos: Se incluyeron pacientes con diagnóstico de ART (≤2 años de evolución) y AR establecida (>2 años de evolución) según criterios ACR æ87. Todos los pacientes completaron los cuestionarios RAID, RAPID3, HAQ-A, y RAQoL. Se consignó la evaluación global de la enfermedad por el paciente y por el médico por Escala Visual Análoga (EVA). Se determinó Eritrosedimentación (ERS) dentro de los 10 días de la visita. Se calcularon los índices compuestos DAS28, IAS y CDAI. Resultados: Se incluyeron 99 pacientes. Un 88,9% de sexo femenino, con una edad mediana de 53 años y un tiempo mediano de evolución de 12 años. El RAID presentó buena correlación con el RAQoL (r = 0,71), HAQ-A (r = 0,62), también con los índices de actividad DAS28 (r = 0,55), RAPID3 (r = 0,90), IAS (r = 0,62), CDAI (r = 0,66). El resultado final del RAID mostró una excelente correlación entre el cálculo ponderado y el promediado (r = 0,99). El tiempo en completar el cuestionario fue de 131 segundos (RIC 122-151), el tiempo mediano de cálculo del ponderado fue de 44 segundos (RIC 40-47) y del promediado fue de 11 segundos (RIC 9,5-12,5). Discusión: El RAID es un cuestionario válido y confiable. Presentó una muy buena correlación con otras medidas de evaluación y constituye una herramienta simple para determinar en forma global el status general del paciente.(AU)

Validación del cuestionario RAPID3 en una cohorte de pacientes con artritis reumatoidea temprana y establecida, y su correlación con otros índices de actividad / Validation of RAPID3 questionnaire in a cohort of patients with early and established rheumatoid arthritis and its correlation with other activity indices

Introducción: El RAPID3 es un índice de actividad que incluye tres medidasauto-reportadas por el paciente: la función física, el dolor y la evaluación global de la enfermedad por el paciente. Objetivos: Validar el cuestionario RAPID3 en pacientes con AR temprana y establecida, evaluar su correlación con otros índices de actividad y medidas de evaluación y determinar el tiempo en completar y calcular el cuestionario.Métodos: Se incluyeron pacientes con diagnóstico de AR temprana (<2 años de evolución) y establecida. Todos los pacientes completaron HAQ-A, RAPID3 y RAQoL. Se determinó evaluación global de la enfermedad por el paciente y el médico por EVA. Se midió ERS el día de la visita. Se calculó DAS28, CDAI e IAS. Se cronometró el tiempo en completar y calcular el cuestionario. Resultados: Se evaluaron 112 pacientes. RAPID3 presentó un buena correlación con DAS28 (r=0,60), CDAI (r=0,60) e IAS (r=0,62) y una muy buena correlación con HAQ-A (r=0,83) y RAQoL (r=0,75). La mediana en completar el cuestionario fue de 139 segundos y la mediana en calcularlo fue de 11 segundos. Discusión: RAPID3 es un cuestionario válido, sencillo, fácil de completar y de rápido cálculo. Presentó una buena correlación con otros índices de actividad como así también con HAQ-A y RAQoL.