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.

Performance of the RABBIT infection risk score in an Argentinian rheumatoid arthritis cohort.

Patients with rheumatic autoimmune diseases have a higher risk of infections compared with age-and sex-matched controls. In Latin America, there are no validated tools to assess the risk of serious infection. The objectives were to estimate the incidence of serious infections in a cohort of rheumatoid arthritis (RA) patients followed for 12 months and to validate the RABBIT risk score for serious infections. Patients with RA were included and followed for 12 months. Baseline sociodemographic data, comorbidities, RA characteristics, and vaccination status were recorded. The baseline RABBIT risk score was calculated. Serious infections were documented, describing site and time since enrollment. Six hundred five patients were included (13 centers). The incidence of serious infection was 5% (95% CI 3-7). The most frequent sites were respiratory and urinary (90%). Performance of RABBIT risk score: patients with no infection during follow-up had a median score of 1.2 (IQR 0.8-2.1) and patients with infection 5.1 (IQR 2.15-12.6) p 0.00001. ROC curve analysis: AUC 0.86 (95% CI 0.8-0.94), best cut-off 2.85 (sensibility 75%, specificity 85%). The incidence of serious infections was 5% during the follow-up. The RABBIT score performed excellently in our patients. Key Points • The RABBIT risk score for serious infections showed an excellent performance in a population different (Latin America) from the original one included in the German registry. • This may assist rheumatologists in selecting drugs for patients according to the individual risk of infection, in a fast and simple way.

Nivel de estrés, medido a través de la Escala de Estrés Percibido (EEP-10), y su asociación con la actividad de la enfermedad en pacientes con Artritis Reumatoidea / Stress level, measured through Perceived Stress Scale (PSS-10), and it's association with disease activity in patients with Rheumatoid Arthritis

El estrés es un factor de riesgo en la patogénesis de las enfermedades reumáticas autoinmunes. Objetivo: Evaluar la asociación entre la actividad de la enfermedad en pacientes con artritis reumatoidea y estrés. Secundarios: Evaluar la asociación de los niveles de estrés percibido con otros índices de actividad, así como también con discapacidad, ansiedad y depresión y calidad de vida. Material y métodos: Se incluyeron pacientes consecutivos, mayores de 18 años, con diagnóstico de AR (ACR 1987 y/o ACR/EULAR 2010). Se consignaron datos sociodemográficos, características de la enfermedad, parámetros de laboratorio y tratamiento actual. Resultados: Se incluyeron 45 pacientes, edad 48 (DE 11) años. Factor reumatoide + 96%, ACPA + 90%. El 26% de los pacientes presentó Remisión/Baja actividad (R/BA) por RAPID3 (2.6±2) VS 74% con moderada/alta actividad (MA/AA) (15±4). Análisis comparativo entre ambos grupos según nivel de estrés percibido: EEP-10 13±6 (RAPID3 R/BA) VS EEP-10 18±6 (RAPID3 MA/AA) (p=0.02). La EEP-10 presentó correlación con ansiedad (HAD-A) (r=0.7, p<0.001), depresión (HAD-D) (r=0.7, p<0.001), con calidad de vida (EQ5D) (r=-0.36, p=0.02) y con discapacidad funcional (HAQ-A) (r=0.55, p=0.001). Conclusión: Los pacientes con AR con elevada actividad de la enfermedad evaluados por RAPID3, DAS28 e IAS presentaron mayores niveles de estrés percibido con respecto a los pacientes con remisión o baja actividad.

Stress is a risk factor in the pathogenesis of autoimmune rheumatic diseases. Objective: To evaluate the association between disease activity in patients with RA. Secondary: To evaluate the association of perceived stress levels with other activity indexes (SDAI, CDAI, DAS28 and IAS) as well as with disability, anxiety and depression and quality of life. Material and methods: Patients consecutive, older than 18 years, with diagnosis of RA (ACR 1987 and / or ACR / EULAR 2010) were included. Sociodemographic data, characteristics of the disease, laboratory parameters and current treatment were recorded. The patients completed: SSP-10, HAQ-A, HAD, EQ-5D, RAPID3, VAS Pain and PGA, the physicians calculated DAS28, IAS, CDAI, SDAI and completed PGA. Results: Forty-five patients with an average age of 48 (SD 11) years were included. Rheumatoid factor + 96%, ACPA + 90%. Twenty six percent of the patients had Remission/Low activity (R/LA) by RAPID3 (2.6 ± 2) VS 74% with Moderate / High Activity (MA/HA) (15 ± 4).Comparative analysis between both groups according to perceived stress scale: PSS-10 13±6 (RAPID3 R/LA) Vs PSS-1018±6 (RAPID3 MA/HA) (p=0.02). The same happened when comparing DAS28 and IAS, where there was a significant difference according to PSS-10. The PSS-10 presented correlation with anxiety (HAD-A) (r=0.7, p<0.001), depression (HAD-D) (r=0.7, p<0.001), with quality of life (EQ5D) (r=- 0.36, p=0.02) and with functional disability (HAQ-A) (r=0.55, p=0.001). Conclusion: Patients with RA with high disease activity evaluated by RAPID3, DAS28 and IAS presented higher levels of perceived stress with respect to patients with remission or low activity

Frequency of human leukocyte antigens class II-DR alleles (HLA-DRB1) in Argentinian patients with early arthritis.

Patients with rheumatoid arthritis (RA) or undifferentiated arthritis (UA) in the CONAART database (Argentine Consortium for Early Arthritis) were assessed for genetic risk factors for RA, specifically for HLA-DRB1 alleles and the PTPN22 rs2476601 polymorphism associated with progression to RA. This is a case-control study. Blood samples were obtained to determine HLA-DRB1 genotypes by PCR-SSO Luminex and PTPN22 (rs2476601) polymorphism by allelic discrimination. A control group of individuals from the general Argentinian population were obtained from the national register of cadaveric organ donors. A total of 1859 individuals were included in this analysis: 399 patients from the CONAART database (347 patients with RA at study end and 52 patients with UA at study end, mean follow-up time 25 ± 18 months) and 1460 individuals from the general Argentinian population. Compared with the controls, the HLA-DRB1*04 and DRB1*09 alleles were more commonly detected in patients with RA diagnosis (OR (95% CI) 2.23 (1.74-2.85) and 1.89 (1.26-2.81)) respectively. Both patients with UA and the general population showed higher frequency of DRB1*07, DRB1*11 and DRB1*15 alleles than patients with RA. PTPN22 rs2476601 polymorphism frequency was higher in RA and UA vs the general population; however, this was significantly different only for RA vs control group (OR [95% CI] = 1.81 [1.10-3.02], P = 0.018. HLA-DRB1 typing and PTPN22 allelic discrimination could distinguish between patients with UA, patients with early RA, and the general population in Argentina. This is the first study of HLA-DRB1 alleles and PTPN22 polymorphism associations with progression to early RA in an Argentinian population.

Prevalence of cardiovascular disease and major risk factors in patients with rheumatoid arthritis: a multinational cross-sectional study.

To compare the prevalence of cardiovascular disease (CVD) and major CVD risk factors among rheumatoid arthritis (RA) patients enrolled in a large US and multinational registry. We compared CVD and CVD risk factor prevalence from 11 countries enrolled in the CORRONA US and CORRONA International registries; patients from the 10 ex-US participating countries were grouped by region (Eastern Europe, Latin America, and India). Unadjusted summary data were presented for demographics and disease characteristics; comparisons for prevalence of CVD risk factors and CVD were age/gender standardized to the age/gender distribution of the US enrolled patients. Overall, 25,987 patients were included in this analysis. Compared to patients from the ex-US regions, US participants had longer disease duration and lower disease activity, yet were more likely to receive a biologic agent. Additionally, CORRONA US participants had the highest body mass index (BMI). Enrolled patients in India had the lowest BMI, were more rarely smokers, and had a low prevalence of hyperlipidemia, hypertension, and prior CVD compared to the US and other ex-US regions. Participants from Eastern Europe had a higher prevalence of hypertension and hyperlipidemia and highest prevalence of all manifestations of CVD. Differences in the prevalence of both CVD and major CVD risk factors were observed across the four regions investigated. Observed differences may be influenced by variations in both non-modifiable/modifiable characteristics of patient populations, and may contribute to heterogeneity on the observed safety of investigational and approved therapies in studies involving RA patients from different origins.

Quality of life of patients with rheumatoid arthritis in Argentina: reliability, validity, and sensitivity to change of a Spanish version of the Rheumatoid Arthritis Quality of Life questionnaire.

The Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire is the first needs-based instrument specifically designed to measure quality of life (QoL) of patients with rheumatoid arthritis (RA). The aims of our study were to develop an Argentinean version of the RAQoL and to determine its reproducibility, validity, and sensitivity to change in patients with RA. Translation process was performed according to internationally accepted methodology. Internal consistency and test-retest reliability were calculated. Criterion and construct validity were assessed by comparing the RAQoL with parameters of disease activity, the Health Assessment Questionnaire (HAQ), and the Medical Outcomes Study 36-item health survey (SF-36) questionnaire. Sensitivity to change was measured at 6-12 months using standardized response mean (SRM). The minimal important change was defined as a change of 1 or 1.96 times the standard error of measurement. A total of 97 patients with RA were included. Cronbach's α was 0.93, and test-retest reliability was 0.95. The RAQoL showed moderate to strong correlation with parameters of disease activity, the HAQ, and the SF-36. Functional status was the main determinant of patients' level of QoL. The SRM of the RAQoL was 0.24. Agreement between 20 % improvement in RAQoL and ACR20 response was moderate. Minimal important change was 2.2 (1 SEM) or 4.3 (1.96 SEM). The Argentinean version of the RAQoL is the first Spanish translation of this questionnaire. Our findings show it to be valid, reliable, and sensitive to changes in RA clinical status.

Epidemiology of spondyloarthritis in Argentina.

INTRODUCTION: Spondyloarthritis (SpA) includes a group of diseases that share immunogenetic, clinical and radiologic findings, with a particular involvement of the axial skeleton and the entheses. METHODS: SpA patients attending ambulatory care in 11 rheumatology services located in 6 Argentine provinces were included in a prospective, observational multicentre cohort of SpA in Argentina (Iberoamerican Spondyloarthritis Registry [RESPONDIA]). Data collected were transmitted online and stored in the Spanish spondyloarthritis registry (REGISPONSER) Web site. Sociodemographic, clinical features and diagnosis, disease activity, functional status, quality of life, work status, radiographic changes and treatment data were collected by means of validated tools. RESULTS: A total of 402 patients were included; 59% were male, with median age of 48.3 years and median disease duration of 8 years; 68.7% of patients belonged to middle and lower-middle social classes. Eighty-six patients were diagnosed with ankylosing spondylitis (AS), 242 with psoriatic arthritis, 25 with reactive arthritis, 10 with SpA associated with inflammatory bowel disease, 33 with undifferentiated SpA and 6 with juvenile AS. The median score was 2.6 for the Bath AS Functional Index, 3.8 for the Bath AS Disease Activity Index and 5 for the Bath AS Radiology Index. The lower social class patients achieved a worse Bath AS Functional Index than other social classes and a worse Bath AS Disease Activity Index, compared with upper-middle class. CONCLUSIONS: The sociodemographic distribution pattern observed in these SpA patients was similar to that expected in the general population of Argentina, with worse functional capacity and higher disease activity observed in the lower social classes.

Factors associated with disability in patients with rheumatoid arthritis.

OBJECTIVE: Analyze disability determinants in a cohort of Argentine patients with rheumatoid arthritis (RA). MATERIAL AND METHODS: Consecutive patients with RA, according to ACR'87 criteria, were recruited from 6 rheumatology centers. Demographic and socioeconomic data, family history, comorbid diseases, extra-articular manifestations and information about received treatments were provided. Disease activity was assessed using Disease Activity Score 28 (DAS 28) and the Health Assessment Questionnaire (HAQ)-A was used for the functional capacity. Hand and feet radiographs were assessed using Sharp-van der Heijde score. RESULTS: A total of 640 patients with RA were included, of which 85.2% were females. Mean age was 53 years (interquartile range [IQR], 44-62) and mean disease duration was 8 years (IQR, 4-14). DAS 28 mean was 2.72 (IQR, 1.7-3.7) and HAQ-A mean was 0.62 (IQR, 0.13-1.25). Multiple linear regression showed that the main variables associated with disability were DAS 28, radiologic damage and age. Main predictors of functional disability in the multiple logistic regression using severe HAQ (>2) as dependent variable were DAS 28 (OR, 2; P < 0.0001); age (OR, 1; P = 0.008); and structural damage (OR, 1; P = 0.001). CONCLUSIONS: In this population, the disease activity was the variable that showed the highest impact on the physical function. Radiologic damage affected HAQ as the disease progressed.

Evaluación de puntos de corte del Índice de Actividad Simplificado (IAS) mediante su comparación con DAS28 / Evaluation of cut-off points of the “Índice de Actividad Simplificado” (IAS) through comparison with DAS28

Introducción: El IAS es un índice de actividad desarrollado en el 2005 para Artritis Reumatoidea, el cual consiste en la suma de articulaciones dolorosas y tumefactas (de un recuento de 28 articulaciones), el valor en centímetros de la evaluación de actividad de la enfermedad realizada por el paciente y por el médico mediante Escala Analógica Visual (EVA), y el valor de la Velocidad de Sedimentación Globular (VSG) dividido en 10. Objetivo: Identificar puntos de corte del IAS para las categorías de actividad de la AR (remisión, baja, moderada y severa) en base a los puntos de cortes establecidos para DAS28. Métodos: Se incluyeron pacientes consecutivos con AR (ACR´87). Se evaluaron las siguientes variables: recuento de articulaciones dolorosas (28) y tumefactas (28), rigidez matinal, EVA del dolor, EVA global paciente y médico, HAQ-A, proteína C reactiva (PCR) en mg/dl y VSG. Se calcularon DAS28, Clinical Disease Activity Index (CDAI) y el IAS. Análisis estadístico: Correlación por test de Spearman (rs). Análisis por curvas ROC. Análisis de Varianza No Paramétrica de Kruskall- Wallis. Prueba No Paramétrica de Mann-Whitney. Un valor de p ≤0.05 fue considerado significativo. Resultados: Se incluyeron para el análisis 336 pacientes (86% mujeres). El IAS presentó una correlación positiva con CDAI y DAS28 (rs 0.9), recuento articular (rs 0.8), EVA global paciente y médico (rs 0.7), EVA del dolor (rs 0.6), HAQ-A y rigidez matinal (rs 0.5). Un valor de IAS de 5.5 diferenció remisión de baja actividad de la AR (Sensibilidad 90%, Especificidad 66%; Área Bajo la Curva - AUC - 0.78); un valor de 10 separó baja de moderada actividad (Sensibilidad 91%, Especificidad 73% - AUC 0.93); y 25 puntos diferenciaron actividad moderadade severa (Sensibilidad 91%, Especificidad 87% - AUC 0.96). Conclusiones: El IAS presenta buena correlación con otros índices de actividad (DAS28, CDAI).

Peripheral musculoskeletal manifestations in polymyalgia rheumatica.

OBJECTIVES: The objectives of this study were to evaluate the frequency and characteristics of the peripheral musculoskeletal manifestations in polymyalgia rheumatica (PMR), evaluate if PMR with peripheral synovitis represents a subset with a more severe disease, and examine for clinical and laboratory characteristics at onset of PMR that might later predict rheumatoid arthritis (RA). PATIENTS AND METHODS: Patients were diagnosed with PMR according to the 1982 Chuang criteria. Patients were followed up between 1990 and 2002. The following musculoskeletal manifestations at onset and during the follow up were considered: peripheral synovitis, distal extremity swelling with pitting edema, carpal tunnel syndrome, and distal tenosynovitis. RESULTS: Thirty-eight of the 74 patients (51%) showed distal musculoskeletal symptoms: 29 (39%) had peripheral synovitis, 4 (5%) presented pitting edema, 4 (5%) experienced carpal tunnel syndrome, and one (1.3%) had distal tenosynovitis. These manifestations resolved completely after corticosteroid therapy was initiated. Peripheral synovitis was oligoarticular and often transient. The joints most frequently involved were the wrist, metacarpophalangeal, and knee. Erythrocyte sedimentation rate (ESR) was normal in 7 patients. When comparing patients with PMR with and without peripheral synovitis, no statistically significant differences were found in the studied variables. Through the first year of follow up, 7 patients fulfilled the American College of Rheumatology 1987 criteria for RA, 2 patients developed giant cell arteritis, and 3 had associated malignancy. Patients who developed RA had statistically significantly increased presence of persistent synovitis and a smaller decrease in mean ESR after treatment with corticosteroids. CONCLUSION: Fifty-one percent of the patients with PMR presented distal musculoskeletal manifestations, with peripheral synovitis being the most frequent one. Patients with PMR with peripheral synovitis did not represent a high-risk subgroup with more severe disease. Seven patients who developed criteria for seronegative RA within the first year of follow up had presented statistically significant persistent synovitis compared with those who continued as PMR and also showed a smaller initial decrease in mean ESR after steroid treatment was initiated. The absence of persistent arthritis and the benign course of the arthritis permit the distinction of PMR from other inflammatory arthropathies.

Rheumatoid nodulosis: is it a different subset of rheumatoid arthritis?

Rheumatoid nodulosis is an entity that describes a particular variant of polyarthritis associated with early manifestations of palindromic rheumatism, radiologic subchondral bone cysts, and subcutaneous rheumatoid nodules. This study describes the clinical, radiologic, histologic, crystallographic, and laboratory findings, as well as the outcome in a group of 16 patients with rheumatoid nodulosis that were followed for a period of 1-12 years. Six of these patients had an aggressive course and developed classic erosive polyarticular rheumatoid arthritis, while the others continued having episodic arthritis without erosive disease. Seven patients had cholesterol crystals in olecranon bursae containing nodules. Second-line drugs used to control the articular manifestations did not improve the nodulosis, erosive, or cystic subchondral bone changes. Rheumatoid nodulosis mimics several other rheumatic diseases, and in about 40%, classic erosive rheumatoid arthritis develops. The presence of cholesterol crystals in rheumatoid nodules or affected bursae can increase the confusion with other crystal-induced arthritis, in particular, tophaceous monosodium urate gout or xanthomatosis.