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Copyright of Reumatología Clínica is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Introduction: The aim of our work is to assess the prevalence of probable major depressive disorder and/or probable generalized anxiety disorder (pMDD/pGAD) in patients with moderate to severe rheumatoid arthritis (RA), and to evaluate the efficacy of tofacitinib on RA symptoms stratified by baseline pMDD/pGAD status. Methods: Data were pooled from five phase 3 randomized controlled trials (RCTs) and one phase 3b/4 RCT, assessing tofacitinib 5 or 10 mg twice daily (BID), adalimumab (two RCTs), or placebo. pMDD/pGAD was defined as Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) score ≤ 38. Efficacy outcomes over 12 months included least squares mean change from baseline in SF-36 MCS score and Health Assessment Questionnaire-Disability Index, proportions of patients with pMDD/pGAD in those with baseline pMDD/pGAD, and American College of Rheumatology 20/50/70 response, and Disease Activity Score in 28 joints, erythrocyte sedimentation rate remission (< 2.6) rates. Results: A total of 4404 patients with non-missing baseline values were included. Baseline pMDD/pGAD was reported by 44.5%, 39.8%, 45.4%, and 39.1% of patients receiving tofacitinib 5 mg BID, tofacitinib 10 mg BID, adalimumab, and placebo, respectively. SF-36 MCS improvements were greater for tofacitinib versus adalimumab/placebo through month 6, with numerical improvements for tofacitinib versus adalimumab sustained through month 12, when the proportions of patients with baseline pMDD/pGAD who continued to have pMDD/pGAD were reduced. RA efficacy outcomes were generally similar in patients with/without baseline pMDD/pGAD. Conclusions: The percentage of patients with pMDD/pGAD reduced from baseline over 1 year of treatment with tofacitinib or adalimumab. Effective treatment of underlying RA may lead to improvements in depression and anxiety, based on the SF-36 MCS. Specially designed studies using gold-standard diagnostic tools would be warranted to investigate this further. Video Abstract available for this article. Trial Registration: NCT00960440, NCT00847613, NCT00814307, NCT00856544, NCT00853385, NCT02187055. 2KFdHwVqrg4vV_WgRB317c Video Abstract (MP4 204475 KB) Plain Language Summary: Tofacitinib is a medicine used to treat rheumatoid arthritis (swollen and painful joints). A total of 4400 patients with moderate or severe rheumatoid arthritis who were taking part in tofacitinib clinical trials completed a survey about their general health and well-being at that time. We used their answers to determine whether they were likely to have depression or anxiety. We then looked at how common depression or anxiety was in patients with rheumatoid arthritis, and whether having depression or anxiety affected how patients responded to tofacitinib treatment. It is important to note that tofacitinib is not approved for the treatment of depression or anxiety, and these clinical trials were not designed to assess whether tofacitinib improved depression or anxiety symptoms. About 40% of patients likely had depression or anxiety when they started a clinical trial. This percentage decreased among patients who received tofacitinib treatment over a year. Patients treated with tofacitinib showed more improvement in their depression or anxiety than those treated with placebo. Over a year of treatment, tofacitinib improved signs and symptoms of rheumatoid arthritis, for example, the number of swollen or painful joints and fatigue. Having depression or anxiety did not change the way that patients responded to tofacitinib. This research shows how treating rheumatoid arthritis symptoms may also improve depression and anxiety symptoms. However, specially designed studies are needed to confirm this. [ABSTRACT FROM AUTHOR]

Objective: To investigate the association among rheumatoid arthritis (RA), saliva production, and periodontal status. Methods: An observational study was carried out on 103 subjects with RA and 103 without RA matched by sex and age. Rheumatologic evaluation included serological and clinical variables. A full mouth periodontal examination was performed according to the American Academy of Periodontology (1999). Resting and stimulated whole salivary flows were determined after spiting during 5 min. Results: RA was associated with a higher prevalence of severe periodontitis (12% vs. 4%), with a marked reduction in resting and stimulated saliva production, and with a higher prevalence of resting (19% vs. 0%) and also stimulated hyposalivation (54% vs. 10%), compared with the control group. The differences in mean resting and stimulated salivary flows between RA and control groups persisted after the exclusion of people with hyposalivation. Saliva production was not associated with the presence or the severity of periodontal disease, or with the rheumatic clinical characteristics of the patients. Conclusions: More than 50% of people with RA have some degree of reduction in their salivary flows, an affection not associated with the periodontal status or rheumatic activity, which are the expression of the two related inflammatory diseases. The influence of autonomic dysfunction on hyposalivation can be considered. While periodontitis would be a disease-associated comorbidity of RA, poor saliva production should be included among the extra-articular manifestations. Key Points • Rheumatoid arthritis patients are more prone to suffer from periodontitis and/or hyposalivation. • Periodontal disease is more prevalent in people with rheumatoid arthritis and also an association was found between the severities of both pathologies. • More than 50% of people with RA would have some degree of reduction in their salivary flows, an affection not associated with the periodontal status or rheumatic activity. • Reduced saliva production in rheumatoid arthritis patients should be included among the extra-articular manifestations. [ABSTRACT FROM AUTHOR]

Copyright of Journal of the Argentine Society of Rheumatology/Revista de la Sociedad Argentina de Reumatología is the property of Editorial Biotecnologica S.R.L and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Introduction: One target of rheumatoid arthritis (RA) treatment is to achieve early sustained remission; over the long term, patients in sustained remission have less structural joint damage and physical disability. We evaluated Simplified Disease Activity Index (SDAI) remission with abatacept + methotrexate versus abatacept placebo + methotrexate and impact of de-escalation (DE) in anti-citrullinated protein antibody (ACPA)-positive patients with early RA. Methods: The phase IIIb, randomized, AVERT-2 two-stage study (NCT02504268) evaluated weekly abatacept + methotrexate versus abatacept placebo + methotrexate. Primary endpoint: SDAI remission (≤ 3.3) at week 24. Pre-planned exploratory endpoint: maintenance of remission in patients with sustained remission (weeks 40 and 52) who, from week 56 for 48 weeks (DE period), (1) continued combination abatacept + methotrexate, (2) tapered abatacept to every other week (EOW) + methotrexate for 24 weeks with subsequent abatacept withdrawal (abatacept placebo + methotrexate), or (3) withdrew methotrexate (abatacept monotherapy). Results: Primary study endpoint was not met: 21.3% (48/225) of patients in the combination and 16.0% (24/150) in the abatacept placebo + methotrexate arm achieved SDAI remission at week 24 (p = 0.2359). There were numerical differences favoring combination therapy in clinical assessments, patient-reported outcomes (PROs) and week 52 radiographic non-progression. After week 56, 147 patients in sustained remission with abatacept + methotrexate were randomized (combination, n = 50; DE/withdrawal, n = 50; abatacept monotherapy, n = 47) and entered DE. At DE week 48, SDAI remission (74%) and PRO improvements were mostly maintained with continued combination therapy; lower remission rates were observed with abatacept placebo + methotrexate (48.0%) and with abatacept monotherapy (57.4%). Before withdrawal, de-escalating to abatacept EOW + methotrexate preserved remission. Conclusions: The stringent primary endpoint was not met. However, in patients achieving sustained SDAI remission, numerically more maintained remission with continued abatacept + methotrexate versus abatacept monotherapy or withdrawal. Trial Registration: ClinicalTrials.gov identifier, NCT02504268. 6DHXqidsCNRrz-f8FYdsgJ Video abstract (MP4 62241 KB) Plain Language Summary: Patients with rheumatoid arthritis (RA) experience inflamed and damaged joints. RA is an autoimmune disease in which proteins called autoantibodies, particularly anti-citrullinated protein autoantibodies, target the patient's own joint tissue and organs by mistake, leading to symptomatic inflammation. Successful treatment can decrease the disease's activity to a state known as remission. Patients in remission may experience little or no symptoms and it may be possible for some to then be able to decrease their treatment. Here, we report the results of a large, international study that looked at two treatments, abatacept and methotrexate, in patients with RA and anti-citrullinated protein autoantibodies. The study had two parts. Firstly, to see how many patients had success (remission) with weekly abatacept and/or methotrexate treatment, and secondly, to see if remission was maintained when treatment was either continued or decreased and stopped. The study showed that the number of patients in remission 6 months after treatment started was not greatly different between patients treated with both abatacept and methotrexate and those treated with just methotrexate. Those taking abatacept and methotrexate together had better remission rates 1 year later. More patients also stayed in remission when they continued to receive both abatacept and methotrexate compared with those who were just treated with abatacept or when their abatacept treatment was decreased and stopped. More patients stayed in remission when abatacept was decreased than when it was stopped. The results from this study may help determine possible future treatment reduction and/or withdrawal plans for some patients with RA. [ABSTRACT FROM AUTHOR]

Introduction: The Routine Assessment of Patient Index Data 3 (RAPID3) is a patient-reported outcome tool recommended for the assessment of disease activity in patients with rheumatoid arthritis (RA) in clinical practice. This analysis evaluated the long-term effect of upadacitinib vs. comparators on RAPID3 scores in patients with RA in the phase 3 SELECT clinical trial program. Methods: This post hoc analysis included data from five randomized controlled trials (RCTs) in patients receiving upadacitinib 15 mg or 30 mg once daily (QD) as monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). The proportions of patients reporting RAPID3 remission (scores ≤ 3) were assessed at week 60. Correlations between absolute scores for RAPID3 and Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), and 28-joint Disease Activity Score with C-reactive protein (DAS28[CRP]) at week 60 were assessed using Spearman correlation coefficients. Results: A total of 3117 patients were included from the SELECT-NEXT, -BEYOND, -MONOTHERAPY, -COMPARE, and -EARLY trials. By week 60, 32–52% of methotrexate-naïve and csDMARD inadequate responder (IR) patients treated with either upadacitinib 15 mg QD or upadacitinib 30 mg QD reported RAPID3 scores consistent with remission. The proportions were slightly lower in the biologic DMARD-IR SELECT-BEYOND population (19–28%). RAPID3 scores highly correlated (Spearman correlation values ≥ 0.58) with CDAI, SDAI, and DAS28(CRP) scores through week 60 (all p < 0.001). Conclusions: Upadacitinib, as monotherapy or in combination with csDMARDs, was associated with patient-reported remission assessed by RAPID3 over 60 weeks across the SELECT RCTs in patients with RA. Trial registration: SELECT-BEYOND (NCT02706847); SELECT-NEXT (NCT02675426); SELECT-MONOTHERAPY (NCT02706951); SELECT-EARLY (NCT02706873); SELECT-COMPARE (NCT02629159). Plain Language Summary: Rheumatoid arthritis (RA) is a disease that causes inflammation of the joints. Doctors have several ways of assessing how bad a patient's disease is, and these often use a combination of signs and symptoms to develop a 'score'. One method is called RAPID3, which is a score based on an overall assessment of the disease by the patient, the level of pain, and the amount of physical disability. An advantage of RAPID3 is that it is quick and easy to use, and since it uses only patient-reported symptoms, it can be measured easily via telemedicine, without the need for an in-person consultation. In this study, we decided to look into the effect of upadacitinib, a drug used for the treatment of RA, on RAPID3 score in patients with RA. We also investigated whether RAPID3 correlates with other ways of measuring RA severity, including scores that use physician-measured factors such as number of affected joints, as this can help show whether RAPID3 is a valid and useful tool. We found that upadacitinib led to long-term improvements in RAPID3 score, and that results were the same in different studies and patient groups, including patients who had not responded well to other treatments. We also found that RAPID3 correlated well with other measures, i.e., improvements in RAPID3 happened in parallel with improvements in other scores. Overall, these results suggest that RAPID3 can be a useful tool in patients with RA. [ABSTRACT FROM AUTHOR]

Objectives: To characterise infections in patients with rheumatoid arthritis (RA) in ORAL Surveillance.Methods: In this open-label, randomised controlled trial, patients with RA aged≥50 years with ≥1 additional cardiovascular risk factor received tofacitinib 5 or 10 mg two times per day or a tumour necrosis factor inhibitor (TNFi). Incidence rates (IRs; patients with first events/100 patient-years) and hazard ratios (HRs) were calculated for infections, overall and by age (50-<65 years; ≥65 years). Probabilities of infections were obtained (Kaplan-Meier estimates). Cox modelling identified infection risk factors.Results: IRs/HRs for all infections, serious infection events (SIEs) and non-serious infections (NSIs) were higher with tofacitinib (10>5 mg two times per day) versus TNFi. For SIEs, HR (95% CI) for tofacitinib 5 and 10 mg two times per day versus TNFi, respectively, were 1.17 (0.92 to 1.50) and 1.48 (1.17 to 1.87). Increased IRs/HRs for all infections and SIEs with tofacitinib 10 mg two times per day versus TNFi were more pronounced in patients aged≥65 vs 50-<65 years. SIE probability increased from month 18 and before month 6 with tofacitinib 5 and 10 mg two times per day versus TNFi, respectively. NSI probability increased before month 6 with both tofacitinib doses versus TNFi. Across treatments, the most predictive risk factors for SIEs were increasing age, baseline opioid use, history of chronic lung disease and time-dependent oral corticosteroid use, and, for NSIs, female sex, history of chronic lung disease/infections, past smoking and time-dependent Disease Activity Score in 28 joints, C-reactive protein.Conclusions: Infections were higher with tofacitinib versus TNFi. Findings may inform future treatment decisions.Trial Registration Number: NCT02092467. [ABSTRACT FROM AUTHOR]

Objective: To compare the Simplified Ankylosing Spondylitis Disease Activity Score (SASDAS) against the Ankylosing Spondylitis Disease Activity Score (ASDAS) for measuring and categorizing disease activity using data from the EMBARK trial (ClinicalTrials.gov: NCT01258738), a randomized controlled trial of etanercept (ETN) for axial spondyloarthritis (axSpA).Methods: Patients with early active axSpA received ETN 50 mg once weekly (n = 106) or placebo (PBO; n = 109) for 12 weeks in a double-blind manner; they then received open-label ETN for 92 weeks. For this analysis, ASDAS-C-reactive protein (CRP) and SASDAS-CRP were calculated at baseline, week 12, and week 24. The SASDAS was calculated by the linear addition of the ASDAS components without adjustment.Results: A very strong correlation, as determined by the Spearman correlation coefficient, was observed between the ASDAS and SASDAS for continuous variables at baseline and during treatment. For pooled categorical data at baseline, the SASDAS placed 69.9% of patients in the same disease categories as the ASDAS but overestimated for 17.8% of patients and underestimated for 12.2% of patients. A similar pattern was seen postbaseline. Cohen weighted [Formula: see text] statistics for all individual and pooled treatments and timepoints (0.54-0.73) reflected moderate to substantial agreement. The capacity to differentiate between treatments (ie, ETN and PBO/ETN) was higher with the ASDAS (effect size -0.74, 95% CI -1.03 to -0.46) compared with the SASDAS (effect size -0.51, 95% CI -0.79 to -0.23), but sensitivity to change was generally similar.Conclusion: A very strong correlation between the SASDAS and ASDAS was observed when considering continuous variables; however, moderate to substantial agreement was observed for categorical data, and the SASDAS classified a lower proportion of patients as being in the inactive and low disease activity categories. [ABSTRACT FROM AUTHOR]

Rheumatoid arthritis (RA) was significantly associated with increased overall risk of periodontitis, both chronic, inflammatory pathologies leading to connective tissue breakdown and bone destruction. To identify clinical and/or serological variables routinely evaluated during follow-up of people with RA which are associated with the severity of their periodontal disease. An observational, cross-sectional study was carried out, which included RA patients according to ACR/EULAR 2010 criteria having chronic periodontal disease. RA clinical parameters (disease duration, erythrocyte sedimentation rate, serum C-reactive protein, disease activity (DAS28) and rheumatoid factor, presence of bone erosions and rheumatic nodules) and also corticosteroid therapy were considered. Periodontitis was evaluated according to the American Academy of Periodontology (1999) and chronic periodontitis was assessed by full mouth periapical radiographic examination, periodontal probing depth, clinical attachment level and bleeding index. A total of 110 subjects with RA and chronic periodontitis were included. The female/male relation was 5.1, and no significant differences between genres were found in rheumatic or oral variables. RA patients with longer disease duration, higher disease activity and with rheumatic nodules had significantly greater periodontitis severity. Multivariate analysis confirmed that severe periodontitis was associated with DAS283 4.1 (OR 51.4, CI 95% 9.4–281.5) and the presence of rheumatic nodules (OR 6.4, CI 95% 1.3–31.6). Disease activity and rheumatic nodules were strongly associated with severe periodontitis. Based on these findings it would be desirable to include interdisciplinary management at an early stage of RA to ensure comprehensive treatment of both pathologies [ABSTRACT FROM AUTHOR]

Evaluar la adherencia al tratamiento con tofacitinib en pacientes con artritis reumatoide (AR) mediante las dos versiones del autocuestionario Compliance Questionnaire Rheumatology , CQR19 y CQR5, determinar las variables asociadas a la adherencia a tofacitinib y comparar el rendimiento de ambos cuestionarios. Estudio de corte transversal. Se incluyeron pacientes ≥ 18 años de edad con AR (ACR/EULAR 2010) en tratamiento con tofacitinib. Se consignaron datos sociodemográficos, características clínicas de la enfermedad, tratamientos y datos sobre la evaluación de los pacientes. Todos los pacientes completaron los autocuestionarios CQR19 y CQR5. Análisis estadístico : Estadística descriptiva. T-test o Mann Whitney para variables continuas y test de chi cuadrado o test exacto de Fisher para las categóricas. Índice de concordancia kappa. Regresión logística múltiple. Se incluyeron 52 pacientes, 82,7% mujeres, con una edad mediana (m) de 57,7 años, tiempo de evolución de la enfermedad m 16 años. El 63,5% presentaban comorbilidades. El 86,5% de los pacientes estaban tratados con tofacitinib (5 mg dos veces/día) y el 48% recibía tofacitinib en monoterapia. El tiempo m de tratamiento con tofacitinib fue de 13 meses. El 42,3% suspendieron el tratamiento y un solo paciente suspendió definitivamente por falta de provisión. La m de CQR19 fue del 89,5%, y el 84,6% de los pacientes presentaron una adherencia ≥ 80%. Las variables significativamente asociadas con adherencia ≥ 80% fueron la presencia de comorbilidades (p = 0,014) y mayor edad (p = 0,033). Considerando el CQR5, un porcentaje similar de pacientes (82,7%) fueron adherentes al tratamiento, aunque la concordancia con CQR19 fue baja (ƙ: 0,227). En el análisis multivariado, mayor edad fue la única variable independientemente asociada a buena adherencia al tratamiento (p = 0,037). La adherencia al tratamiento con tofacitinib, en ambas formulaciones, fue muy buena. Mayor edad se asoció con mejor adherencia al tratamiento. La concordancia entre los cuestionarios CQR19 y CQR5 fue baja. To evaluate the adherence to treatment with tofacitinib in patients with rheumatoid arthritis (RA) using two versions of the self-questionnaire Compliance Questionnaire Rheumatology, CQR19 and CQR5, to determine the variables associated with adherence to tofacitinib and to compare the performance of both questionnaires. A cross-sectional study was carried out. We included patients ≥ 18 years old, with RA (ACR/EULAR criteria 2010) under treatment with tofacitinib. Sociodemographic data, clinical characteristics, treatment and data on patient evaluation. All the patients completed self-questionnaires CQR19 and CQR5. Statistical analysis: Descriptive statistics. T-test or Mann Whitney to compare the continuous variables, chi2 test or Fisher's exact test for the categorical ones. Kappa concordance index. Multiple logistic regression. We included 52 patients, 82.7% women, with a median (m) age of 57.7 years, disease duration m 16 years, 63.5% had comorbidities. Of the patients, 86.5% were treated with tofacitinib (5 mg BID) and 48% received tofacitinib as monotherapy. The median time of tofacitinib treatment was 13 months, 42.3% suspended treatment, and only one patient permanently stopped treatment due to lack of provision. Median CQR19 was 89.5%, and 84.6% had an adherence ≥ 80%. The variables significantly associated with adherence ≥ 80% were the presence of comorbidities (P =.014) and older age (P =.033). Considering the CQR5, a similar percentage of patients (82.7%) were adherents to treatment, however, the concordance with CQR19 was low. In the multivariate analysis, older age was the only variable independently associated with good adherence to treatment. Treatment adherence to tofacitinib was very good for both presentations. Older age was associated with higher adherence. The agreement between the questionnaires CQR19 and CQR5 was low. [ABSTRACT FROM AUTHOR]

Background: In patients with rheumatoid arthritis (RA), qualitative alterations of low and high-density lipoproteins (LDL and HDL, respectively) might partially explain their increased cardiovascular risk. Tocilizumab has been associated with an increase in lipids, including triglyceride (TG) and cholesterol levels. The aim of this study is to evaluate the effect of tocilizumab on certain LDL and HDL characteristics (oxidized LDL levels, HDL-associated enzymes, chemical composition of both total HDL and HDL3c subpopulation, and their capacity to promote cellular cholesterol efflux) at baseline and 3 months after the start of treatment in patients with RA. Methods: Twenty-eight RA patients (ACR/EULAR 2010 criteria) with indication of treatment with tocilizumab were included in the present study. Clinical assessment [Health assessment questionnaire (HAQ)], disease activity score 28 (DAS28), high-sensitivity C reactive protein (hsCRP) concentration, lipid profile, and lipoprotein (a) [Lp(a)] levels were evaluated in all patients at baseline and after 3 months of treatment with tocilizumab. Lipoprotein characteristics were evaluated through the levels of oxidized LDL (OxLDL), the activity of paraoxonase (PON) 1, the composition of total HDL and small, dense HDL3c subpopulation, and their ability to promote cellular cholesterol efflux. Results: After 3 months of treatment with tocilizumab, HAQ (− 23%, p < 0.05), DAS28 (− 49%, p < 0.001), and hsCRP (− 94%, p < 0.01) levels decreased significantly. Total cholesterol (TC), LDL-C, non-HDL-C, and apo B levels showed a significant increase after treatment (TC: + 7.0%, p < 0.01; LDL-C: + 10%, p < 0.01; non-HDL-C: + 9.9%, p < 0.01; and apo B: + 9.6%, p < 0.05). Decreases in Lp(a) and OxLDL levels were also observed after treatment [Lp(a): − 50%, p < 0.01; and oxLDL: − 5.4%, p < 0.05]. The latter was in accordance with the increment detected in PON activity. No changes were observed in HDL capacity to promote cholesterol efflux (p > 0.05) in the whole group. Conclusions: Treatment with tocilizumab reduced hsCRP levels and displayed positive effects on certain lipoprotein-related parameters, such as a potent decrease inLp(a) and a reduction in OxLDL levels. Moreover, HDL capacity to promote cellular cholesterol efflux was maintained after 3 months of treatment. [ABSTRACT FROM AUTHOR]

Rheumatoid Arthritis (RA) is a chronic inflammatory autoimmune systemic disease that preferentially affects small and large joints with a progressive course and can become deforming and disabling. In recent years, much progress has been made in the evaluation of inflammation and disease activity, however, there are other factors that have a high impact on the quality of life of these patients, such as depression, anxiety, fatigue, sleep disorders, suicidal behavior, fibromyalgia, sexual activity, sarcopenia, frailty, cachexia and obesity that are not always evaluated by rheumatologists. This review shows that the evaluation and timely detection of these aspects in patients with RA could interfere with the prognosis and improve their quality of life. [ABSTRACT FROM AUTHOR]

To validate the Quality of Life-Rheumatoid Arthritis Scale II (QOL-RA II) in an Argentinean cohort of patients with rheumatoid arthritis (RA). Patients ≥ 18 years old, with a diagnosis of RA according to ACR-EULAR 2010 criteria, were included in a cross-sectional study. Sociodemographic data, comorbidities, RA characteristics, disease activity, and current treatment were registered. Questionnaires were administered, including EQ-5D-3 L, QOL-RA II, HAQ-A, and PHQ-9. The QOL-RA II was re-administered in 20 patients to evaluate reproducibility. Four hundred and thirty patients were included. Median QOL-RA was 6.6 (IQR 5.3–8). Mean time to complete it was 1.7 ± 0.57 min and to calculate it was 12 ± 1.7 s. 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) and moderate with DAS28 (Rho, 0.38), and CDAI (Rho, 0.46). Worse quality of life was observed in patients not doing physical activity, unemployed, and current smokers. 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. QOL-RA II demonstrated good construct validity, reproducibility, and reliability. It was easy to complete and calculate and does not require a license for its use, thus making it the optimal tool for assessing the quality of life in Spanish-speaking patients with RA. Key Points • The evaluation of quality of life is very important in patients with Rheumatoid Arthritis. • Most of the questionnaires used to assess the quality of life require a license to use. • QOL-RA II is a valid and simple questionnaire to evaluate the quality of life of patients with RA and does not require a license for its use. [ABSTRACT FROM AUTHOR]

Objective: To evaluate longterm drug survival (proportion of patients still receiving treatment) and discontinuation of etanercept (ETN), infliximab (IFX), adalimumab (ADA), certolizumab pegol (CZP), and golimumab (GOL) using observational data from patients with rheumatoid arthritis (RA).Methods: Following a systematic literature review, drug survival at 12 and 12-24 months of followup was estimated by summing proportions of patients continuing treatment and dividing by number of studies. Drug survival at ≥ 36 months of followup was estimated through Metaprop.Results: There were 170 publications included. In the first-line setting, drug survival at 12 months with ETN, IFX, or ADA was 71%, 69%, and 70%, respectively, while at 12-24 months the corresponding rates were 63%, 57%, and 59%. In the second-line setting, drug survival at 12 months with ETN, IFX, or ADA was 61%, 69%, and 55%, respectively, while at 12-24 months the corresponding rates were 53%, 39%, and 43%. Drug survival at ≥ 36 months with ETN, IFX, or ADA in the first-line setting was 59% (95% CI 46-72%), 49% (95% CI 43-54%), and 51% (95% CI 41-60%), respectively, while in the second-line setting the corresponding rates were 56% (95% CI 52-61%), 48% (95% CI 40-55%), and 41% (95% CI 36-47%). Discontinuation of ETN, IFX, and ADA at 36 months of followup was 38-48%, 42-62%, and 38-59%, respectively. Data on CZP and GOL were scarce.Conclusion: After > 12 months of followup, more patients with RA receiving ETN remain on treatment compared with other tumor necrosis factor inhibitors. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficacy and safety of ustekinumab in 3 randomized, placebo‐controlled studies in patients with axial spondyloarthritis (SpA). Studies 1 and 2 included patients with radiographic axial SpA (anti–tumor necrosis factor [anti‐TNF]–naive patients and patients with inadequate response or intolerance to anti‐TNF, respectively); study 3 patients had nonradiographic axial SpA. Methods: In all 3 studies, patients were randomly assigned (1:1:1) to receive subcutaneous ustekinumab at 45 mg or 90 mg or placebo up to 24 weeks, after which placebo‐treated patients were rerandomized to receive ustekinumab at 45 mg or 90 mg. The primary end point in studies 1 and 2 was the proportion of patients who met the Assessment of SpondyloArthritis international Society criteria for 40% improvement in disease activity (achieved an ASAS40 response). The primary end point in study 3 was the proportion of patients who achieved an ASAS20 response. Other disease activity and safety measures were also evaluated. A week 24 analysis of study 1 was preplanned to determine continuation of studies 2 and 3. Results: For study 1, the primary and major secondary end points were not met, and the study was discontinued. As a result, studies 2 and 3 were prematurely discontinued before they were fully enrolled. For all 3 studies, neither ustekinumab dose group demonstrated clinically meaningful improvement over placebo on key efficacy end points. The proportion of patients experiencing adverse events in the ustekinumab groups was consistent with that in previous studies. Conclusion: In these 3 placebo‐controlled trials, efficacy of ustekinumab in the treatment of axial SpA was not demonstrated. The safety profile was consistent with that of studies in other indications. [ABSTRACT FROM AUTHOR]

Objective: The blockade of inflammatory mediators produced by biological therapies is associated with an increased risk of opportunistic infections, as for example Mycobacterium tuberculosis (MT). Given the endemic situation of tuberculosis (TB) in some countries and immunosuppression/anergy of patients with chronic inflammatory arthritis, we wonder whether it is necessary to monitor the MT infection after starting the biological treatment. To evaluate the frequency of the tuberculin skin test (TST) conversion and its association with an active TB infection and other disease variables. Methods: Patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), and spondyloarthritis (SpA) receiving treatment with anti-TNF, tocilizumab, and/or abatacept agents were included into the study. Patients had to have a negative TST (<5 mm) at the baseline, and a second TST was performed 2-22 months after the initiation of biologic therapy. The TST conversion was considered as a variation =5 mm between the two TSTs performed within an interval between 2 months and 2 years. Results: A total of 85 patients were included into the study, and 78.8% were women, with a median schooling duration of 12 years. A total of 74.1% of patients had RA, 16.5% psoriatic arthritis, and 4.7% AIJ and ankylosing spondylitis. Regarding treatment, 75.3% received anti-TNF therapy (31.8% etanercept, 21.2% adalimumab, 17.6% infliximab, 3.5% golimumab, and 1.2% certolizumab), 15.3% tocilizumab, and 9.4% abatacept. Eight patients (9.4%) developed a TST conversion. The shift was more frequent in men (62.5%) than in women (37.5%) (p=0.009), and in those with a prolonged disease duration (X 226±109 vs X130±105 [p=0.017]). This association remained after adjusting for other variables. All patients who developed a TST conversion received prophylactic isoniazid, and only one patient with other risk factors developed active TB. Conclusion: The frequency of a TST conversion in patients with chronic inflammatory arthritis was low and was associated with male gender and longer disease duration. [ABSTRACT FROM AUTHOR]

Objective: The blockade of inflammatory mediators produced by biological therapies is associated with an increased risk of opportunistic infections, as for example Mycobacterium tuberculosis (MT). Given the endemic situation of tuberculosis (TB) in some countries and immunosuppression/anergy of patients with chronic inflammatory arthritis, we wonder whether it is necessary to monitor the MT infection after starting the biological treatment. To evaluate the frequency of the tuberculin skin test (TST) conversion and its association with an active TB infection and other disease variables. Methods: Patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), and spondyloarthritis (SpA) receiving treatment with anti-TNF, tocilizumab, and/or abatacept agents were included into the study. Patients had to have a negative TST (<5 mm) at the baseline, and a second TST was performed 2-22 months after the initiation of biologic therapy. The TST conversion was considered as a variation ≥5 mm between the two TSTs performed within an interval between 2 months and 2 years. Results: A total of 85 patients were included into the study, and 78.8% were women, with a median schooling duration of 12 years. A total of 74.1% of patients had RA, 16.5% psoriatic arthritis, and 4.7% AIJ and ankylosing spondylitis. Regarding treatment, 75.3% received anti-TNF therapy (31.8% etanercept, 21.2% adalimumab, 17.6% infliximab, 3.5% golimumab, and 1.2% certolizumab), 15.3% tocilizumab, and 9.4% abatacept. Eight patients (9.4%) developed a TST conversion. The shift was more frequent in men (62.5%) than in women (37.5%) (p=0.009), and in those with a prolonged disease duration (X 226±109 vs X130±105 [p=0.017]). This association remained after adjusting for other variables. All patients who developed a TST conversion received prophylactic isoniazid, and only one patient with other risk factors developed active TB. Conclusion: The frequency of a TST conversion in patients with chronic inflammatory arthritis was low and was associated with male gender and longer disease duration. [ABSTRACT FROM AUTHOR]

The Qualisex questionnaire was developed and validated to assess sexuality in patients with rheumatoid arthritis. To the best of our knowledge, there is no instrument to evaluate sexuality in axial spondyloarthritis (axSpA). For this reason, the objective of this study was to validate and adapt the Qualisex questionnaire in axSpA and evaluate the impact of the disease on patients’ sexuality. Cross sectional study. Consecutive patients, with ≥ 21 years of age, diagnosed with axSpA according to ASAS’09 criteria were included. Sexual health was assessed using the Qualisex questionnaire. The original version was translated to Spanish and adapted to axSpA. Internal consistency, and test re-test reliability was calculated. Criterion and construct validity were assessed by comparing the Qualisex with parameters of disease activity functional capacity and quality of life. 61 patients were invited to participate in the study, 11 of whom refused. 50 patients were included; 40 (80%) were males, with a median age of 47 years (IQR 21-72) and a median disease duration of 13 years (IQR 1-46). Reproducibility was excellent with an ICC of 0.99 (95% CI 0.65-1). The Qualisex had a good correlation with different disease evaluation parameters. The Qualisex was significantly higher among women (5.4 in women vs. 2.5 in men, p = 0.02), unemployed (4.7 in unemployed vs. 2.3 in employed, p = 0.01), in patients with higher disease activity (4.2 in active patients vs. 1.6 in inactive patients, p = 0.01), and it was lower in patients receiving biologic therapy (BT) (1.9 with BT vs. 3.8 without BT, p = 0.01). Multivariable analysis showed that female sex, longer disease duration and higher disease activity were independently associated with a greater impact on sexuality. The Qualisex adapted to axSpA is a valid and reliable questionnaire. Female axSpA patients, those with longer disease duration and higher disease activity presented a worse sexual life. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to compare the frequency of comorbidities among patients with ax-SpA in the general population and to evaluate the impact of these comorbidities on the functional status and quality of life. Methods: Patients with ax-SpA fulfilling the modified New York 1984 criteria for Ankylosing Spondylitis (AS) and/or Assessment of SpondyloArthritis International Society (ASAS) 2009 criteria for patients with ax-SpA belonging to the ESPAXIA cohort ("Estudio de eSPondiloartritis Axial Irep Argentina") were included. Data regarding sociodemographics, comorbidities, and disease characteristics were recorded. Statistical analysis included descriptive statistics using the student t-test, Chi-square, and Fisher's exact test. Multiple logistic regression analysis was performed. A p value <0.05 was considered significant. Results: In total, 86 patients were included, 80% were males with a median age of 46 years (interquartile range [IQR]: 32-58) and a median disease duration of 19 years (IQR: 13-31). The most frequent comorbidities reported were hypertension (26.7%), gastritis (25.6%), dyslipidemia (24.4%), gallstone (12.8%), nephrolithiasis (11.6%), anemia (10.5%), hypothyroidism (7%), and type 2 diabetes (6%). The prevalence of these comorbidities in patients with ax-SpA was similar to that observed in the general population, with the exception of a higher frequency of nephrolithiasis among patients with ax-SpA (11.6% in ax-SpA vs 3.96% in the general population). We further categorized the study population into three groups: patients with no comorbidities, those with 1 or 2 comorbidities, and those with =3 comorbidities. The presence of =3 comorbidities was associated with older age, longer disease duration, worse disease activity, functional status, and quality of life as compared with the patients without comorbidities. In multivariate analysis, older age was the only variable independently associated with the presence of comorbidities. Conclusion: The frequency of comorbidities in the ax-SpA cohort was high, and the only variable associated with a higher prevalence of comorbidities was older age. Nephrolithiasis was more frequent in the patients with ax-SpA than that reported in the general population. [ABSTRACT FROM AUTHOR]

Abstract: Aim: To evaluate etanercept in patients from Latin America, Central/Eastern Europe, and Asia with non‐radiographic axial spondyloarthritis (nr‐axSpA). Methods: A subset analysis was performed on nr‐axSpA patients from Argentina, Colombia, the Czech Republic, Hungary, Russia and Taiwan who were enrolled in EMBARK (NCT01258738). Patients received either etanercept 50 mg or placebo once weekly. The primary endpoint was proportion of patients achieving 40% improvement from baseline based on Assessment of SpondyloArthritis International Society (ASAS) criteria. Secondary endpoints included other efficacy assessments, health‐related quality of life (HRQoL) and safety. Results: Of the 117 patients in this subset, 59 were treated with etanercept and 58 received placebo. At week 12, numerically greater improvements from baseline were observed for all efficacy endpoints in etanercept‐treated patients compared with those receiving placebo. Statistically significant differences between the two treatment groups were observed for proportion of patients achieving ASAS40 (P = 0.0413, at week 8), ASAS5/6 (P = 0.0126), Ankylosing Spondylitis Disease Activity Score ‐ C‐reactive protein (CRP) inactive disease (P = 0.0093), Spondyloarthritis Research Consortium of Canada magnetic resonance imaging of sacroiliac joint scores (P = 0.0014), high‐sensitivity CRP (P=0.032), and erythrocyte sedimentation rate (P = 0.0082). Statistically significant improvements in the etanercept‐treated group compared with placebo group were observed for nocturnal back pain (P = 0.040), total back pain (P = 0.025), physician global assessment of disease (P = 0.023), and Work Productivity and Activity Impairment Questionnaire percent impairment while working (P = 0.047). Adverse events were similar between the two treatment groups. Conclusions: In this subset of patients with nr‐axSpA from Latin America, Central/Eastern Europe, and Asia, treatment with etanercept, compared with placebo, resulted in improved disease symptoms and patient HRQoL. Etanercept was well tolerated. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the long-term clinical and imaging efficacy of etanercept in patients with early, active nonradiographic axial spondyloarthritis (SpA).Methods: Adult patients who satisfied the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial SpA (but not the modified New York radiographic criteria), with symptom duration >3 months to <5 years, and who were unresponsive to ≥2 nonsteroidal antirheumatic drugs (NSAIDs) received double-blind etanercept 50 mg/week or placebo for 12 weeks, followed by open-label etanercept 50 mg/week to week 104. Clinical, magnetic resonance imaging (MRI; Spondyloarthritis Research Consortium of Canada [SPARCC] scores), and safety outcomes at 104 weeks were analyzed.Results: Of 215 randomized patients (etanercept: n = 106; placebo: n = 109), 205 entered the study (etanercept/etanercept: n = 100; placebo/etanercept: n = 105) and 169 completed the open-label period (etanercept/etanercept: n = 83; placebo/etanercept: n = 86). At week 104, 61 of 81 (75%), 49 of 81 (61%), 48 of 80 (60%), and 57 of 81 (70%) patients who received etanercept throughout the trial achieved ASAS20, ASAS40, Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease, and Bath Ankylosing Spondylitis Disease Activity Index criteria for 50% improvement (BASDAI 50) scores, respectively (observed). From baseline to week 104, continued improvements in clinical outcomes (ASDAS-C-reactive protein: -1.5 and -1.7; BASDAI: -3.3 and -3.8 [last observation carried forward]), and SPARCC MRI scores (sacroiliac joint: -6.0 and -3.4; spinal: -2.1 and -0.8 [observed]) were seen in patients receiving etanercept/etanercept and placebo/etanercept. During the study, 8% in the etanercept/etanercept group and 7% in the placebo/etanercept group had serious adverse events; no new safety signals were seen.Conclusion: Patients with early, active nonradiographic axial SpA and an inadequate response to at least 2 NSAIDs demonstrated improvement in clinical and imaging outcomes that were sustained through 104 weeks of etanercept treatment. [ABSTRACT FROM AUTHOR]

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The aim of this study was to analyze the influence of nucleotide transition (G/A) in position −2518 of the MCP-1 gene related to the susceptibility of developing RA. Two hundred twenty-three consecutive RA patients according to 2010 ACR/EULAR criteria were included; 120 healthy subjects were used as controls. MCP-1 −2518 A/G polymorphism (AG + GG) was present in 162 (72.6 %) RA patients and in 63 (52.5 %) healthy subjects [OR 2.44 (IC95% 1.53-3.88, p = 0.0002)]; associations for heterozygotes and homozygotes were OR 1.92 (IC95% 1.19-3.15, p = 0.001) and OR 5.19 (IC95% 2.34-11.51, p = 0.001), respectively. In Argentine patients, MCP-1 gene polymorphism confers susceptibility for developing RA. [ABSTRACT FROM AUTHOR]

Some reports describe an increased mortality in patients with ankylosing spondylitis (AS) compared to the general population. The aims of this study were to evaluate the cumulative survival in patients with AS and to establish possible factors associated with mortality. In cross-sectional retrospective study, AS patients were included according to 1984 modified NY criteria, in the 2000-2010 period, the prevalence of mortality was determined by review of medical records, telephone contact, family reports, and death certificates, and it was compared with mortality in Argentina's general population. One hundred twenty-seven patients were studied, 96 (75.6 %) were male, median age 49 years (interquartile range (IQR) 34-60) and median disease duration 8 years (IQR 4-17). During the follow-up period, 9 patients died (7.1 %). The median estimated survival from diagnosis of AS was 39 years (IQR 34-50) and median cumulative survival was 76 years (IQR 74-85). Cardiovascular disease was the most frequent cause of death (5/9 patients). Deceased patients had a mean age and a mean AS disease duration significantly higher than living patients (68.1 ± 12.4 years vs 46.4 ± 15.09 years, p = 0.0001 and 33 ± 13.7 years vs 12 ± 10.7 years, p = 0.001, respectively), higher frequency of total surgeries [3/5 (60 %) vs 5/105 (4.76 %), p = 0.002] and cauda equina syndrome [3/6 (50 %) vs 2/116 (1.72 %), p = 0.001], respectively. Frequency of mortality in AS patients was higher than the crude mortality rate of Argentina's general population in the same period, with cardiovascular cause being the most frequent one. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficacy and safety of etanercept (ETN) after 48 weeks in patients with early active non-radiographic axial spondyloarthritis (nr-axSpA).Methods: Patients meeting Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA, but not modified New York radiographic criteria, received double-blind ETN 50 mg/week or placebo (PBO) for 12 weeks, then open-label ETN (ETN/ETN or PBO/ETN). Clinical, health, productivity, MRI and safety outcomes were assessed and the 48-week data are presented here.Results: 208/225 patients (92%) entered the open-label phase at week 12 (ETN, n=102; PBO, n=106). The percentage of patients achieving ASAS40 increased from 33% to 52% between weeks 12 and 48 for ETN/ETN and from 15% to 53% for PBO/ETN (within-group p value <0.001 for both). For ETN/ETN and PBO/ETN, the EuroQol 5 Dimensions utility score improved by 0.14 and 0.08, respectively, between baseline and week 12 and by 0.23 and 0.22 between baseline and week 48. Between weeks 12 and 48, MRI Spondyloarthritis Research Consortium of Canada sacroiliac joint (SIJ) scores decreased by -1.1 for ETN/ETN and by -3.0 for PBO/ETN, p<0.001 for both. Decreases in MRI SIJ inflammation and C-reactive protein correlated with several clinical outcomes at weeks 12 and 48.Conclusions: Patients with early active nr-axSpA demonstrated improvement from week 12 in clinical, health, productivity and MRI outcomes that was sustained to 48 weeks.Trial Registration Number: NCT01258738. [ABSTRACT FROM AUTHOR]

Aim: A polymorphism in the tumor necrosis factor-alpha (TNF-α) promoter region has been associated with disease susceptibility and progression in rheumatoid arthritis (RA). The presence of an adenosine (TNF2 allele) instead of a guanine (TNF1 allele) at position -308 may be responsible for a general increase in the transcriptional activity of the TNF-α gene. Our aim was to evaluate the association of the TNF2 allele with the risk of disease development and/or progression of RA in an Argentine population cohort. Methods: Two hundred and twenty-three consecutive patients with RA according to the 1987 criteria of the American College of Rheumatology were included in the study. Clinical variables, Disease Activity Score 28, Health Assessment Questionnaire and Rheumatoid Arthritis Quality of Life were recorded. The radiographic erosions were determined by the method of Sharp/van der Heijde. A group of 111 healthy subjects matched by sex and age was used as a control. All samples were genotyped for the -308 G/A TNF-α polymorphism. Results: No significant differences were observed either in the frequency of the TNF2 allele or in the genotypic distributions of the -308 G/A TNF-α polymorphism (P > 0.05) between the control group and the RA patients. No association was found between the TNF2 allele and the variables related to the course and outcome of the disease (P > 0.05). Conclusion: In this cohort of Argentinean patients with RA, the TNF2 allele was neither associated with susceptibility to the disease nor was it associated with the variables related to the course and outcome of the disease. Key words: -308 G/A TNF-α, polymorphism, rheumatoid arthritis, tumor necrosis factor-alpha. [ABSTRACT FROM AUTHOR]

In psoriatic arthritis (PsA), genetic factors play a substantial role in disease susceptibility as well as in its expression. This study aims to determine the distribution of class I and class II HLA antigens in PsA patients and secondly to analyze the influence of genetic factors in the clinical expression of the disease. Consecutive PsA patients (CASPAR criteria) with less than 1 year of disease duration were included. Sociodemographic and clinical data were recorded. Blood samples were obtained, DNA was extracted by polymerase chain reaction (PCR), and class I (A, B, and C) and class II (DR) HLA antigens were determined by oligotyping. A control group of 100 nonrelated healthy controls from the general population served as control. p values were corrected (pc) according to the number of alleles tested. A total of 73 patients were included, 37 were females (50.7 %) with a median disease duration of 72 months (interquartile range (IQR) 24-149). Thirty-three patients (45.2 %) had a family history of psoriasis. When analyzing all the class I and class II HLA antigens, a significantly higher frequency of B38 (odds ratio (OR) 2.95, p = 0.03) and Cw6 (OR 2.78, p = 0.009) was found in PsA patients compared to the control group. On the contrary, the HLA- A11 (OR 0.14, p = 0.04) and B7 (OR 0.31, p = 0.03) were significantly more frequent among healthy controls. Furthermore, B18 was significantly more frequent in patients with early arthritis onset (less than 40 years): seven patients (22.6 %) with early onset compared to two patients (4.8 %) with late onset ( p = 0.03). No association between HLA- B27 and spondylitis or HLA- DR4 with polyarticular involvement was observed. The HLA- B38 and Cw6 alleles are associated with a greater PsA susceptibility in Argentine population. [ABSTRACT FROM AUTHOR]

The objective of the study was to evaluate work disability and its main associated factors in patients with early arthritis. Argentine Consortium for Early Arthritis (CONAART) is the first early arthritis cohort in Argentina. Patients with one or more swollen joints and less than 2 years of symptoms duration were followed up prospectively in 13 departments of rheumatology. Social, demographic, familiar, clinical, and laboratory data were recollected. At first year and every year, X-rays of hands and feet were performed and working status and pharmaco-economic data were recollected. Work status (employed, unemployed, retired) and type of work were assessed by direct interview using a predesigned questionnaire. Eight hundred forty-eight patients were included, rheumatoid arthritis (RA) = 483 (57 %)and undifferentiated arthritis (UA) = 365 (43 %), 694 (81.8 %) were women, median age was 46 years (interquartile range (IQR) 35-55.7) and median symptoms duration 7 months (IQR 3-12). Patients with RA had significantly higher disease activity, worse functional capacity and quality of life, and more severe radiological damage compared to UA patients. However work disability (unemployed patient) was comparable between groups (RA = 21 % versus UA = 18.6 % p = NS). In both groups, unemployed patients had higher disease activity score of 28 joints (DAS28), worse Health Assessment Questionnaire (HAQ) values, and less years of formal education ( p value <0.005 in all comparisons). Radiological damage was greater in unemployed patients but this difference did not reach statistical significance. In multivariate analysis, disease activity was the main variable associated with unemployment in both groups. Joint involvement was the main cause of work disability in this cohort of patients with early arthritis, independently of the final diagnosis. Key messages: 1. Work disability is higher in patients with inflammatory arthritis as compared to the general population. 2. Prevalence of work disability is comparable among patients with undifferentiated and rheumatoid arthritis. 3. Disease activity is the main disease variable associated with work disability. [ABSTRACT FROM AUTHOR]

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 6.0-21.0; M 15.0, R 7.0-24.0; M 10.0, R 5.0-17.0; p = 0.006). Current smokers had higher rheumatoid factor titer ( M 160.0, R 80.0-341.0) than former smokers ( M 146.8, R 6.03-255.5) and never smokers ( M 15.0, R 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. [ABSTRACT FROM AUTHOR]

The most frequently reported symptoms by patients with ankylosing spondylitis (AS) are pain, stiffness, and fatigue. Previous studies have estimated a 63 % prevalence of fatigue in AS, with a low correlation of fatigue with pain and functional capacity. The objective of this study is to assess fatigue prevalence in AS patients and establish the main associated factors. A case-control study including AS patients according to New York modified criteria was carried out. The control group included individuals of the general population without rheumatic conditions, matched by gender, age, and socioeconomic level. Disease-related variables were recorded. Functional capacity, disease activity, and quality of life were assessed using Bath Ankylosing Spondylitis Funcional Index (BASFI), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and ankylosing spondylitis quality of life (ASQoL). CES-D questionnaire was used to evaluate depression and fatigue severity scale (FSS) to evaluate fatigue. Sixty-four consecutive AS patients and 95 controls were included. Patients' median age was 44 years (interquartile range (IQR), 33.25-53), 89.1 % were male, and had a median disease duration of 17 years (IQR, 10.3-25). Fatigue prevalence in AS was 73.4 % compared to 30.5 % in the control group ( p < 0.001; OR, 2.08 (95 % CI, 1.53-2.83)). Furthermore, fatigue in AS correlated with ASQoL ( r = 0.65), BASFI ( r = 0.52), BASDAI ( r = 0.52), and depression ( r = 0.51), whereas no correlation with age or disease duration was found. In the linear regression analysis using fatigue as the dependent variable, depression was the only associated variable ( p = 0.01). No association with age, gender, disease duration, BASDAI, BASFI, or presence of comorbidities was found. Finally, BASDAI fatigue question correlated with the FSS ( r = 0.55). Fatigue was significantly more prevalent in AS than in healthy controls. The main determinant factor of fatigue was the presence of depression, explaining 30 % of its variability. Recognizing these factors could have important therapeutic implications. [ABSTRACT FROM AUTHOR]

To determine the prevalence of and associated factors to work instability (WI) in rheumatoid arthritis (RA) Argentinean patients. Observational cross-sectional study that assessing employment status in currently working RA patients. They answered the validated version of RA work instability scale (RA-WIS). High-risk WI was considered when RA-WIS was ≥17. Factors associated with high-risk WI were examined by univariable and multivariable analysis. Four-hundred and fifty RA patients were enrolled; of these, 205 patients were currently employed, but only 172 have completed questionnaires required [RA-WIS and health assessment questionnaire (HAQ-A)]. Their mean age was 49.3 ± 10.8 years; 81.3 % were female; and their mean disease duration was 8.1 ± 7.2 years. Fifty-two percent of patients were doing manual work. The mean RA-WIS score was 11.4 ± 6.8, and 41 % of patients had a high-risk WI. High-risk WI was associated with radiographic erosions ( p < 0.001) and HAQ-A >0.87 ( p < 0.001) in the univariable analysis, whereas in the multivariable logistic regression analysis the variables associated with a high-risk WI were as follows: HAQ-A >0.87 [odds ratio (OR) 12.31; 95 % CI 5.38-28.18] and the presence of radiographic erosions (OR 4.848; 95 % CI 2.22-10.5). In this model, having a higher monthly income (OR 0.301; 95 % CI 0.096-0.943) and a better functional class (OR 0.151; 95 % CI 0.036-0.632) were protective. Forty-one percent of RA working patients had high-risk WI. The predictors of high RA-WIS were HAQ-A ≥0.87 and radiographic erosions, whereas having a better functional class and have higher incomes were protective. [ABSTRACT FROM AUTHOR]

The aim of this study is to determine the prevalence of psoriatic arthritis (PsA) according to Classification of Psoriatic Arthritis (CASPAR) criteria, Assessment of Spondyloarthritis International Society (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 % had nail involvement. Seventeen patients had peripheral arthritis as follows: nine mono/oligoarticular and eight polyarthritis. Median arthritis duration was of 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. [ABSTRACT FROM AUTHOR]

Background Over the last decade, significant progresses have been achieved in the development and validation of new tools for the evaluation of disease activity in axial spondyloarthritis (SpA). Despite they play a key role in the assessment of these patients, the calculation scores are relatively complex and difficult to be quickly assessed in the busy daily clinical practice. Objectives To test the construct validity of the Simplified Ankylosing Spondylitis Disease Activity Score (SADSAS) to define disease activity and compare its internal and external responsiveness with the Ankylosing Spondylitis Disease Activity Score (ASDAS) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in patients with axial SpA. Methods The patient cohort comprised 397 consecutive axial SpA patients who had never been treated with tumor necrosis factor (TNF) blockers. Clinical and laboratory outcome assessments were performed at baseline, and at week 24. The following parameters were evaluated: BASDAI, ASDAS-CRP, ASDAS-ESR, and SASDAS. Construct convergent validity was evaluated by correlating SASDAS with ASDAS ERS/CRP, BASDAI, Bath Ankylosing Spondylitis Functional Index (BASFI) and EuroQol five-dimensional (EQ-5D) questionnaire. One hundred and fifty-six patients were observed longitudinally for 6 months. Responsiveness was assessed after six months of treatment with sulfasalazine (SSZ) or biologics. Internal responsiveness was evaluated by using the effect size (ES) and standardized response mean (SRM). External responsiveness was investigated by receiver operating characteristic (ROC) analysis. Change scores were compared by calculating paired t-test statistic for the difference. Results In testing for convergent validity a strong correlations (p < 0.0001) were observed between both SASDAS and ASDAS-ESR (r = 0.835), and ASDAS-CRP (r = 0.805). Strong correlations (p < 0.0001) were also found between SASDAS and BASDAI score (r = -0.886), SASDAS and BASFI scores (rho = 0.588) and SASDAS and EQ-5D scores (rho = -0.579). The cross-classification showed a significant overall agreement (defined as the percentage of observed exact agreements) for SASDAS vs ASDAS-ESR (weighted k = 0.704) and for SASDAS vs ASDAS-CRP (k = 0.661). The most efficient composite measure in detecting change was the ASDAS-CRP (ES 1.95 and SRM 0.97). The responsiveness of SASDAS was slightly higher to ASDAS-ESR with an ES of 1.62 and 1.33, and an SRM of 0.88 and 0.71, respectively. The BASDAI appear to be the less responsive (ES = 0.93 and SRM = 0.52). The area under ROC curve of the SASDAS gives similar results to those provided by ASDAS CRP/ESR. The score changes of all combinations were highly correlated (p < 0.0001). Conclusions The new SASDAS is a highly effective measure in assessing disease activity and it showed comparable internal and external responsiveness with respect to the ASDAS ESR/CRP response criteria in patients with axial SpA. SASDAS is easy to calculate and, therefore, appear suitable for clinical decision making, epidemiologic research, and clinical trials. [ABSTRACT FROM AUTHOR]

Objective To assess the efficacy of etanercept in the treatment of early active nonsteroidal antiinflammatory drug (NSAID)-refractory nonradiographic axial spondyloarthritis (SpA). Methods The study population consisted of patients who met the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial SpA but not the modified New York radiographic criteria for ankylosing spondylitis (as assessed by a radiologist at the central trial site), had a symptom duration of >3 months but <5 years, had a score of ≥4 on the Bath Ankylosing Spondylitis Disease Activity Index, and had been treated unsuccessfully with ≥2 NSAIDs. Patients were randomized to receive etanercept 50 mg/week or placebo and continued background NSAID treatment for 12 weeks (double-blind study); during the subsequent open-label period, all patients received etanercept 50 mg/week. The primary study end point was meeting the ASAS criteria for 40% improvement (ASAS40) at week 12. Magnetic resonance imaging (MRI) of the sacroiliac joints and spine was performed at baseline and week 12. Results One hundred six patients were randomized to the etanercept group and 109 to the placebo group. Of the 215 patients, the mean ± SD age at baseline was 32.0 ± 7.8 years, 154 (72%) were HLA-B27 positive, and 174 (81%) had MRI-confirmed sacroiliitis. At 12 weeks, the proportion of patients with improvement according to the ASAS40 was significantly higher in the etanercept group than in the placebo group (34 of 105 [32%] versus 17 of 108 [16%]; P = 0.006). Patients who received etanercept exhibited a greater reduction in MRI-based scores for sacroiliac joint inflammation (−46.9% versus −10.9%; P < 0.001) and spinal inflammation (−45.4% versus −33.4%; P = 0.04) compared with placebo-treated patients at week 12. Post hoc analyses suggested a possible association between higher baseline C-reactive protein levels or MRI sacroiliac joint inflammation scores and higher rates of ASAS40 response to etanercept. At week 24, patients in the placebo group who had switched to etanercept at 12 weeks exhibited improvement similar to that observed in patients who had received etanercept for 24 weeks. Conclusion In patients with nonradiographic axial SpA, etanercept treatment was associated with rapid, significant improvement in symptomatic disease activity, function, and systemic and skeletal inflammation over 12 weeks; clinical/functional improvement was sustained over 24 weeks. [ABSTRACT FROM AUTHOR]

Objectives To compare over 2 years the safety, efficacy and radiographic outcomes of subcutaneous abatacept versus adalimumab, in combination with methotrexate (MTX), in patients with rheumatoid arthritis (RA). Methods AMPLE is a phase IIIb, 2-year, randomised, investigator-blinded study with a 1-year primary endpoint. Biologic-naive patients with active RA and an inadequate response to MTX were randomised to 125 mg abatacept weekly or 40 mg adalimumab bi-weekly, both with a stable dose of MTX. Results Of 646 patients randomised, 79.2% abatacept and 74.7% adalimumab patients completed year 2. At year 2, efficacy outcomes, including radiographic, remained comparable between groups and with year 1 results. The American College Rheumatology 20, 50 and 70 responses at year 2 were 59.7%, 44.7% and 31.1% for abatacept and 60.1%, 46.6% and 29.3% for adalimumab. There were similar rates of adverse events (AEs) and serious adverse events (SAEs). More serious infections occurred with adalimumab (3.8% vs 5.8%) including two cases of tuberculosis with adalimumab. There were fewer discontinuations due to AEs (3.8% vs 9.5%), SAEs (1.6% vs 4.9%) and serious infections (0/12 vs 9/19 patients) in the abatacept group. Injection site reactions (ISRs) occurred less frequently with abatacept (4.1% vs 10.4%). Conclusions Through 2 years of blinded treatment in this first head-to-head study between biologic diseasemodifying antirheumatic drugs in RA patients with an inadequate response to MTX, subcutaneous abatacept and adalimumab were similarly efficacious based on clinical, functional and radiographic outcomes. Overall, AE frequency was similar in both groups but there were less discontinuations due to AEs, SAEs, serious infections and fewer local ISRs with abatacept. ClinicalTrials.gov Identifier NCT00929864. [ABSTRACT FROM AUTHOR]