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Objective.To evaluate the safety of the methotrexate (MTX)–leflunomide (LEF) combination in rheumatoid arthritis (RA), comparing it with other therapeutic schemes involving conventional synthetic (cs-) and biologic (b-) disease-modifying antirheumatic drugs (DMARDs) or Janus kinase inhibitors (JAKi).Methods.Patients with RA starting a treatment course with a csDMARD (without previous use of bDMARD or JAKi) or their first bDMARD/JAKi were followed up in a registry-based, multicentric cohort study in Brazil (BiobadaBrasil). The primary outcome was the incidence of serious adverse events (SAEs); secondary outcomes included serious infections. Multivariate Cox proportional hazards models and propensity score matching analysis (PSMA) were used for statistical comparisons.Results.In total, 1671 patients (5349 patient-years [PY]) were enrolled; 452 patients (1537 PY) received MTX + LEF. The overall incidence of SAEs was 5.6 per 100 PY. The hazard of SAEs for MTX + LEF was not higher than for MTX or LEF (adjusted HR [aHR] 1.00, 95% CI 0.76–1.31, P= 0.98). MTX + LEF presented a lower hazard of SAEs (aHR 0.56, 95% CI 0.36–0.88, P= 0.01) and infectious SAEs (aHR 0.48, 95% CI 0.25–0.94, P= 0.03) than bDMARDs/JAKi with MTX or LEF. MTX + LEF presented lower hazard of SAEs than MTX + sulfasalazine (SSZ; aHR 0.33, 95% CI 0.16–0.65, P= 0.002). Analysis using PSMA confirmed the results obtained with traditional multivariate Cox analysis.Conclusion.In our study, MTX + LEF presented a relatively good overall safety profile in comparison to MTX + SSZ and schemes involving advanced therapies in RA.

Juvenile Sjögren's syndrome (SS) is a rare, poorly defined, and possibly underdiagnosed condition affecting children and adolescents. The aim of this study was to characterize symptoms and clinical findings of juvenile SSand to explore the clinical application of major salivary gland ultrasonography (SGUS) in patients with juvenile SS. A cross‐sectional multicenter study recruited patients with disease onset until age 18 years (n = 67). Disease characteristics were recorded, and unstimulated whole sialometry and SGUSexamination of the parotid and submandibular salivary glands were performed. The female:male ratio was 58:9. The mean age at first symptom was 10.2 years and 12.1 years at diagnosis. Ocular and oral symptoms were noted in 42 of 67 patients (63%) and 53 of 66 patients (80%), respectively. The American‐European Consensus Group or American College of Rheumatology/European League Against Rheumatism classification criteria for primary SSwere fulfilled by 42 of 67 patients (63%). Pathologic SGUSfindings were observed in 41 of 67 patients (61%); 26 of 41 SGUS+ patients (63%) fulfilled primary SScriteria. Salivary gland enlargements/parotitis were noted in 37 of 58 patients and were nonsignificantly associated with SGUS+ status (P= 0.066). The mean levels of saliva were 5.6 ml/15 minutes in SGUS– patients compared to 3.3 ml/15 minutes in the SGUS+ patients (P= 0.049). A total of 36 of 41 SGUS+ patients (88%) were anti‐Ro/La+ compared to 14 of 26 SGUS– patients (54%) (P= 0.001). In addition, 24 of 39 SGUS+ patients (62%) were positive for rheumatoid factor (RF), whereas only 5 of 25 SGUS– patients (20%) were RF+ (P= 0.001). Juvenile SSis characterized by a large spectrum of clinical symptoms and findings. Several glandular and extraglandular parameters such as hyposalivation, swollen salivary glands, and autoantibodies are associated with pathologic SGUSfindings.

To analyze the clinical and epidemiologic characteristics of juvenile-onset spondyloarthritis (SpA) (< 16 years) and compare them with a group of adult-onset (≥ 16 years) SpA patients.

Avaliar incidência de tuberculose e triagem para tuberculose latente em brasileiros com artrite reumatoide em uso de agentes biológicos na prática clinica.

To assess the incidence of tuberculosis and to screen for latent tuberculosis infection among Brazilians with rheumatoid arthritis using biologics in clinical practice.

To analyze quality of life and demographic and clinical variables associated to its impairment in a large Brazilian cohort of patients with spondyloarthritis (SpA).

Analisar as variáveis demográficas e clínicas associadas à diminuição da qualidade de vida em uma grande coorte brasileira de pacientes com espondiloartrite (EpA).

Fazer a adaptação transcultural do Eular Sjögren's Syndrome Patient Reported Index (ESSPRI) para a língua portuguesa e avaliar as suas propriedades psicométricas.

The recommendations proposed by the Sjögren's Syndrome Committee of the Brazilian Society of Rheumatology for the treatment of Sjögren's syndrome were based on a systematic review of literature in Medline (PubMed) and the Cochrane databases until October 2014 and on expert opinion in the absence of studies on the subject. 131 articles classified according to Oxford & Grade were included. These recommendations were developed in order to guide the management and facilitate the access to treatment for those patients with an appropriate indication, considering the Brazilian socioeconomic context and pharmacological agents available in this country.

As recomendações propostas pela Comissão de Síndrome de Sjögren da Sociedade Brasileira de Reumatologia para tratamento da síndrome de Sjögren foram baseadas em uma revisão sistemática da literatura nas bases de dados Medline (PubMed) e Cochrane até outubro de 2014 e opinião de especialistas na ausência de artigos sobre o assunto. Foram incluídos 131 artigos classificados de acordo com Oxford & Grade. Essas recomendações foram elaboradas com o objetivo de orientar o manejo adequado e facilitar o acesso aos tratamentos para aqueles pacientes com adequada indicação de recebê‐los, considerando o contexto socioeconômico brasileiro e os medicamentos disponíveis no país.

To carry out the cross-cultural adaptation of EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) for Portuguese language and evaluate its psychometric properties.

To perform a cross-cultural adaptation and validation of the Profile of Fatigue and Discomfort – Sicca Symptoms Inventory (short form) (PROFAD-SSI-SF) questionnaire assessing the subjective aspects of the symptoms of primary Sjögren syndrome (pSS), for the Brazilian Portuguese language.

Fazer a adaptação transcultural e a validação do Profile of Fatigue and Discomfort –Sicca Symptoms Inventory (short form) (Profad‐SSI‐SF), questionário que avalia os aspectos subjetivos dos sintomas da síndrome de Sjögren primária (SSp), para a língua portuguesa brasileira.

Avaliar os resultados da aplicação do Índice de Atividade de Doença da Espondilite Anquilosante de Bath (BASDAI) numa série de pacientes brasileiros com EpA e estabelecer suas correlações com as variáveis específicas do grupo.

To analyze the results of the application of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in a large series of Brazilian patients with the diagnosis of SpA and establish its correlations with specific variables into the group.

Analisar as características clínicas e epidemiológicas das espondiloartrites (EpA) de início juvenil (< 16 anos) e compará‐las com um grupo de pacientes com EspA de início na vida adulta (≥ 16 anos).

Few studies have evaluated the profile of use of disease modifying drugs (DMD) in Brazilian patients with spondyloarthritis (SpA).

To evaluate the effects of aerobic training and stretching on serum levels of serotonin (5HT) and its main metabolite 5-hydroxindolacetic acid (5HIAA).

The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) is an index of primary Sjögren's syndrome (PSS) systemic activity.

Objective.To analyze the clinical effect of enthesitis in a large Brazilian cohort of patients with spondyloarthritis (SpA).Methods.A common protocol of investigation was prospectively applied to 1505 patients with SpA in 29 centers in Brazil. Clinical and demographic variables and disease indexes were investigated. The Maastricht Ankylosing Spondylitis Enthesitis Score was used to investigate the enthesitis component. Ankylosing spondylitis was the most frequent disease in the group (65.4%). Others were psoriatic arthritis (18.4%), undifferentiated SpA (6.7%), reactive arthritis (3.3%), and enteropathic arthritis (3.2%).Results.At least 1 affected enthesis was observed in 54% of the patients with SpA, with a mean of 2.12 ± 2.98 entheses affected. According to the clinical presentation, enthesitis was significantly more frequent in patients with axial + peripheral joint involvement compared to isolated axial or peripheral involvement (p < 0.001). There was a statistical association between the presence of enthesites and axial symptoms (buttock pain, cervical pain, and hip pain), and peripheral symptoms (lower limb arthritis, number of painful and swollen joints; p < 0.05). Patients with enthesitis also presented higher mean scores of Bath Ankylosing Spondylitis Functional Index (BASFI; p < 0.001), Bath Ankylosing Spondylitis Disease Activity Index (p < 0.001), and Ankylosing Spondylitis Quality of Life (ASQoL; p < 0.001). Multivariate logistic regression showed that BASFI (p < 0.0001; OR 74.839), ASQoL (p = 0.0001; OR 14.645), and Achilles tendonitis (p = 0.0059; OR 7.593) were associated with work incapacity.Conclusion.The clinical presence of enthesitis in this large cohort of patients with SpA was frequent and was associated with a significant increase in disease activity and decline in functional capacity and quality of life.

Não há estudo anterior sobre a prevalência de síndrome de Sjögren (SS) no Brasil. O objetivo deste estudo foi avaliar a prevalência de SS na população geral de Vitória, estado do Espírito Santo, Brasil. Trata-se de estudo epidemiológico, observacional e transversal com 1.205 indivíduos randomizados, cujas idades variaram de 18 a 65 anos, residentes em Vitória. Os indivíduos foram triados para xerostomia e xeroftalmia por meio de entrevista domiciliar. Aqueles com sintomas “sicca” foram convidados a comparecer ao hospital para realizar avaliação médica adicional, avaliação do fluxo salivar não estimulado, teste de Schirmer I, exame de sangue e biopsia de glândula salivar labial menor. Os sintomas “sicca” foram identificados em 18% (217 indivíduos) da amostra. Dos 217 indivíduos com sintomas “sicca”, 127 (58%) estavam disponíveis para exame. Nessa amostra, 61,7% eram mulheres e 46,8% usavam medicação. A síndrome “sicca” foi confirmada em 12% deles por pelo menos um exame (fluxo salivar ou teste de Schirmer I). Dois pacientes (0,17%) preencheram quatro critérios classificatórios americano-europeus (95% IC=0,020–0,5983).

To compare the clinical effectiveness of aerobic exercise in the water with walking/jogging for women with fibromyalgia (FM).Sixty sedentary women with FM, ages 18–60 years, were randomly assigned to either deep water running (DWR) or land‐based exercises (LBE). Patients were trained for 15 weeks at their anaerobic threshold. Visual analog scale of pain, Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory, Short Form 36 Health Survey (SF‐36), and a patient's global assessment of response to therapy (PGART) were measured at baseline, week 8, and week 15. Statistical analysis included all patients.Four patients dropped out from each group. Both groups improved significantly at week 15 compared with baseline, with an average 36% reduction in pain intensity. For PGART, 40% of the DWR group and 30% of the LBE group answered “much better” at posttreatment. FIQ total score and FIQ depression improvements in the DWR group were faster (week 8) than the LBE group and kept improving (week 15; P < 0.05). Only the DWR group showed improvements in SF‐36 role emotional (P = 0.006). No significant between‐group differences were observed for peak oxygen uptake and other outcomes.DWR is a safe exercise that has been shown to be as effective as LBE regarding pain. However, it has been shown to bring more advantages related to emotional aspects. Aerobic gain was similar for both groups, regardless of symptom improvement. Therefore, DWR could be studied as an exercise option for patients with FM who have problems adapting to LBE or lower limbs limitations.

OBJECTIVE: To compare 2 exercise modalities, aerobic fitness training and stretching exercises, in patients with fibromyalgia (FM) in relation to function, pain, quality of life, depression, and anxiety, and to correlate the cardiorespiratory fitness gain with symptom improvement. METHODS: Seventy-six women with FM between 18 and 60 years old were randomized to either an aerobic program or stretching program, for 20 weeks. They were evaluated at the beginning of the program and after 10 and 20 weeks in relation to the improvement of aerobic fitness, flexibility, function, Fibromyalgia Impact Questionnaire (FIQ), Short-form Health Survey (SF-36), and depression and anxiety levels. Ventilatory anaerobic threshold (VT) and maximum oxygen uptake (VO2max) were determined by expired gas analyses. RESULTS: Aerobic exercise was superior to stretching in relation to VO2 max, VT, function, depression, pain, and the emotional aspects and mental health domains of SF-36. Patients in the stretching group showed no improvement in depression, "role emotional," and "mental health." No association was noted between improvement in aerobic fitness as measured by VT and the improvement of pain, function, or scores in FIQ and SF-36. CONCLUSION: Our results confirm that aerobic exercise is beneficial to patients with FM, but the cardiorespiratory fitness gain is not related to improvement of FM symptoms.

OBJECTIVE: To compare maximum oxygen uptake and anaerobic threshold in patients with fibromyalgia (FM) and healthy sedentary controls matched by sex, age, weight, and body mass index. METHODS: Fifty women with FM aged 18-60 years and 50 healthy sedentary controls were studied. All were submitted to a maximum treadmill incremental test. Expired gas, ventilatory anaerobic threshold, and maximum oxygen uptake (VO2max) were evaluated. The influence of FM on quality of life was evaluated by questionnaires: the Fibromyalgia Impact Questionnaire and the Medical Outcomes Study Short-Form (SF-36). RESULTS: In patients with FM, the anaerobic threshold and peak oxygen uptake were significantly reduced. Maximum heartbeat rate was significantly lower in FM, indicating submaximum effort. Linear regression data showed a correlation between peak VO2 and the "Role-physical" domain of the SF-36. No such correlations were noted with anaerobic threshold. CONCLUSION: These results confirm the hypothesis of lower physical fitness in patients with FM. Considering that patients with FM do not achieve a maximum effort, ventilatory anaerobic threshold should be considered as a better fitness index than VO2max.

There has been no previous prevalence study about of Sjögren's syndrome (SS) in Brazil. The aim was to evaluate the SS prevalence in a general population in Vitória, ES, Brazil. This was an epidemiological, observational, and cross-sectional study conducted on 1,205 randomized people, aged 18–65 years, who lived in Vitória. The subjects were screened for xerostomia and xerofphthalmia through home interviews. Those with sicca symptoms were asked to report to a hospital for further medical evaluation, unstimulated salivary flow, Schirmer I test, blood analysis and minor labial salivary biopsy. Sicca symptoms were found in 18% (217 subjects) of the sample. Of the 217 subjects with sicca symptoms, 127 (58%) were available for examination. In this sample, 61.7% were female and 46.8% were under medication. Sicca syndrome was confirmed in 12% by at least one examination (salivary flow or Schirmer I). Two patients (0.17%) matched four criteria according to American-European Criteria (95% CI=0.020–0.5983).

Acute fibrinous and organizing pneumonia (AFOP), recently described, is a histologic pattern characterized by the presence of fibrin “balls” within alveolar spaces. The term undifferentiated connective tissue disease (UCTD) is used to identify autoimmune systemic diseases that do not fulfill the criteria to be classified as a definitive connective tissue disease. The AFOP has never been reported in association with UCTD. The present reported case is a 39-year-old Caucasian, female with dry cough and progressive dyspnea. Eight months later, she was diagnosed with “organizing pneumonia” based on clinical history and radiologic images. She manifested Raynaud’s Phenomenon, sicca syndrome, boot and gloves neuropathic pain, and previous hypothyroidism. Antinuclear antibody, rheumatoid factor, and specific autoantibodies were negative. Salivary gland biopsy and electroneuromyiography were normal. The capillaroscopy showed a “scleroderma” pattern with capillary deletion and ectasia. She experienced clinical and radiologic worsening. Despite being submitted to cyclophosphamide pulse, she developed hemorrhage and then died. Thoracotomy pulmonary specimen showed histological pattern of AFOP. This paper shows a rare association of AFOP with UCTD.