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Psoriatic arthritis (PsA) is a chronic and systemic immune disease characterized by inflammation of peripheral and/or axial joints and entheses in patients with psoriasis (PsO). Extra-articular and extracutaneous manifestations and numerous comorbidities can also be present. These recommendations replace the previous version published in May 2013. A systematic review of the literature retrieved 191 articles that were used to formulate 12 recommendations in response to 12 clinical questions, divided into 4 sections: diagnosis, non-pharmacological treatment, conventional drug therapy and biologic therapy. These guidelines provide evidence-based information on the clinical management for PsA patients. For each recommendation, the level of evidence (highest available), degree of strength (Oxford) and degree of expert agreement (interrater reliability) are reported.

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Spondyloarthritis is a group of chronic inflammatory systemic diseases characterized by axial and/or peripheral joints inflammation, as well as extra-articular manifestations. The classification axial spondyloarthritis is adopted when the spine and/or the sacroiliac joints are predominantly involved. This version of recommendations replaces the previous guidelines published in May 2013.A systematic literature review was performed, and two hundred thirty-seven studies were selected and used to formulate 29 recommendations answering 15 clinical questions, which were divided into four sections: diagnosis, non-pharmacological therapy, conventional drug therapy and biological therapy. For each recommendation the level of evidence supporting (highest available), the strength grade according to Oxford, and the degree of expert agreement (inter-rater reliability) is informed.These guidelines bring evidence-based information on clinical management of axial SpA patients, including, diagnosis, treatment, and prognosis.

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BACKGROUND The safety profile of biologic drugs might present substantial regional differences. Since 2009, the Brazilian Society of Rheumatology has maintained BIOBADABRASIL (Brazilian Registry for Biologic Drugs), a registry for monitoring of biologic therapies in rheumatic diseases. OBJECTIVES The aim of this study was to verify the incidence rate (IR) of serious infections in rheumatoid arthritis (RA) and spondyloarthritis (SpA) patients on biologic drugs. METHODS BIOBADABRASIL prospectively included patients with rheumatic diseases who started the first biologic drug or a synthetic disease-modifying antirheumatic drug as a parallel control group. This study focuses on serious infectious adverse events (SIAEs) in RA and SpA patients on biologic drugs compared with controls, from January 2009 to June 2015. Time of exposure was set from initiation of the drug to the date of last administration or censorship. Serious infectious adverse events IR was calculated per 1000 patient/years with 95% confidence interval (CI). RESULTS A total of 1698 patients (RA, 1121; SpA, 577) were included, 7119 patient/years. Serious infectious adverse events were more common among patients on tumor necrosis factor inhibitors (TNFi's) than controls (adjusted IR ratio, 2.96 [95% CI, 2.01-4.36]; p < 0.001). Subsequent TNFi was associated with a higher SIAEs incidence when compared with first TNFI (adjusted IR ratio, 1.55 [95% CI, 1.15-2.08]; p = 0.004). Serious infectious adverse events were associated with age and corticosteroids intake. Serious infectious adverse events were more frequent in the respiratory tract in all subgroups. CONCLUSIONS In BIOBADABRASIL, biologic drugs, especially the subsequent TNFi, were associated with a higher risk of serious infections compared with synthetic DMARDs. Corticosteroid intake and age represented risk factors for SIAEs. Constant monitoring is required to follow the safety profile of drugs in the clinical setting of rheumatic conditions in Brazil.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Claudio Carneiro,1,2 Mario Chaves,2 Gustavo Verardino,2 Ana Paula Frade,3 Pedro Guimaraes Coscarelli,4 Washington Alves Bianchi,5,6 Marcia Ramos-e-Silva,3 Sueli Carneiro2,3 1Health Ministry, 2Sector of Dermatology, School of Medical Sciences and University Hospital, State University of Rio de Janeiro, 3Sector of Dermatology, University Hospital and School of Medicine, Federal University of Rio de Janeiro, 4General Medicine Department, University Hospital and School of Medical Sciences, State University of Rio de Janeiro, 5Sector of Rheumatology, Santa Casa da Misericórdia, 6University Hospital and School of Medical Sciences, State University of Rio de Janeiro, Rio de Janeiro, Brazil Background: Psoriatic arthritis is associated with psychosocial morbidity and decrease in quality of life. Psychiatric comorbidity also plays an important role in the impairment of quality of life and onset of fatigue.Objectives: This study aimed to assess the prevalence of fatigue in psoriatic arthritis patients and to correlate it to quality of life indexes, functional capacity, anxiety, depression and disease activity.Patients and methods: This cross-sectional study was performed on outpatients with psoriatic arthritis. Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F; version 4) was used to measure fatigue; 36-Item Short Form Health Survey (SF-36) and Psoriasis Disability Index (PDI) to measure quality of life; Health Assessment Questionnaire (HAQ) to assess functional capacity; Hospital Anxiety and Depression (HAD) scale to measure anxiety and depression symptoms; Psoriasis Area and Severity Index (PASI), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Clinical Disease Activity Index (CDAI) to evaluate clinical activity.Results: In all, 101 patients with mean age of 50.77years were included. The mean PDI score was 8.01; PASI score, 9.88; BASDAI score, 3.59; HAQ score, 0.85; HAD – Anxiety (HAD A) score, 7.39; HAD Depression (HAD D) score, 5.93; FACIT–Fatigue Scale (FACIT-FS) score, 38.3 and CDAI score, 2.65. FACIT-FS was statistically associated with PASI (rs –0.345, p

Background: As Brazil is accountable for 33% of the tuberculosis (TB) burden in Americas, with an annual incidence of 33.5/100,000 in 2017[1], the occurrence of tuberculosis infection in patients with rheumatic diseases in use of biological therapy is a recurrent concern. Objectives: To assess incident TB among patients with rheumatic disease in use of biological therapy in a country with high incidence of TB. Methods: BiobadaBrasil is a multicentric prospective cohort study involving patients with rheumatic diseases who started the first biologic or a synthetic disease modifying anti-rheumatic drug (DMARD)[6]. This analysis includes patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) recruited from Jan 2009 to Aug 2018 and followed-up for one or multiple courses of treatment until censoring or incident TB. The primary outcome was the incidence of tuberculosis (in any organ site). The history of exposure to tuberculosis, chest Rx, screening and treatment for latent tuberculosis infection (LBTI), and use of prophylactic isoniazid were evaluated before each course of treatment. Multivariate Cox proportional hazards models (with DMARDs included as time-varying covariates) were used to estimate hazard ratios (HR) and 95% confidence intervals (CI); analyses were performed with the Survival package of R. Results: Sample: 2858 patients (female =70,2%; RA = 72%, AS=20%, and PsA = 8%). A total of 31 (1.1%) patients developed tuberculosis during treatment. One patient on abatacept and one on tocilizumab developed TB while all the others were on TNF-inhibitors(29). The median (interquartile range) exposure to the current DAMRD course was 11.1 (5.9-20) months. TB patients did not significantly differ from others regarding disease duration, sex or age. Almost half (n=14,45%) of TB patients did not present evidence of previous exposure or any screening positive test for TB; 9 (29%) TB patients had received adequate LTBI treatment (isoniazid) recently or in the past. Furthermore, 8(26%) had incomplete/inconsistent screening. The overall incidence of TB was 1.9/1000 patients/year, and was not significantly different among the diseases (1.63 for RA, 2.06, for AS, and 3.79/1000/year for PsA). In univariate analysis, exposure to anti-TNF monoclonal antibodies (HR 3.1, 95%CI 1.18-8.15, P=0.02) and presence of any marker of previous contact with TB (positive history of TB, known contact with TB, positive TST, or abnormal chest X-ray: HR 4.2 (2.1-8.5, p Conclusion: Monoclonal anti-TNF antibodies and previous exposure/diagnosis of TB are independent risk factors for developing TB in Brazil. TB cases occurred both early and lately during treatment courses, suggesting LTBI screening failures, treatment non-adherence or re-exposure. Current application and content of the protocol for screening and treatment of LTBI needs to be reviewed. References [1] WHO TB report2018.https://www.who.int/tb/publications/global_report/en/ [2] Rev Bras Reumatol Engl Ed. 2017;57Suppl 2:477-483. doi: 10.1016/j.rbre.2017.05.005. Acknowledgement: monitor P Cabral, MDs N Sacilotto, H Pereira, F Sztajnbok. Disclosure of Interests: Ana Medeiros: None declared, M Bredemeier: None declared, V Valim: None declared, M Pinheiro Consultant for: Janssen, Pfizer, Speakers bureau: Abbot,Janssen,Novartis, C Macieira: None declared, A Duarte: None declared, B Stadler: None declared, R Ranza: None declared, M Bertolo: None declared, J Miranda Speakers bureau: Pfizer, C Brenol Speakers bureau: Pfizer, Roche, Janssen, Bristol., G Castro: None declared, V Fernandes Speakers bureau: Janssen, D Titton: None declared, F Sauma: None declared, I Pereira: None declared, R Botelho: None declared, H Carvalho: None declared, A Hayata: None declared, P Louzada: None declared, A Ranzolin: None declared, S Studart: None declared, G Castelar: None declared, A Kakehasi Grant/research support from: Abbvie, UCB, JANSSEN, ROCHE, NOVARTIS, PFIZER, Consultant for: Abbvie, UCB, JANSSEN, ROCHE, NOVARTIS, PFIZER, Paid instructor for: JANSSEN, Speakers bureau: Abbvie, UCB, JANSSEN, ROCHE, NOVARTIS, PFIZER, W Bianchi: None declared, R Acayaba: None declared, I Silveira: None declared, H Resende: None declared, J Amaral: None declared, L Rocha: None declared, M Gazzeta: None declared, L Carvalho: None declared, S Schowalski: None declared, D Feldman: None declared, I Laurindo Consultant for: Abbvie, UCB, GSK, JANSSEN, LILLY, NOVARTIS, PFIZER, Paid instructor for: Abbvie, JANSSEN, Speakers bureau: Abbvie, UCB, GSK, JANSSEN, LILLY, NOVARTIS, PFIZER, ROCHE, J Provenza: None declared

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

To identify baseline predictors of remission and low disease activity (LDA) in early rheumatoid arthritis (RA) from the GLADAR (Grupo Latino Americano De estudio de la Artritis Reumatoide) cohort.Patients with 1- and 2-year follow-up visits were included. Remission and LDA were defined by DAS28-ESR ( 2.6 and ≤ 3.2, respectively). Baseline predictors examined were gender, ethnicity, age at diagnosis, socioeconomic status, symptoms' duration, DMARDs, RF, thrombocytosis, anemia, morning stiffness, DAS28-ESR (and its components), HAQ-DI, DMARDs and corticosteroid use, and Sharp-VDH score. Multivariable binary logistic regression models (excluding DAS28-ESR components to avoid over adjustment) were derived using a backward selection method (α-level set at 0.05).Four hundred ninety-eight patients were included. Remission and LDA/remission were met by 19.3% and 32.5% at the 1-year visit, respectively. For the 280 patients followed for 2 years, these outcomes were met by 24.3% and 38.9%, respectively. Predictors of remission at 1 year were a lower DAS28-ESR (OR 1.17; CI 1.07-1.27; p = 0.001) and HAQ-DI (OR 1.48; CI 1.04-2.10; p = 0.028). At 2 years, only DAS28-ESR (OR 1.40; CI 1.17-1.6; p 0.001) was a predictor. Predictors of LDA/remission at 1 year were DAS28-ESR (OR 1.42; CI 1.26-1.61; p 0.001), non-use of corticosteroid (OR 1.74; CI 1.11-2.44; p = 0.008), and male gender (OR 1.77; CI 1.2-2.63; p = 0.036). A lower baseline DAS28-ESR (OR 1.45; CI 1.23-1.70; p 0.001) was the only predictor of LDA/remission at 2 years.A lower disease activity consistently predicted remission and LDA/remission at 1 and 2 years of follow-up in early RA patients from the GLADAR cohort. Key Points • In patients with early RA, a lower disease activity at first visit is a strong clinical predictor of achieving remission and LDA subsequently. • Other clinical predictors of remission and LDA to keep in mind in these patients are male gender, non-use of corticosteroids and low disability at baseline. • Not using corticosteroids at first visit is associated with a lower disease activity and predicts LDA/remission at 1 year in these patients.

Objectives to analyse disease activity of RA patients at the start of treatment with a biologic agent (adalimumab, infliximab, certolizumab, etanercept, golimumab, abatacept, rituximab and tocilizumab -bDMARDs), target (tofacitinib-tsDMARDs) therapy or conventional DMARDs (comparison cohort of RA patients – csDMARDs). Methods BiobadaBrasil is a prospective observational cohort study, part of an international initiative (biobadaAmerica) in collaboration with BiobadaSeR; established in 2009, is an ongoing study supported by the Brazilian Society of Rheumatology (29 public centres located at academic instituitions and 2 in private practice) focused on the study of adverse events in patients on biologic therapy. Additionally, by decision of its investigators, disease activity scores were also recorded at the beginning of each treatment. Sex, age, disease duration, RA -DAS-28, concomitant treatments at baseline were collected. Results expressed in mean ±SD,%(n) Results -Data from 1984 RA patients (67% on ts/bDMARDs) were analysed: 86% of the patients were women; mean age=56.6±14.95 years; disease duration=14.4±9.42; 87% RF positive. There were 3802 treatment courses, 67% with aTNF (Adalimumab-ADA, Certolizumab-CTZ, Etanercept-ETA, Golimumab-GOL, Infliximab-INFL), 33% non-aTNF (Abatacept-ABA, Rituximab-RIT, Tocilizumab-TCL) including Tofacitinib-TOF. The table 1 below depicted the medications prescribed at the initiation of a new treatment course: Considering the more recent medications patients beginning TCL have more active disease than the ones beginning GOL and CTZ (p Conclusions patterns of bDMARDS, csDMARDS and corticosteroid use clearly surfaced. Possibilities of improvement can be addressed. Acknowledgements for data monitoring P Cabral; contributing to BiobadaBrasil registry, R. Giorgi, H. Pereira, M. Scheinberg, F. Sztajnbok, W. Vieira Disclosure of Interest None declared

The original version of this article, unfortunately, contained an error. The first and family name of Loreto Massardo was interchanged and is now presented correctly in this article.

ResumoObjetivoAvaliar 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.MétodosUm protocolo comum de investigação foi prospectivamente aplicado em 1.492 pacientes brasileiros classificados como EpA pelos critérios do Grupo Europeu de Estudo das Espondiloartropatias (ESSG), acompanhados em 29 centros de referência em reumatologia no Brasil. Variáveis clínicas, demográficas e índices de doença foram colhidos. Os valores totais do BASDAI foram comparados com a presença das diferentes variáveis.ResultadosO valor médio do BASDAI foi de 4,20 ± 2,38. Os escores médios do BASDAI foram mais elevados nos pacientes com forma clínica combinada, comparado às formas axiais e periféricas isoladas, nos pacientes do sexo feminino e nos sedentários. Com relação ao componente axial, valores mais altos do BASDAI estiveram significativamente associados à lombalgia inflamatória, à dor alternante em nádegas, à dor cervical e ao acometimento de coxofemorais. Houve associação estatística entre os valores do BASDAI e o comprometimento periférico, relacionado ao número de articulações inflamadas, tanto dos membros inferiores quanto dos membros superiores, e às entesites. A positividade do HLA‐B27 e a presença de manifestações extra‐articulares não estiveram correlacionadas com os valores médios do BASDAI. Valores mais baixos do BASDAI estiveram associados ao uso de agentes biológicos (p

Objectives To assess the incidence of tuberculosis and to screen for latent tuberculosis infection among Brazilians with rheumatoid arthritis using biologics in clinical practice. Patients and methods This cohort study used data from the Brazilian Registry of Biological Therapies in Rheumatic Diseases (Registro Brasileiro de Monitoração de Terapias Biológicas - BiobadaBrasil), from 01/2009 to 05/2013, encompassing 1552 treatments, including 415 with only synthetic disease-modifying anti-rheumatic drugs, 942 synthetic DMARDs combined with anti-tumor necrosis factor (etanercept, infliximab, adalimumab) and 195 synthetic DMARDs combined with other biologics (abatacept, rituximab and tocilizumab). The occurrence of tuberculosis and the drug exposure time were assessed, and screening for tuberculosis was performed. Statistical analysis: Unpaired t-test and Fisher's two-tailed test; p < 0.05. Results The exposure times were 981 patient-years in the controls, 1744 patient-years in the anti-TNF group (adalimumab = 676, infliximab = 547 and etanercept = 521 patient-years) and 336 patient-years in the other biologics group. The incidence rates of tuberculosis were 1.01/1000 patient-years in the controls and 2.87 patient-years among anti-TNF users (adalimumab = 4.43/1000 patient-years; etanercept = 1.92/1000 patient-years and infliximab = 1.82/1000 patient-years). No cases of tuberculosis occurred in the other biologics group. The mean drug exposure time until the occurrence of tuberculosis was 27(11) months for the anti-TNF group. Conclusions The incidence of tuberculosis was higher among users of synthetic DMARDs and anti-TNF than among users of synthetic DMARDs and synthetic DMARDs and non-anti-TNF biologics and also occurred later, suggesting infection during treatment and no screening failure. Resumo Objetivos Avaliar incidência de tuberculose e triagem para tuberculose latente em brasileiros com artrite reumatoide em uso de agentes biológicos na prática clinica. Pacientes e métodos Estudo de coorte com dados do Registro Brasileiro de Monitoração de Terapias Biológicas (BiobadaBrasil), de 01/2009 a 05/2013, abrangeu 1.552 tratamentos, 415 somente com drogas modificadoras do curso da doença (MMCDs) sintéticas, 942 MMCDs sintéticas em associação com anti-TNF (etanercepte, infliximabe, adalimumabe) e 195 MMCDs sintéticas em associação com outros biológicos (abatacepte, rituximabe e tocilizumabe). Avaliaram-se ocorrência de tuberculose, tempo de exposição às drogas e triagem para TB. Análise estatística: teste t não pareado e teste de Fisher bicaudal; p < 0,05. Resultados O tempo de exposição dos controles foi de 981 pacientes-ano, do grupo de anti-TNF foi de 1.744 pacientes-ano (adalimumabe = 676, infliximabe = 547 e etanercepte = 521 pacientes-ano) e o de outros biológicos de 336 pacientes-ano. A incidência de TB foi de 1,01/1.000 pacientes-ano nos controles e de 2,87 pacientes-ano nos usuários de anti-TNF (adalimumabe = 4,43/1.000 pacientes-ano; etanercepte = 1,92/1.000 pacientes-ano e infliximabe = 1,82/1.000 pacientes-ano). Não houve casos de tuberculose no grupo de outros biológicos. O tempo médio de exposição até a ocorrência de tuberculose foi de 27(11) meses para o grupo anti-TNF. Conclusões A incidência de tuberculose foi maior nos usuários de MMCDs sintéticas e anti-TNF do que nos usuários de MMCDs sintéticas e de MMCDs sintéticas e biológicos não anti-TNF, e também mais tardia, sugerindo infecção durante o tratamento, e não falha na triagem.

The aim of the present study was to analyze the score of fatigue in a large cohort of Brazilian patients with SpA, comparing different disease patterns and its association with demographic and disease-specific variables.A common protocol of investigation was prospectively applied to 1492 Brazilian patients classified as SpA according to the European Spondyloarthropathies Study Group (ESSG) criteria, attended at 29 reference centers. Clinical and demographic variables were recorded. Fatigue was evaluated using the first item of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questionnaire.The mean BASDAI fatigue score was 4.20 ± 2.99. There was no significant difference in the fatigue score between the different SpA. Fatigue was higher in female patients (p0.001), with mixed (axial + peripheral) involvement (p0.001) and in those who did not practice exercises (p0.001). Higher scores of fatigue were significantly associated with inflammatory low back pain (p = 0.013), alternating buttock pain (p = 0.001), cervical pain (p = 0.001), and hip involvement (p = 0.005). Fatigue presented a moderate positive statistical correlation with Bath Ankylosing Spondylitis Functional Index (BASFI) (0.469; p0.001) and Ankylosing Spondylitis Quality of Life (0.462; p0.001).In this large series of Brazilian SpA patients, higher fatigue scores were associated with female gender, sedentary, worse functionality, and quality of life.

ObjectivesFatigue is a highly subjective and extremely common symptom in patients with rheumatoid arthritis although it is difficult to characterize and define. The aim of this study was to assess fatigue in a cohort of Brazilian patients, and to analyze the relationship be- tween fatigue and disease-specific variables.Methods371 Brazilian patients diagnosed with rheumatoid arthritis according to the 1987 American College of Rheumatology classification criteria were prospectively investigated. Demographic, clinical and laboratorial data were obtained from hospitals records. The number of painful joints, bone mass index, disease duration, quality of life, functional ca- pacity, anxiety and depression were recorded. Fatigue was evaluated using the subscale of Fatigue Assessment of Chronic Illness Therapy (FACIT-FATIGUE scale).ResultsThe median fatigue score was 42.0 (10.0), negatively correlated with functional ca- pacity (-0.507; P < 0.001), anxiety and depression (-0.542 and -0.545; P < 0.001 respectively), and predominantly with physical domain of Short Form 36-item quality of life question- naire (SF-36P: 0.584; P < 0.001). The scores were not associated with the erythrocyte sedi- mentation rate (-0.118; P < 0.05), C-reactive protein (-0.089; P < 0.05), disease activity (-0.250; P < 0.001) or the number of painful joints (-0.135; P < 0.01). Confidence interval of 95% was applied for all measures.ConclusionsIn this series of Brazilian patients with rheumatoid arthritis, we suggest a new significance for fatigue complains as an independent parameter not related with number of painful joints, disease or inflammatory activity scores. Psychological and functional impairments appear to be more related to fatigue. Additional studies and inclusion of stan- dard measures for monitoring fatigue complains are required.

Introdução: Poucos estudos avaliaram o perfil do uso de drogas modificadoras de doença (DMD) em pacientes brasileiros com diagnóstico de espondiloartrite (EpA). Métodos: Um protocolo comum de investigação foi prospectivamente aplicado em 1505 pacientes classificados como EpA pelos critérios do Grupo Europeu de Estudo das Espondiloartrites (ESSG), acompanhados em 29 centros de referência em Reumatologia no Brasil. Variáveis clínicas e demográficas foram obtidas e avaliadas, analisando-se suas correlações com o uso das DMD metotrexato (MTX) e sulfasalazina (SSZ). Resultados: Pelo menos uma DMD foi utilizada por 73,6% dos pacientes, sendo MTX por 29,2% e SSZ por 21,7%, enquanto 22,7% utilizaram ambas as drogas. O uso do MTX foi significativamente associado ao acometimento periférico, e a SSZ foi associada ao comprometimento axial, sendo que as duas drogas foram mais utilizadas, isoladas ou combinadas, no comprometimento misto (p < 0,001). O uso de uma DMD esteve significativamente associado à etnia branca (MTX; p = 0,014), lombalgia inflamatória (SSZ; p = 0,002), dor em nádegas (SSZ; p = 0,030), cervicalgia (MTX; p = 0,042), artrite de membros inferiores (MTX; p < 0,001), artrite de membros superiores (MTX; p < 0,001), entesite (p = 0,007), dactilite (MTX; p < 0,001), doença inflamatória intestinal (SSZ; p < 0,001) e acometimento ungueal (MTX; p < 0,001). Conclusão: O uso de pelo menos uma DMD foi referido por mais de 70% dos pacientes numa grande coorte brasileira de pacientes com EpA, sendo o uso do MTX mais associado ao acometimento periférico e o uso da SSZ mais associado ao acometimento axial. Introduction: Few studies have evaluated the profile of use of disease modifying drugs (DMD) in Brazilian patients with spondyloarthritis (SpA). Methods: A common research protocol was applied prospectively in 1505 patients classified as SpA by criteria of the European Spondyloarthropathies Study Group (ESSG), followed at 29 referral centers in Rheumatology in Brazil. Demographic and clinical variables were obtained and evaluated, by analyzing their correlation with the use of DMDs methotrexate (MTX) and sulfasalazine (SSZ). Results: At least one DMD was used by 73.6 % of patients: MTX by 29.2 % and SSZ by 21.7%, while 22.7 % used both drugs. The use of MTX was significantly associated with peripheral involvement, and SSZ was associated with axial involvement, and the two drugs were more administered, separately or in combination, in the mixed involvement (p < 0.001). The use of a DMD was significantly associated with Caucasian ethnicity (MTX , p = 0.014), inflammatory back pain (SSZ, p = 0.002) , buttock pain (SSZ, p = 0.030), neck pain (MTX, p = 0.042), arthritis of the lower limbs (MTX, p < 0.001), arthritis of the upper limbs (MTX, p < 0.001), enthesitis (p = 0.007), dactylitis (MTX, p < 0.001), inflammatory bowel disease (SSZ, p < 0.001) and nail involvement (MTX, p < 0.001). Conclusion: The use of at least one DMD was reported by more than 70% of patients in a large cohort of Brazilian patients with SpA, with MTX use more associated with peripheral involvement and the use of SSZ more associated with axial involvement.

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.

Objective: To analyze quality of life and demographic and clinical variables associated to its impairment in a large Brazilian cohort of patients with spondyloarthritis (SpA). Methods: A common protocol of investigation was applied to 1465 Brazilian patients classified as SpA according to the European Spondyloarthropaties Study Group (ESSG) criteria, attended at 29 reference centers for Rheumatology in Brazil. Clinical and demographic variables were recorded. Quality of life was analyzed through the Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire. Results: The mean ASQoL score was 7.74 (+/- 5.39). When analyzing the specific diseases in the SpA group, the ASQoL scores did not present statistical significance. Demographic data showed worse scores of ASQoL associated with female gender (p = 0.014) and African Brazilian ethnicity (p

Objective.Spondyloarthritides (SpA) can present different disease spectra according to ethnic background. The Brazilian Registry of Spondyloarthritis (RBE) is a nationwide registry that comprises a large databank on clinical, functional, and treatment data on Brazilian patients with SpA. The aim of our study was to analyze the influence of ethnic background in SpA disease patterns in a large series of Brazilian patients.Methods.A common protocol of investigation was prospectively applied to 1318 SpA patients in 29 centers distributed through the main geographical regions in Brazil. The group comprised whites (65%), African Brazilians (31.3%), and people of mixed origins (3.7%). Clinical and demographic variables and various disease index scores were compiled. Ankylosing spondylitis (AS) was the most frequent disease in the group (65.1%); others were psoriatic arthritis (18.3%), undifferentiated SpA (6.8%), enteropathic arthritis (3.7%), and reactive arthritis (3.4%).Results.White patients were significantly associated with psoriasis (p = 0.002), positive HLA-B27 (p = 0.014), and use of corticosteroids (p < 0.0001). Hip involvement (p = 0.02), axial inflammatory pain (p = 0.04), and radiographic sacroiliitis (p = 0.025) were associated with African Brazilian descent. Sex distribution, family history, and presence of peripheral arthritis, uveitis, dactylitis, urethritis, and inflammatory bowel disease were similar in the 3 groups, as well as age at disease onset, time from first symptom until diagnosis, and use of anti-tumor necrosis factor-α agents (p > 0.05). Schober test and thoracic expansion were similar in the 3 groups, whereas African Brazilians had higher Maastricht Ankylosing Spondylitis Enthesitis Scores (p = 0.005) and decreased lateral lumbar flexion (p = 0.003), while whites had a higher occiput-to-wall distance (p = 0.02). African Brazilians reported a worse patient global assessment of disease (p = 0.011). Other index scores and prevalence of work incapacity were similar in the 3 groups, although African Brazilians had worse performance in the Ankylosing Spondylitis Quality of Life questionnaire (p < 0.001).Conclusion.Ethnic background is associated with distinct clinical aspects of SpA in Brazilian patients. African Brazilian patients with SpA have a poorer quality of life and report worse disease compared to whites.

OBJETIVOS: O presente estudo teve por objetivo descrever o processo de implementação de um registro nacional em um país em desenvolvimento (Brasil) e relatar os principais resultados preliminares do registro BiobadaBrasil. MATERAL E MÉTODOS: Através de um acordo com a PANLAR, o protocolo Biobadaser foi utilizado como modelo para a implementação de um novo registro no nosso país. Durante os dois primeiros anos desse esforço, o protocolo original foi adaptado, traduzido e apresentado a todos os reumatologistas brasileiros. Durante dez meses, dados de 1.037 pacientes (750 tratados com biológicos e 287 controles) de 15 centros foram coletados. RESULTADOS: A maioria dos pacientes tinha artrite reumatoide (AR) (n = 723). Infliximabe foi o agente anti-TNF mais usado, e a exposição total a biológicos foi 2.101 pacientes-ano. A razão mais comum para suspensão da droga foi ineficiência ou perda de efetividade (50%), e 30% dos pacientes interromperam o tratamento devido a eventos adversos. Três casos de tuberculose foram observados no grupo biológico, representando maior incidência do que aquela da população brasileira geral. Infecções foram observadas em 23% dos pacientes do grupo biológico, sendo o trato respiratório superior o local mais comumente afetado. Apenas um caso de hanseníase tuberculoide foi observado. Nenhuma morte nem malignidade atribuível ao efeito dos medicamentos foi observada até fevereiro de 2010. CONCLUSÕES: A implementação do registro foi bem sucedida. Embora recente, o registro BiobadaBrasil já forneceu importantes dados. OBJECTIVES: The present study aimed at describing the implementation process of a national registry in a developing country (Brazil) and at reporting the main preliminary results of the BiobadaBrasil registry. MATERIAL AND METHODS: Through a PANLAR agreement, the Biobadaser protocol was used as a model for implementing the new registry in our country. During the first two years of this effort, the original protocol was adapted, translated, and presented to all Brazilian rheumatologists. For ten months, data of 1,037 patients (750 subjects treated with biological drugs and 287 control subjects) from 15 centers were collected. RESULTS: Most patients had rheumatoid arthritis (RA) (n = 723). Infliximab was the most frequently used anti-TNF agent, and the total exposure to biologic drugs was 2,101 patient-years. The most common reason for interrupting drug use was lack or loss of efficacy (50%), while 30% withdrew from the treatment arm due to adverse events. Three cases of tuberculosis were observed in the biologic group, with an incidence higher than that of the general Brazilian population. Infections were observed in 23% of the biologic group, and the upper respiratory tract was the most commonly affected site. Only one case of tuberculoid leprosy was observed. No deaths or malignancies attributed to drug effects were observed as of February 2010. CONCLUSIONS: The implementation of the BiobadaBrasil registry was successful, and, although recent, the registry has provided important data.

Gustavo G. Resende a,*, Cristina C. D. Lannaa, Adriana B. Bortoluzzob, Celio R. Goncalvesc, Percival D. Sampaio -Barrosc, Jose Antonio Braga da Silvad, Antonio Carlos Ximenese, Manoel B. Bertolo f, Sandra L.E. Ribeiro g, Mauro Keisermanh, Rita Menini, Thelma L. Skare j, Sueli Carneirok, Valderilio F. Azevedol, Walber P. Vieiram, Elisa N. Albuquerquen, Washington A. Bianchio, Rubens Bonfiglioli p, Cristiano Campanholoq, Hellen M. S. Carvalhor, Izaias P. Costas, Angela P. Duartet, Charles L. Kohemu, Nocy Leitev, Sonia A. L. Limaw, Eduardo S. Meirelles x, Ivânio A. Pereiray, Marcelo M. Pinheiro z, Elizandra Polito A, Francisco Airton C. RochaB, Mittermayer B. SantiagoC, Maria de Fatima L. C. SaumaD, Valeria ValimE

Relapsing Polychondritis (RP) is a rare systemic disease of unknown etiology, characterized by recurrent inflammation of cartilaginous structures and other connective tissues, including the ears, nose, joints, respiratory tract, and others. Due to the presence of typical signs and symptoms, biopsy is seldom necessary. Treatment includes corticosteroids, occasionally associated with immunosuppressive agents, but refractory cases are described. Recent reports suggest that anti-TNF agents, such as infliximab, may be of value in patients who do not respond to conventional therapy, but experience with this treatment is scarce. In this paper, the authors report the case of a patient with RP refractory to combined treatment with corticosteroids and immunosuppressive agents, who showed a good response to infliximab.

Policondrite Recidivante (PR) é uma doença sistêmica rara de etiologia desconhecida, que se caracteriza por inflamação recorrente da cartilagem e de outros tecidos conjuntivos, incluindo orelhas, nariz, articulações e trato respiratório. Devido à riqueza de sinais e sintomas, a biópsia local raramente é necessária para o estabelecimento do diagnóstico. O tratamento inclui glicocorticoides, eventualmente associado a agentes imunossupressores, mas, mesmo assim, casos refratários são descritos. Relatos recentes sugerem que agentes anti-TNF como infliximabe podem ser de valia em pacientes que não respondem ao tratamento convencional, mas a experiência ainda é limitada. Neste trabalho, os autores discutem o caso de uma paciente com PR que se mostrará refratária à combinação de corticoide e imunossupressores que apresentou boa resposta ao infliximabe.Relapsing Polychondritis (RP) is a rare systemic disease of unknown etiology, characterized by recurrent inflammation of cartilaginous structures and other connective tissues, including the ears, nose, joints, respiratory tract, and others. Due to the presence of typical signs and symptoms, biopsy is seldom necessary. Treatment includes corticosteroids, occasionally associated with immunosuppressive agents, but refractory cases are described. Recent reports suggest that anti-TNF agents, such as infliximab, may be of value in patients who do not respond to conventional therapy, but experience with this treatment is scarce. In this paper, the authors report the case of a patient with RP refractory to combined treatment with corticosteroids and immunosuppressive agents, who showed a good response to infliximab.

OBJETIVO: Avaliar a funcao endotelial em pacientes com artrite reumatoide, pela dilatacao fluxo-mediadada arteria braquial. MATERIAIS E METODOS: Sessenta e oito pacientes, sendo 32 com artrite reumatoide e36 do grupo controle, foram avaliadas pela dilatacao fluxo-mediada da arteria braquial (metodo ultra-sono-grafico, no modo B, de avaliacao de risco cardiovascular). Em um segundo tempo, foi avaliada a correlacaoentre a dilatacao fluxo-mediada da arteria braquial, a proteina C reativa e o tempo de doenca em pacientescom artrite reumatoide. RESULTADOS: A dilatacao fluxo-mediada da arteria braquial na artrite reumatoidefoi igual a 5,6 ± 9,69% e no grupo controle foi igual a 23,24 ± 5,65%, diferenca estatisticamente signi-ficante (p < 0,00001). A proteina C-reativa teve resultado de 4,8 ± 9,1 mg/l. A correlacao entre a idade,a dilatacao fluxo-mediada da arteria braquial e a proteina C reativa nas pacientes com artrite reumatoide naomostrou resultado estatisticamente significante. CONCLUSAO: Mulheres com artrite reumatoide apresen-tam importante disfuncao endotelial quando comparadas com mulheres normais.Unitermos: Artrite reumatoide; Disfuncao endotelial; Dilatacao fluxo-mediada da arteria braquial.Brachial artery flow-mediated dilatation in women with rheumatoid arthritis.OBJECTIVE: To evaluate the endothelial function in patients with rheumatoid arthritis by means of brachialartery flow-mediated vasodilation. MATERIALS AND METHODS: Sixty-eight patients, 32 with rheumatoidarthritis and 36 in the control group, underwent brachial artery flow-mediated dilatation (B-mode ultrasoundfor evaluating cardiovascular risk). Afterwards, the correlation among brachial artery flow-mediated vasodi-lation, C-reactive protein, and disease duration in patients with rheumatoid arthritis was evaluated. RESULTS:The brachial artery flow-mediated dilatation of the brachial artery in rheumatoid arthritis corresponded to5.6 ± 9.69%, and in the control group, to 23.24 ± 5.65%, with a statistically significant difference (p

Objetivo 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). Pacientes e métodos Coorte prospectiva, observacional e multicêntrica com 1.424 pacientes com diagnóstico de EspA de acordo com o European Spondyloarthropathy Study Group (ESSG) submetidos a um protocolo comum de investigação e recrutados em 29 centros de referência participantes do Registro Brasileiro de Espondiloartrites (RBE). Os pacientes foram divididos em dois grupos: idade no início

Objetivos: A fadiga é um sintoma altamente subjetivo e extremamente comum em pacientes com artrite reumatoide, embora seja difícil de caracterizar e definir. O objetivo desse estudo foi avaliar a fadiga em uma coorte de pacientes brasileiros e analisar a relação entre fadiga e variáveis específicas da doença. Métodos: Foram prospectivamente investigados 371 pacientes brasileiros diagnosticados com artrite reumatoide, de acordo com os critérios de classificação do Colégio Americano de Reumatologia de 1987. Dados demográficos, clínicos e laboratoriais foram obtidos dos registros clínicos. Foram registrados o número de articulações dolorosas, índice de massa corporal, duração da doença, qualidade de vida, capacidade funcional, ansiedade e depressão. A fadiga foi avaliada com o uso da subescala específica da escala Fatigue Assessment of Chronic Illness Therapy (FACIT-FATIGUE). Resultados: O escore mediano para fadiga foi 42 (10), negativamente correlacionado com a capacidade funcional (-0,507; p < 0,001), ansiedade e depressão (-0,542 e -0,545; p < 0,001, respectivamente) e predominantemente com o domínio físico do questionário Short Form-36 para qualidade de vida (SF-36P: 0,584; p < 0,001). Não houve correlação entre os escores e a velocidade de sedimentação das hemácias (-0,118; p

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.Prospective, observational and multicentric cohort with 1,424 patients with the diagnosis of SpA according to the European Spondyloarthropathy Study Group (ESSG) submitted to a common protocol of investigation and recruited in 29 reference centers participants of the Brazilian Registry of Spondyloarthritis (RBE - Registro Brasileiro de Espondiloartrites). Patients were divided in two groups: age at onset16 years (JOSpA group) and age at onset ≥ 16 years (AOSpA group).Among the 1,424 patients, 235 presented disease onset before 16 years (16.5%). The clinical and epidemiologic variables associated with JOSpA were male gender (p0.001), lower limb arthritis (p=0.001), enthesitis (p=0.008), anterior uveitis (p=0.041) and positive HLA-B27 (p=0.017), associated with lower scores of disease activity (Bath Ankylosing Spondylitis Disease Activity Index - BASDAI; p=0.007) and functionality (Bath Ankylosing Spondylitis Functional Index - BASFI; p=0.036). Cutaneous psoriasis (p0.001), inflammatory bowel disease (p=0.023), dactylitis (p=0.024) and nail involvement (p=0.004) were more frequent in patients with adult-onset SpA.Patients with JOSpA in this large Brazilian cohort were characterized predominantly by male gender, peripheral involvement (arthritis and enthesitis), positive HLA-B27 and lower disease scores.

As doenças inflamatórias intestinais (doença de Crohn e retocolite ulcerativa) apresentam manifestações extraintestinais em um quarto dos pacientes, sendo a mais comum a artrite enteropática. MÉTODOS: Estudo prospectivo, observacional e multicêntrico, realizado com pacientes de 29 centros de referência participantes do Registro Brasileiro de Espondiloartrites (RBE), que se incorpora ao grupo RESPONDIA (Registro Ibero-americano de Espondiloartrites). Dados demográficos e clínicos de 1472 pacientes foram colhidos, e aplicaram-se questionários padronizados de avaliação de mobilidade axial, de qualidade de vida, de envolvimento entesítico, de atividade de doença e de capacidade funcional. Exames laboratoriais e radiográficos foram realizados. Objetivamos, neste presente artigo, comparar as características clínicas, epidemiológicas, genéticas, imagenológicas, de tratamento e prognóstico de enteroartríticos com os outros espondiloartríticos nesta grande coorte brasileira. RESULTADOS: Foram classificados como enteroartrite 3,2% dos pacientes, sendo que 2,5% tinham espondilite e 0,7%, artrite (predomínio periférico). O subgrupo de indivíduos com enteroartrite apresentava maior prevalência de mulheres (P < 0,001), menor incidência de dor axial inflamatória (P < 0,001) e de entesite (P = 0,004). O HLA-B27 foi menos frequente no grupo de enteroartríticos (P = 0,001), mesmo se considerado apenas aqueles com a forma axial pura. Houve menor prevalência de sacroiliíte radiológica (P = 0,009) e também menor escore radiográfico (BASRI) (P = 0,006) quando comparado aos pacientes com as demais espondiloartrites. Também fizeram mais uso de corticosteroides (P < 0,001) e sulfassalasina (P < 0,001) e menor uso de anti-inflamatórios não hormonais (P < 0,001) e metotrexato (P = 0,001). CONCLUSÃO: Foram encontradas diferenças entre as enteroartrites e as demais espondiloartrites, principalmente maior prevalência do sexo feminino, menor frequência do HLA-B27, associados a uma menor gravidade do acometimento axial. Inflammatory bowel diseases (Crohn’s disease and ulcerative rectocolitis) have extraintestinal manifestations 25% of the patients, with the most common one being the enteropathic arthritis. Methods: Prospective, observational, multicenter study with patients from 29 reference centers participating in the Brazilian Registry of Spondyloarthritis (RBE), which incorporates the RESPONDIA (Ibero-American Registry of Spondyloarthritis) group. Demographic and clinical data were collected from 1472 patients and standardized questionnaires for the assessment of axial mobility, quality of life, enthesitic involvement, disease activity and functional capacity were applied. Laboratory and radiographic examinations were performed. The aim of this study is to compare the clinical, epidemiological, genetic, imaging, treatment and prognosis characteristics of patients with enteropathic arthritis with other types of spondyloarthritis in a large Brazilian cohort. Results: A total of 3.2% of patients were classified as having enteroarthritis, 2.5% had spondylitis and 0.7%, arthritis (peripheral predominance). The subgroup of individuals with enteroarthritis had a higher prevalence in women (P < 0.001), lower incidence of inflammatory axial pain (P < 0.001) and enthesitis (P = 0.004). HLA-B27 was less frequent in the group with enteroarthritis (P = 0.001), even when considering only those with the pure axial form. There was a lower prevalence of radiographic sacroiliitis (P = 0.009) and lower radiographic score (BASRI) (P = 0.006) when compared to patients with other types of spondyloarthritis. They also used more corticosteroids (P < 0.001) and sulfasalazine (P < 0.001) and less nonsteroidal anti-inflammatory drugs (P < 0.001) and methotrexate (P = 0.001). Conclusion: There were differences between patients with enteroarthritis and other types of spondyloarthritis, especially higher prevalence of females, lower frequency of HLA-B27, associated with less severe axial involvement.

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.A common protocol of investigation was prospectively applied to 1492 Brazilian patients classified as SpA according to the European Spondyoarthropathies Study Group (ESSG), attended at 29 referral centers of Rheumatology in Brazil. Clinical and demographic variables, and disease indices (BASDAI, Basfi, Basri, Mases, ASQol) were applicated. The total values of BASDAI were compared to the presence of the different variables.The mean score of BASDAI was 4.20 ± 2.38. The mean scores of BASDAI were higher in patients with the combined (axial + peripheral + entheseal) (4.54 ± 2.38) clinical presentation, compared to the pure axial (3.78 ± 2.27) or pure peripheral (4.00 ± 2.38) clinical presentations (p0.001). BASDAI also presented higher scores associated with the female gender (p0.001) and patients who did not practice exercises (p0.001). Regarding the axial component, higher values of BASDAI were significantly associated with inflammatory low back pain (p0.049), alternating buttock pain (p0.001), cervical pain (p0.001) and hip involvement (p0.001). There was also statistical association between BASDAI scores and the peripheral involvement, related to the lower (p=0.004) and upper limbs (p=0.025). The presence of enthesitis was also associated to higher scores of BASDAI (p=0.040). Positive HLA-B27 and the presence of cutaneous psoriasis, inflammatory bowel disease, uveitis and urethritis were not correlated with the mean scores of BASDAI. Lower scores of BASDAI were associated with the use of biologic agents (p0.001).In this heterogeneous Brazilian series of SpA patients, BASDAI was able to demonstrate "disease activity" in patients with axial as well as peripheral disease.

IntroductionFew studies have evaluated the profile of use of disease modifying drugs (DMD) in Brazilian patients with spondyloarthritis (SpA).MethodsA common research protocol was applied prospectively in 1505 patients classified as SpA by criteria of the European Spondyloarthropathies Study Group (ESSG), followed at 29 referral centers in Rheumatology in Brazil. Demographic and clinical variables were obtained and evaluated, by analyzing their correlation with the use of DMDs methotrexate (MTX) and sulfasalazine (SSZ).ResultsAt least one DMD was used by 73.6% of patients: MTX by 29.2% and SSZ by 21.7%, while 22.7% used both drugs. The use of MTX was significantly associated with peripheral involvement, and SSZ was associated with axial involvement, and the two drugs were more administered, separately or in combination, in the mixed involvement (p < 0.001). The use of a DMD was significantly associated with Caucasian ethnicity (MTX, p = 0.014), inflammatory back pain (SSZ, p = 0.002), buttock pain (SSZ, p = 0.030), neck pain (MTX, p = 0.042), arthritis of the lower limbs (MTX, p < 0.001), arthritis of the upper limbs (MTX, p < 0.001), enthesitis (p = 0.007), dactylitis (MTX, p < 0.001), inflammatory bowel disease (SSZ, p < 0.001) and nail involvement (MTX, p < 0.001).ConclusionThe use of at least one DMD was reported by more than 70% of patients in a large cohort of Brazilian patients with SpA, with MTX use more associated with peripheral involvement and the use of SSZ more associated with axial involvement.

Background The safety profile of biologic drugs might have substantial regional differences. Since 2009, the Brazilian Society of Rheumatology runs BiobadaBrasil, a registry for monitoring of biologic therapies in rheumatic diseases, in collaboration with other Latin America countries (BiobadaAmerica) and with Biobadaser Objectives To report the incidence of serious adverse events (SAE) in Rheumatoid Arthritis (RA) patients exposed to biologic drugs in Brazil Methods BiobadaBrasil counts on thirty two centers, from almost all Brazilian states, that prospectively include patients with active rheumatic diseases who started a biologic drug or a synthetic DMARD as a parallel control group. A constant three level monitory of data quality is maintained (online, by phone and “in situ”). This study focuses on SAE (for definition: Protocolo 1.1 at https://biobadaser.ser.es/biobadamerica/Brasil/cgi-bin/upload/documentacion.aspx) in RA patients exposed to biologics from January 2009 to June 2015. Time of exposure was set from start of the drug to the date of last administration or censorship. Continuous variables were expressed as mean with standard deviation (SD). SAE incidence rate was calculated per 1000 patient/years with 95%CI Results Out of a total of 1649 subjects with RA, 1121 were exposed to biologics (4735 p/y), 91% a-TNFs, follow-up 2.8 (2.2) yrs, 85% females, at baseline: age 50 (14) yrs, disease duration 9 (8) yrs, DAS28 5.4 (1.4). Controls were 528 (1971 p/y), follow-up 3.6 (2.2) yrs, 86% females, at baseline: age 54 (13) yrs, disease duration 6 (8) yrs, DAS28 5.1 (3.1). The incidence rates of SAE in the biologics and control groups were 86 [78, 94] vs 34 [27, 44] (ratio 2.5 [1.9, 3.3], p Conclusions In the BiobadaBrasil registry the incidence of SAE is 2 fold higher with biologics than with synthetic DMARDs, and higher with subsequent a-TNF than with the first Acknowledgement for data monitoring P Cabral, for contributing to BiobadaBrasil registry, L.Barbosa, W.Chahade, A.Hayata, A.Kakehasi, M.Pinheiro, A.Ranzolin, M.Scheinberg, F.Sztajnbok, I.Silveira Disclosure of Interest None declared

Background The safety profile of biologic drugs might have substantial regional differences. Since 2009, the Brazilian Society of Rheumatology runs BiobadaBrasil, a registry for monitoring of biologic therapies in rheumatic diseases, in collaboration with other Latin America countries (BiobadaAmerica) and with Biobadaser Objectives To report the incidence of serious infectious adverse events (SIAE) in Rheumatoid Arthritis (RA) and Spondyloarthritis (SpA) patients exposed to biologic a-TNF drugs in Brazil Methods BiobadaBrasil counts on thirty two centers, from almost all Brazilian states, that prospectively include patients with active rheumatic diseases who started a biologic drug or a synthetic DMARD as a parallel control group. A constant three level monitory of data quality is maintained (online, by phone and “in situ”). This study focuses on SIAE (for definition: Protocolo 1.1 at https://biobadaser.ser.es/biobadamerica/Brasil/cgi-bin/upload/documentacion.aspx) in RA and SpA (Ankylosing Spondylitis+Psoriatic Arthritis) patients exposed to a-TNFs from January 2009 to June 2015. Time of exposure was set from start of the drug to the date of last administration or censorship. Continuous variables were expressed as mean with standard deviation (SD). SAE incidence rate was calculated per 1000 patient/years with 95%CI Results 1601 subjects with RA (1024) and SpA (577) exposed to a-TNF drugs were included in BiobadaBrasil, 6298 p/y, follow-up 2.9 (2.3) yrs, 65% females, at baseline: age 52 (12.5) yrs, disease duration 8.6 (8) yrs. Controls were 572 (RA 528, SpA 44), 2093 p/y, follow-up 3.6 (2.2) yrs, 90% females, at baseline: age 55 (13) yrs, disease duration 5.3 (7.3) yrs. The incidence rates of SIAE were: a-TNF RA & SpA 35 [30,40] vs controls 15 [10,21], ratio 2.34 [1.6,3.5] p Conclusions In BiobadaBrasil registry, patients exposed to a-TNF drugs had an incidence rate of serious infections 2-fold that of the control group, significantly lower in SpA than in RA. Acknowledgement for data monitoring P Cabral, for contributing to BiobadaBrasil registry, L.Barbosa, W.Chahade, A.Hayata, A.Kakehasi, M.Pinheiro, A.Ranzolin, M.Scheinberg, F.Sztajnbok, I.Silveira Disclosure of Interest None declared

Background Herpes Zoster has been reported with increased frequency in association with rheumatic diseases and biologic therapy. Objectives To study herpes zoster (HZ) in patients with rheumatic diseases included in the Brazilian Register for monitoring of biologic therapies in rheumatic diseases - BiobadaBrasil, Methods BiobadaBrasi is a prospective observational cohort study, part of an international initiative (biobadaAmerica) in collaboration with BiobadaSer. Patients with rheumatic diseases are enrolled at the moment of introduction of their first biologic therapy; a comparison cohort of patients with active RA receiving traditional disease-modifying antirheumatic drugs (DMARDs) was recruited in parallel in each center. This register was established in 2009 and is an ongoing study ran by the Brazilian Society of Rheumatology comprising 32 centers (30 public, located at academic centres, 2 private) in almost all states of the country. Data quality is under constant monitoring (online, by phone and “in situ”). In this report all biologic administered to more than a hundred patients were included: abatacept, adalimumab, etanercept, infliximab, rituximab and tocilizumab. Data was expressed as mean (SD); crude incidence rates (IR) were calculated as number of HZ episodes per 1000 patient-years- IR (1000 patient-years). Results Up to January 2016, 2715 patients were included in the register, 70% female, mean age 51 (14.3) yrs, submitted to 3770 treatments; 1721 patients with diagnosis of RA; $54 with AS and APs=181. 61 HZ episodes were related including only one relapse reported in a 44years-old female patient with AR and in use of rituximab. The crude IR (95% CI) of HZ in the study population (biologic agentes) was 8.3 (1000 patient-years) vs 4.45 (1000 patient-years) in the control population (traditional DMARds), (p=0,7 95%CI-3,7–4,7). Only 6 cases were considered severe by the investigators, two of them were HZ ophthalmicus, one periorbital and all lead to some impairment. These patients were taking different biologic agents (etanercept, adalimumab, infliximab – 2 patients) and one was using traditional DMARDS. Treatment with steroids (HR 1.99; 95%CI 1.092–3.6) was the only factor associated with zoster development. There was no difference in age, sex, specific disease or biologic agent associated with HZ episodes. Conclusions In our database, the risk of HZ was significantly increased in association with corticosteroid treatment but neither with biologic agents nor with inflammatory rheumatic diseases. Acknowledgement for monitor P Cabral, for contribution to the BiobadaBrasil registry, L.Barbosa, W.Chahade, A.Hayata, A.Kakehasi, M.Pinheiro, A.Ranzolin, M.Scheinberg, F.Sztajnbok, I.Silveira Disclosure of Interest None declared