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.

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.

Objective 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. Methods 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. Results 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. Conclusion 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.

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Tumor necrosis factor-α (TNF-α) inhibitors are increasingly becoming the standard of care for treating a number of inflammatory diseases. However, treatment with TNF-α inhibitors carries an inherent risk of compromising the immune system, resulting in an increased susceptibility to infections and malignancies. This increased risk of infection is of particular concern in Asia, Eastern Europe, and Latin America where tuberculosis (TB) and viral hepatitis are endemic. In this brief review, we examine the literature and review the impact of TNF-α inhibitors on the incidence and the reactivation of latent disease with respect to TB, hepatitis C infection, and hepatitis B infection. Our findings show that TNF-α inhibitors are generally safe, if used with caution. Patients should be screened prior to the initiation of TNF-α inhibitor treatment and given prophylactic treatment if needed. In addition, patients should be monitored during treatment with TNF-α inhibitors and after treatment has stopped to ensure that infections, if detected, are treated promptly and effectively. Our analysis is consistent with other reports and guidelines.

Rheumatoid arthritis is a systemic inflammatory disorder characterized by joint articular pain and disability. Although there is scarcity of data available on the incidence and prevalence of RA in Latin America, there is a growing recognition of this disease where chronic diseases are on the rise and infectious disease on the decline. RA is a substantial burden to patients, society, and the healthcare system. The heterogeneity identified within RA presents an opportunity for personalized medicine, especially in regions with such demographic diversity as that of Latin America. To understand the long-term effects of treatment for RA especially on safety, registries have been established, a number of which have been created in Latin America. Despite their weaknesses (e.g., lack of controls and randomization), registries have provided additional and complementary information on the use of biologics in clinical practice in Latin America and other regions. Although certain challenges remain in the implementation and maintenance of registries, they continue to provide real-life data to clinical practice contributing to improved patient care.

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BackgroundHerpes Zoster has been reported with increased frequency in association with rheumatic diseases and biologic therapy.ObjectivesTo study herpes zoster (HZ) in patients with rheumatic diseases included in the Brazilian Register for monitoring of biologic therapies in rheumatic diseases - BiobadaBrasil,MethodsBiobadaBrasi 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).ResultsUp 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.ConclusionsIn our database, the risk of HZ was significantly increased in association with corticosteroid treatment but neither with biologic agents nor with inflammatory rheumatic diseases.Acknowledgementfor 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.SilveiraDisclosure of InterestNone declared