Brazilian recommendations on the safety and effectiveness of the yellow fever vaccination in patients with chronic immune-mediated inflammatory diseases.

BACKGROUND: In Brazil, we are facing an alarming epidemic scenario of Yellow fever (YF), which is reaching the most populous areas of the country in unvaccinated people. Vaccination is the only effective tool to prevent YF. In special situations, such as patients with chronic immune-mediated inflammatory diseases (CIMID), undergoing immunosuppressive therapy, as a higher risk of severe adverse events may occur, assessment of the risk-benefit ratio of the yellow fever vaccine (YFV) should be performed on an individual level. Faced with the scarcity of specific orientation on YFV for this special group of patients, the Brazilian Rheumatology Society (BRS) endorsed a project aiming the development of individualized YFV recommendations for patients with CIMID, guided by questions addressed by both medical professionals and patients, followed an internationally validated methodology (GIN-McMaster Guideline Development). Firstly, a systematic review was carried out and an expert panel formed to take part of the decision process, comprising BRS clinical practitioners, as well as individuals from the Brazilian Dermatology Society (BDS), Brazilian Inflammatory Bowel Diseases Study Group (GEDIIB), and specialists on infectious diseases and vaccination (from Tropical Medicine, Infectious Diseases and Immunizations National Societies); in addition, two representatives of patient groups were included as members of the panel. When the quality of the evidence was low or there was a lack of evidence to determine the recommendations, the decisions were based on the expert opinion panel and a Delphi approach was performed. A recommendation was accepted upon achieving ≥80% agreement among the panel, including the patient representatives. As a result, eight recommendations were developed regarding the safety of YFV in patients with CIMID, considering the immunosuppression degree conferred by the treatment used. It was not possible to establish recommendations on the effectiveness of YFV in these patients as there is no consistent evidence to support these recommendations. CONCLUSION: This paper approaches a real need, assessed by clinicians and patient care groups, to address specific questions on the management of YFV in patients with CIMID living or traveling to YF endemic areas, involving specialists from many areas together with patients, and might have global applicability, contributing to and supporting vaccination practices. We recommended a shared decision-making approach on taking or not the YFV.

Changing rate of serious infections in biologic-exposed rheumatoid arthritis patients. Data from South American registries BIOBADABRASIL and BIOBADASAR.

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.

Brazilian recommendations on the safety and effectiveness of the yellow fever vaccination in patients with chronic immune-mediated inflammatory diseases

Abstract Background: In Brazil, we are facing an alarming epidemic scenario of Yellow fever (YF), which is reaching the most populous areas of the country in unvaccinated people. Vaccination is the only effective tool to prevent YF. In special situations, such as patients with chronic immune-mediated inflammatory diseases (CIMID), undergoing immunosuppressive therapy, as a higher risk of severe adverse events may occur, assessment of the risk-benefit ratio of the yellow fever vaccine (YFV) should be performed on an individual level. Main body of the abstract: Faced with the scarcity of specific orientation on YFV for this special group of patients, the Brazilian Rheumatology Society (BRS) endorsed a project aiming the development of individualized YFV recommendations for patients with CIMID, guided by questions addressed by both medical professionals and patients, followed an internationally validated methodology (GIN-McMaster Guideline Development). Firstly, a systematic review was carried out and an expert panel formed to take part of the decision process, comprising BRS clinical practitioners, as well as individuals from the Brazilian Dermatology Society (BDS), Brazilian Inflammatory Bowel Diseases Study Group (GEDIIB), and specialists on infectious diseases and vaccination (from Tropical Medicine, Infectious Diseases and Immunizations National Societies); in addition, two representatives of patient groups were included as members of the panel. When the quality of the evidence was low or there was a lack of evidence to determine the recommendations, the decisions were based on the expert opinion panel and a Delphi approach was performed. A recommendation was accepted upon achieving ≥80% agreement among the panel, including the patient representatives. As a result, eight recommendations were developed regarding the safety of YFV in patients with CIMID, considering the immunosuppression degree conferred by the treatment used. It was not possible to establish recommendations on the effectiveness of YFV in these patients as there is no consistent evidence to support these recommendations. Conclusion: This paper approaches a real need, assessed by clinicians and patient care groups, to address specific questions on the management of YFV in patients with CIMID living or traveling to YF endemic areas, involving specialists from many areas together with patients, and might have global applicability, contributing to and supporting vaccination practices. We recommended a shared decision-making approach on taking or not the YFV.

The Influence of Income and Formal Education on Damage in Brazilian Patients With Systemic Lupus Erythematosus.

OBJECTIVE: The aim of this study was to evaluate the association of socioeconomic status and American College of Rheumatology/Systemic Lupus International Collaborating Clinics Damage Index (SDI) score in Brazilian patients with systemic lupus erythematosus (SLE). METHODS: Five hundred twenty-three patients (SLE ACR criteria) 18 years or older who were at 12 months or greater since diagnosis were included. Socioeconomic status was assessed by per-capita income and years of education. Race was categorized as white and nonwhite. The SDI and Mexican SLE Disease Activity Index were used. STATISTICAL ANALYSIS: Mean ± SD and median were used for descriptive analysis. Student t test, Mann-Whitney U test, χ test, and Spearman rank correlation coefficient and univariate and multivariate regression analyses were performed. The level of significance was set at 5% for all statistical tests. RESULTS: Ninety-six percent were female, 51.2% were nonwhite, and the mean age was 37.8 ± 1.4 years. Disease duration was 8.2 ± 10.3 years and formal education was 10.2 ± 3.5 years. Unemployment among patients was 63.7%, with median monthly per-capita income of US $276. Mean SDI score was 1.4 ± 1.52, and 65.6% had some type of damage (SDI ≥1). Patients with SDI of 1 or greater had lower income (P = 0.039). Nonwhite patients had higher SDI than did white patients (P = 0.005). The SDI presented a positive correlation with disease duration (P < 0.001) and age (P < 0.001) and a negative correlation with years of education (P = 0.001). Working patients had lower SDI than did inactive ones (P ≤ 0.001). In a multivariate analysis, older age, higher disease duration, nonwhite race, low income, and out-of-work profile were associated with damage. CONCLUSIONS: Besides nonmodifiable characteristics such as longer disease duration and older age, low income was also associated with damage. Therefore, interventions to give adequate socioeconomic support are necessary to improve outcome, mainly in poorer and nonwhite SLE patients.

Treatment of mesenteric angina in patients with Takayasu's arteritis.

Takayasu's arteritis (TA) is an idiopathic chronic inflammatory disease of the connective tissue that affects mainly the aorta and its branches. Treatment is mainly based on corticosteroids and immunosuppressants. We report the case of a 33-year-old female complaining of malaise, fever, myalgia, severe pulsing holocranial headache resistant to analgesics, systemic arterial hypertension hard to control, right lower limb claudication, and severe abdominal pain that worsened after the meals. Angiotomography revealed aneurysm of the ascending aorta, and stenosis of the following vessels: right common iliac artery, renal arteries, and superior mesenteric artery. Those findings supported the diagnosis of mesenteric angina and the interventional approach by use of percutaneous transluminal angioplasty with stent placement.

Tratamento de angina mesentérica em pacientes com arterite de Takayasu / Treatment of mesenteric angina in patients with Takayasu's arteritis

Aarterite de Takayasu (AT) é uma doença inflamatória crônica do tecido conectivo, idiopática, que acomete preferencialmente a aorta e seus ramos. A terapêutica utilizada baseia-se sobretudo no uso de corticosteroides e imunossupressores. É relatado o caso de uma paciente, 33 anos, com mal-estar, febre, mialgia, cefaleia intensa, pulsátil, holocraniana, resistente a analgésicos, hipertensão arterial sistêmica de difícil controle, claudicação no membro inferior direito e dor abdominal de forte intensidade, a qual piorava após a alimentação. A angiotomografia revelou aneurisma da aorta ascendente, estenose da artéria ilíaca comum direita, estenose das artérias renais e estenose da artéria mesentérica superior, fato que embasou o diagnóstico de angina mesentérica e a conduta intervencionista através da angioplastia transluminal percutânea múltipla com a colocação de stents.

Takayasu's arteritis (TA) is an idiopathic chronic inflammatory disease of the connective tissue that affects mainly the aorta and its branches. Treatment is mainly based on corticosteroids and immunosuppressants. We report the case of a 33-year-old female complaining of malaise, fever, myalgia, severe pulsing holocranial headache resistant to analgesics, systemic arterial hypertension hard to control, right lower limb claudication, and severe abdominal pain that worsened after the meals. Angiotomography revealed aneurysm of the ascending aorta, and stenosis of the following vessels: right common iliac artery, renal arteries, and superior mesenteric artery. Those findings supported the diagnosis of mesenteric angina and the interventional approach by use of percutaneous transluminal angioplasty with stent placement.