Predictors of Hospitalization in Breakthrough COVID-19 among Fully Vaccinated Individuals with Immune-Mediated Rheumatic Diseases: Data from SAFER-Study.

Breakthrough COVID-19 (occurring in fully vaccinated people) has been described. Data on its characteristics among immune-mediated rheumatic disease (IMRD) patients are scarce. This study describes breakthrough COVID-19 occurring in IMRD patients participating in the SAFER-study, a Brazilian multicentric cohort evaluating the safety, effectiveness, and immunogenicity of SARS-CoV-2 vaccines in patients with autoimmune diseases. A descriptive analysis of the population and a binary logistic regression model were performed to evaluate the predictors of COVID-19-related hospitalization. A p-value < 0.05 was significant. The included 160 patients were predominantly females (83.1%), with a mean (SD) age of 40.23 (13.19) years. The patients received two (19%), three (70%), or four (11%) vaccine doses. The initial two-dose series was mainly with ChAdOx1 (Oxford/AstraZeneca) (58%) or BBIBP-CorV (Sinopharm-Beijing) (34%). The first booster (n = 150) was with BNT162b2 (BioNtech/Fosun Pharma/Pfizer) (63%) or ChAdOx1 (29%). The second booster (n = 112) was with BNT162b2 (40%) or ChAdOx1 (26%). The COVID-19 hospitalization rate was 17.5%. IMRD moderate/high activity (OR: 5.84; CI: 1.9-18.5; p = 0.002) and treatment with corticosteroids (OR: 2.94; CI: 1.02-8.49; p = 0.0043) were associated with higher odds of hospitalization, while increasing the number of vaccine doses was protective (OR: 0.37; CI: 0.15-0.9; p = 0.032). These findings, along with previous reassuring results about the safety of the COVID-19 vaccines, argue in favor of booster vaccination in IMRD patients.

Safety of CoronaVac and ChAdOx1 vaccines against SARS-CoV-2 in patients with rheumatoid arthritis: data from the Brazilian multicentric study safer.

BACKGROUND: Patients with immune-mediated rheumatic diseases (IMRDs) have been prioritized for COVID-19 vaccination to mitigate the infection severity risks. Patients with rheumatoid arthritis (RA) are at a high risk of severe COVID-19 outcomes, especially those under immunosuppression or with associated comorbidities. However, few studies have assessed the safety of the COVID-19 vaccine in patients with RA. OBJECTIVE: To evaluate the safety of vaccines against SARS-CoV-2 in patients with RA. METHODS: This data are from the study "Safety and Efficacy on COVID-19 Vaccine in Rheumatic Diseases," a Brazilian multicentric prospective phase IV study to evaluate COVID-19 vaccine in IMRDs in Brazil. Adverse events (AEs) in patients with RA of all centers were assessed after two doses of ChAdOx1 (Oxford/AstraZeneca) or CoronaVac (Sinovac/Butantan). Stratification of postvaccination AEs was performed using a diary, filled out daily and returned at the end of 28 days for each dose. RESULTS: A total of 188 patients with RA were include, 90% female. CoronaVac was used in 109 patients and ChAdOx1 in 79. Only mild AEs were observed, mainly after the first dose. The most common AEs after the first dose were pain at the injection (46,7%), headache (39,4%), arthralgia (39,4%), myalgia (30,5%) and fatigue (26,6%), and ChAdOx1 had a higher frequency of pain at the injection (66% vs 32 %, p < 0.001) arthralgia (62% vs 22%, p < 0.001) and myalgia (45% vs 20%, p < 0.001) compared to CoronaVac. The more common AEs after the second dose were pain at the injection (37%), arthralgia (31%), myalgia (23%), headache (21%) and fatigue (18%). Arthralgia (41,4% vs 25%, p = 0.02) and pain at injection (51,4% vs 27%, p = 0.001) were more common with ChAdOx1. No serious AEs were related. With Regard to RA activity level, no significant difference was observed between the three time periods for both COVID-19 vaccines. CONCLUSION: In the comparison between the two immunizers in patients with RA, local reactions and musculoskeletal symptoms were more frequent with ChAdOx1 than with CoronaVac, especially after the first dose. In summary, the AE occurred mainly after the first dose, and were mild, like previous data from others immunizing agents in patients with rheumatoid arthritis. Vaccination did not worsen the degree of disease activity.

Challenges in the Management of Psoriatic Arthritis in Latin America: A Systematic Review.

PURPOSE: In 2020, the International League of Associations for Rheumatology published recommendations for managing psoriatic arthritis (PsA), aiming to adapt the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis and the European Alliance of Associations for Rheumatology recommendations to low-income countries. At that time, the paucity of clinical studies examining the management of patients with PsA in Latin America was remarked on by the international working group. Therefore, the primary objective of this systematic literature review was to investigate the main challenges in managing PsA in Latin America as described in recent publications. METHODS: A systematic literature review of trials reporting at least one challenge/difficulty in the management of PsA in Latin America was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. References published in the PubMed, EMBASE, and LILACS (Latin American and Caribbean Health Sciences Literature) databases between 1980 and February 2023 were included. The selection of references was conducted independently by 2 researchers in the Rayyan Qatar Computing Research Institute program. Two other reviewers independently extracted data. All challenges were noted and categorized into domains. Data analysis was descriptive. FINDINGS: The search strategy yielded 2085 references, with 21 studies included in the final analysis. Most studies were conducted in Brazil (66.6%; n = 14) and were observational studies (100%; N = 21). Difficulties faced by PsA patients and physicians included the high incidence of opportunistic infections (described in 42.8% of the publications; n = 9), followed by nonadherence to therapy, discordance between patients and physicians regarding remission rates, low drug persistence, limited access to disease-modifying antirheumatic drugs, issues related to the storage of biologic drugs, elevated cost of biologic drugs, limited access to medical care, diagnostic delay, and the individual- and country-level impact of socioeconomic factors on work- and health-related outcomes. IMPLICATIONS: Challenges in the management of PsA in Latin America extend beyond the care of opportunistic infections, encompassing several other socioeconomic factors. More research is needed to better understand the peculiarities of treating PsA in Latin America to improve patient care. PROSPERO identifier: CRD42021228297.

Tradução e adaptação cultural da ferramenta de avaliação de riscos ergonômicos de membros superiores ­ Hand Arm Risk Assessment Method ­ HARM-BR / Translation with cultural adaptation of the risk assessment tool for upper limbs ­ Hand Arm Risk Assessment Method HARM-BR

Lesões musculoesqueléticas nos membros superiores estão intimamente ligadas a limitações funcionais e incapacidades. Estas lesões podem estar relacionadas ao trabalho e são conhecidas como Lesões por Esforços Repetitivos (LER) ou Distúrbios Osteomusculares Relacionados ao Trabalho (DORT). A avaliação ergonômica visa detectar os fatores de riscos para o desenvolvimento das LER/DORT e assim, intervenções e/ou ações preventivas possam ser implementadas. Para isso, são necessárias ferramentas observacionais de avaliação traduzidas e validadas para que resultados fidedignos sejam alcançados. O questionário HARM 2.0 é uma ferramenta de avaliação específica que indica se há risco de lesão em diversas tarefas que utilizam majoritariamente os membros superiores durante sua jornada de trabalho. Objetivo: Conduzir a tradução e adaptação transcultural do questionário HARM 2.0 para ser usado para avaliação e prevenção de riscos de lesões relacionadas ao trabalho. Métodos: A tradução e adaptação transcultural seguiu um protocolo composto por quatro estágios: tradução, síntese, retrotradução, revisão pelo comitê de especialistas e aprovação do conteúdo pelas autoras da versão original. Resultados: O estágio inicial (Estágio I) de tradução do questionário HARM 2.0 transcorreu sem intercorrências. Com relação ao grau de dificuldade, o tradutor expert referiu facilidade ao traduzir os itens e instruções do instrumento, enquanto a tradutora leiga considerou a dificuldade como moderada. Conclusão: O instrumento HARM-BR 2.0 apresentou resultados satisfatórios no processo de tradução e adaptação transcultural, estando sua versão disponível para uso. Futuros estudos são necessários para analisar as suas propriedades de medidas para a população brasileira de trabalhadores.

Musculoskeletal injuries in the upper limbs are closely associated with limitations and disabilities. These injuries can be work-related and are known as Repetitive Strain Injuries (RSI) or Work-Related Musculoskeletal Disorders (WRMD). The ergonomic evaluation aims to detect the risk factors for the development of RSI/WRMD and, therefore, preventive or intervention strategies can be implemented. Translated and validated observational assessments are required to achieve reliable results. The HARM 2.0 questionnaire is a specific assessment tool that indicates the risk of injury in several tasks that use the upper limbs in the work environment. Objective:The objective of this study is to conduct the translation and cross-cultural adaptation of the HARM 2.0 questionnaire for the assessment and prevention of work-related injuries. Methods:Translation and cross-cultural adaptation protocol consisting of four stages: translation, synthesis, back-translation, review by the Expert Committee, and approval by the authors of the original version. Results:The initial stage (Stage I) of translation of the HARM 2.0 questionnaire was regular and had no significant issues. Regarding the difficulty, the expert translator referred that translating the HARM items and instructions was easy, whereas the lay translator considered the scale moderate. Conclusion:The scale HARM-BR 2.0 presents satisfactory results in the process of translation and cross-cultural adaptation and its version available to use. Future studies should be conducted to establish its measurement properties for the Brazilian population.

Incidence of tuberculosis in patients receiving anti-TNF therapy for rheumatic diseases: a systematic review.

INTRODUCTION: The TNF inhibitors were the first immunobiologicals used to treat rheumatic diseases, but their use is associated with an increased risk of tuberculosis. The primary objective is to estimate the incidence of tuberculosis in patients with rheumatic diseases exposed to anti-TNF therapy. The secondary objectives are to evaluate the incidence of tuberculosis by region and subgroups of diseases, to review the presentation of tuberculosis in these patients, and to assess the time elapsed between onset of anti-TNF therapy and development of active granulomatous disease. METHODS: A systematic review of the literature was conducted in MEDLINE, the Cochrane Library, and LILACS. The primary endpoint was described as incidence and secondary outcomes, through subgroup analyses and comparisons of means. RESULTS: We included 52 observational studies. Among the exposed patients, 947 cases of tuberculosis were documented (62.2% pulmonary), with a cumulative incidence of 9.62 cases per 1000 patients exposed. TB incidence across different continents was distributed as follows: South America, 11.75 cases/1000 patients exposed; North America, 4.34 cases/1000 patients exposed; Europe, 6.28 cases/1000 patients exposed; and Asia, 13.47 cases/1000 patients exposed. There were no significant differences in TB incidence among the described diseases. The mean time elapsed from start of anti-TNF therapy until the endpoint was 18.05 months. CONCLUSION: The incidence of TB in patients with rheumatic diseases exposed TNF inhibitor considering all countries was 9.62 cases per 1000 patients exposed. TB incidence was higher in South America and Asia compared with North America and Europe. Most cases occurred in the first XX months of use, and the pulmonary form predominated.Key Points• Higher incidence of tuberculosis in patients exposed to anti-TNF compared with the general population.• Higher incidence of TB in countries of South America and Asia compared with North America and Europe.

A population-based study of tuberculosis incidence among rheumatic disease patients under anti-TNF treatment.

INTRODUCTION: Tuberculosis (TB) is an infectious disease caused by Mycobacterium tuberculosis. The advent of immunobiologic therapy with TNF inhibitors agents, has been associated with a significant increase in incident cases of tuberculosis in this population. OBJECTIVE: To estimate the incidence of tuberculosis in patients receiving TNF inhibitors therapy for rheumatic diseases. As secondary objectives, we sought to evaluate mortality and the clinical impact of screening for latent tuberculosis infection. METHODS: This retrospective study included patients with rheumatic diseases of Public Health System from the Brazilian state, a high TB incidence area, who received prescriptions of TNF inhibitors agents between 2006 and 2016. RESULTS: A total of 5853 rheumatic disease patients were included. Patients were predominantly women (68.7%) aged 49.5 (± 14.7) years old. Forty-three cases of TB were found (2.86 cases per 1000 person-years; 18 times higher than in the general population). Adalimumab and certolizumab users presented a higher risk for TB development compared to etanercept users (RR: 3.11, 95%CI 1.16-8.35; 7.47, 95%CI 1.39-40.0, respectively). In a subgroup of patients, screening for latent tuberculosis infection was performed in 86% of patients, and 30.2% had a positive tuberculin skin test. Despite latent TB treatment, TB was diagnosed in 2 out of 74 (2.7%) patients. Overall, TB diagnosis did not increase mortality. CONCLUSION: In this population-based study of rheumatic disease patients from a high incident area, TNF inhibitor exposure was associated with an 18-time increased TB incidence. Adalimumab and certolizumab were associated with greater and earlier TB diagnosis compared to etanercept.