Résumé
Abstract Introduction Seasonal influenza A (H3N2) virus is an important cause of morbidity and mortality in the last 50 years in population that is greater than the impact of H1N1. Data assessing immunogenicity and safety of this virus component in juvenile systemic lupus erythematosus (JSLE) is lacking in the literature. Objective To evaluate short-term immunogenicity and safety of influenza A/Singapore (H3N2) vaccine in JSLE. Methods 24 consecutive JSLE patients and 29 healthy controls (HC) were vaccinated with influenza A/Singapore/ INFIMH-16-0019/2016(H3N2)-like virus. Influenza A (H3N2) seroprotection (SP), seroconversion (SC), geometric mean titers (GMT), factor increase in GMT (FI-GMT) titers were assessed before and 4 weeks post-vaccination. Disease activity, therapies and adverse events (AE) were also evaluated. Results JSLE patients and controls were comparable in current age [14.5 (10.1-18.3) vs. 14 (9-18.4) years, p = 0.448] and female sex [21 (87.5%) vs. 19 (65.5%), p = 0.108]. Before vaccination, JSLE and HC had comparable SP rates [22 (91.7%) vs. 25 (86.2%), p = 0.678] and GMT titers [102.3 (95% CI 75.0-139.4) vs. 109.6 (95% CI 68.2-176.2), p = 0.231]. At D30, JSLE and HC had similar immune response, since no differences were observed in SP [24 (100%) vs. 28 (96.6%), p = 1.000)], SC [4 (16.7%) vs. 9 (31.0%), p = 0.338), GMT [162.3 (132.9-198.3) vs. 208.1 (150.5-287.8), p = 0.143] and factor increase in GMT [1.6 (1.2-2.1) vs. 1.9 (1.4-2.5), p = 0.574]. SLEDAI-2K scores [2 (0-17) vs. 2 (0-17), p = 0.765] and therapies remained stable throughout the study. Further analysis of possible factors influencing vaccine immune response among JSLE patients demonstrated similar GMT between patients with SLEDAI < 4 compared to SLEDAI ≥ 4 ( p = 0.713), as well as between patients with and without current use of prednisone ( p = 0.420), azathioprine ( p = 1.0), mycophenolate mofetil ( p = 0.185), and methotrexate ( p = 0.095). No serious AE were reported in both groups and most of them were asymptomatic (58.3% vs. 44.8%, p = 0.958). Local and systemic AE were alike in both groups ( p > 0.05). Conclusion This is the first study that identified adequate immune protection against H3N2-influenza strain with additional vaccine-induced increment of immune response and an adequate safety profile in JSLE. ( www.clinicaltrials.gov , NCT03540823).
Résumé
Fundamentos: Estudos realizados no Brasil sugerem um percentual de até 60% de coronariografias normais em pacientes do Sistema Único de Saúde (SUS). Objetivo: Determinar se entre os pacientes referidos a um hospital universidade (HU) federal no Rio de Janeiro(RJ) e submetidos a coronariografias, a consulta cardiológica reduziu o percentual de exames sem lesões obstrutivas. Métodos: Estudo quase-experimental com todos os pacientes referidos do SUS e submetidos à coronariografia no HU entre janeiro 2007 e dezembro 2009. Eles foram estratificados em dois grupos (com e sem consulta ambulatorial) e comparados em relação ao percentual de coronariografias sem lesões obstrutivas (desfecho primário). Idade, sexo e fatores de risco cardiovascular também foram avaliados. Resultados: Foram incluídos 207 pacientes, dos quais 74 não realizaram consulta cardiológica antes do procedimento. A média da idade foi 58,5 anos e 58,9% eram homens. A prevalência de doença coronariana (DAC) obstrutiva (no mínimo uma lesão >- 70%) foi 62,3%. Sexo masculino, diabetes, dislipidemia, tabagismo, infarto do miocárdio e disfunção ventricular foram associados à DAC obstrutiva. A consulta cardiológica prévia no HU foi menos frequente entre aqueles com doença (61,2% x 69,2%; p=0,24). Nos pacientes <51 anos, o percentual de exames sem DAC onstrutiva foi maior entre aqueles com consulta prévia (66,7% x 33,3%; p=0,038). O percentual de coronariografias sem DAC obstrutiva entre os pacientes encaminhados a um HU federal no RJ entre 2007 e 2009 foi elevado em relação ao alvo estabelecido pela American College of Cardiology, e consultas cardiológicas prévias não foram capazes de reduzi-lo.