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1.
Annals of the Rheumatic Diseases ; 81:980, 2022.
Article in English | EMBASE | ID: covidwho-2009208

ABSTRACT

Background: Patients with autoimmune infammatory diseases (AID) have been prioritized for urgent vaccination to mitigate COVID-19 risk. However, few studies in the literature assessed the immunogenicity and safety of the COVID-19 vaccine in patients with AID. Objectives: In this context, the present study aims to evaluate the immunogenic-ity and safety of the vaccine against COVID-19 in patients with AID. Methods: These data are from 'Safety and efficacy on COVID-19 Vaccine in Rheumatic Disease'-SAFER study, a Brazilian multicentric prospective phase IV study to evaluate COVID-19 Vaccine in AID, in the real-life, in Brazil. Immunogenicity and adverse events (AE) from a single center were assessed, after 2 doses of ChAdOx1 (Oxford/AstraZeneca), 8 weeks of interval, in patients with AID and healthy controls (HC). Inclusion criteria were age ≥ 18 years and fulflling criteria according to international classifcation for AID. Exclusion criteria: pregnancy, previous severe AE to any vaccine, other immunosuppression causes. Stratifcation of post-vaccination AE was performed using a diary, flled out daily and returned at the end of 28 days for each dose. Participants were followed up through blood collection for measurement of IgG antibodies against SARS-CoV-2 spike receptor-binding domain by chemiluminescence (SARS-CoV-2 IgG II Quant assay, Abbott Laboratories, Abbott Park, IL, USA) at baseline and 28 days after the second dose. The seropositivity was defned for titers ≥50 AU/mL. Quantitative analyses were presented as observed frequency, percentage, central tendency, and variability measurements. The sample's normal distribution was verifed through the Shapiro-Wilk test. The Kruskal-Wallis test and the post-hoc Dwass-Steel-Critchlow-Fligner pairwise comparisons test were used to compare the IgG-S titers between the groups through the evaluation period. Categorical data were addressed using the Fisheŕs exact or Chi-squared (χ2) test. An alpha level of 5% signifcance was used in all analyses. Results: A total of 377 volunteers with AID and 50 HC were included in the study. Patients with spondyloarthritis (N=64), systemic lupus erythematosus (N=63), rheumatoid arthritis (N=61), primary Sjögren's syndrome (N=61), vasculitis (N=31), systemic sclerosis (N=14), inflammatory myopathy (N=9), Crohńs disease (N=49), ulcerative colitis (N=11) and other systemics AID (N=12) were evaluated. Both groups had female predominance (73.5% vs. 74.0%, p=0.937) and were homogeneous for age (43.5 vs. 41.7,p=0.308). The seroconversion among those not reactive (IgG-S negative at baseline) (46 HC and 191 AID), 28 days after second dose was 97.1% for spondyloar-thritis (p=0.425), systemic lupus erythematosus 88.2% (0.006), rheumatoid arthritis 93.5% (0.158), primary Sjögren's syndrome 92.6% (0.133), systemic sclerosis or inflammatory myopathy 47.1% (0.001), inflammatory bowel disease 100% (0.999) and vasculitis 80% (0.006), while in healthy control was 100%. In comparison with HC, there was a statistically significant difference in IgG-S titles only in systemic sclerosis or inflammatory myopathy (1.694 AU/ml vs. 3.719 AU/ml;p=0.006). Both groups only presented mild AE. Pain at the injection (85.7% vs. 78.4%, p=0.239), headache (67.3% vs. 53.8, p=0.074) and fatigue (59.2% Vs. 46.2%, p=0.089) were more common in HC than AID. Overall, reactions like arthralgia (52.6 vs. 22.4%, p<0.001), hematoma (14.1 vs. 4.1%, p=0.05), cutaneous rash (9.5 vs. 0%, p=0.024) were more frequent in AID. Most participants related that they felt safer after receiving a COVID-19 vaccination, and 52.4% did not reported a worse patient global assessment (PGA) index. Conclusion: In conclusion, our data indicated that ChAdOx1 vaccine is safe and induced high titers and seroconversion rate in AID. More severe AID, such as vasculitis, systemic lupus erythematosous, and systemic sclerosis and myositis showed a lower seroconversion rate. Further analysis will explore the association between immunossupressant and reactivity, and booster dose.

2.
Annals of the Rheumatic Diseases ; 80(SUPPL 1):909-910, 2021.
Article in English | EMBASE | ID: covidwho-1358867

ABSTRACT

Background: The role of chronic use of hydroxychloroquine (HCQ) in rheumatic disease (RD) patients during the SARS-CoV-2 pandemic is still subject of discussion. Objectives: To compare the occurrence of COVID-19 and its outcomes between RD patients on HCQ use with individuals from the same household not taking the drug during community viral transmission in an observational prospective multicenter study in Brazil. Methods: Participants were enrolled and monitored through 24-week (From March 29th to Sep 30th, 2020) regularly scheduled phone calls performed by trained medical professionals. Epidemiological and demographic data, as well as RD disease activity status and current treatment data, specific information about COVID-19, hospitalization, need for intensive care, and death was recorded in both groups and stored in the Research Electronic Data Capture (REDCap) database. COVID-19 was defined according to the Brazilian Ministry of Health (BMH) criteria. The statistical analysis was performed using IBM-SPSS v.20.0 software. Group comparisons were made using the Man-Whitney, Chi-Square and Fisher Exact Test, as well as multivariate regression models adjusted to confounders. Survival curves were performed using Kaplan-Meier analysis. Results: A total of 10,427 participants mean age (SD) of 44.04 (14.98) years were enrolled, including 6004 (57.6%) rheumatic disease patients, of whom 70.8% had systemic lupus erythematosus (SLE), 6.7% rheumatoid arthritis (RA), 4% primary Sjögren's syndrome (pSS), 1.8% mixed connective tissue disease (DMTC), 1% systemic sclerosis (SSc) and others (15.9), including overlap syndromes. In total, 1,132 (10.8%) participants fulfilled criteria for COVID-19, being 6.7% RD patients and 4.1% controls (p=0.002). A recent influenza vaccination had a protective role (p<0.001). Moderate and severe COVID-19 included the need for hospitalization, intensive care, mechanical ventilation or death. Infection severity was not different between groups (p=0.391) (Table 1). After adjustments for multiple confounders, the main risk factors significantly associated with COVID-19 were higher education level (OR=1.29 95%CI 1.05-1.59), being healthcare professionals (OR=1.91;95%CI 1.45-2.53), presence of two comorbidities (OR=1.31;95%CI 1.01-1.66) and three or more comorbidities associated (OR=1.69;95%CI 1.23-2.32). Interestingly, age ≥=65 years (OR=0.20;95%CI 0.11-0.34) was negatively associated. Regarding RD, the risk factors associated with COVID-19 diagnosys were SLE (OR= 2.37;95%CI 1.92-293), SSc (OR=2.25;95%CI 1.05-4.83) and rituximab use (OR=1.92;95%CI 1.13-3.26). In addition, age ≥=65 years (OR=5.47;95%CI 1.7-19.4) and heart disease (OR=2.60;95%CI 1.06-6.38) were associated with hospitalization. Seven female RD patients died, six with SLE and one with pSS, and the presence of two or more comorbidities were associated with higher mortality rate. Conclusion: Chronic HCQ use did not prevent COVID-19 in RD compared to their household cohabitants. Health care profession, presence of comorbidities LES, SSc and rituximab were identified as main risk factors for COVID-19 and aging and heart disease as higher risk for hospitalization. Our data suggest these outcomes could be considered to manage them in clinical practice.

3.
Annals of the Rheumatic Diseases ; 80(SUPPL 1):1448, 2021.
Article in English | EMBASE | ID: covidwho-1358707

ABSTRACT

Background: Mental health was widely affected during the new coronavirus pandemic. In addition, some measures adopted by most countries in order to contain the virus spread, such as isolation and social distancing, leading to the interruption of routine activities, including partial or complete interruption of face-to-face classes may be associated with increased stress, depression and anxiety among undergraduate medical students (1). From March to September, 2020, the Brazilian Society of Rheumatology carried out the Mario Pinotti II Project (MPII), a prospective, multicenter, observational cohort study designed to monitor the COVID-19 in patients with rheumatic disease on hydroxychloroquine, using periodic telephone calls performed by undergraduate medical students (2). Objectives: To compare the mental health status of medical students who were participating from the MPII with theirs colleagues not involved in this project. Methods: A web-based survey via google forms platform was developed by a panel composed of undergraduate medical students, rheumatologists, medical school professors, and a psychology professor. It included details on demographic and life habits data and domains regarding depression, anxiety and stress, using the DASS-21 (Depression, Anxiety & Stress Scale), Brazilian version. Data collection occurred from July 20th to August 31st, 2020. Statistical analysis was performed using the SPSS version 20.0. Univariate and multivariate linear regression analysis were performed to verify associations with the DASS-21, defined as dependent variable. A p-value < 0.05 was deemed as significant. This study was approved by the Institutional Research Ethics Committee. Results: A total of 684 undergraduate medical students were included in this study, of whom 228 as MPII volunteers (VG) and 456 as control group (CG). Median age was 23 years (IQ 21-24) and the CG was older than the VG (p<0.03). Most of them were white (68.8%) and women (63%). There were no significant differences regarding comorbidities, ethnicity, smoking status, alcohol intake and physical activity. Older age, male gender, participation of MPII study, absence of a worsening in sleep pattern during the pandemic and a lower number of prior comorbidities were associated with lower DASS21 scores, suggesting a better mental health (Table 1). Conclusion: Several aspects may be involved with mental health, including increased emotional maturity, gender and sleep pattern. Although with marginal independent association, medical students with participation in the MPII study had better mental health than their student colleagues not engaged with this research. Our data pointed out that voluntary participation in a research project which foresees interaction by telephone contact with rheumatic patients, professors, rheumatologists, and colleagues is associated with better mental health.

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