Introdução A pandemia de COVID-19 iniciou a corrida do desenvolvimento de vacinas globalmente. Os trabalhadores da saúde foram o primeiro grupo a receber imunizantes, e no Brasil os mais utilizados foram CoronaVac e AstraZeneca. O presente estudo teve como objetivo avaliar a imunogenicidade e a duração da resposta às vacinas Coronavac e Astrazeneca. Métodos Este estudo de coorte foi realizado no Hospital Universitário da Universidade Federal do Espírito Santo (HUCAM-UFES/EBSERH). No total, 476 trabalhadores da saúde foram recrutados, 261 e 215 foram completamente imunizados com duas doses da vacina CoronaVac (VAC) e AstraZeneca (AZV), respectivamente. Dentre os que receberam o esquema vacinal VAC, a média de idade foi 43 anos. Dentre os que receberam o esquema vacinal AZV, a média de idade foi 44 anos. Os participantes foram acompanhados por meio de coletas de sangue para dosagem dos níveis de anticorpos IgG e IgG anti-spike (IgG-S), no dia da primeira dose (D0), 28 dias após a primeira dose (D28), 28 dias após a segunda dose (D28*) e 180 dias após a primeira dose (D180). Resultados Antes da vacinação, 17,5% foram reagentes ao IgG e 42,8% ao IgG-S no grupo VAC (n = 257) e 13,2% para IgG e 29,7% IgG-S foram reativos no AZV. Em ambos os grupos, os níveis de anticorpos foram crescentes com pico 28 dias após a segunda dose com taxa de soroconversão de 100% e queda dos títulos após 180 dias. Após 180 dias, 92,9% se mantivessem reativos no grupo VAC e 100% no AZV no seguimento de 6 meses. No grupo VAC o pico de IgG total foi de 2,17mEq/dL e IgG-S de 1700 AU/mL. Em relação ao grupo de AstraZeneca o pico foi 5617, ± 6101,8 AU/mL. Conclusão A reatividade humoral induzida pelas vacinas AstraZeneca e CoronaVac foi alta, com taxa de soroconversão de 100% com os dois imunizantes após a segunda dose. A CoronaVac induziu menores títulos de IgG-S, bem como redução de reatividade após 6 meses. Embora não esteja bem estabelecido correlatos de proteção, os títulos mais baixos e queda mais rápida dos níveis de anticorpos específicos, indica necessidade de reforço ou terceira dose. Apoio e financiamento HUCAM-UFES, EBSERH, ICEPi/SESA.
BackgroundThe ChAdOx1, Coronavac, BNT162B2 and Janssen vaccines are available for the primary and booster immunization of immunosuppressed patients. However, there are few studies in the literature that assess the immunogenicity and safety of the different platforms COVID-19 vaccines in patients with autoimmune diseases (AID).ObjectivesThe present study aims to evaluate the immunogenicity through anti-spike IgG antibodies 28 days after the booster dose in the heterologous boost groups compared with homologous regimen of the vaccine against COVID-19 in patients with AID.MethodsThese data are from SAFER study: “Safety and efficacy on Covid-19 Vaccine in Rheumatic Disease”, a multicentric prospective phase IV study, in real life, in Brazil, started on May 2021. Data from this analysis were from 8 centers, from all Brazilian areas, after 2 or 3 doses of vaccine against COVID-19 in patients with AID age ≥ 18 years. Exclusion criteria were pregnancy, previous severe adverse events (AE) to any vaccine or other imunosuppression causes. Demographics, diagnoses and therapeutic regimens were collected via participant report through the Research Electronic Data Capture tool. Available vaccines were adenoviral vectored vaccine (ChAdOx1, Astrazeneca and Ad26.COV2-S, Janssen), mRNA vaccine (BNT162b2, Pfizer–BioNTech) or inactivated SARS-COV-2 vaccine (Coronavac). Participants were followed up by means of blood collection for measurement of IgG antibody against SARS-CoV-2 spike receptor-binding domain by chemiluminescence (SARS-CoV-2-IgG-II Quant assay, Abbott-Laboratories) at baseline and 28 days after the first, 2nd and 3rd doses. The seropositivity was defined for titers IgG-Spike ≥7.1 BAU/mL. The ANOVA, the post-hoc Tukey and pairwise comparisons tests were used to compare the IgG-S titles between the groups. An alpha level of 5% significance was used in all analyses.ResultsA total of 1096 participants were included and followed from the first dose. 709 patients AID received the complete 3-dose regimen: systemic lupus erythematosus (N=238, 33.6%), rheumatoid arthritis (N=143, 20.2%), spondyloarthritis (N=96, 13.5%), primary Sjögren’s syndrome (N=56, 7.9),), inflammatory bowel disease (N=50, 7,1%), vasculitis (N=31, 4.4%), systemic sclerosis (N=25, 3.5%), Behçet syndrome (N= 19, 2.7%) myositis (N= 12, 1.7%), other systemic AID (N= 39, 5.5%). Mean age was 41.59 (12.2), female N=556, (78.4%) and admixed race (N=370, 52.2%). Primary immunization was performed with Coronavac in 265 (37.4%), ChAdOx1 in 403 (56.8%) and Pfizer in 41 (5.8%) AID patients. After the 2nd dose (28 days), the booster was performed with Coronavac (N=10, 1.4%), ChAdOx1 (N=226, 31.9%), Pfizer (N=464, 65.4%) and Janssen (N=9, 1.3%). Anti-spike IgG antibodies were analyzed in the 657 patients who received the three doses. All patients had a substantial increase in IgG antibody concentrations 28dy after the booster vaccine with median 275.9 BAU/ml (88.8 - 1000.9) vs. 1217.2 (402.3 - 3213.7) booster vaccine. All heterologous regimens (N=515) had anti-spike IgG responses at day 28 that were superior to homologous booster (N=194) with median titers 1596.5 (543.9-3769.4) vs. 620.3 BAU/mL (180.3-1987.0), p<0.001 (figure 1). The seropositivity rates were higher and similar in both groups (Heterologous 98.4% vs. Homologous 95.9%, p=0.07).ConclusionAll vaccines administered as third dose induced an increase in IgG-S titers antibodies, which could improve protection against COVID-19 in AID patients. Heterologous booster vaccination produced greater humoral immune responses than homologous booster, which is relevant in this immunosuppressed population.Reference[1]Machado PM et al. Safety of vaccination against SARS-CoV-2 in people with rheumatic and musculoskeletal diseases: results from the EULAR Coronavirus Vaccine (COVAX) physician-reported registry. Ann Rheum Dis. 2022;81(5):695- 709.Acknowledgements:NIL.Disclosure of InterestsNone Declared.
BACKGROUNDAdult-onset Still's disease (AOSD) remains a rare multisystemic autoinflammatory disorder of unknown etiology, including the archetype of nonfamilial, or sporadic (Fautrel 2008, McGonagle and McDermott 2006, Peckham et al. 2017) and difficult diagnosis because of the wide range of differential diagnoses (Gerfaud-Valentin et al. 2014a). The disease may be life-threatening, leading to death because of severe complications, including macrophage activation syndrome (MAS), cardiopulmonary system involvement, and fulminant hepatitis (Gerfaud-Valentin et al. 2014a). MAS occurs in about 12 to 15% of AOSD cases, being an important manifestation which can limit life expectancy (Gerfaud-Valentin et al. 2014b, Hot et al. 2010. CASE REPORTA 48-year-old woman was hospitalized on February 17, 2022 with fever that started one month earlier associated with pruritic confluent macropapular rash on upper limbs, trunk and back and oligoarthritis in hands, knees and ankles. Serologies tests were made for viral hepatitis, HIV, syphilis, dengue, chikungunya, zika, parvovirus, aspergillosis, histoplasmosis and paracoccidioidomycosis; results were negative, endocarditis was excluded. Thus, the diagnosis of Still's disease was confirmed by the clinical presentation of the patient and the laboratory results: leukocytosis (26,740 μL), hyperferritinemia (17,150 μL), nonreactive autoantibody and increased liver enzymes. The patient was treated with oral prednisone 1 mg/kg to attenuate the systemic condition. After changed the laboratory to pancytopenia and fever daily, it was suggestive for MAS and a red bone marrow biopsy confirming which showed granulocytic hyperplasia and hemophagocytic syndrome. Furthermore, the immunophenotypic study identified T lymphocytosis at the expense of CD8 T lymphocytes, without phenotypic and polyclonal aberrations to TRBC1, in addition to the absence of CD25, which may correspond to a condition secondary to an inflammatory/infectious process. After 10 days, she returned with daily fever and worsening laboratory tests, which improved with pulse therapy of methylprednisolone 1 g/day for 3 days. CONCLUSIONAOSD has an unknown etiology and the diagnosis is clinical, being realized by exclusion. In this report we present a patient who envolved with pancytopenia and fever had the disease with MAS and was refractory to treatment with oral corticosteroids, just pulse therapy was effective. This case is relevant once it shows a disease that is an important cause of fever with obscure origin, which can be fatal if not properly diagnosed and treated.
BackgroundPatients with autoimmune inflammatory 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.ObjectivesIn this context, the present study aims to evaluate the immunogenicity and safety of the vaccine against COVID-19 in patients with AID.MethodsThese 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 fulfilling criteria according to international classification for AID. Exclusion criteria: pregnancy, previous severe AE to any vaccine, other immunosuppression causes. Stratification of post-vaccination AE was performed using a diary, filled 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 defined for titers ≥50 AU/mL. Quantitative analyses were presented as observed frequency, percentage, central tendency, and variability measurements. The sample’s normal distribution was verified 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 Fisher´s exact or Chi-squared (χ2) test. An alpha level of 5% significance was used in all analyses.ResultsA 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), Crohn´s 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 spondyloarthritis (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.ConclusionIn 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.AcknowledgementsAcknowledgements to DECIT/MS and ICEPI/SESA for supporting the study.Disclosure of InterestsNone declared
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