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      A prospective multicenter study assessing humoral immunogenicity and safety of the mRNA SARS-CoV-2 vaccines in Greek patients with systemic autoimmune and autoinflammatory rheumatic diseases

      research-article
      a , b , , a , b , a , b , a , c , 1 , a , 1 , a , 1 , d , 1 , e , 1 , a , 1 , f , d , g , 1 , g , 1 , h , i , j , k , l , m , f , n , e , o , a , b , 2 , p , 2
      Journal of Autoimmunity
      Elsevier Ltd.
      mRNA SARS-COV-2 vaccine, Systemic autoimmune rheumatic disease, Immunosuppressive treatment, Treatment modification, Anti-SARS-CoV-2 antibody response, SAARD, systemic autoimmune and autoinflammatory rheumatic diseases, JAKi, JAK inhibitors, GC, glucocorticoids, MTX, methotrexate, RTX, rituximab, MMF, mycophenolate mofetil, GDPR, General Data Protection Regulation, EULAR, European Alliance of Associations for Rheumatology, ACR, American College of Rheumatology, OD, optical density, FCBF, fast correlation based feature, LR, logistic regression, TNFi, tumor necrosis factor inhibitors

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          Abstract

          Objectives

          To investigate humoral responses and safety of mRNA SARS-CoV-2 vaccines in systemic autoimmune and autoinflammatory rheumatic disease (SAARD) patients subjected or not to treatment modifications during vaccination.

          Methods

          A nationwide, multicenter study, including 605 SAARD patients and 116 controls, prospectively evaluated serum anti-SARS-CoV-2 S1-protein IgG antibody titers, side-effects, and disease activity, one month after complete vaccination, in terms of distinct treatment modification strategies (none, partial and extended modifications). Independent risk factors associated with hampered humoral responses were identified by data-driven multivariable logistic regression analysis.

          Results

          Patients with extended treatment modifications responded to vaccines similarly to controls as well as SAARD patients without immunosuppressive therapy (97.56% vs 100%, p = 0.2468 and 97.56% vs 97.46%, p > 0.9999, respectively). In contrast, patients with partial or without therapeutic modifications responded in 87.50% and 84.50%, respectively. Furthermore, SAARD patients with extended treatment modifications developed higher anti-SARS-CoV-2 antibody levels compared to those without or with partial modifications (median:7.90 vs 7.06 vs 7.1, p = 0.0003 and p = 0.0195, respectively). Mycophenolate mofetil (MMF), rituximab (RTX) and methotrexate (MTX) negatively affected anti-SARS-CoV-2 humoral responses. In 10.5% of vaccinated patients, mild clinical deterioration was noted; however, no differences in the incidence of deterioration were observed among the distinct treatment modification SAARD subgroups. Side-effects were generally comparable between SAARD patients and controls.

          Conclusions

          In SAARD patients, mRNA SARS-CoV-2 vaccines are effective and safe, both in terms of side-effects and disease flares. Treatment with MMF, RTX and/or MTX compromises anti-SARS-CoV-2 antibody responses, which are restored upon extended treatment modifications without affecting disease activity.

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          Most cited references43

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          Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

          Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Results A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. Conclusions A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)
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            Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

            Abstract Background Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle–encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19. Methods This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States. Persons at high risk for SARS-CoV-2 infection or its complications were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo 28 days apart. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with SARS-CoV-2. Results The trial enrolled 30,420 volunteers who were randomly assigned in a 1:1 ratio to receive either vaccine or placebo (15,210 participants in each group). More than 96% of participants received both injections, and 2.2% had evidence (serologic, virologic, or both) of SARS-CoV-2 infection at baseline. Symptomatic Covid-19 illness was confirmed in 185 participants in the placebo group (56.5 per 1000 person-years; 95% confidence interval [CI], 48.7 to 65.3) and in 11 participants in the mRNA-1273 group (3.3 per 1000 person-years; 95% CI, 1.7 to 6.0); vaccine efficacy was 94.1% (95% CI, 89.3 to 96.8%; P<0.001). Efficacy was similar across key secondary analyses, including assessment 14 days after the first dose, analyses that included participants who had evidence of SARS-CoV-2 infection at baseline, and analyses in participants 65 years of age or older. Severe Covid-19 occurred in 30 participants, with one fatality; all 30 were in the placebo group. Moderate, transient reactogenicity after vaccination occurred more frequently in the mRNA-1273 group. Serious adverse events were rare, and the incidence was similar in the two groups. Conclusions The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.)
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              2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative.

              The 1987 American College of Rheumatology (ACR; formerly, the American Rheumatism Association) classification criteria for rheumatoid arthritis (RA) have been criticized for their lack of sensitivity in early disease. This work was undertaken to develop new classification criteria for RA. A joint working group from the ACR and the European League Against Rheumatism developed, in 3 phases, a new approach to classifying RA. The work focused on identifying, among patients newly presenting with undifferentiated inflammatory synovitis, factors that best discriminated between those who were and those who were not at high risk for persistent and/or erosive disease--this being the appropriate current paradigm underlying the disease construct "rheumatoid arthritis." In the new criteria set, classification as "definite RA" is based on the confirmed presence of synovitis in at least 1 joint, absence of an alternative diagnosis that better explains the synovitis, and achievement of a total score of 6 or greater (of a possible 10) from the individual scores in 4 domains: number and site of involved joints (score range 0-5), serologic abnormality (score range 0-3), elevated acute-phase response (score range 0-1), and symptom duration (2 levels; range 0-1). This new classification system redefines the current paradigm of RA by focusing on features at earlier stages of disease that are associated with persistent and/or erosive disease, rather than defining the disease by its late-stage features. This will refocus attention on the important need for earlier diagnosis and institution of effective disease-suppressing therapy to prevent or minimize the occurrence of the undesirable sequelae that currently comprise the paradigm underlying the disease construct "rheumatoid arthritis."
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                Author and article information

                Journal
                J Autoimmun
                J Autoimmun
                Journal of Autoimmunity
                Elsevier Ltd.
                0896-8411
                1095-9157
                28 October 2021
                December 2021
                28 October 2021
                : 125
                : 102743
                Affiliations
                [a ]Department of Pathophysiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece
                [b ]Institute for Autoimmune Systemic and Neurologic Diseases, Athens, Greece
                [c ]Department of Physiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece
                [d ]Rheumatology Clinic, Department of Internal Medicine, Faculty of Medicine, University of Ioannina, Ioannina, Greece
                [e ]Department of Medicine and Clinical Immunology, Euroclinic of Athens, Athens, Greece
                [f ]Unit of Medical Technology and Intelligent Information Systems, University of Ioannina, Ioannina, Greece
                [g ]Department of Rheumatology, “Asklepieion” General Hospital, Athens, Greece
                [h ]Rheumatology Department, KAT General Hospital, Athens, Greece
                [i ]Rheumatology Clinic, Naval Hospital of Athens, Athens, Greece
                [j ]Department of Rheumatology, Evaggelismos Athens General Hospital, Athens, Greece
                [k ]Department of Rheumatology, Peripheral General Hospital Athens Giorgos Gennimatas, Athens, Greece
                [l ]Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, University of Patras, Patras, Greece
                [m ]First Department of Internal Medicine, University Hospital of Alexandroupolis, Democritus University of Thrace, Alexandroupolis, Greece
                [n ]Biomedical Research Section, Institute of Molecular Biology and Biotechnology, Ioannina, Greece
                [o ]Department of Nutrition and Clinical Dietetics, Harokopio University, Athens, Greece
                [p ]Academy of Athens, Athens, Greece
                Author notes
                []Corresponding author.Department of Pathophysiology, School of Medicine, National and Kapodistrian University of Athens, 75 Mikras Asias street, Athens, 11527, Greece.
                [1]

                Equal contribution.

                [2]

                Senior co-authors.

                Article
                S0896-8411(21)00151-7 102743
                10.1016/j.jaut.2021.102743
                8552665
                34757289
                a26363a6-a9ed-434b-b11a-fc4502ebdd26
                © 2021 Elsevier Ltd. All rights reserved.

                Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

                History
                : 27 September 2021
                : 23 October 2021
                : 24 October 2021
                Categories
                Article

                Immunology
                mrna sars-cov-2 vaccine,systemic autoimmune rheumatic disease,immunosuppressive treatment,treatment modification,anti-sars-cov-2 antibody response,saard, systemic autoimmune and autoinflammatory rheumatic diseases,jaki, jak inhibitors,gc, glucocorticoids,mtx, methotrexate,rtx, rituximab,mmf, mycophenolate mofetil,gdpr, general data protection regulation,eular, european alliance of associations for rheumatology,acr, american college of rheumatology,od, optical density,fcbf, fast correlation based feature,lr, logistic regression,tnfi, tumor necrosis factor inhibitors

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