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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.
Tzioufas, Athanasios G; Bakasis, Athanasios-Dimitrios; Goules, Andreas V; Bitzogli, Kleopatra; Cinoku, Ilir I; Chatzis, Loukas G; Argyropoulou, Ourania D; Venetsanopoulou, Aliki I; Mavrommati, Maria; Stergiou, Ioanna E; Pezoulas, Vasilis; Voulgari, Paraskevi V; Katsimpari, Chaido; Katechis, Spyridon; Gazi, Souzana; Katsifis, Gkikas; Sfontouris, Charalampos I; Georgountzos, Athanasios I; Liossis, Stamatis-Nick; Papagoras, Charalampos; Fotiadis, Dimitrios I; Skopouli, Fotini N; Vlachoyiannopoulos, Panayiotis G; Moutsopoulos, Haralampos M.
Afiliación
  • Tzioufas AG; Department of Pathophysiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece; Institute for Autoimmune Systemic and Neurologic Diseases, Athens, Greece. Electronic address: agtzi@med.uoa.gr.
  • Bakasis AD; Department of Pathophysiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece; Institute for Autoimmune Systemic and Neurologic Diseases, Athens, Greece.
  • Goules AV; Department of Pathophysiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece; Institute for Autoimmune Systemic and Neurologic Diseases, Athens, Greece.
  • Bitzogli K; Department of Pathophysiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
  • Cinoku II; Department of Physiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
  • Chatzis LG; Department of Pathophysiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
  • Argyropoulou OD; Department of Pathophysiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
  • Venetsanopoulou AI; Rheumatology Clinic, Department of Internal Medicine, Faculty of Medicine, University of Ioannina, Ioannina, Greece.
  • Mavrommati M; Department of Medicine and Clinical Immunology, Euroclinic of Athens, Athens, Greece.
  • Stergiou IE; Department of Pathophysiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
  • Pezoulas V; Unit of Medical Technology and Intelligent Information Systems, University of Ioannina, Ioannina, Greece.
  • Voulgari PV; Rheumatology Clinic, Department of Internal Medicine, Faculty of Medicine, University of Ioannina, Ioannina, Greece.
  • Katsimpari C; Department of Rheumatology, "Asklepieion" General Hospital, Athens, Greece.
  • Katechis S; Department of Rheumatology, "Asklepieion" General Hospital, Athens, Greece.
  • Gazi S; Rheumatology Department, KAT General Hospital, Athens, Greece.
  • Katsifis G; Rheumatology Clinic, Naval Hospital of Athens, Athens, Greece.
  • Sfontouris CI; Department of Rheumatology, Evaggelismos Athens General Hospital, Athens, Greece.
  • Georgountzos AI; Department of Rheumatology, Peripheral General Hospital Athens Giorgos Gennimatas, Athens, Greece.
  • Liossis SN; Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, University of Patras, Patras, Greece.
  • Papagoras C; First Department of Internal Medicine, University Hospital of Alexandroupolis, Democritus University of Thrace, Alexandroupolis, Greece.
  • Fotiadis DI; Unit of Medical Technology and Intelligent Information Systems, University of Ioannina, Ioannina, Greece; Biomedical Research Section, Institute of Molecular Biology and Biotechnology, Ioannina, Greece.
  • Skopouli FN; Department of Medicine and Clinical Immunology, Euroclinic of Athens, Athens, Greece; Department of Nutrition and Clinical Dietetics, Harokopio University, Athens, Greece.
  • Vlachoyiannopoulos PG; Department of Pathophysiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece; Institute for Autoimmune Systemic and Neurologic Diseases, Athens, Greece.
  • Moutsopoulos HM; Academy of Athens, Athens, Greece.
J Autoimmun ; 125: 102743, 2021 12.
Article en En | MEDLINE | ID: mdl-34757289
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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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Enfermedades Autoinmunes / Enfermedades Reumáticas / Enfermedades Autoinflamatorias Hereditarias / Anticuerpos Neutralizantes / Vacuna BNT162 / Vacuna nCoV-2019 mRNA-1273 / Anticuerpos Antivirales Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adolescent / Adult / Aged / Aged80 / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: J Autoimmun Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2021 Tipo del documento: Article

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Enfermedades Autoinmunes / Enfermedades Reumáticas / Enfermedades Autoinflamatorias Hereditarias / Anticuerpos Neutralizantes / Vacuna BNT162 / Vacuna nCoV-2019 mRNA-1273 / Anticuerpos Antivirales Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adolescent / Adult / Aged / Aged80 / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: J Autoimmun Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2021 Tipo del documento: Article