1. 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.
- Author
-
Tzioufas AG, Bakasis AD, Goules AV, Bitzogli K, Cinoku II, Chatzis LG, Argyropoulou OD, Venetsanopoulou AI, Mavrommati M, Stergiou IE, Pezoulas V, Voulgari PV, Katsimpari C, Katechis S, Gazi S, Katsifis G, Sfontouris CI, Georgountzos AI, Liossis SN, Papagoras C, Fotiadis DI, Skopouli FN, Vlachoyiannopoulos PG, and Moutsopoulos HM
- Subjects
- 2019-nCoV Vaccine mRNA-1273 adverse effects, Adolescent, Adult, Aged, Aged, 80 and over, Autoimmune Diseases drug therapy, BNT162 Vaccine adverse effects, COVID-19 prevention & control, Female, Greece, Hereditary Autoinflammatory Diseases drug therapy, Humans, Immunoglobulin G blood, Male, Methotrexate adverse effects, Methotrexate therapeutic use, Middle Aged, Mycophenolic Acid adverse effects, Mycophenolic Acid therapeutic use, Prospective Studies, Rheumatic Diseases drug therapy, Rituximab adverse effects, Rituximab therapeutic use, SARS-CoV-2 immunology, Young Adult, 2019-nCoV Vaccine mRNA-1273 immunology, Antibodies, Neutralizing blood, Antibodies, Viral blood, Autoimmune Diseases immunology, BNT162 Vaccine immunology, Hereditary Autoinflammatory Diseases immunology, Rheumatic Diseases immunology
- 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., (Copyright © 2021 Elsevier Ltd. All rights reserved.)
- Published
- 2021
- Full Text
- View/download PDF