Immune Response and Safety of SARS-CoV-2 mRNA-1273 Vaccine in Patients With Myasthenia Gravis
Por:
Reyes-Leiva, D, Lopez-Contreras, J, Moga, E, Pla-Junca, F, Lynton-Pons, E, Rojas-Garcia, R, Turon-Sans, J, Querol, L, Olive, M, Alvarez-Velasco, R, Caballero-Avila, M, Carbayo, A, Vesperinas-Castro, A, Domingo, P, Illa, I, Gallardo, E, Cortes-Vicente, E
Publicada:
1 jul 2022
Resumen:
Background and Objectives Evidence regarding the safety and efficacy of messenger RNA (mRNA) vaccines in patients with myasthenia gravis (MG) after immunosuppressive therapies is scarce. Our aim is to determine whether the mRNA-1273 vaccine is safe and able to induce humoral and cellular responses in patients with MG. Methods We performed an observational, longitudinal, prospective study including 100 patients with MG of a referral center for MG in our country, conducted from April 2021 to November 2021 during the vaccination campaign. The mRNA-1273 vaccine was scheduled for all participants. Blood samples were collected before vaccination and 3 months after a second dose. Clinical changes in MG were measured using the MG activities of daily life score at baseline and 1 week after the first and second doses. A surveillance of all symptoms of coronavirus disease 2019 (COVID-19) was conducted throughout the study. Humoral and cellular immune responses after vaccination were assessed using a spike-antibody ELISA and interferon gamma release assay in plasma. The primary outcomes were clinically significant changes in MG symptoms after vaccination, adverse events (AEs), and seroconversion and T-cell immune response rates. Results Ninety-nine patients completed the full vaccination schedule, and 98 had 2 blood samples taken. A statistically significant worsening of symptoms was identified after the first and second doses of the mRNA-1273 vaccine, but this was not clinically relevant. Mild AEs occurred in 14 patients after the first dose and in 21 patients after the second dose. Eighty-seven patients developed a humoral response and 72 patients showed a T-cell response after vaccination. A combined therapy with prednisone and other immunosuppressive drugs correlated with a lower seroconversion ratio (OR = 5.97, 95% CI 1.46-24.09, p = 0.015) and a lower T-cell response ratio (OR = 2.83, 95% CI 1.13-7.13, p = 0.024). Discussion Our findings indicate that the mRNA vaccination against COVID-19 is safe in patients with MG and show no negative impact on the disease course. Patients achieved high humoral and cellular immune response levels. Classification of Evidence This study provides Class IV evidence that patients with MG receiving the mRNA-1273 vaccine did not show clinical worsening after vaccination and that most of the patients achieved high cellular or immune response levels.
Filiaciones:
Reyes-Leiva, D:
Univ Autonoma Barcelona, Neuromuscular Dis Unit, Dept Neurol, Hosp Santa Creu & St Pau,Dept Med, Barcelona, Spain
Ctr Invest Biomed Red Enfermedades Raras CIBERER, Valencia, Spain
Lopez-Contreras, J:
Hosp Santa Creu & Sant Pau, Serv Med Interna, Unidad Enfermedades Infecciosas, Barcelona, Spain
Moga, E:
Univ Autonoma Barcelona, Biomed Res Inst St Pau IIB St Pau, Hosp Santa Creu & St Pau, Dept Immunol, Barcelona, Spain
Pla-Junca, F:
Ctr Invest Biomed Red Enfermedades Raras CIBERER, Valencia, Spain
Lynton-Pons, E:
Univ Autonoma Barcelona, Biomed Res Inst St Pau IIB St Pau, Hosp Santa Creu & St Pau, Dept Immunol, Barcelona, Spain
Rojas-Garcia, R:
Univ Autonoma Barcelona, Neuromuscular Dis Unit, Dept Neurol, Hosp Santa Creu & St Pau,Dept Med, Barcelona, Spain
Ctr Invest Biomed Red Enfermedades Raras CIBERER, Valencia, Spain
Turon-Sans, J:
Univ Autonoma Barcelona, Neuromuscular Dis Unit, Dept Neurol, Hosp Santa Creu & St Pau,Dept Med, Barcelona, Spain
Ctr Invest Biomed Red Enfermedades Raras CIBERER, Valencia, Spain
Querol, L:
Univ Autonoma Barcelona, Neuromuscular Dis Unit, Dept Neurol, Hosp Santa Creu & St Pau,Dept Med, Barcelona, Spain
Ctr Invest Biomed Red Enfermedades Raras CIBERER, Valencia, Spain
Olive, M:
Univ Autonoma Barcelona, Neuromuscular Dis Unit, Dept Neurol, Hosp Santa Creu & St Pau,Dept Med, Barcelona, Spain
Ctr Invest Biomed Red Enfermedades Raras CIBERER, Valencia, Spain
Alvarez-Velasco, R:
Univ Autonoma Barcelona, Neuromuscular Dis Unit, Dept Neurol, Hosp Santa Creu & St Pau,Dept Med, Barcelona, Spain
Ctr Invest Biomed Red Enfermedades Raras CIBERER, Valencia, Spain
Caballero-Avila, M:
Univ Autonoma Barcelona, Neuromuscular Dis Unit, Dept Neurol, Hosp Santa Creu & St Pau,Dept Med, Barcelona, Spain
Ctr Invest Biomed Red Enfermedades Raras CIBERER, Valencia, Spain
Carbayo, A:
Univ Autonoma Barcelona, Neuromuscular Dis Unit, Dept Neurol, Hosp Santa Creu & St Pau,Dept Med, Barcelona, Spain
Ctr Invest Biomed Red Enfermedades Raras CIBERER, Valencia, Spain
Vesperinas-Castro, A:
Univ Autonoma Barcelona, Neuromuscular Dis Unit, Dept Neurol, Hosp Santa Creu & St Pau,Dept Med, Barcelona, Spain
Domingo, P:
Hosp Santa Creu & Sant Pau, Serv Med Interna, Unidad Enfermedades Infecciosas, Barcelona, Spain
Illa, I:
Univ Autonoma Barcelona, Neuromuscular Dis Unit, Dept Neurol, Hosp Santa Creu & St Pau,Dept Med, Barcelona, Spain
Ctr Invest Biomed Red Enfermedades Raras CIBERER, Valencia, Spain
Gallardo, E:
Univ Autonoma Barcelona, Neuromuscular Dis Unit, Dept Neurol, Hosp Santa Creu & St Pau,Dept Med, Barcelona, Spain
Ctr Invest Biomed Red Enfermedades Raras CIBERER, Valencia, Spain
Cortes-Vicente, E:
Hosp Santa Creu & St Pau IIB St Pau, Inst Recerca, Neuromuscular Dis Lab, Barcelona, Spain
Ctr Invest Biomed Red Enfermedades Raras CIBERER, Valencia, Spain
Green Published, gold, Gold
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