tetano
Editor, Senior Moderator
Neurol Neuroimmunol Neuroinflamm
. 2022 Jun 21;9(4):e200002.
doi: 10.1212/NXI.0000000000200002. Print 2022 Jul.
Immune Response and Safety of SARS-CoV-2 mRNA-1273 Vaccine in Patients With Myasthenia Gravis
David Reyes-Leiva[SUP] 1 [/SUP], Joaquín López-Contreras[SUP] 1 [/SUP], Esther Moga[SUP] 1 [/SUP], Francesc Pla-Juncà[SUP] 1 [/SUP], Elionor Lynton-Pons[SUP] 1 [/SUP], Ricardo Rojas-Garcia[SUP] 1 [/SUP], Janina Turon-Sans[SUP] 1 [/SUP], Luis Querol[SUP] 1 [/SUP], Montse Olive[SUP] 1 [/SUP], Rodrigo Álvarez-Velasco[SUP] 1 [/SUP], Marta Caballero-Ávila[SUP] 1 [/SUP], Álvaro Carbayo[SUP] 1 [/SUP], Ana Vesperinas-Castro[SUP] 1 [/SUP], Pere Domingo[SUP] 1 [/SUP], Isabel Illa[SUP] 1 [/SUP], Eduard Gallardo[SUP] 1 [/SUP], Elena Cortés-Vicente[SUP] 2 [/SUP]
Affiliations
Abstract
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.
. 2022 Jun 21;9(4):e200002.
doi: 10.1212/NXI.0000000000200002. Print 2022 Jul.
Immune Response and Safety of SARS-CoV-2 mRNA-1273 Vaccine in Patients With Myasthenia Gravis
David Reyes-Leiva[SUP] 1 [/SUP], Joaquín López-Contreras[SUP] 1 [/SUP], Esther Moga[SUP] 1 [/SUP], Francesc Pla-Juncà[SUP] 1 [/SUP], Elionor Lynton-Pons[SUP] 1 [/SUP], Ricardo Rojas-Garcia[SUP] 1 [/SUP], Janina Turon-Sans[SUP] 1 [/SUP], Luis Querol[SUP] 1 [/SUP], Montse Olive[SUP] 1 [/SUP], Rodrigo Álvarez-Velasco[SUP] 1 [/SUP], Marta Caballero-Ávila[SUP] 1 [/SUP], Álvaro Carbayo[SUP] 1 [/SUP], Ana Vesperinas-Castro[SUP] 1 [/SUP], Pere Domingo[SUP] 1 [/SUP], Isabel Illa[SUP] 1 [/SUP], Eduard Gallardo[SUP] 1 [/SUP], Elena Cortés-Vicente[SUP] 2 [/SUP]
Affiliations
- PMID: 35728947
- DOI: 10.1212/NXI.0000000000200002
Abstract
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.