Este articulo es un Preprint
Los preprints son informes de investigación preliminares que no han sido certificados por revisión por pares. No deben considerarse para guiar la práctica clínica o los comportamientos relacionados con la salud y no deben publicarse en los medios como información establecida.
Los preprints publicados en línea permiten a los autores recibir comentarios rápidamente, y toda la comunidad científica puede evaluar de forma independiente el trabajo y responder adecuadamente. Estos comentarios se publican junto con los preprints para que cualquiera pueda leer y servir como una revisión pospublicación.
Methotrexate Hampers Immunogenicity to BNT162b2 mRNA COVID-19 Vaccine in Immune-Mediated Inflammatory Disease
Preprint
en En
| PREPRINT-MEDRXIV
| ID: ppmedrxiv-21256917
Artículo de revista
Un artículo publicado en revista científica está disponible y probablemente es basado en este preprint, por medio del reconocimiento de similitud realizado por una máquina. La confirmación humana aún está pendiente.
Ver artículo de revista
Un artículo publicado en revista científica está disponible y probablemente es basado en este preprint, por medio del reconocimiento de similitud realizado por una máquina. La confirmación humana aún está pendiente.
Ver artículo de revista
ABSTRACT
ObjectiveTo investigate the humoral and cellular immune response to mRNA COVID-19 vaccines in patients with immune-mediated inflammatory diseases (IMIDs) on immunomodulatory treatment. MethodsEstablished patients at NYU Langone Health with IMID (n=51) receiving the BNT162b2 mRNA vaccination were assessed at baseline and after second immunization. Healthy subjects served as controls (n=26). IgG antibody responses to the spike protein were analyzed for humoral response. Cellular immune response to SARS-CoV-2 was further analyzed using high-parameter spectral flow cytometry. A second independent, validation cohort of controls (n=182) and patients with IMID (n=31) from Erlangen, Germany were also analyzed for humoral immune response. ResultsAlthough healthy subjects (n=208) and IMID patients on biologic treatments (mostly on TNF blockers, n=37) demonstrate robust antibody responses (over 90%), those patients with IMID on background methotrexate (n=45) achieve an adequate response in only 62.2% of cases. Similarly, IMID patients do not demonstrate an increase in CD8+ T cell activation after vaccination. ConclusionsIn two independent cohorts of IMID patients, methotrexate, a widely used immunomodulator for the treatment of several IMIDs, adversely affected humoral and cellular immune response to COVID-19 mRNA vaccines. Although precise cut offs for immunogenicity that correlate with vaccine efficacy are yet to be established, our findings suggest that different strategies may need to be explored in patients with IMID taking methotrexate to increase the chances of immunization efficacy against SARS-CoV-2 as has been demonstrated for augmenting immunogenicity to other viral vaccines. KEY MESSAGESO_ST_ABSWhat is already known about this subject?C_ST_ABSO_LIThe impact of COVID-19 has been felt across the globe and new hope has arisen with the approval of mRNA vaccines against the SARS-CoV-2. Studies have shown immunogenicity and efficacy rates of over 90% in the immunocompetent adult population. However, there is a lack of knowledge surrounding the response of patients with immune-mediated inflammatory diseases (IMIDs) who may also be on immunomodulatory medications. C_LIO_LIPatients with IMID have been shown to have attenuated immune responses to seasonal influenza vaccination. C_LI What does this study add?O_LIThis study looks at the humoral and cellular immune response to two doses of BNT162b2 mRNA COVID-19 Vaccine in participants with IMID (on immunomodulators) compared with healthy controls. C_LIO_LIIndividuals with IMID on methotrexate demonstrate up to a 62% reduced rate of adequate immunogenicity to the BNT162b2 mRNA vaccination. Those on anti-cytokine or non-methotrexate oral medications demonstrate similar levels of immunogenicity as healthy controls (greater than 90%). C_LIO_LISimilarly, vaccination did not induce an activated CD8+ T cell response in participants on background methotrexate, unlike healthy controls and patients with IMID not receiving methotrexate. C_LI How might this impact of clinical practice or future developments?O_LIThese results suggest that patients on methotrexate may need alternate vaccination strategies such as additional doses of vaccine, dose modification of methotrexate, or even a temporary discontinuation of this drug. Further studies will be required to explore the effect of these approaches on mRNA vaccine immunogenicity. C_LI
cc_no
Texto completo:
1
Colección:
09-preprints
Base de datos:
PREPRINT-MEDRXIV
Tipo de estudio:
Cohort_studies
/
Observational_studies
/
Prognostic_studies
Idioma:
En
Año:
2021
Tipo del documento:
Preprint