Autoimmune systemic diseases (ASD) may show impaired immunogenicity to COVID-19 vaccines. Our prospective observational multicenter study aimed to evaluate the seroconversion after the vaccination cycle and at 6-12-month follow-up, as well the safety and efficacy of vaccines in preventing COVID-19. The study included 478 unselected ASD patients (mean age 59 ± 15 years), namely 101 rheumatoid arthritis (RA), 38 systemic lupus erythematosus (SLE), 265 systemic sclerosis (SSc), 61 cryoglobulinemic vasculitis (CV), and a miscellanea of 13 systemic vasculitis. The control group included 502 individuals from the general population (mean age 59 ± 14SD years). The immunogenicity of mRNA COVID-19 vaccines (BNT162b2 and mRNA-1273) was evaluated by measuring serum IgG-neutralizing antibody (NAb) (SARS-CoV-2 IgG II Quant antibody test kit; Abbott Laboratories, Chicago, IL) on samples obtained within 3 weeks after vaccination cycle. The short-term results of our prospective study revealed significantly lower NAb levels in ASD series compared to controls [286 (53–1203) vs 825 (451–1542) BAU/mL, p < 0.0001], as well as between single ASD subgroups and controls. More interestingly, higher percentage of non-responders to vaccine was recorded in ASD patients compared to controls [13.2% (63/478), vs 2.8% (14/502); p < 0.0001]. Increased prevalence of non-response to vaccine was also observed in different ASD subgroups, in patients with ASD-related interstitial lung disease (p = 0.009), and in those treated with glucocorticoids (p = 0.002), mycophenolate-mofetil (p < 0.0001), or rituximab (p < 0.0001). Comparable percentages of vaccine-related adverse effects were recorded among responder and non-responder ASD patients. Patients with weak/absent seroconversion, believed to be immune to SARS-CoV-2 infection, are at high risk to develop COVID-19. Early determination of serum NAb after vaccination cycle may allow to identify three main groups of ASD patients: responders, subjects with suboptimal response, non-responders. Patients with suboptimal response should be prioritized for a booster-dose of vaccine, while a different type of vaccine could be administered to non-responder individuals.

Impaired immunogenicity to COVID-19 vaccines in autoimmune systemic diseases. High prevalence of non-response in different patients’ subgroups / Ferri, C.; Ursini, F.; Gragnani, L.; Raimondo, V.; Giuggioli, D.; Foti, R.; Caminiti, M.; Olivo, D.; Cuomo, G.; Visentini, M.; Cacciapaglia, F.; Pellegrini, R.; Pigatto, E.; Urraro, T.; Naclerio, C.; Tavoni, A.; Puccetti, L.; Varcasia, G.; Cavazzana, I.; L'Andolina, M.; Ruscitti, P.; Vadacca, M.; Gigliotti, P.; La Gualana, F.; Cozzi, F.; Spinella, A.; Visalli, E.; Dal Bosco, Y.; Amato, G.; Masini, F.; Pagano Mariano, G.; Brittelli, R.; Aiello, V.; Caminiti, R.; Scorpiniti, D.; Rechichi, G.; Ferrari, T.; Monti, M.; Elia, G.; Franceschini, F.; Meliconi, R.; Casato, M.; Iannone, F.; Giacomelli, R.; Fallahi, P.; Santini, S. A.; Zignego, A. L.; Antonelli, A.. - In: JOURNAL OF AUTOIMMUNITY. - ISSN 0896-8411. - 125:(2021), pp. 102744-N/A. [10.1016/j.jaut.2021.102744]

Impaired immunogenicity to COVID-19 vaccines in autoimmune systemic diseases. High prevalence of non-response in different patients’ subgroups

Ferri C.;Giuggioli D.;Cuomo G.;Spinella A.;Masini F.;Aiello V.;Monti M.;
2021

Abstract

Autoimmune systemic diseases (ASD) may show impaired immunogenicity to COVID-19 vaccines. Our prospective observational multicenter study aimed to evaluate the seroconversion after the vaccination cycle and at 6-12-month follow-up, as well the safety and efficacy of vaccines in preventing COVID-19. The study included 478 unselected ASD patients (mean age 59 ± 15 years), namely 101 rheumatoid arthritis (RA), 38 systemic lupus erythematosus (SLE), 265 systemic sclerosis (SSc), 61 cryoglobulinemic vasculitis (CV), and a miscellanea of 13 systemic vasculitis. The control group included 502 individuals from the general population (mean age 59 ± 14SD years). The immunogenicity of mRNA COVID-19 vaccines (BNT162b2 and mRNA-1273) was evaluated by measuring serum IgG-neutralizing antibody (NAb) (SARS-CoV-2 IgG II Quant antibody test kit; Abbott Laboratories, Chicago, IL) on samples obtained within 3 weeks after vaccination cycle. The short-term results of our prospective study revealed significantly lower NAb levels in ASD series compared to controls [286 (53–1203) vs 825 (451–1542) BAU/mL, p < 0.0001], as well as between single ASD subgroups and controls. More interestingly, higher percentage of non-responders to vaccine was recorded in ASD patients compared to controls [13.2% (63/478), vs 2.8% (14/502); p < 0.0001]. Increased prevalence of non-response to vaccine was also observed in different ASD subgroups, in patients with ASD-related interstitial lung disease (p = 0.009), and in those treated with glucocorticoids (p = 0.002), mycophenolate-mofetil (p < 0.0001), or rituximab (p < 0.0001). Comparable percentages of vaccine-related adverse effects were recorded among responder and non-responder ASD patients. Patients with weak/absent seroconversion, believed to be immune to SARS-CoV-2 infection, are at high risk to develop COVID-19. Early determination of serum NAb after vaccination cycle may allow to identify three main groups of ASD patients: responders, subjects with suboptimal response, non-responders. Patients with suboptimal response should be prioritized for a booster-dose of vaccine, while a different type of vaccine could be administered to non-responder individuals.
125
102744
N/A
Impaired immunogenicity to COVID-19 vaccines in autoimmune systemic diseases. High prevalence of non-response in different patients’ subgroups / Ferri, C.; Ursini, F.; Gragnani, L.; Raimondo, V.; Giuggioli, D.; Foti, R.; Caminiti, M.; Olivo, D.; Cuomo, G.; Visentini, M.; Cacciapaglia, F.; Pellegrini, R.; Pigatto, E.; Urraro, T.; Naclerio, C.; Tavoni, A.; Puccetti, L.; Varcasia, G.; Cavazzana, I.; L'Andolina, M.; Ruscitti, P.; Vadacca, M.; Gigliotti, P.; La Gualana, F.; Cozzi, F.; Spinella, A.; Visalli, E.; Dal Bosco, Y.; Amato, G.; Masini, F.; Pagano Mariano, G.; Brittelli, R.; Aiello, V.; Caminiti, R.; Scorpiniti, D.; Rechichi, G.; Ferrari, T.; Monti, M.; Elia, G.; Franceschini, F.; Meliconi, R.; Casato, M.; Iannone, F.; Giacomelli, R.; Fallahi, P.; Santini, S. A.; Zignego, A. L.; Antonelli, A.. - In: JOURNAL OF AUTOIMMUNITY. - ISSN 0896-8411. - 125:(2021), pp. 102744-N/A. [10.1016/j.jaut.2021.102744]
Ferri, C.; Ursini, F.; Gragnani, L.; Raimondo, V.; Giuggioli, D.; Foti, R.; Caminiti, M.; Olivo, D.; Cuomo, G.; Visentini, M.; Cacciapaglia, F.; Pellegrini, R.; Pigatto, E.; Urraro, T.; Naclerio, C.; Tavoni, A.; Puccetti, L.; Varcasia, G.; Cavazzana, I.; L'Andolina, M.; Ruscitti, P.; Vadacca, M.; Gigliotti, P.; La Gualana, F.; Cozzi, F.; Spinella, A.; Visalli, E.; Dal Bosco, Y.; Amato, G.; Masini, F.; Pagano Mariano, G.; Brittelli, R.; Aiello, V.; Caminiti, R.; Scorpiniti, D.; Rechichi, G.; Ferrari, T.; Monti, M.; Elia, G.; Franceschini, F.; Meliconi, R.; Casato, M.; Iannone, F.; Giacomelli, R.; Fallahi, P.; Santini, S. A.; Zignego, A. L.; Antonelli, A.
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