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, Sa; Zignego, Al; Antonelli, A.. - In: JOURNAL OF AUTOIMMUNITY. - ISSN 0896-8411. - (2022). [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

Visentini M;La Gualana F;Casato M;
2022

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.
2022
Autoimmune systemic diseases; COVID-19 vaccine; Cryoglobulinemic vasculitis; Neutralizing antibodies; Rheumatoid arthritis; Systemic lupus; Systemic sclerosis; Systemic vasculitis.
01 Pubblicazione su rivista::01a Articolo in rivista
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, Sa; Zignego, Al; Antonelli, A.. - In: JOURNAL OF AUTOIMMUNITY. - ISSN 0896-8411. - (2022). [10.1016/j.jaut.2021.102744]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1621723
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