11 results on '"La Gualana F"'
Search Results
2. AB1169 IMMUNOMODULATORY EFFECTS OF SARS-CoV-2 VACCINATION: INCREASE OF REGULATORY T CELLS AFTER mRNA VACCINE
- Author
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La Gualana, F., primary, Villani, F., additional, Cusano, G., additional, Gragnani, L., additional, Stefanini, L., additional, Santini, S., additional, Basili, S., additional, Casato, M., additional, Fiorilli, M., additional, and Visentini, M., additional
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- 2022
- Full Text
- View/download PDF
3. Impaired immunogenicity to COVID-19 vaccines in autoimmune systemic diseases. High prevalence of non-response in different patients' subgroups
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Domenico Olivo, E. Pigatto, Francesca La Gualana, Giorgio Amato, Ilaria Cavazzana, Rosario Foti, Antonio Tavoni, Raffaele Brittelli, Tommaso Ferrari, Francesco Masini, Marcella Visentini, Stefano Angelo Santini, Dilia Giuggioli, Franco Franceschini, Vincenzo Raimondo, Laura Gragnani, Giuseppa Pagano Mariano, Poupak Fallahi, Vincenzo Aiello, Lorenzo Puccetti, C. Naclerio, Riccardo Meliconi, Giovanna Cuomo, Amelia Spinella, Ylenia Dal Bosco, Alessandro Antonelli, Daniela Scorpiniti, M. Vadacca, Piero Ruscitti, Milvia Casato, Elisa Visalli, Florenzo Iannone, Maurizio Caminiti, Fabio Cacciapaglia, Francesco Ursini, Clodoveo Ferri, T. Urraro, Rodolfo Caminiti, Monica Monti, Massimo L'Andolina, Giovanni Rechichi, Anna Linda Zignego, Roberto Giacomelli, Giuseppe Varcasia, Roberta Pellegrini, Franco Cozzi, Pietro Gigliotti, Giusy Elia, 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., 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., and Antonelli A.
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Male ,History ,Polymers and Plastics ,Binding Antibody Units, BAU ,Antibodies, Viral ,Gastroenterology ,Industrial and Manufacturing Engineering ,Cryoglobulinemic vasculitis, CV ,Scleroderma ,Systemic sclerosi ,Systemic lupu ,Anti-citrullinated protein antibodies, ACPA ,Systemic vasculitis ,Lupus Erythematosus, Systemic ,Immunology and Allergy ,Medicine ,Viral ,Prospective Studies ,Prospective cohort study ,Neutralizing ,education.field_of_study ,Autoimmune systemic diseases ,COVID-19 vaccine ,Cryoglobulinemic vasculitis ,Neutralizing antibodies ,Rheumatoid arthritis ,Systemic lupus ,Systemic sclerosis ,Immunogenicity ,Vaccination ,Middle Aged ,Neutralizing antibody, NAb ,Rheumatoid factor, RF ,Italy ,Female ,Rituximab ,Systemic sclerosis, SSc ,Adverse events, AEs ,2019-nCoV Vaccine mRNA-1273 ,Human ,medicine.drug ,medicine.medical_specialty ,Systemic lupus erythematosus, SLE ,Immunology ,Population ,Autoimmune systemic disease ,Autoimmune Disease ,Article ,Antibodies ,Autoimmune Diseases ,Internal medicine ,Neutralizing antibodie ,Humans ,Business and International Management ,Seroconversion ,education ,Settore BIO/10 - BIOCHIMICA ,Vaccine Potency ,Rheumatoid arthriti ,BNT162 Vaccine ,Scleroderma, Systemic ,Lupus Erythematosus ,Cryoglobulinemic vasculiti ,SARS-CoV-2 ,business.industry ,Systemic ,Systemic Vasculiti ,COVID-19 ,medicine.disease ,Antibodies, Neutralizing ,Autoimmune systemic diseases, ASD ,Prospective Studie ,World Health Organization, WHO ,Rheumatoid arthritis, RA ,Systemic Vasculitis ,business - 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.
- Published
- 2022
4. Absent or suboptimal response to booster dose of COVID-19 vaccine in patients with autoimmune systemic diseases
- Author
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Clodoveo Ferri, Laura Gragnani, Vincenzo Raimondo, Marcella Visentini, Dilia Giuggioli, Serena Lorini, Rosario Foti, Fabio Cacciapaglia, Maurizio Caminiti, Domenico Olivo, Giovanna Cuomo, Roberta Pellegrini, Erika Pigatto, Teresa Urraro, Caterina Naclerio, Antonio Tavoni, Lorenzo Puccetti, Ilaria Cavazzana, Piero Ruscitti, Marta Vadacca, Francesca La Gualana, Franco Cozzi, Amelia Spinella, Elisa Visalli, Ylenia Dal Bosco, Giorgio Amato, Francesco Masini, Giuseppa Pagano Mariano, Raffaele Brittelli, Vincenzo Aiello, Daniela Scorpiniti, Giovanni Rechichi, Giuseppe Varcasia, Monica Monti, Giusy Elia, Franco Franceschini, Milvia Casato, Francesco Ursini, Roberto Giacomelli, Poupak Fallahi, Stefano Angelo Santini, Florenzo Iannone, Carlo Salvarani, Anna Linda Zignego, Alessandro Antonelli, Ferri, C., Gragnani, L., Raimondo, V., Visentini, M., Giuggioli, D., Lorini, S., Foti, R., Cacciapaglia, F., Caminiti, M., Olivo, D., Cuomo, G., Pellegrini, R., Pigatto, E., Urraro, T., Naclerio, C., Tavoni, A., Puccetti, L., Cavazzana, I., Ruscitti, P., Vadacca, M., La Gualana, F., Cozzi, F., Spinella, A., Visalli, E., Bosco, Y. D., Amato, G., Masini, F., Mariano, G. P., Brittelli, R., Aiello, V., Scorpiniti, D., Rechichi, G., Varcasia, G., Monti, M., Elia, G., Franceschini, F., Casato, M., Ursini, F., Giacomelli, R., Fallahi, P., Santini, S. A., Iannone, F., Salvarani, C., Zignego, A. L., and Antonelli, A.
- Subjects
Autoimmune systemic diseases ,Booster vaccine ,COVID-19 vaccine ,Cryoglobulinemic vasculitis ,Neutralizing antibodies ,Rheumatoid arthritis ,Systemic lupus ,Systemic sclerosis ,Systemic vasculitis ,Antibodies, Viral ,BNT162 Vaccine ,Humans ,Immunization, Secondary ,Vaccination ,COVID-19 ,COVID-19 Vaccines ,Secondary ,Immunology ,Autoimmune systemic disease ,Antibodies ,Systemic sclerosi ,Systemic lupu ,Neutralizing antibodie ,Immunology and Allergy ,Viral ,Settore BIO/10 - BIOCHIMICA ,Rheumatoid arthriti ,Cryoglobulinemic vasculiti ,Systemic vasculiti ,Immunization ,Human - Abstract
Autoimmune systemic diseases (ASD) show impaired immunogenicity to COVID-19 vaccines. Our prospective observational multicenter study aimed at evaluating the seroconversion elicited by COVID-19 vaccine over the entire vaccination cycle including the booster dose. Among 478 unselected ASD patients originally evaluated at the end of the first vaccination cycle (time 1), 344 individuals were re-evaluated after a 6-month period (time 2), and 244 after the booster vaccine dose (time 3). The immunogenicity of mRNA COVID-19 vaccines (BNT162b2 and mRNA-1273) was assessed by measuring serum IgG-neutralizing antibody (NAb) on samples obtained at the three time points in both patients and 502 age-matched controls. In the 244 ASD group that received booster vaccine and monitored over the entire follow-up, the mean serum NAb levels (time 1, 2, and 3: 696.8±52.68, 370.8±41.92, and 1527±74.16SD BAU/mL, respectively; p 
- Published
- 2022
5. High prevalence of past hepatitis B virus infection in diffuse large B cell lymphoma: a retrospective study from Italy.
- Author
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Visentini M, Pica A, D'Ippolito G, Sculco E, La Gualana F, Gragnani L, Miglionico M, Mazzaro C, Fiorilli M, Basili S, Martelli M, Di Rocco A, Casato M, Gentile G, and Pulsoni A
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- Humans, Male, Female, Hepatitis B virus metabolism, Retrospective Studies, Hepatitis B Surface Antigens, Prevalence, Hepatitis B Antibodies, Hepatitis B, Chronic complications, Hepatitis B, Chronic epidemiology, Hepatitis B epidemiology, Hepatitis B complications, Lymphoma, Large B-Cell, Diffuse diagnosis
- Abstract
Studies from high endemic areas, mostly China, indicate that surface antigen positive (HBsAg
pos ) chronic hepatitis B virus (HBV) infection is associated with an increased risk of developing diffuse large B-cell lymphoma (DLBCL), whereas studies in low endemic areas have provided conflicting results. Past infection, serologically defined by negative HBsAg and positive anti-core antibody (HBsAgneg HBcAbpos ), has also been suggested to increase the risk of B-cell non-Hodgkin's lymphoma (NHL) in high endemic areas. We retrospectively reviewed unselected clinical records of 253 patients with DLBCL (54% male, aged 60.3 ± 14.6 years at diagnosis) and 694 patients with different types of indolent B-cell NHL (46% male, aged 61.7 ± 12.8 years). Patients were seen at a single center in Italy between 2001 and 2022 and HBV serological status (HBsAg, HBsAb, HBcAb, HBeAg, HBeAb, and HBV DNA) was analyzed through enzyme-linked immunosorbent assays and molecular assays; patients infected with hepatitis C virus or human immunodeficiency virus were excluded. We used an unconditional multiple logistic regression model including as matching variables gender, age at diagnosis, immigrant status, and HBV serological status. Patients with DLBCL had, compared to indolent NHL, a higher prevalence of HBsAgpos active infection (odds ratio (OR) 2.8, 95% confidence interval (95% CI) 1.2-6.3, p = 0.014). Strikingly, patients with DLBCL had also a significantly higher prevalence of past infection (OR 2.4, 95% CI 1.5-4.0, p = 0.0006). Male gender was associated with increased risk of DLBCL independently of the HBV serological status. These findings suggest that both past and active HBV infection may increase the risk of DLBCL in a low endemic area. Our study needs confirmation by studies in areas or populations with different rates of chronic or past HBV infection., (© 2023. The Author(s).)- Published
- 2023
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6. Opposite Effects of mRNA-Based and Adenovirus-Vectored SARS-CoV-2 Vaccines on Regulatory T Cells: A Pilot Study.
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La Gualana F, Maiorca F, Marrapodi R, Villani F, Miglionico M, Santini SA, Pulcinelli F, Gragnani L, Piconese S, Fiorilli M, Basili S, Casato M, Stefanini L, and Visentini M
- Abstract
New-generation mRNA and adenovirus vectored vaccines against SARS-CoV-2 spike protein are endowed with immunogenic, inflammatory and immunomodulatory properties. Recently, BioNTech developed a noninflammatory tolerogenic mRNA vaccine (MOGm1Ψ) that induces in mice robust expansion of antigen-specific regulatory T (Treg) cells. The Pfizer/BioNTech BNT162b2 mRNA vaccine against SARS-CoV-2 is identical to MOGm1Ψ except for the lipid carrier, which differs for containing lipid nanoparticles rather than lipoplex. Here we report that vaccination with BNT162b2 led to an increase in the frequency and absolute count of CD4
pos CD25high CD127low putative Treg cells; in sharp contrast, vaccination with the adenovirus-vectored ChAdOx1 nCoV-19 vaccine led to a significant decrease of CD4pos CD25high cells. This pilot study is very preliminary, suffers from important limitations and, frustratingly, very hardly can be refined in Italy because of the >90% vaccination coverage. Thus, the provocative perspective that BNT162b2 and MOGm1Ψ may share the capacity to promote expansion of Treg cells deserves confirmatory studies in other settings.- Published
- 2023
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7. The Effect of SARS-CoV-2 Vaccination on B-Cell Phenotype in Systemic Sclerosis Patients.
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Pellicano C, Colalillo A, Basile V, Marino M, Basile U, La Gualana F, Mezzaroma I, Visentini M, and Rosato E
- Abstract
Objective: to assess the influence of SARS-CoV-2 mRNA vaccine on B-cell phenotypes in systemic sclerosis (SSc)., Methods: peripheral blood B-cell subpopulations were evaluated before (t1) and 3 months (t3) after the second dose of vaccine in 28 SSc patients. Peripheral blood B-cell subpopulations were evaluated in 21 healthy controls (HCs) only at t1. Anti-spike IgG levels were evaluated at t3 in both cohorts., Results: SSc patients presented higher naive, double-negative, and CD21
low B cells compared to HCs. IgM-memory and switched-memory B cells were lower in SSc patients than HCs. No differences in anti-spike IgG levels after vaccination were observed between SSc patients and HCs. Anti-spike IgG levels after vaccination were lower in SSc patients with increased CD21low B cells at baseline compared to SSc patients with normal CD21low B cells. A positive correlation was found between IgG levels and naive B cells. A negative linear correlation was shown between IgG levels and IgM-memory, switched-memory, double-negative, and CD21low B cells., Conclusions: SARS-CoV-2 mRNA vaccine response is normal in SSc patients not undergoing immunosuppressive therapy. The normal number of naive B cells is a positive marker of antibody response. The increased percentage of CD21low B cells represents a negative marker of antibody response.- Published
- 2022
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8. Absent or suboptimal response to booster dose of COVID-19 vaccine in patients with autoimmune systemic diseases.
- Author
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Ferri C, Gragnani L, Raimondo V, Visentini M, Giuggioli D, Lorini S, Foti R, Cacciapaglia F, Caminiti M, Olivo D, Cuomo G, Pellegrini R, Pigatto E, Urraro T, Naclerio C, Tavoni A, Puccetti L, Cavazzana I, Ruscitti P, Vadacca M, La Gualana F, Cozzi F, Spinella A, Visalli E, Bosco YD, Amato G, Masini F, Mariano GP, Brittelli R, Aiello V, Scorpiniti D, Rechichi G, Varcasia G, Monti M, Elia G, Franceschini F, Casato M, Ursini F, Giacomelli R, Fallahi P, Santini SA, Iannone F, Salvarani C, Zignego AL, and Antonelli A
- Subjects
- Antibodies, Viral, BNT162 Vaccine, Humans, Immunization, Secondary, Vaccination, COVID-19 prevention & control, COVID-19 Vaccines
- Abstract
Autoimmune systemic diseases (ASD) show impaired immunogenicity to COVID-19 vaccines. Our prospective observational multicenter study aimed at evaluating the seroconversion elicited by COVID-19 vaccine over the entire vaccination cycle including the booster dose. Among 478 unselected ASD patients originally evaluated at the end of the first vaccination cycle (time 1), 344 individuals were re-evaluated after a 6-month period (time 2), and 244 after the booster vaccine dose (time 3). The immunogenicity of mRNA COVID-19 vaccines (BNT162b2 and mRNA-1273) was assessed by measuring serum IgG-neutralizing antibody (NAb) on samples obtained at the three time points in both patients and 502 age-matched controls. In the 244 ASD group that received booster vaccine and monitored over the entire follow-up, the mean serum NAb levels (time 1, 2, and 3: 696.8 ± 52.68, 370.8 ± 41.92, and 1527 ± 74.16SD BAU/mL, respectively; p < 0.0001) were constantly lower compared to controls (p < 0.0001), but they significantly increased after the booster dose compared to the first two measurements (p < 0.0001). The percentage of patients with absent/suboptimal response to vaccine significantly decreased after the booster dose compared to the first and second evaluations (time 1, 2, and 3: from 28.2% to 46.3%, and to 7.8%, respectively; p < 0.0001). Of note, the percentage of patients with absent/suboptimal response after the booster dose was significantly higher compared to controls (19/244, 7.8% vs 1/502, 0.2%; p < 0.0001). Similarly, treatment with immune-modifiers increased the percentage of patients exhibiting absent/suboptimal response (16/122, 13.1% vs 3/122, 2.46%; p = 0.0031). Overall, the above findings indicate the usefulness of booster vaccine administration in ASD patients. Moreover, the persistence of a significantly higher percentage of individuals without effective seroconversion (7.8%), even after the booster dose, warrants for careful monitoring of NAb levels in all ASD patients to identify those with increased risk of infection. In this particularly frail patients' setting, tailored vaccination and/or therapeutic strategy are highly advisable., (Copyright © 2022 Elsevier Ltd. All rights reserved.)
- Published
- 2022
- Full Text
- View/download PDF
9. Flares of mixed cryoglobulinaemia vasculitis after vaccination against SARS-CoV-2.
- Author
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Visentini M, Gragnani L, Santini SA, Urraro T, Villa A, Monti M, Palladino A, Petraccia L, La Gualana F, Lorini S, Marri S, Madia F, Stefanini L, Basili S, Fiorilli M, Ferri C, Zignego AL, and Casato M
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- Adult, Aged, Female, Humans, Male, Middle Aged, Symptom Flare Up, COVID-19 prevention & control, COVID-19 Vaccines adverse effects, Cryoglobulinemia immunology, SARS-CoV-2 immunology, Vasculitis chemically induced
- Abstract
Competing Interests: Competing interests: None declared.
- Published
- 2022
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10. COVID-19 vaccine immunogenicity in 16 patients with autoimmune systemic diseases. Lack of both humoral and cellular response to booster dose and ongoing disease modifying therapies.
- Author
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Gragnani L, Visentini M, Lorini S, La Gualana F, Santini SA, Cacciapaglia F, Tavoni A, Cuomo G, Fallahi P, Iannone F, Antonelli A, Casato M, Zignego AL, and Ferri C
- Abstract
Background: Patients with autoimmune systemic diseases (ASDs) represent a frail population during the ongoing COVID-19 pandemic. The vaccination is the major preventive measure; however, a significant number of ASD patients show an impaired production of anti-COVID-19 neutralizing antibodies (NAb), possibly counterbalanced by adequate T-cell response. The present study aimed at evaluating both humoral and cellular response to COVID-19 vaccine booster dose in this particular setting., Patients and Methods: Serum NAb titer and T-cell response (measuring interferon gamma -IFN-γ- release) were evaluated 3 weeks after the COVID-19 vaccine booster dose, in 17 patients (12 F, mean age 68.8 ± 15.3 SD yrs) with different ASDs, compared to 17 healthy controls (HCs)., Results: The analysis excluded one patient reporting symptoms of COVID-19 only after the immunogenicity tests had been performed.The NAb levels were significantly lower in ASD compared to HCs (p < 0.0001); moreover, patients showed a higher percentage of negative/sub-optimal humoral response (31% vs 0% of HCs; p = 0.0184).The study of cellular response showed lower levels of IFN-γ for both Ag1 ( p = 0.0032) and Ag2 (p = 0.0136) in ASD patients compared to HCs, as well lower rate of adequate T-cell response compared to HCs (50% vs 94%; p = 0.0066).Disease modifying therapies (DMT) were administered in all patients with deficient NAb production (5/5, 100%), but in only 3/11 (27%) of responders ( p = 0.025).Worthy to note, 3/16 (19%) ASD patients developed neither humoral nor cellular responses, all treated with DMT., Conclusions: The impaired immunogenicity to COVID-19 vaccine booster and even more the concomitant lack of both humoral and cellular response might represent a high risk for severe COVID-19, particularly in ASD patients undergoing DMT.These frail subjects should be tightly monitored for their immune protection and prioritized for the fourth dose of COVID-19 vaccine. Moreover, in the occurrence of SARS-CoV2 infection, treatments with specific monoclonal antibodies and/or antivirals may be highly recommendable., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2022 The Authors.)
- Published
- 2022
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11. Impaired immunogenicity to COVID-19 vaccines in autoimmune systemic diseases. High prevalence of non-response in different patients' subgroups.
- Author
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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, and Antonelli A
- Subjects
- COVID-19 prevention & control, Female, Humans, Italy, Lupus Erythematosus, Systemic immunology, Male, Middle Aged, Prospective Studies, SARS-CoV-2 immunology, Scleroderma, Systemic immunology, Systemic Vasculitis immunology, Vaccination, Vaccine Potency, 2019-nCoV Vaccine mRNA-1273 immunology, Antibodies, Neutralizing blood, Antibodies, Viral blood, Autoimmune Diseases blood, Autoimmune Diseases immunology, BNT162 Vaccine immunology
- 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., (Copyright © 2021 Elsevier Ltd. All rights reserved.)
- Published
- 2021
- Full Text
- View/download PDF
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