A prospective multicenter study assessing humoral immunogenicity and safety of the mRNA SARS-CoV-2 vaccines in Greek patients with systemic autoimmune and autoinflammatory rheumatic diseases

Tzioufas, Athanasios G.; Bakasis, Athanasios‐Dimitrios; Goules, Andreas V.; Bitzogli, Kleopatra; Cinoku, Ilir I.; Chatzis, Loukas; Argyropoulou, Ourania D; Venetsanopoulou, Aliki; Mavrommati, Maria; Stergiou, Ioanna Ε.; Pezoulas, Vasileios C.; Voulgari, Paraskevi V.; Katsimpari, Chaido; Katechis, Spyridon; Gazi, Souzana; Katsifis, Gikas; Sfontouris, Charalampos; Georgountzos, A.; Liossis, Stamatis–Nick C.; Papagoras, Charalampos; Fotiadis, Dimitrios I.; Skopouli, Fotini N.; Vlachoyiannopoulos, Panayiotis G.; Moutsopoulos, Haralampos Μ.

doi:10.1016/j.jaut.2021.102743

Cited by 47 publications

(50 citation statements)

References 45 publications

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“…Interestingly, older age was a risk factor for an attenuated vaccination response to SARS-CoV-2 in this work. These initial findings by Geisen et al [ 14 ] and Furer et al [ 15 ] could essentially be confirmed by other research groups [ 2 , 5 , 16 , 17 ]. Whereas bDMARDs directed against cytokines, such as anti-TNFalpha or anti-IL-17, are associated with only a little or no attenuation of the humoral vaccine response, this type of immune response seems to be reduced in the case of biologics directed against cells, such as rituximab or abatacept, but also in the case of csDMARDs, such as mycophenolate mofetil, methotrexate or prednisolone [ 3 , 18 , 19 ].…”

Section: Discussionsupporting

confidence: 63%

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Methotrexate significantly reduces the humoral vaccination response against SARS-CoV-2 in older but not younger patients with rheumatoid arthritis

et al. 2022

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To assess the humoral response to vaccination against SARS-CoV-2 in patients with rheumatoid arthritis treated with methotrexate (MTX). In total, 142 fully vaccinated individuals were included at 6 ± 1 weeks after their second vaccination [BioNTech/Pfizer (70.4%), AstraZeneca (20.4%), and Moderna (9.2%)]. The primary goal was to assess the humoral immune response as measured by titres of neutralising antibodies against the S1 antigen of SARS-CoV-2. In a cross-sectional, single-centre study, titres were compared between patient subgroups with (n = 80) and without (n = 62) methotrexate exposure. MTX patients showed a significantly reduced humoral response to vaccination in the oldest patient subgroup (> 70 years: P = 0.038), whereas titres of neutralising antibodies were not significantly different between MTX and non-MTX patients in patients less than 70 years of age (< 56 years: P = 0.234; 56–70 years: P = 0.446). In patients > 70 years, non-MTX patients showed a maximum immune response in 76.5% of cases, whereas this percentage was reduced to 53.7% in study participants on MTX medication (effect size d = 0.21). Older age in patients with rheumatoid arthritis in combination with methotrexate results in a significantly reduced humoral response after vaccination against SARS-CoV-2. Our data underline the importance of age regarding the humoral response and may support the temporary cessation of methotrexate, particularly in elderly patients in the context of vaccination against SARS-CoV-2.

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Section: Discussionsupporting

confidence: 63%

“…Tzioufas et al studied the effect of modifications of DMARD therapy during the vaccination phase [ 17 ]. They found that extensive suspension of DMARD therapy [ 22 ] resulted in equalisation of vaccination response between patients with inflammatory rheumatic diseases and healthy controls, again underscoring the influence of therapy.…”

Section: Discussionmentioning

confidence: 99%

Methotrexate significantly reduces the humoral vaccination response against SARS-CoV-2 in older but not younger patients with rheumatoid arthritis

et al. 2022

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“…This could be partially explained by immunosenescence along with enriched comorbidities in older individuals [29]. As far as immunosuppressive treatment is concerned, a variety of studies, mainly on solid-organ transplanted patients and patients with autoimmune rheumatic diseases, have shown the correlation between immunosuppression and antibody formation after SARS-CoV-2 vaccination [13,[30][31][32][33][34].…”

Section: Discussionmentioning

confidence: 99%

Antibody Responses after SARS-CoV-2 Vaccination in Patients with Liver Diseases

Bakasis

Bitzogli

Mouziouras

et al. 2022

Viruses

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The novel mRNA-based vaccines against SARS-CoV-2 display encouraging safety and efficacy profiles. However, there is a paucity of data regarding their immunogenicity and safety in patients with liver diseases (PWLD), especially in those with cirrhosis. We prospectively assessed anti-SARS-CoV-2 S-spike IgG antibodies and neutralizing activity in fully vaccinated PWLD (n = 87) and controls (n = 40). Seroconversion rates were 97.4% (37/38) in cirrhotic PWLD, 87.8% (43/49) in non-cirrhotic PWLD and 100% (40/40) in controls. Adequate neutralizing activity was detected in 92.1% (35/38), 87.8% (43/49) and 100% (40/40) of cirrhotics, non-cirrhotics and controls, respectively. On multivariable analysis, immunosuppressive treatment was negatively correlated with anti-SARS-CoV-2 antibody titers (coefficient (SE): −2.716 (0.634), p < 0.001) and neutralizing activity (coefficient (SE): −24.379 (4.582), p < 0.001), while age was negatively correlated only with neutralizing activity (coefficient (SE): −0.31(0.14), p = 0.028). A total of 52 responder PWLD were reassessed approximately 3 months post-vaccination and no differences were detected in humoral responses between cirrhotic and non-cirrhotic PWLD. No significant side effects were noted post vaccination, while no symptomatic breakthrough infections were reported during a 6-month follow up. Overall, our study shows that m-RNA-based SARS-CoV-2 vaccines are safe and efficacious in PWLD. However, PWLD under immunosuppressive treatment and those of advanced age should probably be more closely monitored after vaccination.

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“…Humoral and cellular immune responses to COVID-19 mRNA vaccines are reduced in patients with immune-mediated inflammatory diseases on background methotrexate ( 31 ). Moreover, treatment with mycophenolate mofetil and rituximab also compromise anti-SARS-CoV-2 antibody responses ( 32 ). However, according to the updated international recommendations for the management of autoimmune bullous diseases during COVID-19 pandemic, lowering the dosage of immunomodulatory medications before or during the vaccination is not advisable due to the risk of exacerbations ( 33 ).…”

Section: Discussionmentioning

confidence: 99%

Bullous Pemphigoid Associated With COVID-19 Vaccines: An Italian Multicentre Study

et al. 2022

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Bullous pemphigoid (BP) is an autoimmune bullous disease caused by circulating autoantibodies toward the hemidesmosomal antigens BP180 and BP230. Cases of BP have been described following vaccinations against tetanus, poliomyelitis, diphtheria, influenza, pneumococcus, meningococcus, hepatitis B and rabies. The putative mechanism by which COVID-19-vaccines may induce BP has not been clarified. An Italian multicentre study was conducted to collect clinical, histopathological and immunopathological data of patients with BP associated with COVID-19-vaccines. Twenty-one cases were collected, including 9 females and 12 males (M/F = 1.3) with a median age at diagnosis of 82 years. Seventeen patients received the COMIRNATY Pfizer-BioNTech vaccine, two the Moderna mRNA-1273 vaccine, one the ChAdOx1/nCoV-19-AstraZeneca/ Vaxzevria vaccine and one received the first dose with the ChAdOx1/nCoV-19-AstraZeneca/Vaxzevria vaccine and the second dose with the COMIRNATY Pfizer-BioNTech vaccine. Median latency time between the first dose of anti-SARS-CoV-2 vaccine and the onset of cutaneous manifestations was 27 days. Median BPDAI at onset was 42. Eleven out of seventeen patients (65%) had positive titres for anti-BP180 antibodies with a median value of 106.3 U/mL on ELISA; in contrast, only five out of seventeen (29%) were positive for anti-BP230 antibodies, with a median of 35.3 U/mL. In conclusion, in terms of mean age, disease severity at diagnosis and clinical phenotype vaccine-associated BP patients seem to be similar to idiopathic BP with an overall benign course with appropriate treatment. On the other hand, the slight male predominance and the reduced humoral response to BP230 represent peculiar features of this subset of patients.

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A prospective multicenter study assessing humoral immunogenicity and safety of the mRNA SARS-CoV-2 vaccines in Greek patients with systemic autoimmune and autoinflammatory rheumatic diseases

Cited by 47 publications

References 45 publications

Methotrexate significantly reduces the humoral vaccination response against SARS-CoV-2 in older but not younger patients with rheumatoid arthritis

Methotrexate significantly reduces the humoral vaccination response against SARS-CoV-2 in older but not younger patients with rheumatoid arthritis

Antibody Responses after SARS-CoV-2 Vaccination in Patients with Liver Diseases

Bullous Pemphigoid Associated With COVID-19 Vaccines: An Italian Multicentre Study

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