Safety and tolerability of mRNA COVID-19 vaccines in people with antiphospholipid antibodies

Sciascia, Savino; Costanzo, Piera; Radin, Massimo; Schreiber, Karen; Vaccarino, A; Cecchi, Irene; Baldovino, Simone; Roccatello, Dario

doi:10.1016/s2665-9913(21)00320-9

Cited by 13 publications

(11 citation statements)

References 5 publications

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“…Indeed, we found that, globally, IgM or IgG levels are increased upon infection with SARS-CoV-2, with 66% of individuals having aPL against ≥1 antigen (non-infected controls: 15%), 40% against ≥2 antigens (non-infected controls: 0%), and 21.3% against ≥3 antigens (non-infected controls: 0%), using a threshold of OD ≥ 50. Thus, the prevalence of aPL was higher in our study than previously reported [ 13 , 15 , 50 , 51 , 55 ], despite not including LA in the measurements, and in spite of omitting IgA aPL. Importantly, we detected significant distributional changes between non-infected controls and SARS-CoV-2-infected individuals for IgM aPL against AnV, β2, and PT using Fisher’s exact test (p-values < 0.01), and for β2, and PT using Wilcoxon rank sum test (p-values < 0.01 after Benjamini-Hochberg correction).…”

Section: Discussioncontrasting

confidence: 75%

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Anti-prothrombin autoantibodies enriched after infection with SARS-CoV-2 and influenced by strength of antibody response against SARS-CoV-2 proteins

et al. 2021

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Antiphospholipid antibodies (aPL), assumed to cause antiphospholipid syndrome (APS), are notorious for their heterogeneity in targeting phospholipids and phospholipid-binding proteins. The persistent presence of Lupus anticoagulant and/or aPL against cardiolipin and/or β2 glycoprotein I have been shown to be independent risk factors for vascular thrombosis and pregnancy morbidity in APS. aPL production is thought to be triggered by–among other factors–viral infections, though infection-associated aPL have mostly been considered non-pathogenic. Recently, the potential pathogenicity of infection-associated aPL has gained momentum since an increasing number of patients infected with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has been described with coagulation abnormalities and hyperinflammation, together with the presence of aPL. Here, we present data from a multicentric, mixed-severity study including three cohorts of individuals who contracted SARS-CoV-2 as well as non-infected blood donors. We simultaneously measured 10 different criteria and non-criteria aPL (IgM and IgG) by using a line immunoassay. Further, IgG antibody response against three SARS-CoV-2 proteins was investigated using tripartite automated blood immunoassay technology. Our analyses revealed that selected non-criteria aPL were enriched concomitant to or after an infection with SARS-CoV-2. Linear mixed-effects models suggest an association of aPL with prothrombin (PT). The strength of the antibody response against SARS-CoV-2 was further influenced by SARS-CoV-2 disease severity and sex of the individuals. In conclusion, our study is the first to report an association between disease severity, anti-SARS-CoV-2 immunoreactivity, and aPL against PT in patients with SARS-CoV-2.

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Section: Discussioncontrasting

confidence: 75%

“…Some studies found no direct relationship of aPL-positivity with thrombotic events [ 8 , 45 – 49 ], which could be due to different epitope specificity, i.e. different aPL subtypes [ 50 , 51 ] compared to APS. Conversely, other studies found an association of elevated aPL (e.g.…”

Section: Discussionmentioning

confidence: 99%

Anti-prothrombin autoantibodies enriched after infection with SARS-CoV-2 and influenced by strength of antibody response against SARS-CoV-2 proteins

et al. 2021

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“…The identification of belimumab, as the most implicated therapy, is in line with this hypothesis as more than 50% of patients were receiving this therapy in addition to conventional treatments, probably identifying a subgroup of patients with a more aggressive disease (in Italy, due to eligibility criteria, belimumab can be prescribed only in patients with an active disease despite the conventional immunosuppressive therapy). The lack of any association with the serological profile is reassuring: our data confirmed that positive anti-phospholipid antibodies do not represent a major concern for the risk of thrombosis in patients undergoing anti-SARS-CoV-2 vaccination [ 19 ].…”

Section: Discussionsupporting

confidence: 53%

The Impact of Anti-SARS-CoV-2 Vaccine in Patients with Systemic Lupus Erythematosus: A Multicentre Cohort Study

Gerosa

Schioppo²,

Argolini

et al. 2022

Vaccines

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Vulnerable subjects, including systemic lupus erythematosus (SLE) patients, have been prioritised to receive anti-SARS-CoV-2 vaccines. Few data about the safety of these vaccines in SLE are available. The aim of our study is to investigate the safety of anti-SARS-CoV-2 vaccines in SLE. We included 452 SLE patients, referring to seven tertiary centres, who were immunised. A total of 119 (26%) reported side effects (SE) after the first and/or the second shot (the most frequent SE were fever, local reaction, fatigue, and arthralgia). Patients with constitutional symptoms and those on an immunosuppressive regimen (especially belimumab) showed more SE. In addition, 19 (4%) had a flare after the immunisation (flares classified by organ involvement: six musculoskeletal with constitutional symptoms, four renal, three cardio-respiratory, three haematological, two mucocutaneous). None of the patients needed hospitalisation and none died. Moreover, 15 required a transient increase in corticosteroids and four were treated with steroid pulses. One patient required an additional rituximab course. Anti-dsDNA, moderate/high DAS before vaccine, and belimumab were found more frequently in patients with disease flare. Anti-SARS-CoV-2 vaccines are safe in SLE patients, and they should be recommended in these patients, as the potential benefits widely outweigh the risk of SE. Treatment adjustment might be considered with the aim of minimising SE risk and flare.

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“…A recent study reported anti-PF4 antibodies in aPL-positive patients were not affected by COVID-19 vaccination [ 17 ]. Two surveys in patients with aPL antibodies reported that COVID-19 vaccination did not result in severe adverse events [ 18 , 19 ]. A study reported that COVID-19 vaccine did not affect aCL and anti-β2GP1 IgG and IgM titres in primary APS patients [ 20 ].…”

Section: Discussionmentioning

confidence: 99%

COVID-19 vaccine affects neither prothrombotic antibody profile nor thrombosis in primary anti-phospholipid syndrome: a prospective study

et al. 2022

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Objective To explore whether inactivated COVID-19 vaccine influences the profile of prothrombotic autoantibodies and induces thrombotic events in primary antiphospholipid syndrome (APS) patients. Methods We enrolled 39 primary APS patients who received two doses of inactivated SARS-CoV-2 vaccine (BBIBPCorV, Sinopharm, Beijing, China) voluntarily in this prospective cohort. Prothrombotic autoantibodies were determined before vaccination and four weeks after the 2nd dose of vaccination. Thrombotic disorders were evaluated via hospital site visits and assessments. Results There was no significant difference in the presence of all eleven autoantibodies detected before and four weeks after vaccination: for aCL, IgG (14 vs. 16, P= 0.64), IgM (13 vs. 19, P= 0.34), IgA (2 vs. 3, P= 0.64); anti-β2GP1, IgG (12 vs. 12, P= 1.00), IgM (5 vs. 8, P= 0.36), IgA (4 vs. 3, P= 0.69); aPS/PT IgG (13 vs. 16, P= 0.48), IgM (17 vs. 22, P= 0.26); LAC (22 vs. 28, P= 0.16); aPF4-heparin (0 vs. 0, P= 1.00), and antinuclear antibody (ANA) (23 vs. 26, P= 0.48). Notably, the distribution of aPL profile in pre- and post- vaccination cohort was not affected by SARS-CoV-2 vaccination: for patients with low-risk aPL profile (11 vs. 10, P= 0.799) and patients with high-risk aPL profile (28 vs. 29, P= 0.799), respectively. Furthermore, no case exhibited symptoms of the thrombotic disorder during a minimum follow-up period of 12 weeks. There was no adjustment to the ongoing treatment regimens following SARS-CoV-2 vaccination. Conclusions Inactivated SARS-CoV-2 vaccine does not influence the profile of antiphospholipid antibodies and anti-PF4-heparin antibodies nor induces thrombotic events in primary APS patients.

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Safety and tolerability of mRNA COVID-19 vaccines in people with antiphospholipid antibodies

Cited by 13 publications

References 5 publications

Anti-prothrombin autoantibodies enriched after infection with SARS-CoV-2 and influenced by strength of antibody response against SARS-CoV-2 proteins

Anti-prothrombin autoantibodies enriched after infection with SARS-CoV-2 and influenced by strength of antibody response against SARS-CoV-2 proteins

The Impact of Anti-SARS-CoV-2 Vaccine in Patients with Systemic Lupus Erythematosus: A Multicentre Cohort Study

COVID-19 vaccine affects neither prothrombotic antibody profile nor thrombosis in primary anti-phospholipid syndrome: a prospective study

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