Difference in safety and humoral response to mRNA SARS-CoV-2 vaccines in patients with autoimmune neurological disorders: the ANCOVAX study

Giannoccaro, Maria Pia; Vacchiano, Veria; Leone, Marta; Camilli, Federico; Zenesini, Corrado; Balboni, Alice; Tappatà, Maria; Borghi, Annamaria; Salvi, Fabrizio; Rinaldi, Rita; Felice, Giulia Di; Lodi, Vittorio; Lazzarotto, Tiziana; Liguori, Rocco

doi:10.1007/s00415-022-11142-7

Cited by 10 publications

(23 citation statements)

References 31 publications

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“…In several cohorts of immunocompromised patients impaired humoral immune response after complete SARS-CoV-2 immunization has been described ( 6 – 10 ).…”

Section: Introductionmentioning

confidence: 99%

SARS-CoV-2 IgG spike protein antibody response in mRNA-1273 Moderna® vaccinated patients on maintenance immunoapheresis – a cohort study

et al. 2022

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BackgroundThe SARS-CoV-2 pandemic increased mortality and morbidity among immunocompromised populations. Vaccination is the most important preventive measure, however, its effectiveness among patients depending on maintenance immunoglobulin G (IgG) apheresis to control autoimmune disease activity is unknown. We aimed to examine the humoral immune response after mRNA-1273 Moderna® vaccination in immunoapheresis patients.MethodsWe prospectively monitored SARS-CoV-2 IgG spike (S) protein antibody levels before and after each IgG (exposure) or lipid (LDL) apheresis (controls) over 12 weeks and once after 24 weeks. Primary outcome was the difference of change of SARS-CoV-2 IgG S antibody levels from vaccination until week 12, secondary outcome was the difference of change of SARS-CoV-2 IgG S antibody levels by apheresis treatments across groups.ResultsWe included 6 IgG and 18 LDL apheresis patients. After 12 weeks the median SARS-CoV-2 IgG S antibody level was 115 (IQR: 0.74, 258) in the IgG and 1216 (IQR: 788, 2178) in the LDL group (p=0.03). Median SARS-CoV-2 IgG S antibody reduction by apheresis was 76.4 vs. 23.7% in the IgG and LDL group (p=0.04). The average post- vs. pre-treatment SARS-CoV-2 IgG S antibody rebound in the IgG group vs. the LDL group was 46.1 and 6.44%/week from prior until week 12 visit.ConclusionsIgG apheresis patients had lower SARS-CoV-2 IgG S antibody levels compared to LDL apheresis patients, but recovered appropriately between treatment sessions. We believe that IgG apheresis itself probably has less effect on maintaining the immune response compared to concomitant immunosuppressive drugs. Immunization is recommended independent of apheresis treatment.

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“…In several cohorts of immunocompromised patients impaired humoral immune response after complete SARS-CoV-2 immunization has been described ( 6 – 10 ).…”

Section: Introductionmentioning

confidence: 99%

SARS-CoV-2 IgG spike protein antibody response in mRNA-1273 Moderna® vaccinated patients on maintenance immunoapheresis – a cohort study

et al. 2022

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“…Patients with multiple sclerosis who received the Pfizer vaccine while being treated with anti-CD20 therapy [54], fingolimod continuation [31], and other immunosuppressants [34] had lower IgG titers compared with untreated patients or patients who discontinued the therapy. In comparison with healthy controls, patients with autoimmune neurological disorder who had received the Pfizer or Moderna vaccines had decreased seroconversion rates [34] and anti-S1 IgG [53,60] and anti-S(RBD) specific IgG levels [52].…”

Section: Immunogenicitymentioning

confidence: 93%

“…Autoimmune medications given to the patients included alemtuzumab [29,34,48,66], abatacept [8,33,35,39,47,57,58,63,[72][73][74][75]94,98], anti-CD20/-B cell depleting therapy [8,29,[32][33][34][35]37,[39][40][41]43,45,[47][48][49][52][53][54][55]57,60,[62][63][64][65][66]72,74,75,87,89,92,94,[96]…”

Section: Study Characteristicsmentioning

confidence: 99%

Efficacy, Immunogenicity, and Safety of COVID-19 Vaccines in Patients with Autoimmune Diseases: A Systematic Review and Meta-Analysis

Widhani,

Hasibuan,

Rismawati

et al. 2023

Vaccines

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Patients with autoimmune diseases are among the susceptible groups to COVID-19 infection because of the complexity of their conditions and the side effects of the immunosuppressive drugs used to treat them. They might show impaired immunogenicity to COVID-19 vaccines and have a higher risk of developing COVID-19. Using a systematic review and meta-analysis, this research sought to summarize the evidence on COVID-19 vaccine efficacy, immunogenicity, and safety in patients with autoimmune diseases following predefined eligibility criteria. Research articles were obtained from an initial search up to 26 September 2022 from PubMed, Embase, EBSCOhost, ProQuest, MedRxiv, bioRxiv, SSRN, EuroPMC, and the Cochrane Center of Randomized Controlled Trials (CCRCT). Of 76 eligible studies obtained, 29, 54, and 38 studies were included in systematic reviews of efficacy, immunogenicity, and safety, respectively, and 6, 18, and 4 studies were included in meta-analyses for efficacy, immunogenicity, and safety, respectively. From the meta-analyses, patients with autoimmune diseases showed more frequent breakthrough COVID-19 infections and lower total antibody (TAb) titers, IgG seroconversion, and neutralizing antibodies after inactivated COVID-19 vaccination compared with healthy controls. They also had more local and systemic adverse events after the first dose of inactivated vaccination compared with healthy controls. After COVID-19 mRNA vaccination, patients with autoimmune diseases had lower TAb titers and IgG seroconversion compared with healthy controls.

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“…[ 2 , 3 ] In this scenario, the management of patients with chronic conditions and those receiving immunosuppressive treatments has been challenging, given the higher risk of COVID-19-associated morbidity and poorer characterisation of the response to mRNA vaccines. [ 4 , 5 ] Real-world data has confirmed that mRNA vaccines are effective and well-tolerated in most patients with autoimmune neurological conditions [6] , [7] , [8] , including myasthenia gravis (MG). [9] , [10] , [11] , [12] However, in patients on B cell-depleting therapies, uncertainty remains around the robustness of protective immunity after vaccination.…”

Section: Introductionmentioning

confidence: 99%

Immunological response after SARS-CoV-2 infection and mRNA vaccines in patients with myasthenia gravis treated with Rituximab

Damato

Spagni

Monte

et al. 2023

Neuromuscular Disorders

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Difference in safety and humoral response to mRNA SARS-CoV-2 vaccines in patients with autoimmune neurological disorders: the ANCOVAX study

Cited by 10 publications

References 31 publications

SARS-CoV-2 IgG spike protein antibody response in mRNA-1273 Moderna® vaccinated patients on maintenance immunoapheresis – a cohort study

SARS-CoV-2 IgG spike protein antibody response in mRNA-1273 Moderna® vaccinated patients on maintenance immunoapheresis – a cohort study

Efficacy, Immunogenicity, and Safety of COVID-19 Vaccines in Patients with Autoimmune Diseases: A Systematic Review and Meta-Analysis

Immunological response after SARS-CoV-2 infection and mRNA vaccines in patients with myasthenia gravis treated with Rituximab

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