Evidence map›Paper›PMID 34757289›Full record

ArticleJournal of autoimmunity2021

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.

Athanasios G Tzioufas, Athanasios-Dimitrios Bakasis, Andreas V Goules, Kleopatra Bitzogli, Ilir I Cinoku, Loukas G Chatzis, Ourania D Argyropoulou, Aliki I Venetsanopoulou, Maria Mavrommati, Ioanna E Stergiou and 14 more

Abstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of autoimmunity, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors.

Athanasios G TzioufasDepartment of Pathophysiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece; Institute for Autoimmune Systemic and Neurologic Diseases, Athens, Greece. Electronic address: agtzi@med.uoa.gr.
Athanasios-Dimitrios BakasisDepartment of Pathophysiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece; Institute for Autoimmune Systemic and Neurologic Diseases, Athens, Greece.
Andreas V GoulesDepartment of Pathophysiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece; Institute for Autoimmune Systemic and Neurologic Diseases, Athens, Greece.
Kleopatra BitzogliDepartment of Pathophysiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Ilir I CinokuDepartment of Physiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Loukas G ChatzisDepartment of Pathophysiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Ourania D ArgyropoulouDepartment of Pathophysiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Aliki I VenetsanopoulouRheumatology Clinic, Department of Internal Medicine, Faculty of Medicine, University of Ioannina, Ioannina, Greece.
Maria MavrommatiDepartment of Medicine and Clinical Immunology, Euroclinic of Athens, Athens, Greece.
Ioanna E StergiouDepartment of Pathophysiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Vasilis PezoulasUnit of Medical Technology and Intelligent Information Systems, University of Ioannina, Ioannina, Greece.
Paraskevi V VoulgariRheumatology Clinic, Department of Internal Medicine, Faculty of Medicine, University of Ioannina, Ioannina, Greece.
Chaido KatsimpariDepartment of Rheumatology, "Asklepieion" General Hospital, Athens, Greece.
Spyridon KatechisDepartment of Rheumatology, "Asklepieion" General Hospital, Athens, Greece.
Souzana GaziRheumatology Department, KAT General Hospital, Athens, Greece.
Gkikas KatsifisRheumatology Clinic, Naval Hospital of Athens, Athens, Greece.
Charalampos I SfontourisDepartment of Rheumatology, Evaggelismos Athens General Hospital, Athens, Greece.
Athanasios I GeorgountzosDepartment of Rheumatology, Peripheral General Hospital Athens Giorgos Gennimatas, Athens, Greece.
Stamatis-Nick LiossisDivision of Rheumatology, Department of Internal Medicine, Faculty of Medicine, University of Patras, Patras, Greece.
Charalampos PapagorasFirst Department of Internal Medicine, University Hospital of Alexandroupolis, Democritus University of Thrace, Alexandroupolis, Greece.
Dimitrios I FotiadisUnit of Medical Technology and Intelligent Information Systems, University of Ioannina, Ioannina, Greece; Biomedical Research Section, Institute of Molecular Biology and Biotechnology, Ioannina, Greece.
Fotini N SkopouliDepartment of Medicine and Clinical Immunology, Euroclinic of Athens, Athens, Greece; Department of Nutrition and Clinical Dietetics, Harokopio University, Athens, Greece.
Panayiotis G VlachoyiannopoulosDepartment of Pathophysiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece; Institute for Autoimmune Systemic and Neurologic Diseases, Athens, Greece.
Haralampos M MoutsopoulosAcademy of Athens, Athens, Greece.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo investigate humoral responses and safety of mRNA SARS-CoV-2 vaccines in systemic autoimmune and autoinflammatory rheumatic disease (SAARD) patients subjected or not to treatment modifications during vaccination.

methodsA nationwide, multicenter study, including 605 SAARD patients and 116 controls, prospectively evaluated serum anti-SARS-CoV-2 S1-protein IgG antibody titers, side-effects, and disease activity, one month after complete vaccination, in terms of distinct treatment modification strategies (none, partial and extended modifications). Independent risk factors associated with hampered humoral responses were identified by data-driven multivariable logistic regression analysis.

resultsPatients with extended treatment modifications responded to vaccines similarly to controls as well as SAARD patients without immunosuppressive therapy (97.56% vs 100%, p = 0.2468 and 97.56% vs 97.46%, p > 0.9999, respectively). In contrast, patients with partial or without therapeutic modifications responded in 87.50% and 84.50%, respectively. Furthermore, SAARD patients with extended treatment modifications developed higher anti-SARS-CoV-2 antibody levels compared to those without or with partial modifications (median:7.90 vs 7.06 vs 7.1, p = 0.0003 and p = 0.0195, respectively). Mycophenolate mofetil (MMF), rituximab (RTX) and methotrexate (MTX) negatively affected anti-SARS-CoV-2 humoral responses. In 10.5% of vaccinated patients, mild clinical deterioration was noted; however, no differences in the incidence of deterioration were observed among the distinct treatment modification SAARD subgroups. Side-effects were generally comparable between SAARD patients and controls.

conclusionsIn SAARD patients, mRNA SARS-CoV-2 vaccines are effective and safe, both in terms of side-effects and disease flares. Treatment with MMF, RTX and/or MTX compromises anti-SARS-CoV-2 antibody responses, which are restored upon extended treatment modifications without affecting disease activity.

Indexed as

2019-nCoV Vaccine mRNA-1273AdolescentAdultAgedAged, 80 and overAntibodies, NeutralizingAntibodies, ViralAutoimmune DiseasesBNT162 VaccineCOVID-19FemaleGreeceHereditary Autoinflammatory DiseasesHumansImmunoglobulin GMale2019-nCoV Vaccine mRNA-1273Antibodies, NeutralizingAntibodies, ViralBNT162 VaccineImmunoglobulin GMethotrexateMycophenolic AcidRituximabAnti-SARS-CoV-2 antibody responseImmunosuppressive treatmentmRNA SARS-COV-2 vaccineSystemic autoimmune rheumatic diseaseTreatment modification

Identifiers

PMID34757289
PMCPMC8552665

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.