Evidence map›Paper›PMID 34476603›Full record

ArticleRheumatology international2021

Local and systemic reactogenicity of COVID-19 vaccine BNT162b2 in patients with systemic lupus erythematosus and rheumatoid arthritis.

Lars Erik Bartels, Christian Ammitzbøll, Jakob Bøgh Andersen, Signe Risbøl Vils, Clara Elbæk Mistegaard, Anders Dahl Johannsen, Marie-Louise From Hermansen, Marianne Kragh Thomsen, Christian Erikstrup, Ellen-Margrethe Hauge and 1 more

Abstract read
In one paragraph

Article in Rheumatology international, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 5 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

30 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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  20. Immunizing the imperfect immune system: Coronavirus disease 2019 vaccination in patients with inborn errors of immunity.Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2022
    Review
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

11 authors.

Lars Erik BartelsDepartment of Rheumatology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 59, Entrance E, 8200, Aarhus, Denmark.ORCID http://orcid.org/0000-0002-9101-1076
Christian AmmitzbøllDepartment of Rheumatology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 59, Entrance E, 8200, Aarhus, Denmark. chramm@rm.dk.ORCID http://orcid.org/0000-0002-8535-1613
Jakob Bøgh AndersenDepartment of Rheumatology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 59, Entrance E, 8200, Aarhus, Denmark.ORCID http://orcid.org/0000-0003-0189-4096
Signe Risbøl VilsDepartment of Rheumatology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 59, Entrance E, 8200, Aarhus, Denmark.ORCID http://orcid.org/0000-0002-9212-921X
Clara Elbæk MistegaardDepartment of Rheumatology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 59, Entrance E, 8200, Aarhus, Denmark.ORCID http://orcid.org/0000-0002-6359-2192
Anders Dahl JohannsenDepartment of Rheumatology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 59, Entrance E, 8200, Aarhus, Denmark.ORCID http://orcid.org/0000-0001-5975-9394
Marie-Louise From HermansenDepartment of Rheumatology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 59, Entrance E, 8200, Aarhus, Denmark.ORCID http://orcid.org/0000-0002-9108-8604
Marianne Kragh ThomsenDepartment of Clinical Microbiology, Aarhus University Hospital, Aarhus, Denmark.ORCID http://orcid.org/0000-0002-3645-6689
Christian ErikstrupDepartment of Clinical Immunology, Aarhus University Hospital, Aarhus, Denmark.ORCID http://orcid.org/0000-0001-6551-6647
Ellen-Margrethe HaugeDepartment of Rheumatology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 59, Entrance E, 8200, Aarhus, Denmark.ORCID http://orcid.org/0000-0003-2562-9174
Anne TroldborgDepartment of Rheumatology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 59, Entrance E, 8200, Aarhus, Denmark.ORCID http://orcid.org/0000-0002-9501-1268

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were launched in December 2020. Vaccination of patients with rheumatic diseases is recommended, as they are considered at higher risk of severe COVID-19 than the general population. Patients with rheumatic disease have largely been excluded from vaccine phase 3 trials. This study explores the safety and reactogenicity of BNT162b2 among patients with rheumatic diseases. Patients with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA), median age 58.8 years, 285 subjects in total, were vaccinated twice with the BNT162b2 (Pfizer/BioNTech). Questionnaires on reactogenicity matching the original phase 3 study were answered seven days after completed vaccination. The majority of SLE and RA patients experienced either local (78.0%) or systemic reactions (80.1%). Only 1.8% experienced a grade-4 reaction. Compared to the original study, we found more frequent fatigue [Odds ratio (OR) 2.2 (1.7-2.8)], headache [OR 1.7 (1.3-2.2)], muscle pain [OR 1.8 (1.4-2.3)], and joint pain [OR 2.3 (1.7-3.0)] in patients. In contrast, the use of antipyretics was less frequent [OR 0.5 (0.3-0.6)]. Patients with SLE and RA experience reactogenicity to the Pfizer-BioNTech BNT162b2 COVID-19 vaccine. Reactogenicity was more frequent in patients, however, not more severe compared with healthy controls.

Indexed as

AgedArthritis, RheumatoidBNT162 VaccineCase-Control StudiesCOVID-19COVID-19 VaccinesFemaleHumansLupus Erythematosus, SystemicMaleMiddle AgedPatient Reported Outcome MeasuresSARS-CoV-2VaccinationBNT162 VaccineCOVID-19 VaccinesArthritis, rheumatoidCOVID-19Lupus erythematosus, systemicOutcome measuresPatient reportedVaccination

Identifiers

PMID34476603
PMCPMC8412379

What OpenQuestion holds

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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.