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Observational Study
. 2022 Jan;74(1):28-32.
doi: 10.1002/art.41924. Epub 2021 Dec 3.

Disease Flare and Reactogenicity in Patients With Rheumatic and Musculoskeletal Diseases Following Two-Dose SARS-CoV-2 Messenger RNA Vaccination

Caoilfhionn M Connolly  1 , Jake A Ruddy  1 , Brian J Boyarsky  1 , Iulia Barbur  1 , William A Werbel  1 , Duvuru Geetha  1 , Jacqueline M Garonzik-Wang  1 , Dorry L Segev  1 , Lisa Christopher-Stine  1 , Julie J Paik  1
Affiliations
Observational Study

Disease Flare and Reactogenicity in Patients With Rheumatic and Musculoskeletal Diseases Following Two-Dose SARS-CoV-2 Messenger RNA Vaccination

Caoilfhionn M Connolly et al. Arthritis Rheumatol. 2022 Jan.

Abstract

Objective: To evaluate disease flare and postvaccination reactions (reactogenicity) in patients with rheumatic and musculoskeletal diseases (RMDs) following 2-dose SARS-CoV-2 messenger RNA (mRNA) vaccination.

Methods: RMD patients (n = 1,377) who received 2-dose SARS-CoV-2 mRNA vaccination between December 16, 2020 and April 15, 2021 completed questionnaires detailing local and systemic reactions experienced within 7 days of each vaccine dose (dose 1 and dose 2), and 1 month after dose 2, detailing any flares of RMD. Associations between demographic/clinical characteristics and flares requiring treatment were evaluated using modified Poisson regression.

Results: Among the patients, 11% reported flares requiring treatment; there were no reports of severe flares. Flares were associated with prior SARS-CoV-2 infection (incidence rate ratio [IRR] 2.09, P = 0.02), flares in the 6 months preceding vaccination (IRR 2.36, P < 0.001), and the use of combination immunomodulatory therapy (IRR 1.95, P < 0.001). The most frequently reported local and systemic reactions included injection site pain (87% after dose 1, 86% after dose 2) and fatigue (60% after dose 1, 80% after dose 2). Reactogenicity increased after dose 2, particularly for systemic reactions. No allergic reactions or SARS-CoV-2 diagnoses were reported.

Conclusion: Flares of underlying RMD following SARS-CoV-2 vaccination were uncommon. There were no reports of severe flares. Local and systemic reactions typically did not interfere with daily activity. These early safety data can help address vaccine hesitancy in RMD patients.

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Conflict of interest statement

CONFLICT OF INTEREST

Dorry L. Segev, MD PhD has the following financial disclosures: consulting and speaking honoraria from Sanofi, Novartis, CSL Behring, Jazz Pharmaceuticals, Veloxis, Mallinckrodt, Thermo Fisher Scientific.

Lisa Christopher-Stine has the following financial disclosures: consultant fees from Janssen, Boehringer-Ingelheim, Mallinckrodt, EMD-Serono, Allogene, and ArgenX.

Duvuru Geetha has the following disclosures: consultant to ChemoCentryx and Aurinia

The other authors of this manuscript have no financial disclosures or conflicts of interest to disclose as described by Arthritis & Rheumatology

Figures

Figure 1.
Figure 1.
Local site and systemic adverse reactions in 1377 patients with RMD within 7 days after D1 and D2 of SARS-CoV-2 mRNA vaccination.
See this image and copyright information in PMC

References

    1. Estimated Disease Burden of COVID-19. Centers for Disease Control and Prevention. Accessed May 21st 2021. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/burden.html
    1. Oliver SE, Gargano JW, Marin M, Wallace M, Curran K, Chamberland M et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Moderna COVID-19 vaccine: United States, December 2020. MMWR Morb Mortal Wkly Rep 2021;69(5152):1653–1656. - PMC - PubMed
    1. Oliver SE, Gargano JW, Marin M, Wallace M, Curran K, Chamberland M et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Moderna COVID-19 vaccine: United States, December 2020. MMWR Morb Mortal Wkly Rep 2021;69(5152):1653–1656. - PMC - PubMed
    1. Trends in number of COVID-19 vaccinations in the US. Centers for Disease Control and Prevention. Accessed May 15, 2021. https://covid.cdc.gov/covid-data-tracker/#vaccination-trends
    1. Anderson RM, Vegvari C, Truscott J, Collyer BS. Challenges in creating herd immunity to SARS-CoV-2 infection by mass vaccination. 2020. November 21;396(10263):1614–1616. - PMC - PubMed

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