Factors associated with COVID-19 breakthrough infection among vaccinated patients with rheumatic diseases: A cohort study.

Publisher: W.B. Saunders Country of Publication: United States NLM ID: 1306053 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-866X (Electronic) Linking ISSN: 00490172 NLM ISO Abbreviation: Semin Arthritis Rheum Subsets: MEDLINE

Publication: Philadelphia Pa : W.B. Saunders
Original Publication: New York, Stratton.

Breakthrough Infections*/epidemiology ; COVID-19*/epidemiology ; COVID-19*/prevention & control ; COVID-19 Vaccines* ; Rheumatic Diseases*/epidemiology; Female ; Humans ; Male ; Middle Aged ; 2019-nCoV Vaccine mRNA-1273 ; BNT162 Vaccine ; Cohort Studies ; SARS-CoV-2

Objective: Rheumatic disease patients on certain immunomodulators are at increased risk of impaired humoral response to SARS-CoV-2 vaccines. We aimed to identify factors associated with breakthrough infection among patients with rheumatic diseases.
Methods: We identified patients with rheumatic diseases being treated with immunomodulators in a large healthcare system who received at least two doses of either the mRNA-1273 (Moderna) or BNT162b2 (Pfizer-BioNTech) vaccines or one dose of the Johnson & Johnson-Janssen (J&J) vaccine. We followed patients until SARS-CoV-2 infection, death, or December 15, 2021, when the Omicron variant became dominant in our region. We estimated the association of baseline characteristics with the risk of breakthrough infection using multivariable Cox regression.
Results: We analyzed 11,468 patients (75% female, mean age 60 years). Compared to antimalarial monotherapy, multiple immunomodulators were associated with higher risk of infection: anti-CD20 monoclonal antibodies (aHR 5.20, 95% CI: 2.85, 9.48), CTLA-4 Ig (aHR 3.52, 95% CI: 1.90, 6.51), mycophenolate (aHR 2.31, 95% CI: 1.25, 4.27), IL-6 inhibitors (aHR 2.15, 95% CI: 1.09, 4.24), JAK inhibitors (aHR 2.02, 95% CI: 1.01, 4.06), and TNF inhibitors (aHR 1.70, 95% CI: 1.09, 2.66). mRNA-1273 recipients had a lower risk of breakthrough infection compared to BNT162b2 recipients (aHR 0.66, 95% CI: 0.50, 0.86). There was no association of sex, body mass index, smoking status, race, or ethnicity with risk of breakthrough infection.
Conclusion: Among patients with rheumatic diseases, multiple immunomodulators were associated with increased risk of breakthrough infection. These results highlight the need for additional mitigation strategies in this vulnerable population.
Competing Interests: Declaration of interests NJP reports consulting fees from FVC Health unrelated to the current work. JAS reports research support from Bristol Myers Squibb and consultancy fees from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Gilead, Inova Diagnostics, Janssen, Optum, and Pfizer. ZSW reports research support from Bristol-Myers Squibb and Principia/Sanofi and consulting fees from Zenas Biopharma, Horizon, Sanofi, Shionogi, Viela Bio, and MedPace. All other authors report no competing interests.
(Copyright © 2022 Elsevier Inc. All rights reserved.)

R01 AR077607 United States AR NIAMS NIH HHS; P30 AR072577 United States AR NIAMS NIH HHS; R03 AR078938 United States AR NIAMS NIH HHS; P30 AR070253 United States AR NIAMS NIH HHS; K23 AR073334 United States AR NIAMS NIH HHS

EPK39PL4R4 (2019-nCoV Vaccine mRNA-1273)
0 (BNT162 Vaccine)
0 (COVID-19 Vaccines)

COVID-19 breakthrough infections

SARS-CoV-2 variants

Date Created: 20221108 Date Completed: 20230215 Latest Revision: 20231207

20231215

PMC9605731

10.1016/j.semarthrit.2022.152108

36347211