Background/Purpose: While COVID-19 vaccinations are a critical tool to prevent severe infections, poor immunogenicity in immunocompromised people threatens vaccine effectiveness. We analyzed clinical characteristics of patients reported to the COVID-19 Global Rheumatology Alliance registry who developed COVID-19 after vaccination against SARS-CoV-2.
Methods: We included individuals partially or fully vaccinated against SARS-CoV-2, who had SARS-CoV-2 infection between January 5, 2021 and August 27, 2021. We analyzed patients’ demographic and clinical characteristics, and COVID-19 symptoms and outcomes. Partially vaccinated was defined as being ≥14 days after the first dose in a 2-dose series or within 13 days of a single-dose vaccine. Fully vaccinated was defined as infection occurring ≥14 days after the second dose in a 2-dose series or 2 weeks after a single-dose vaccine. We excluded those who were within 14 days of their first dose of a 2-dose series. Among the fully vaccinated, we described baseline medications and outcomes, and included additional clinical details for those who were hospitalized.
Results: We included 115 partially or fully vaccinated individuals with rheumatic disease who developed SARS-CoV-infection (mean age 53 years, 73% female, 58% White) (Table 1). The most common rheumatic diseases were RA (43.5%), SLE (13%) and PsA (10%); 20% had moderate/high disease activity. The most common comorbidities were hypertension (30%), lung disease (21%), and obesity (19%). The majority (59%) received mRNA vaccines. The most common COVID-19 symptoms were cough (65%), fever (54%), and malaise (36%); 7% reported no symptoms. Among the fully vaccinated (n=39), infection occurred a mean of 86.5 (+/- 58.24) days after the second dose, and 29% were hospitalized. Eleven (28%) were on methotrexate, 11 (28%) were on B cell-depleting therapies (BCDT), 11 (28%) were on other antimetabolites, and 5 (23%) were on other biologic DMARDs. The majority (67%) were not taking systemic glucocorticoids. All but two cases continued their antirheumatic medications before or after their vaccine doses. Of those fully vaccinated and hospitalized (n=11; age range 36-71 years), six had pre-existing lung disease and two had no reported comorbidities (Table 2). Two patients with comorbid lung disease subsequently died (one requiring non-invasive and the other requiring invasive mechanical ventilation).
Conclusion: The majority of fully vaccinated individuals with breakthrough infections in this series were on anti-metabolites or BCDT. Additional strategies, including additional vaccine doses, medication interruption, and monoclonal antibody pre-and post-exposure prophylaxis may be needed to protect this high-risk population.
^Conventional synthetic DMARD (csDMARD) medications included: antimalarials (hydroxychloroquine, chloroquine), azathioprine, cyclophosphamide, cyclosporine, leflunomide, methotrexate, mycophenolate mofetil/mycophenolic acid, sulfasalazine, tacrolimus; Biologic or targeted synthetic DMARDs (b/tsDMARD) included: abatacept, belimumab, CD_20 inhibitors, IL_1 inhibitors, IL-6 inhibitors, IL_12/23 inhibitors, IL_17 inhibitors, anti-TNF, and Janus-kinase inhibitors
#Confirmed COVID_19 diagnosis: Diagnosis made via PCR, antigen, or antibody test.
*Fully vaccinated: infection >14 days after 2nd dose of two dose vaccine, or 1st if Janssen/Johnson & Johnson
Abbreviations: BCDT, B cell depleting therapy; MMF, mycophenolate mofetile/mycophenolic acid
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