Introduction/Aims
We studied COVID‐19 vaccination‐related adverse events (ADEs) 7‐days post‐vaccination in patients with idiopathic inflammatory myopathies (IIMs) and other systemic autoimmune and inflammatory disorders (SAIDs).
Methods
7‐day vaccine ADEs were collected in an international patient self‐reported e‐survey. Descriptive statistics and multivariable regression were performed.
Results
10,900 respondents [1227 IIMs; 4640 SAIDs; 5033 healthy controls (HCs), median age 42 (IQR 30‐55) years, 74% female, 45% Caucasian, 69% completely vaccinated] were analysed. 76.3% IIMs patients reported minor and 4.6% major ADEs. Patients with active IIMs reported more frequent major [OR 2.7 (1.04‐7.3)] and minor [OR 1.5 (1.1‐2.2)] ADEs than inactive IIMs. Rashes were more frequent in IIMs [OR‐2.3(1.2‐4.2)] than HCs. ADEs were not impacted by steroid dose, although hydroxychloroquine and intravenous/subcutaneous immunoglobulins were associated with a higher risk of minor ADEs [OR 1.9 (1.1‐3.3), OR 2.2 (1.1‐4.3)]. Overall, ADEs were less frequent in inclusion body myositis (IBM) and BNT162b2 (Pfizer) vaccine recipients
Discussion
7‐day post‐vaccination ADEs were comparable in patients with IIMs, SAIDs, and HCs, except for a higher risk of rashes in IIMs. Patients with DM, active disease may be at higher risk, and IBM patients at lower risk of specific ADEs. Overall, the benefit of preventing severe COVID‐19 through vaccination likely outweighs the risk of vaccine‐related ADEs
Our results may inform future guidelines regarding COVID‐19 vaccination in patients with SAIDs, and specifically in IIMs. Studies to evaluate long‐term outcomes and disease flares are needed to shed more light on developing future COVID‐19 vaccination guidelines.
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Vaccine hesitancy is considered a major barrier to achieving herd immunity against COVID-19. While multiple alternative and synergistic approaches including heterologous vaccination, booster doses, and antiviral drugs have been developed, equitable vaccine uptake remains the foremost strategy to manage pandemic. Although none of the currently approved vaccines are live-attenuated, several reports of disease flares, waning protection, and acute-onset syndromes have emerged as short-term adverse events after vaccination. Hence, scientific literature falls short when discussing potential long-term effects in vulnerable cohorts. The COVAD-2 survey follows on from the baseline COVAD-1 survey with the aim to collect patient-reported data on the long-term safety and tolerability of COVID-19 vaccines in immune modulation. The e-survey has been extensively pilot-tested and validated with translations into multiple languages. Anticipated results will help improve vaccination efforts and reduce the imminent risks of COVID-19 infection, especially in understudied vulnerable groups.
Coronavirus disease 2019 (COVID-19)-associated immune dysregulation is believed to trigger the onset of various autoimmune diseases. These occur either during active COVID-19 or soon after recovery. We report ileocolonic Crohn's disease in a 35-year-old woman after her recovery from a milder form of COVID-19. She achieved remission of her symptoms with oral corticosteroids and sulfasalazine.
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