Patients with RMDs and nrADs are more likely to experience early adverse events after COVID-19 vaccination than healthy controls.

Allessia Alunno, MD

The results of a new study were presented at EULAR 2023, held May 31 to June 3, in Italy, by Allessia Alunno, MD. Dr. Alunno and colleagues evaluated COVID-19 severity, breakthrough infections, vaccine-related adverse events, and post-vaccine flares in patients aged 18 to 35. Data from 2021–2022 were collected from the international COVID-19 Vaccination in autoimmune diseases (COVAD) 1 and 2 questionnaires.

The data included 6,010 responders, among them 1,692 with rheumatic and musculoskeletal diseases (RMDs), 400 with non-rheumatic autoimmune diseases (nrADs), and 3,918 healthy controls. The cohort with RMDs and nrADs had a mean disease duration of 7 years and comprised predominantly women (over 80%), while the proportion was lower in the control group (64%). At least two vaccinations were administered to 75% to 83% of the cohort. “We observed that over 90% of patients with RMDs and only 20% with nrAD were exposed to immunosuppressants before vaccination,” Dr. Alunno described.

Overall, 24% to 28% of the study cohort ever tested positive for SARS-CoV-2 infection. The infections were nearly always symptomatic, but hospitalization, oxygen need, or intensive care admission was rarely necessary. Looking at the likelihood of being infected pre- or post-vaccination, the results among the groups differed. Pre-vaccination infections were less frequent in patients with RMDs compared with controls (OR, 0.6; 95% CI, 0.4-0.9) but similar in nrAD compared with controls. “This can be easily attributed to the straight shielding in people receiving immunosuppressants in the early phases of the pandemic,” Dr. Alluno commented. In contrast, patients with RMDs post-vaccination were nearly three times more likely to have infection than controls (OR, 2.7; 95% CI, 2.1-3.5).

In terms of clinical manifestations, patients with RMDs were more prone to arthritis than controls, independent of the time of infection. Flares were self-reported post-infection by 5% in the RMD group and 1.5% in the nrAD group and post-vaccination by 10% and 7%, respectively. Of note, only 41% of patients experiencing a flare in the RMD group and 27% in the nrAD group reported requiring a change in the dose or type of medication.

The likelihood for early mild adverse events after one or two vaccine doses was about twice as high for both disease groups compared with healthy controls (OR, 2.4; 95% CI, 2.0-3.1 for RMDs and OR, 2.0; 95% CI, 1.4-2.9 for nrAD). Differences between groups for late, mild, or severe adverse events were not significant after any number of vaccine doses.

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