COVID-19 Vaccine Safety, Tolerability Assessed Among Patients With RA

Patients with rheumatoid arthritis (RA) may tolerate the COVID-19 vaccines, primarily experiencing minor adverse events (AEs) that are similar compared with those in the general population, according to study findings published in Rheumatology (Oxford).

Researchers conducted an international, cross-sectional, multicenter, survey-based study to evaluate short-term COVID-19 vaccination-related AEs in patients with RA, other autoimmune rheumatic diseases (except RA and inflammatory myositis), nonrheumatic autoimmune diseases (nrAIDs), and healthy control participants.

A total of 9462 respondents completed the survey between March and December 2021, with 1347 (14.2%; 74.2% women; 49.3% White) diagnosed with RA. Most patients received the Pfizer vaccine (39.3%). Prior to vaccination, 996 (74.2%) patients with RA reported active disease status.

Of the 1347 patients, 1037 (76.9%) reported minor AEs within 7 days following COVID-19 vaccination, the most common AEs being fatigue (27.2%) headache (25.6%), and body ache (22.7%). Pain at the injection site occurred in 798 (59.2%) patients with RA.

A total of 56 (4.2%) patients reported major AEs, including anaphylaxis (0.1%), marked difficulty breathing (0.5%), throat closure (0.4%), and severe rashes (0.6%), which required urgent medical attention. Three (0.2%) patients required hospitalization.

Vaccine-related AEs occurred at similar rates among patients with active and inactive disease, except a higher frequency of dizziness in active vs inactive RA (odds ratio [OR], 2.1; 95% CI, 1.1-3.9; P =.021).

Vaccine-related AEs occurred at similar rates among patients with RA vs patients with other AIRDs and healthy control participants. However, patients with RA vs those with nrAIDs had a lower incidence of overall and minor AEs (adjusted OR, 0.7; 95% CI, 0.5-0.9; P =.017) and injection site pain (OR, 0.6; 95% CI, 0.5-0.8; P =.002).

Of note, patients with RA receiving treatment with methotrexate and hydroxychloroquine had fewer minor AEs following vaccination.

Overall, AEs were more common in patients who received the mRNA COVID-19 vaccines (Pfizer and Moderna).

Study limitations included the dependence of results on self-reported online surveys without health care provider verification; selection bias given that participants needed computers to access the surveys; and lack of long-term follow-up regarding safety of COVID-19 vaccination among patients with RA.

“Despite the differences in AE frequency across different COVID-19 vaccines, all were well tolerated in patients with RA…,” the study authors said. “The study will hopefully pave the way forward for greater confidence and better uptake of COVID-19 vaccines in this particularly vulnerable group of individuals, as advocated by the recent European and American guidelines,” they added.

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.