COVID-19 Vaccine Generally Safe, Well-Tolerated in Rheumatic, Musculoskeletal Diseases

The COVID-19 vaccine is generally safe and well-tolerated in people living with rheumatic and musculoskeletal diseases, according to research results presented at ACR Convergence 2021, the annual meeting of the American College of Rheumatology.^1-3

“[C]oncerns prevail about the effectiveness and safety of vaccination against COVID-19, especially with respect to triggering [rheumatic and musculoskeletal disease] flares,” wrote authors of one abstract.¹ For both patients and health care providers, these concerns are validated by the knowledge that clinical trials on the safety and efficacy of these vaccines “did not include patients with autoimmune diseases,” according to another team of researchers.²

In the first of 3 abstracts,¹ German researchers reviewed data from the observational, longitudinal German COVID-19 vaccination registry, which launched on February 8, 2021. These registry data were voluntarily entered by patients with rheumatic and musculoskeletal diseases who received at least 1 COVID-19 vaccine before May 29, 2021.

Investigators reviewed data from a total of 866 patients (median age, 54 years; 81% women). Fifty percent of patients had been diagnosed with rheumatoid arthritis, while 31% had spondyloarthritis. The most common treatment at the time of vaccination was conventional synthetic disease-modifying antirheumatic drug therapy, followed by glucocorticoids (33%), tumor necrosis factor inhibitors (23%), Janus kinase inhibitors (9%), and interleukin-17 inhibitors (5%). Over the previous 12-month period, 42% of patients reported no disease activity, and comorbidities—most commonly, arterial hypertension—was present in 40% of patients.

The majority of patients in the registry were vaccinated with the Pfizer-BioNTech vaccine (67%), while 28% were vaccinated with the AstraZeneca vaccine—which is not yet approved by the FDA for use in the United States.

Following the first vaccine, disease flares were indicated in only 13% of participants; within this group, 6% required a change in immunomodulation treatment. In 41% of these participants, an increase in glucocorticoid dose was sufficient for patients to cope with the flare.

These preliminary results, the researchers concluded, “support the recommendation for COVID-19 vaccination” in patients with rheumatic and musculoskeletal diseases.

In the second abstract,² researchers sought to compare the frequency and severity of adverse events after vaccination between patients with autoimmune diseases and healthy controls. Study data were collected via digital questionnaire to participants enrolled in 2 ongoing prospective cohort studies at the Amsterdam Rheumatology & Immunology Center and Amsterdam UMC.

In total, 501 participants with autoimmune diseases (rheumatic disease n=420; multiple sclerosis n=81) and 184 healthy controls (mean ages, 63±11 years and 64±11 years, respectively; 66% and 65% women) received a Pfizer-BioNTech or AstraZeneca COVID-19 vaccine. A majority of patients in the control group experienced “at least 1 mild adverse event” (56% vs 58%); only 23% and 21% of participants experienced a moderate adverse event, and only 1% of patients in the autoimmune disease group experienced a severe adverse event (0% in the control group), making severe adverse events rare.

Overall, 5% of participants reported experiencing a deterioration of their autoimmune disease after vaccination.

These data, wrote the researchers, “demonstrate that patients with autoimmune diseases are not at an increased risk of experiencing adverse events from vaccination” with the Pfizer-BioNTech, Moderna, or AstraZeneca vaccine.

In a US-based study, researchers sought to characterize the rates and types of COVID-19 vaccine side effects in a population of adults living with rheumatic diseases.³ Data were collected from adults enrolled in FORWARD, The National Databank for Rheumatic Diseases who answered supplemental COVID-19 vaccination questionnaires during March and April 2021.

In a group of 1825 respondents, 48% reported experiencing side effects—most commonly arm soreness, fatigue, muscle aches, and headache. Although the ranked frequency did not differ by vaccine type, the incidence of each side effect was significantly higher among participants who received the Moderna vaccine.

Younger age, female sex, higher education, full vaccination, and higher COVID-19 related stress were all associated with a higher risk of experiencing side effects. In both Pfizer-BioNTech and Moderna groups, differences in side effect experience by age “held true,” according to researchers (odds ratios [ORs], 0.96 and 0.97, respectively). Differences by sex and by COVID-19 related stress were specific to Moderna vaccine recipients (ORs, 1.83 and 1.5) while differences by education were specific to those who received the Pfizer-BioNTech vaccine (OR, 1.16).

“A lack of reactogenicity with rheumatic disease, severity, and treatments may be reassuring for the vaccine hesitant,” the researchers concluded.³

While further research is needed, overall, these studies demonstrate both the tolerability and the low risk of disease flare associated with vaccination against COVID-19.

References

1. Hasseli R, Hoyer BF, Lorenz H-M, et al. Safety of COVID-19 vaccines after first vaccination in patients with rheumatic diseases in a patient reported survey. Presented at: ACR Convergence 2021; November 3-9, 2021. Abstract 0100.
2. Boekel L, Kummer L, van Dam K, et al. Adverse events of first SARS-CoV-2 vaccinations are comparable for patients with autoimmune diseases and the general population. Presented at: ACR Convergence 2021; November 3-9, 2021. Abstract 0104.
3. Michaud K, Cornish A, Freifeld A, Katz P, Wipfler K. COVID-19 mRNA vaccine side effects among individuals with rheumatic disease. Presented at: ACR Convergence 2021; November 3-9, 2021. Abstract 0116.