Double-dose vaccination against SARS-CoV-2 in patients with rheumatic and musculoskeletal diseases (RMDs) doesn’t appear to boost the risk of flares, a new study shows. The risk of adverse effects after vaccination is high, just as it is in the general population, but no patients experienced allergic reactions.
Dr. Caoilfhionn Connolly
“Our findings suggest that COVID-19 vaccines are safe in patients with rheumatic and musculoskeletal diseases. Overall, rates of flare are low and mild, while local and systemic reactions should be anticipated,” lead author Caoilfhionn Connolly, MD, MSc, a rheumatology fellow at Johns Hopkins University, Baltimore, said in an interview. “Many of our patients are at increased risk of severe infection and or complications from COVID-19. It has been shown that patients with RMDs are more willing to reconsider vaccination if it is recommended by a physician, and these data should help inform these critical discussions.”
The study appeared Aug. 4 in Arthritis & Rheumatology.
According to Dr. Connolly, the researchers launched their study to better understand the effect of two-dose SARS-CoV-2 messenger RNA vaccinations authorized for emergency use by the Food and Drug Administration (Pfizer and Moderna vaccines) on immunosuppressed patients. As she noted, patients with RMDs were largely excluded from vaccine trials, and “studies have shown that some patients with RMDs are hesitant about vaccination due to the lack of safety data.”
Some data about this patient population have started to appear. A study published July 21 in Lancet Rheumatology found that patients with systemic lupus erythematosus (SLE) reported few flares within a median of 3 days after receiving one or two doses of various COVID-19 vaccines. Side effects were common but were mainly mild or moderate.
For the new study, researchers surveyed 1,377 patients with RMDs who’d received two vaccination doses between December 2020 and April 2021. The patients had a median age of 47, 92% were female, and 10% were non-White. The patients had a variety of RMDs, including inflammatory arthritis (47%), SLE (20%), overlap connective tissue disease (20%), and Sjögren’s syndrome and myositis (each 5%).
A total of 11% said they’d experienced a flare that required treatment, but none were severe. In comparison, 56% of patients said they had experienced a flare of their RMD in the 6 months prior to their first vaccine dose. Several groups had a greater likelihood of flares, including those who’d had COVID-19 previously (adjusted incidence rate ratio [IRR], 2.09; P = .02). “COVID-19 can cause both acute and delayed inflammatory syndromes through activation of the immune system,” Dr. Connolly said. “Vaccination possibly triggered further activation of the immune system resulting in disease flare. This is an area that warrants further research.”
Patients who took combination immunomodulatory therapy were also more likely to flare after vaccination (IRR, 1.95; P < .001). And patients were more likely to report flares after vaccination if they experienced a flare in the 6 months preceding vaccination (IRR, 2.36; P < .001). “This may suggest more active disease at baseline,” Dr. Connolly said. “It is difficult to differentiate whether these patients would have experienced flare even without the vaccine.”
A number of factors didn’t appear to affect the likelihood of flares: gender, age, ethnicity, type of RMD, and type of vaccine.
Local and systemic side effects were frequently reported, including injection site pain (87% and 86% after first and second doses, respectively) and fatigue (60% and 80%, respectively). As is common among people receiving COVID-19 vaccines, side effects were more frequent after the second dose.
As for future research, “we are evaluating the long-term safety and efficacy of the COVID-19 vaccines in patients with RMDs,” study coauthor Julie J. Paik, MD, assistant professor of medicine at Johns Hopkins, said in an interview. “We are also evaluating the impact of changes in immunosuppression around vaccination.”
Dr. Julie J. Paik
The study was funded by the Ben-Dov family and grants from several institutes of the National Institutes of Health. Dr. Connolly and Dr. Paik reported no relevant disclosures. Other study authors reported various financial relationships with pharmaceutical companies.