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No significant changes in the rate of flares during the 6-month period pre- or post-vaccination were observed in patients with either rheumatoid arthritis or psoriatic arthritis.
The COVID-19 vaccination was not linked to increased rates of flares in patients with rheumatoid arthritis (RA) and psoriatic arthritis (PsA), according to a study published in Rheumatic & Musculoskeletal Diseases.1 However, there may be a potential risk of increased disease activity in patients with PsA treated with interleukin inhibitors (IL)-12/23 and patients with RA treated with IL-6 and Janus kinase inhibitors (JAK).
Although vaccines are an essential part of infectious disease prevention, patients with autoimmune conditions, rheumatic diseases, and those treated with medications that impact the immune system are often concerned about the immunogenicity, efficacy, and safety of vaccination.2 The introduction of the COVID-19 vaccination has patients and clinicians echoing those same concerns.
“A potential relationship between COVID-19 vaccination and disease flares in RA or PsA is still under debate,” wrote José M Álvaro-Gracia, MD, of the Rheumatology Department at the Hospital General Universitario Gregorio Maranon in Spain, and a team of Spanish investigators. “Some case series-based studies, most of them using questionnaires or proxies, have not detected an association between the 2 conditions. However, some case reports have been published showing disease flare-ups after COVID-19 vaccination.”
The COVID-19 registry in patients with rheumatic diseases (COVIDSER) project, an observational cohort comprised of patients from 3 Spanish database registries, was used to identify 1765 patients with COVID-19, including 1178 (66.7%) with RA and 587 (33.3%) with PsA. Data including demographics, targeted treatments, disease characteristics, vaccination information, such as type and number of injections, and the Disease Activity Score in 28 joints (DAS28) were collected.
Log-linear regression analyzed DAS28-based flare rate distribution pre- and post-vaccination, while contingency analyses evaluated categorized disease activity distribution pre- and post-vaccination. A random coefficient model determined the influence of vaccination on DAS28 variation as a continuous measure.
All patients in the study were being treated with targeted therapy at the time of vaccination, with half (50.3%) receiving tumor necrosis factor inhibitors (TNFs). The median post-vaccination follow-up period was 90 days for patients with RA and 79 days for patients with PsA.
The distribution of categorized disease activity and flare rates was not significantly changed by the COVID-19 vaccination. Further, log-linear regression reported no significant changes in the rate of flares during the 6-month period after vaccination when compared with the 6-month period prior to vaccination in either condition (12.6% vs 14.2% for RA, respectively; 10.2% vs 9.9% for PsA, respectively). The random coefficient models analyzing DAS28 variations reported similar results, with no significant variations in disease activity after vaccination in the RA and PsA groups.
Interestingly, patients with RA receiving JAK and IL-6 treatment had a worsening of disease activity (1.436 ± 0.531, P = .007; 1.201 ± 0.550, P = .029, respectively) when compared with patients treated with TNF. Patients with PsA treated with IL-12/23 also had a worsening of disease activity (4.476±1.906, p=0.019) when compared with TNF treatment.
Investigators noted that using data from a well-established national registry strengthened the study and lessened the possibility of selection bias. Further, the follow-up time was able to determine changes in disease activity as a response to vaccination. However, assessing disease activity in patients with PsA using DAS28 is limiting, particularly in patients with non-polyarticular or RA-like patterns. They also warn of the possibility, albeit limited, that certain flares were not detected during the disease activity assessment post-vaccination.
“Our data provide reassurance about the lack of flaring effect of COVID-19 vaccination in patients with RA and PsA treated with targeted therapies,” investigators concluded. “However, using a random coefficient model, we detected a possible association between increased disease activity and COVID-19 vaccination in patients treated with JAK, IL-6 or IL-12/23. This certainly warrants further confirmation using data drawn from other registries, especially if the current trend towards revaccination with COVID-19 vaccines continues.”