COVID-19 vaccine safety data 'provide reassurance' for patients with rheumatic diseases
Adverse events were rare and mild in patients with rheumatic diseases who received a COVID-19 vaccine, according to data from the EULAR–COVID-19 Registry presented at the EULAR 2021 Congress.
“Vaccines are a key pillar of public health,” Pedro M. Machado, MD, PhD, FRCP, associate professor and consultant rheumatologist at University College London, in the U.K., said in his presentation. “However, vaccination also raises questions, especially for patients with inflammatory rheumatic diseases and/or treated with drugs that may influence their immune system.”
Machado presented data on vaccine safety among patients with rheumatic and musculoskeletal diseases using information from the EULAR COVID-19 Vaccination (COVAX) Registry.
From its launch date on Feb. 5 through April 27, data for 1,519 patients were reported to the observational registry. “Data are entered voluntarily by clinicians or associated health care professionals,” Machado said.
Machado reported that 68% of registrants were women, while 57% were older than 60 years, with a mean age of 63 years (SD, 16). The range was 15 to 97 years.
Twenty-eight countries contributed patient data to the registry, with 60% coming from France and 13% coming from Italy.
Patients with inflammatory RMDs comprised 91% of the cohort, while 51% had inflammatory joint diseases, 19% had connective tissue disease, 16% had vasculitis and 4% had other immune mediated inflammatory diseases. Patients with non-inflammatory or mechanical RMDs comprised 9% of the group.
The most commonly reported individual diagnosis was rheumatoid arthritis, at 30%, followed by axial spondyloarthritis (8%), psoriatic arthritis (8%), systemic lupus erythematosus (7%) and polymyalgia rheumatica (6%).
Machado reported that 45% of patients were being treated with conventional synthetic disease-modifying antirheumatic drugs at the time of vaccination, while 36% were receiving biologic DMARDs, 31% on systemic glucocorticoids, 3% on targeted synthetic DMARDs and 6% were receiving systemic immunosuppressive drugs including azathioprine, mycophenolate, cyclosporine, cyclophosphamide or tacrolimus.
More patients were being treated with methotrexate than with any other DMARD, at 29%, while 18% were receiving TNF inhibitors, 10% antimalarials and 6% rituximab (Rituxan, Genentech).
The majority of the cohort received the Pfizer vaccine (78%), while 16% received AstraZeneca, 5% received Moderna and 1% either received another vaccine or had unknown status. Machado also reported that 66% of the group had received two vaccine doses and 34% had received one dose.
There were 18 COVID-19 diagnoses reported after vaccination, or 1% of the study population. These diagnoses occurred in a mean duration of 24 days (SD, 17). A mean duration of 41 days (SD, 26) elapsed between the first dose and case report, while 26 days (SD, 23) elapsed between the second dose and case report.
Five percent of patients with inflammatory RMDs experienced a disease flare, with 1.2% of those incidents being classified as severe.
A mean duration from the closest vaccination to flare of an inflammatory RMD was 5 days (SD, 5), according to Machado.
Arthritis flares were most common, at 2.5%, while 2.1% experienced an arthralgia flare, 0.8% each experienced a cutaneous flare or increase in fatigue.
Adverse events that were potentially associated with the vaccine were reported by 31% of patients. The majority of these events were “typical” early adverse events that occurred within 7 days of the dose, with 19% events being injection site pain, 11% reporting fatigue, 7% reporting headaches and 6% reporting generalized muscle pain, according to Machado.
While 2% of patients experienced organ or systemic adverse events, just 0.1% reported severe events. One of the severe events was a case of hemiparesis in a patient with systemic sclerosis/SLE overlap syndrome, while the other was a case of giant cell arteritis in a patient with osteoarthritis.
“The safety profiles for COVID-19 vaccines in patients with rheumatic diseases was very reassuring,” Machado said, adding that the events reported were, by and large, the same as those reported in the general population and observed with many other vaccines. “These initial findings should provide reassurance to rheumatologists and vaccine recipients, and they should promote confidence in COVID-19 vaccine safety in patients with rheumatic disease, particularly those with inflammatory conditions and/or taking immunomodulatory treatments.”