The safety profile of COVID-19 vaccines in patients with inflammatory rheumatic and musculoskeletal diseases (I-RMD) has been described by researchers as “reassuring” following a large-scale analysis of data from the EULAR Coronavirus Vaccine (COVAX) physician-reported registry.
The research team, led by Dr Pedro Machado, an Associate Professor and Consultant in Rheumatology and Neuromuscular Diseases at University College London, found that the “overwhelming majority” of patients in the registry “tolerated their vaccination well”, with rare or very rare reports of I-RMD flare, serious adverse events (AEs) and breakthrough infections.
The team looked at data within the international registry from 5,121 patients, 90% of which had an I-RMD and 10% a non inflammatory-RMD. The majority had been vaccinated against COVID-19 with the Pfizer/BioNTech vaccine (70%), while 17% received AstraZeneca/Oxford and 8% Moderna.
In the cohort, inflammatory joint diseases (58%), connective tissue diseases (18%) and vasculitis (12%) were the most frequent diagnoses, and, with regard to treatment, 54% had received conventional synthetic disease-modifying antirheumatic drugs (DMARDs), 42% biological DMARDs and 35% immunosuppressants.
According to findings of the analysis, published in the British Medical Journal, I-RMD flares were reported in 4.4% of cases, of which just 0.6% were classed as severe and 1.5% needed a change in medication. The most common were arthritis flare (2.1%), polyarthralgia (1.8%) and increase in fatigue (0.7%).
The researchers found no significant differences between the vaccines with regard to the proportion of patients experiencing a flare, flare severity and flare-related medication changes, however, the percentage of flares was slightly higher in patients with moderate/high disease activity (5.2%) versus those in remission/low disease disease activity (4.8%), which “raises the possibility of an association between higher disease activity and higher flare rate,” the authors noted.
Patients with inflammatory joint diseases (5.1%) reported a slightly higher rate of flares versus connective tissue disease (3.1%) and vasculitis (3.2%), but flare prevalence was found to be similar across most medication groups in patients with I-RMDs cases, with just a slightly higher percentage seen in those taking monotherapy or combination therapies of TNF-inhibitors (5.5%), other biologicals (5.3%) other conventional synthetic (cs) DMARDs (excluding methotrexate) (4.7%) and targeted synthetic (ts) DMARDs (4.6%) compared two other medications (2.7%-3.6%).
Adverse events were reported in 37% of I-RMD cases and 40% of NI-RMD. Overall, just 0.5% of these were considered serious, with a lower proportion in patients with I-RMD (0.4%) than in those with NI-RMD (1.9%)). Three of 27 serious adverse events (cardiac and gastrointestinal in nature) were life threatening and occurred in Pfizer/BioNTech vaccine recipients in the I-RMD group; all were resolved. Six in the I-RMD group following vaccination with Pfizer/BioNTech resulted in hospitalisation and related to haematologic, immunological, viral infection or neck swelling events.
With regard to vaccine type, there was a slightly higher percentage of side effects in I-RMD patients who had taken the Moderna vaccine (42%) compared to the others (32%–37%), and similar percentage was also seen across different groups of medicines, expect for patients on other csDMARDs (42% versus 33%–35%).
Also of note, the research found that breakthrough infections were recorded in just 0.7% of I-RMD patients and 1.1% of NI-RMD patients, providing further evidence on the vaccines’ effectiveness at preventing COVID-19 in both groups.
Dr Machado told the limbic that the findings “should provide reassurance to rheumatologists, other health professionals and vaccine recipients, and promote confidence in the safety of COVID-19 vaccination in people with inflammatory rheumatic diseases.
“Our data will support discussions about the safety and positive benefit/risk ratio of COVID-19 vaccination for people with inflammatory rheumatic diseases, [and] will also help support the development of new and updated recommendations by competent organisations”.