Glucocorticoids, abatacept, mycophenolate mofetil, and methotrexate undermine the immunogenicity of the Pfizer BioNTech vaccine as well in this population1. A second study investigated the safety profiles of COVID-19 vaccines in patients with rheumatic and musculoskeletal diseases (RMD). The results demonstrated that COVID-19 vaccines are safe and well tolerated in these patients2.
In a prospective, observational, open-label, controlled multicentre study, presented by Dr Victoria Furer (Tel Aviv Sourasky Medical Center, Israel), immunogenicity, safety, and efficacy of the Pfizer BioNTech vaccine were investigated in an adult autoimmune inflammatory rheumatic diseases (AIIRDs) population (n=686, mean age 59) 2–6 weeks after the second vaccine dose was administered. The control group consisted of 121 healthy individuals1. A value of >15 binding antibody units (BAUs) was considered as a cut-off of seropositivity. The seropositivity rate was 86% in the AIIRD group versus 100% in the control group. Patients treated with rituximab showed the lowest seropositivity rates (41.4%).
Other DMARDs that were associated with reduced seropositivity rates were glucocorticoids (66.2%), abatacept (62.5%), mycophenolate mofetil (64.3%), and to a lesser extent methotrexate (84.1%). In addition, lower seropositivity rates were more often observed in patients >65 years (79.3%) and for certain AIIRD diagnoses (rheumatoid arthritis 82.1%; idiopathic inflammatory myopathies 36.8%; and ANCA-associated vasculitis 30.77%). Dr Furer argued that in order to improve immunogenicity of the Pfizer BioNTech vaccine, postponing treatment with rituximab or holding treatment with mycophenolate mofetil or abatacept, particularly when combined with methotrexate, should be considered.
Dr Pedro Machado (University College London, UK) presented the results of a study analysing safety data of COVID-19 vaccines (Pfizer BioNTech 78%, Moderna 5%, AstraZeneca 16%, other 1%) used in RMD patients (n=1519, mean age 63, 68% women) from the COVAX registry2. The results demonstrated that the safety profile of the vaccines among patients with RMD was similar to that of the general population. Adverse events (AEs) occurred in 31% of the patients.
Pain at the injection site, fatigue, headache, and generalised muscle pain were the most common AEs. Systemic/organ side effects were reported in 33 cases. These AEs were diverse and mostly mild or moderate. Severe AEs were reported in 2 cases: 1 case of transient hemiparesis in a patient with systemic sclerosis and systemic lupus erythematosus, and a case of giant cell arteritis in a patient with osteoarthritis.
1. Furer V, et al. Immunogenicity and safety of the BNT162b2 mRNA COVID-19 vaccine in adult patients with autoimmune inflammatory rheumatic diseases (AIIRD) compared to the general population: a multicenter study. LB0003, EULAR 2021 Virtual Congress, 2-5 June.
2. Machado PM. COVID-19 vaccine safety in patients with rheumatic and musculoskeletal disease. LB0002, EULAR 2021 Virtual Congress, 2-5 June.