New work presented at the 2025 annual EULAR congress in Barcelona focuses on the recombinant zoster vaccine (RZV), which contains recombinant glycoprotein E – the major target of CD4+T-cells. The abstract describes the tolerability and safety of RZV in patients with inflammatory rheumatic and musculoskeletal diseases (iRMD), showcasing interim data from an ongoing study.
In total, 150 adults with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), or giant cell arteritis (GCA) who had an indication to receive RZV were prospectively included. Of these, 21.3% had a history of HZ, and everyone received RZV at Month 0; 90% also received a dose at Month 2. Safety assessments were performed at Months 2, 3, 6, and 12.
Most adverse events (AE) occurred within a few days after vaccination. In total, 139 (46.8%) localized and 158 (53.2%) generalized AE occurred up to Month 3. At that point, pain at the site of injection was the most frequent AE, reported by 32.7% of patients. This was followed by fever (14.1%), fatigue (9.4%), musculoskeletal pain (8.1%), swelling at the injection site (6.4%) and redness at the injection site (6.4%). Infections (4.7%), worsening of the disease (3.7%) and other AEs (7.7%) were reported until Month 3.
Disease flares were reported by patients at Months 2, 3, 6 and 12, but of these only 1.6–8.6% fulfilled the predefined flare criteria. Hospitalisation due to disease flare was needed for 3 patients – 2 with GCA and 1 with RA. Lead author Uta Kiltz said "over the observed period of 12 months, this can be interpreted as a low rate of events."
Overall, 10 serious AEs were reported in 9 patients during follow-up (3 flares, 4 malignancies, and 3 comorbidities), but no patient reported an AE of special interest or a breakthrough infection. Of note, the malignancies were considered not to be related to the vaccination.
The authors concluded that the majority of patients tolerated RZV well, with only a few reports of flare and serious AEs. These findings are reassuring for rheumatologists and future vaccine recipients, and support confidence in RZV safety for patients with an iRMD.
Source
Kiltz U, et al. Tolerability and safety of recombinant zoster vaccine in patients with inflammatory rheumatic musculoskeletal diseases - a prospective longitudinal study over 12 months. Presented at EULAR 2025; OP0034. Ann Rheum Dis 2025; DOI: 10.1136/annrheumdis-2025-eular.B293.
References
1. Thomas SL, Hall AJ. What does epidemiology tell us about risk factors for herpes zoster? Lancet Infect Dis 2004;4(1):26–33. DOI: 10.1016/s1473-3099(03)00857-0.
2. Furie V, et al. 2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis 2020;79(1):39–52. DOI: 10.1136/annrheumdis-2019-215882.
About EULAR
EULAR is the European umbrella organisation representing scientific societies, health professional associations and organisations for people with rheumatic and musculoskeletal diseases (RMDs). EULAR aims to reduce the impact of RMDs on individuals and society, as well as improve RMD treatments, prevention, and rehabilitation. To this end, EULAR fosters excellence in rheumatology education and research, promotes the translation of research advances into daily care, and advocates for the recognition of the needs of those living with RMDs by EU institutions.
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