Recombinant Zoster Vaccine Shows Promise for Patients with Rheumatic Diseases
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A recent study presented at the 2025 EULAR congress in Barcelona suggests that the recombinant zoster vaccine (RZV) is well-tolerated and safe for individuals with inflammatory rheumatic and musculoskeletal diseases (iRMDs).
The study, focusing on RZV which targets CD4+T-cells via recombinant glycoprotein E, assessed the vaccine’s tolerability and safety in iRMD patients. Interim data from an ongoing trial was presented.
Researchers prospectively enrolled 150 adults with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), or giant cell arteritis (GCA), all of whom had an indication for RZV. A little over 21% had a prior history of herpes zoster (HZ). all participants received RZV at Month 0, with 90% receiving a follow-up dose at Month 2. Safety evaluations where conducted at Months 2, 3, 6, and 12.
Most adverse events (aes) occurred shortly after vaccination. Through Month 3, 139 localized AEs (46.8%) and 158 generalized AEs (53.2%) were reported. The most common AE was pain at the injection site (32.7%), 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%), disease worsening (3.7%),and other AEs (7.7%) were also reported up to Month 3.
Low Rate of Disease Flare-Ups
disease flares were reported at various intervals, but only 1.6-8.6% met predefined flare criteria. Three patients required hospitalization due to flares – two with GCA and one with RA. According to lead author Uta Kiltz, “over the observed period of 12 months, this can be interpreted as a low rate of events.”
“Over the observed period of 12 months, this can be interpreted as a low rate of events.”
During the follow-up period, 10 serious AEs were reported in 9 patients, including 3 flares, 4 malignancies, and 3 comorbidities. No patients reported AEs of special interest or breakthrough infections. The malignancies were deemed unrelated to the vaccination.
The study’s authors concluded that RZV was generally well-tolerated, with few reports of flares and serious AEs. These findings offer reassurance to rheumatologists and future vaccine recipients, bolstering confidence in the safety of RZV for patients with iRMDs.
Understanding Herpes Zoster and the RZV Vaccine
Sources
- 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.
- 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.
- 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.
- Centers for Disease Control and Prevention (CDC) – Shingles Facts
- National Health Service (NHS) – Shingles Overview
- U.S. Food and Drug Administration (FDA) – shingrix Approval
- Immunization Action Coalition – Ask the Experts: Shingles Vaccine
- National Center for biotechnology Information (NCBI) – Epidemiology of Herpes Zoster
- World Health Organization (WHO) – herpes Zoster Q&A
