medwireNews: The recombinant zoster vaccine is well tolerated by patients with inflammatory rheumatic and musculoskeletal diseases (RMDs), indicate data from a prospective study, with only a few incidences of flare and serious adverse events (AEs).
“The findings are reassuring for [rheumatologists] and also for future vaccine recipients,” investigator Uta Kiltz, from Ruhr-University Bochum in Germany, told delegates of the EULAR 2025 Congress in Barcelona, Spain.
“I think we have to inform the patients about the higher rate of localized musculoskeletal adverse events during the time of vaccination, but overall I think there is confidence in zoster vaccine safety in patients with RMDs,” she added.
The presenter explained that “while the recombinant zoster vaccine is recommended for immunocompromised individuals, data on its real-world tolerability and safety are still limited.”
To address this limitation, the researchers prospectively recruited 150 patients with an inflammatory RMD and an indication to receive the recombinant zoster vaccine, the two doses of which were given 2 months apart. Safety assessments were conducted at 2, 3, 6, and 12 months after the first dose was administered.
Sixty patients had a diagnosis of rheumatoid arthritis (RA), 60 of axial spondyloarthritis (axSpA), and 30 of giant cell arteritis (GCA). The mean age of the participants was 50.4, 47.7, and 72.5 years, respectively, and a corresponding 63.3%, 31.7%, and 73.3% were women.
In all, 21.7% of RA patients had a history of herpes zoster infection, as did 10.0% of axSpA patients and 43.3% of GCA patients, with the higher rate consistent with the older age of this group.
Kiltz reported that, as expected, the incidence of AEs was highest in the first 3 months, and the occurrence “was closely related to the time of the injections, and especially after month 3, [we] did not see a real increase” in the cumulative rate.
Specifically, 151, 146, 32, and 25 AEs were reported in 99, 92, 25, and 21 patients at months 2, 3, 6, and 12, respectively.
A total of 297 AEs – 139 localized and 158 generalized – occurred over the first 3 months, with the most common being injection site pain, at 32.7%, followed by fever (14.1%), fatigue (9.4%), musculoskeletal pain (8.1%), and swelling and redness at the injection site (each 6.4%).
Infections and disease-specific complaints were reported at all timepoints, with a respective 28 and 23 cases in all, equating to a rate per vaccine dose of 9.5% and 7.8%.
Flares were reported by 29 patients at 2 months, 20 patients at 3 months, 28 patients at 6 months, and 32 patients at 12 months, but the incidence of flares fulfilling predefined criteria was lower, occurring in 11, 12, 13, and 13 patients, respectively.
Two patients – one with RA and one with GCA – required hospitalization at month 2 due to disease flare, and one GCA patient was hospitalized due to an infection at month 3. The author commented in a press release that “over the observed period of 12 months, this can be interpreted as a low rate of events.”
There were 10 serious AEs in nine patients, four of which were malignancies, but these were not considered related to the vaccine, and there were no AEs of special interest or breakthrough infections.
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