A Medical Records Review Study Assessing Safety of Zoster Vaccine Recombinant, Adjuvanted in Patients With Rheumatic Disease.

OBJECTIVE: Patients with rheumatic disease are at increased risk for herpes zoster infection. Because of limited safety data in this population and concerns over vaccine-precipitated flares, there are no guidelines for vaccination with the zoster vaccine recombinant, adjuvanted (ZRA). We evaluated self-reported adverse events (AEs) and disease activity after ZRA administration in adults with rheumatic disease. METHODS: In this medical records review study at our large academic center, patients who had received at least 1 dose of ZRA from January 1, 2018 to March 11, 2020 were assessed. Self-reported AEs and disease activity were monitored 3 months after each ZRA administration. Measures of disease activity were reviewed 6 months before ZRA in those who received both doses, or 3 months before ZRA in those who received 1 dose. RESULTS: We identified 65 patients, of whom 34 (52.3%) received both doses of ZRA. Four patients (6.2%) self-reported AEs after receiving ZRA, all of which were minor and systemic. Three patients (9.2%) developed a flare after receiving ZRA, compared with 8 (12.3%) who experienced a flare in the baseline period. There was no significant change in flare incidence or disease activity after vaccination. Subgroup analysis of those on biologic and nonbiologic disease-modifying antirheumatic drugs revealed no differences in frequency of postvaccination AEs, flares, or disease activity. CONCLUSIONS: In our cohort, disease activity seemed stable when comparing disease markers before and after ZRA administration. In addition, ZRA was well-tolerated with minor AEs. Further studies are needed to guide formal vaccination recommendations.