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.