Real-world Effectiveness of the Adjuvanted Recombinant Zoster Vaccine in ≥50-year-old Adults With Autoimmune Diseases

Abstract

Background: Real-world data on the vaccine effectiveness (VE) of the adjuvanted recombinant zoster vaccine (RZV) to prevent herpes zoster (HZ) among individuals with autoimmune diseases (AIDs) are limited. To address this knowledge gap, we aimed to evaluate the VE of 2 RZV doses against HZ in ≥50-year-old adults with selected AIDs (rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, multiple sclerosis (MS), psoriasis (PsO), and psoriatic arthritis).

Methods: We conducted a retrospective matched cohort study using Optum's deidentified Clinformatics® Data Mart Database datasets from January 2018 to December 2021. Patients were matched by AID condition, age, and medication category, then 1:3 by propensity scores that accounted for the likelihood of receiving RZV, adjusted on selected confounders. For each AID, we calculated HZ incidence rates and RZV VE, overall and stratified by age, sex, time interval between 2 RZV doses, medication category, and time since vaccination.

Results: The 2-dose cohort included 36 645 RZV-vaccinated and 109 229 unvaccinated patients. Two RZV doses offer protection against HZ in patients with AIDs, with VEs ranging from 48.1% for MS to 77.2% for PsO. An overall reduction in HZ incidence from 12.9 (95% confidence interval [CI]: 12.3; 13.5) to 4.3 (95% CI: 3.8; 4.9) per 1000 person-years among vaccinated individuals was found, corresponding to an overall VE against HZ of 66.3% (95% CI: 61.4; 70.7).

Conclusions: Our analysis shows that RZV vaccination prevents HZ in ≥50-year-old adults with selected AIDs, consistent with prior studies.

Keywords: autoimmune diseases; herpes zoster; herpes zoster vaccine; vaccination; vaccine effectiveness.

Graphical Abstract

Figure 1.

Study design. *The index date for the 1-dose and 2-dose cohorts was the date of receipt of the first and second RZV dose, respectively. The index date for unvaccinated patients corresponded to that of the vaccinated patients. Note: Propensity score matching was done at the index date. For each AID condition and sensitivity analyses, separate propensity scores and different sets of potential confounders were included. For stratified analysis with matched variables, individuals were matched on AID condition, age group, and medication category; then 1:3 matched on propensity scores with the list of covariates. Abbreviations: AID, autoimmune disease; CDM, Optum Clinformatics® Data Mart Database; HZ, herpes zoster; IR, incidence rate; non-RZV cohort, unvaccinated patients; RZV, adjuvanted recombinant zoster vaccine; RZV cohort, RZV-vaccinated patients; US, United States; VE, vaccine effectiveness; ZVL, live-attenuated varicella-zoster virus vaccine.

Figure 2.

RZV VE against HZ after 2 RZV doses across selected AIDs. (A) Shows HZ IRs and RZV VE point estimates for each selected AID. (B) Shows HZ IRs and RZV VE point estimates for the selected AIDs altogether, stratified by age, sex, time interval between 2 RZV doses, and time since vaccination. Note: HZ IRs were calculated by dividing the number of HZ cases by the total number of person-years. aHRs and their 95% CIs were obtained from Cox proportional hazards regression models. The VE estimates and their 95% CIs were computed from aHRs: VE = (1−aHR) × 100. Abbreviations: AID, autoimmune disease; CD, Crohn's disease; CI, confidence interval; IBD, inflammatory bowel disease; IR, incidence rate; HZ, herpes zoster; MS, multiple sclerosis; N, number of patients; non-RZV cohort, unvaccinated patients; PsA, psoriatic arthritis; PsO, psoriasis; RA, rheumatoid arthritis; RZV, adjuvanted recombinant zoster vaccine; RZV cohort, RZV-vaccinated patients; SLE, systemic lupus erythematosus; UC, ulcerative colitis; VE, vaccine effectiveness.