PO:08:114 | The adjuvanted recombinant zoster vaccine is effective in preventing herpes zoster among patients ≥50 years of age with selected autoimmune diseases in the united states: a real-world database analysis (2018–2021)

Rosaria Silvestri¹, Dagna Constenla², Germain Lonnet³, Emmanuel Aris³, Nathalie Servotte³, Ramsanjay Rk⁴, Agnes Mwakingwe-Omari², Huifeng Yun² | ¹GSK Verona, Italy; ²GSK Rockville, USA; ³GSK Wavre, Belgium; ⁴GSK Bengaluru, India

Abstract

Background. The adjuvanted recombinant zoster vaccine (RZV) was approved by the US Food and Drug Administration (FDA) for HZ prevention in adults ≥50 YOA in 2017 and for adults ≥18 YOA who are at increased risk of HZ due to immunodeficiency or immunosuppression in 2021. Autoimmune disease (AID) patients are at increased risk of developing HZ compared to the general population. This real-world evidence (RWE) study assessed RZV vaccine effectiveness (VE) in patients ≥50 YOA with selected AIDs (rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, multiple sclerosis, psoriasis and psoriatic arthritis).

Materials and Methods. This retrospective matched cohort study was conducted in patients ≥50 YOA with selected AIDs using Optum’s de-identified Clinformatics Data Mart database from Jan 2018 to Dec 2021. Patients who received 2 doses of RZV (RZV 2-dose cohort) were matched (1:3) by age, medication category and propensity scores to unvaccinated counterparts (non-RZV cohort) [Figure 1]. Incidence rates (IRs) of HZ and VE were calculated overall, stratified by condition, age, gender, time interval between the 2 doses, and time since vaccination. Cox regression models were used to estimate hazard ratios (HRs). VE as % was calculated as (1−HR) × 100. A similar approach was used to evaluate VE for patients who received 1 RZV dose.

Results. We identified 36,645 RZV vaccinated and 109,229 matched non-RZV vaccinated AID patients. Median follow-up was 1.29 (interquartile range [IQR]: 0.73–2.12) and 1.07 (IQR: 0.59–1.95) years for RZV and non-RZV cohorts. IR of HZ was 4.33/1,000 person-years (PY) in the RZV 2-dose cohort and 12.86/1,000 PY in the non-RZV cohort, resulting in an overall VE of 66.3% (95% confidence intervals [CIs]: 61.4–70.7) for AID patients. IRs and VE overall and stratified by each selected AID and variables are presented in Figure 2. Overall VE for AID patients who received 1 RZV dose was 58.3% (95% CIs: 45.8–68.0).

Conclusions. This analysis provides RWE that RZV vaccination is effective in preventing HZ in patients ≥50 YOA with selected AIDs. Our findings are consistent with the available literature on RZV effectiveness, which shows that RZV vaccination is beneficial to specific patient groups.

Keywords

• herpes zoster
• Autoimmune disease
• vaccine effectiveness