POS1476-HPR THE ADJUVANTED RECOMBINANT ZOSTER VACCINE IS EFFECTIVE IN PATIENTS ≥50 YEARS OF AGE WITH RHEUMATOID ARTHRITIS AT INCREASED RISK OF HERPES ZOSTER: RESULTS FROM A REAL-WORLD DATABASE ANALYSIS IN THE UNITED STATES FROM 2018 TO 2021
Authors: D. Constenla, G. Lonnet, E. Aris, H. Wang, R. Rk, A. Mwakingwe-Omari, H. Yun
Journal: Annals of the Rheumatic Diseases (2024)

<h3>Background:</h3> Patients with rheumatoid arthritis (RA) are at higher risk of herpes zoster (HZ) compared to the general population [1] due to the disease and associated therapy (particularly with Janus kinase inhibitors [2]). The adjuvanted recombinant zoster vaccine (RZV) demonstrated high efficacy in immunocompromised adults and is approved for use in HZ prevention by the US Food and Drug Administration (FDA) for immunodeficient/immunosuppressed adults ≥18 years of age (YOA) [3]. RZV is also recommended by the Advisory Committee on Immunization Practices (ACIP) for immunocompromised adults aged ≥19 YOA [4]. This is the first real-world evidence study in a RA population that provides RZV vaccine effectiveness (VE) data for the prevention of HZ in patients ≥50 YOA with RA by medication categories. <h3>Objectives:</h3> To determine VE overall, by age and by medication category after 2 doses of RZV in patients ≥50 YOA with RA. <h3>Methods:</h3> We conducted a retrospective matched cohort study using Jan 2018–Dec 2021 Optum Clinformatics Data Mart, a United States healthcare administrative claims database. Patients ≥50 YOA with RA who received 2 doses of RZV with ≥28 days between doses (RZV [2-dose] cohort) were matched 1:3 to unvaccinated counterparts (non-RZV cohort) by age, medication category and other confounders (propensity score). Five medication categories (mutually exclusive) based on treatment during the baseline period were included (Table 1). The index date for RZV 2-dose cohort was the date of receipt of the second RZV dose and for non-RZV cohort was the same index date as their vaccinated match. The follow-up started from index date + 30 days until the earliest occurrence of HZ, termination of insurance coverage, death, receipt of RZV (non-RZV cohort), receipt of live zoster vaccine, or study end. The first HZ event during follow-up was identified using an algorithm that included ICD-10 diagnosis code, inpatient or outpatient claims and/or HZ antiviral medication used within 7 days before/after HZ diagnosis. Incidence rates (IRs) of HZ were calculated overall, by age and medication category. Cox hazards models were used to estimate overall and stratified hazard ratios (HRs). VE (%) was calculated as (1−HR) × 100. A similar approach was used to estimate overall VE for patients who received 1 RZV dose (index date was the date of receipt of first RZV dose). <h3>Results:</h3> Overall, 15061 (RZV cohort) and 44652 (non-RZV cohort) RA patients were identified and included in 2-dose analysis. Most patients were female and ≥70 YOA (Table 1). The follow-up ranged from &lt;1 year to maximum 3.7 years. The IR of HZ was 5.87/1000 person-years (PY) in the RZV cohort and 15.79/1000 PY in the non-RZV cohort (Figure 1). Overall VE against HZ was 62.8% (95% confidence intervals [CI]: 55.3–69.1). IRs of HZ and VE by age and medication are presented in the Figure 1. VE by used medication ranged between 53.7% (95% CI: 18.2–73.7) in biologics group and 72.3% (95% CI: 52.0–84.0) in no treatment/NSAID/low dose steroids group (Figure 1). Adjusted VE against HZ for RA patients who received 1 RZV dose was 53.7% (95% CIs: 34.3–67.3). The results should be interpreted carefully due to potential retrospective database study limitations, such as residual confounding, selection bias, outcome or medication misclassification and limited follow-up. <h3>Conclusion:</h3> Our data show that a 2-dose RZV vaccination schedule is effective in preventing HZ in patients ≥50 YOA with RA, who are at increased risk of HZ with associated complications due to age and immunosuppressive therapy. The study provides information to healthcare professionals about the benefits of vaccinating with RZV to prevent HZ in patients who have RA and are at risk of HZ. Overall, these results are consistent with the available literature that evaluates the RZV effectiveness in patients with autoimmune diseases [5,6].Funding: GlaxoSmithKline Biologicals SA<sup></sup> <h3>REFERENCES:</h3> [1] Yun et al 2016, Arthritis Rheumatol 68: 2328–37. [2] Olivera et al 2020, Gastroenterology 158: 1554–73. [3] FDA, 2023. Shingrix (STN: 125614). [4] Anderson et al 2022, MMWR Morb Mortal Wkly Rep 71: 80–4. [5] Izurieta et al 2021, Clin Infect Dis 73: 941–8. [6] Xia et al 2022, Front Immunol 13: 978203. <h3></h3> <h3>Acknowledgements:</h3> Nathalie Servotte is acknowledged for programming support. Medical writing (Maria C. Maior) and coordination support were provided by Akkodis Belgium c/o GSK. <h3>Disclosure of Interests:</h3> Dagna Constenla is holding shares in GSK as part of employee remuneration, is employed by GSK, Germain Lonnet is employed by GSK, worked for two CROs: Aixial and Business and Decision Life Science from March 2017 to June 2022, Emmanuel Aris is holding shares in GSK as part of employee remuneration, is employed by GSK, Hao Wang is holding shares in GSK as part of employee remuneration, is employed by GSK, Ramsanjay RK is employed by GSK, Agnes Mwakingwe-Omari is holding shares in GSK as part of employee remuneration, is employed by GSK, Huifeng Yun is holding shares in GSK as part of employee remuneration, is employed by GSK.