(BSPOT55) Use of the Shingrix Vaccine Among Patients with Inflammatory Arthritis and Risk of Cardiovascular Events Following Herpes Zoster

Background: The risk of herpes zoster (HZ) is increased in patients with inflammatory arthritis (IA); although the Shingrix vaccine has been available since 2017, its use in patients with IA has not been well-described. Prior studies have shown an increased risk of stroke and major adverse cardiovascular events (MACE) after HZ, but this risk has not been well-studied in the IA population.

Objectives: To describe the proportion of patients with IA who received Shingrix, and to estimate the risk of CV events (myocardial infarction [MI], stroke, MACE, and VTE [venous thromboembolism]) after HZ.

Methods: We conducted a retrospective cohort study using Optum® Clinformatics Data Mart® US claims data. Participants were adults with psoriatic arthritis, rheumatoid arthritis (RA), or axial spondyloarthritis. Cohort entry was restricted to occur on the date of first IA diagnosis between 20 October 2017 (date of Shingrix FDA approval) and 31 March 2023 (end of data). Demographics and comorbidities prior to cohort entry, and Shingrix use across all data were described. HZ was defined as a diagnosis claim with receipt of antiviral medication within 7 days. Vaccine effectiveness was calculated as (1 - incidence rate ratio of HZ) * 100. To assess the risk of CV events after HZ, self-controlled case series (SCCS) models were constructed among all patients with IA who experienced an outcome of interest. The exposure was HZ, and the outcomes included inpatient MI, stroke, MACE (MI or stroke), and VTE. A sensitivity analysis of VTE including outpatient diagnoses with an anticoagulant prescription within 7 days was performed. Multiple models with risk periods of 30, 45, 60, or 90 days after HZ were examined.

Results: A total of 132,672 patients with IA were included; the mean age was 60.4 years, 71.9% were female and the majority (80.0%) were diagnosed with RA. A total of 28,690 (21.6%) patients were vaccinated with at least one dose of Shingrix and of those, 73.2% received a second dose. HZ occurred in 4,342 (3.3%) patients, including 360 cases after any Shingrix vaccination. The crude incidence rate of HZ after any Shingrix vaccination was 7.41 per 1,000 person-years (PY) compared to 14.76 per 1,000 PY without vaccination, yielding a crude vaccine effectiveness of 50% (44%, 55%). No significant increased risk of MI, stroke, or MACE was observed after HZ. An increased risk of inpatient VTE was observed in the first 60 days (hazard ratio [HR] = 2.13 [1.13, 4.02]) and 90 days (HR = 2.13 [1.22, 3.72]) after HZ.

Conclusions: Use of Shingrix among patients with IA is low, although it has been shown to be safe and effective in multiple studies, and its use is recommended by professional rheumatology organizations. Risk of inpatient VTE was elevated in the 60-90 days after HZ infection.