Real-world data on the use of the Shingrix vaccine among patients with inflammatory arthritis and risk of cardiovascular events following herpes zoster

Abstract

Background: Risk of cardiovascular events may increase after herpes zoster; therefore, American College of Rheumatology guidelines strongly recommend vaccination against herpes zoster in patients aged ≥ 18 years with rheumatic and musculoskeletal diseases taking immunosuppressive medications. Here, we investigated the effectiveness of Shingrix among patients with inflammatory arthritis and estimated the post-herpes zoster risk of cardiovascular events.

Methods: In this retrospective observational cohort study, data were obtained from the Optum™ Clinformatics™ Data Mart on patients aged ≥ 18 years with rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis. The proportions of patients receiving any Shingrix dose, a second dose, and a second dose within 6, 9, and 12 months were calculated. Incidence of herpes zoster following inflammatory arthritis diagnosis was reported. Vaccine effectiveness was calculated as (1 - incidence rate ratio of herpes zoster) × 100. Relative risk of cardiovascular events was assessed independently in the 30-, 45-, 60-, and 90-day periods post-herpes zoster in a subgroup of patients who experienced cardiovascular events.

Results: The final cohort included 132,672 patients with inflammatory arthritis. Mean age was 60.4 years, 71.9% were female, and 80.0% were diagnosed with rheumatoid arthritis. Overall, 28,690 (21.6%) patients received ≥ 1 Shingrix dose, of whom only 73.2% received a second dose. Of those receiving a second dose, 17,598 (83.8%) received it within the recommended 2-6 months after the first. Herpes zoster occurred in 4,342 (3.3%) patients, of which 360 cases occurred after Shingrix vaccination. The incidence rate (95% confidence interval) of herpes zoster per 1,000 person-years was 7.41 (6.64, 8.17) after any Shingrix vaccination vs. 14.76 (14.30, 15.22) without vaccination (crude vaccine effectiveness: 50%). The risk of venous thromboembolic events was elevated in the 60-90 days post-herpes zoster; no significantly increased risk was observed for any other cardiovascular events.

Conclusions: This study showed that the effectiveness of Shingrix in patients with inflammatory arthritis on immunomodulatory treatment was 50%, and the risk of venous thromboembolic events was increased in the 60-90 days after herpes zoster, supporting the recommendation that adults with inflammatory arthritis should receive vaccination against herpes zoster to reduce the risk of such events.

Keywords: Arthritis; Cardiovascular disease; Herpes zoster; Inflammatory disease; Real-world studies; Vaccines.

Fig. 1

Patient flowchart. AIDS acquired immune deficiency syndrome, HIV human immunodeficiency virus, Optum CDM Optum™ Clinformatics™ Data Mart

Fig. 2

IR of herpes zoster by Shingrix vaccination status. Error bars represent 95% CI. The crude incidence rate ratio of herpes zoster comparing “Any Shingrix” to “No Shingrix” was 0.5 (95% CI: 0.44, 0.55). CI confidence interval, IR incidence rate, PY person-years

Fig. 3

Summary of key data from models (i.e., relative incidence rates at 30, 45, 60, and 90 days after herpes zoster). CI confidence interval, IRR incidence rate ratio, MACE major adverse cardiovascular events, VTE venous thromboembolic event