Risk of incident gout following exposure to recombinant zoster vaccine in US adults aged ≥50 years

• Published in: Seminars in arthritis and rheumatism Vol. 68; p. 152518
• Main Authors: Kluberg, Sheryl A., Simon, Andrew L., Alam, Sarah M., Peters, Alexander, Horgan, Casie, Li, Dongdong, Moyneur, Erick, Messenger-Jones, Elizabeth, Platt, Richard, McMahill-Walraven, Cheryl N., Djibo, Djeneba Audrey, Daniels, Kimberly, Jamal-Allial, Aziza, Pernar, Claire H., Ziyadeh, Najat J., Ma, Qianli, Selvan, Mano, Spence, O'Mareen, Oraichi, Driss, Seifert, Harry, Franck, Valentine, Gamble, Susan, Yun, Huifeng
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.10.2024
• Subjects: Arthritis; Infections; Inflammation; Observational study; Vaccine; Viruses; Viruses; Observational study; Infections; Arthritis; Inflammation; Vaccine
• ISSN: 0049-0172; 1532-866X; 1532-866X
• DOI: 10.1016/j.semarthrit.2024.152518

•We assessed risk of new-onset gout following RZV using claims data for adults aged ≥50.•Patients (302) experienced post-RZV gout events: 153 in RW and 149 in CW.•We found no statistically significant association between RZV and incident gout. To assess whether recombinant zoster vaccine (RZV) is associated with an increased risk of new-onset gout among US adults aged ≥50 years. We conducted a real-world, retrospective safety study with a self-controlled risk interval (SCRI) design using administrative claims data. We included health plan members aged ≥50 years with RZV exposure, followed by incident gout within 60 days. Days 1−30 following RZV exposure were considered the risk window (RW), and days 31−60 were considered the control window (CW). We estimated the risk ratio (RR) of gout in the RW versus CW, using a conditional Poisson model. The primary analysis estimated the risk of incident gout following any RZV dose. Sensitivity analyses evaluated dose 1- and dose 2-specific risks, risk among patients compliant with recommended dose spacing of 60−183 days, adjustment for seasonality, and restriction to the pre-COVID-19 era (before December 1, 2019). A total of 461,323 individuals received ≥1 RZV dose; we included 302 individuals (mean age 72.5 years; 66 % male) with evidence of new-onset gout within 60 days in SCRI analyses. A total of 153 (50.7 %) individuals had gout events in the RW and 149 (49.3 %) in the CW (RR 1.03; 95 % confidence interval 0.81, 1.29). All sensitivity analyses had consistent results, with no association of RZV with incident gout. In a population of US adults aged ≥50 years, there was no statistically significant increase in the risk of gout during the 30 days immediately after RZV exposure, compared with a subsequent 30-day CW.