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

IF 4.6 2区 医学 Q1 RHEUMATOLOGY
Sheryl A. Kluberg , Andrew L. Simon , Sarah M. Alam , Alexander Peters , Casie Horgan , Dongdong Li , Erick Moyneur , Elizabeth Messenger-Jones , Richard Platt , Cheryl N. McMahill-Walraven , Djeneba Audrey Djibo , Kimberly Daniels , Aziza Jamal-Allial , Claire H. Pernar , Najat J. Ziyadeh , Qianli Ma , Mano Selvan , O'Mareen Spence , Driss Oraichi , Harry Seifert , Huifeng Yun
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Abstract

Objective

To assess whether recombinant zoster vaccine (RZV) is associated with an increased risk of new-onset gout among US adults aged ≥50 years.

Methods

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).

Results

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.

Conclusion

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.

年龄≥50 岁的美国成年人接种重组带状疱疹疫苗后发生痛风的风险
目标评估重组带状疱疹疫苗(RZV)是否会增加年龄≥50 岁的美国成年人新发痛风的风险。方法我们利用行政索赔数据开展了一项真实世界的回顾性安全性研究,该研究采用了自控风险区间(SCRI)设计。我们纳入了年龄≥50 岁、接触过 RZV 并在 60 天内发生痛风的健康计划成员。暴露于 RZV 后的第 1-30 天被视为风险窗口 (RW),第 31-60 天被视为对照窗口 (CW)。我们使用条件泊松模型估算了 RW 与 CW 的痛风风险比 (RR)。主要分析估算了任何RZV剂量后发生痛风的风险。敏感性分析评估了剂量 1 和剂量 2 的特异性风险、符合 60-183 天推荐剂量间隔的患者的风险、季节性调整以及仅限于前 COVID-19 时代(2019 年 12 月 1 日之前)。结果 共有 461323 人接受了≥1 次 RZV 剂量;我们在 SCRI 分析中纳入了 302 人(平均年龄 72.5 岁;66% 为男性),他们在 60 天内有新发痛风的证据。在 RW 中,共有 153 人(50.7%)发生痛风,在 CW 中,共有 149 人(49.3%)发生痛风(RR 1.03;95% 置信区间为 0.81,1.29)。所有敏感性分析的结果一致,RZV 与痛风事件没有关联。结论在年龄≥50 岁的美国成年人群中,与随后 30 天的 CW 相比,RZV 暴露后 30 天内的痛风风险没有统计学意义上的显著增加。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
9.20
自引率
4.00%
发文量
176
审稿时长
46 days
期刊介绍: Seminars in Arthritis and Rheumatism provides access to the highest-quality clinical, therapeutic and translational research about arthritis, rheumatology and musculoskeletal disorders that affect the joints and connective tissue. Each bimonthly issue includes articles giving you the latest diagnostic criteria, consensus statements, systematic reviews and meta-analyses as well as clinical and translational research studies. Read this journal for the latest groundbreaking research and to gain insights from scientists and clinicians on the management and treatment of musculoskeletal and autoimmune rheumatologic diseases. The journal is of interest to rheumatologists, orthopedic surgeons, internal medicine physicians, immunologists and specialists in bone and mineral metabolism.
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