SARS-CoV-2 疫苗接种对炎症性肠病活动和疫苗相关不良事件发展的影响：来自 PREVENT-COVID 的结果。

Impact of SARS-CoV-2 Vaccination on Inflammatory Bowel Disease Activity and Development of Vaccine-Related Adverse Events: Results From PREVENT-COVID.

机构信息

Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Division of Pediatric Gastroenterology, Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

出版信息

Inflamm Bowel Dis. 2022 Oct 3;28(10):1497-1505. doi: 10.1093/ibd/izab302.

DOI:10.1093/ibd/izab302

PMID:34871388

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8822409/

Abstract

BACKGROUND

Severe acute respiratory syndrome coronavirus 2 vaccination is recommended for all individuals with inflammatory bowel disease (IBD), including those on immunosuppressive therapies; however, little is known about vaccine safety and efficacy in these patients or the impact of vaccination on IBD disease course.

METHODS

We evaluated coronavirus disease 2019 (COVID-19) vaccine-related adverse events (AEs) and the effect of vaccination on IBD disease course among participants in the PREVENT-COVID (Partnership to Report Effectiveness of Vaccination in populations Excluded from iNitial Trials of COVID) study, a prospective, observational cohort study. Localized and systemic reactions were assessed via questionnaire. Disease flare was defined by worsening IBD symptoms and change in IBD medications. Outcomes were stratified by vaccine type and IBD medication classes.

RESULTS

A total of 3316 individuals with IBD received at least 1 COVID-19 vaccine. Injection site tenderness (68%) and fatigue (46% dose 1, 68% dose 2) were the most commonly reported localized and systemic AEs after vaccination. Severe localized and systemic vaccine-related AEs were rare. The mRNA-1273 vaccine was associated with significantly greater severe AEs at dose 2 (localized 4% vs 2%, systemic 15% vs 10%; P < .001 for both). Prior COVID-19 infection, female sex, and vaccine type were associated with severe systemic reactions to dose 1, while age <50 years, female sex, vaccine type, and antitumor necrosis factor and vedolizumab use were associated with severe systemic reactions to dose 2. Overall rates (2%) of IBD flare were low following vaccination.

CONCLUSIONS

Our findings provide reassurance that the severe acute respiratory syndrome coronavirus 2 vaccine is safe and well tolerated among individuals with IBD, which may help to combat vaccine hesitancy and increase vaccine confidence.

摘要

背景

建议所有炎症性肠病（IBD）患者，包括正在接受免疫抑制治疗的患者，接种严重急性呼吸综合征冠状病毒 2 疫苗；然而，人们对这些患者的疫苗安全性和有效性知之甚少，也不知道疫苗接种对 IBD 病程的影响。

方法

我们评估了在预防 COVID-19（排除在 COVID-19 初始试验之外的人群报告疫苗有效性的合作研究）研究中，COVID-19 疫苗相关不良事件（AE）以及疫苗接种对 IBD 病程的影响，这是一项前瞻性观察队列研究。通过问卷评估局部和全身反应。疾病发作定义为 IBD 症状恶化和 IBD 药物改变。根据疫苗类型和 IBD 药物类别对结果进行分层。

结果

共有 3316 名 IBD 患者至少接种了 1 剂 COVID-19 疫苗。接种后最常见的局部和全身 AE 是注射部位压痛（68%）和疲劳（第 1 剂 46%，第 2 剂 68%）。严重的局部和全身疫苗相关 AE 很少见。mRNA-1273 疫苗在第 2 剂时与更严重的 AE 显著相关（局部 4%对 2%，全身 15%对 10%；均 <0.001）。既往 COVID-19 感染、女性和疫苗类型与第 1 剂时严重全身反应相关，而年龄<50 岁、女性、疫苗类型以及使用抗肿瘤坏死因子和 vedolizumab 与第 2 剂时严重全身反应相关。接种疫苗后 IBD 发作的总发生率（2%）较低。