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Safety of Recombinant Zoster Vaccine in Patients with Inflammatory Bowel Disease.
Digestive Diseases and Sciences ( IF 2.5 ) Pub Date : 2020-01-02 , DOI: 10.1007/s10620-019-06016-4
Venkata R Satyam 1 , Pei-Hsuan Li 2 , Jason Reich 2 , Taha Qazi 2, 3 , Ansu Noronha 2 , Sharmeel K Wasan 2 , Francis A Farraye 2, 4
Affiliation  

BACKGROUND Patients with inflammatory bowel disease (IBD) are at increased risk of developing herpes zoster. In October 2017, the FDA approved a two-dose adjuvanted, recombinant herpes zoster vaccine (RZV). There is a theoretical concern that vaccine adjuvants may cause flares in patients with immune-mediated diseases. We aimed to assess the rates of IBD flare and adverse reactions after administration of RZV in a cohort of patients with IBD. METHODS We conducted a prospective observational study of patients with IBD who received RZV between February 2018 and July 2019 at a tertiary IBD referral center. IBD activity scores were collected from patients during office visit or phone call after vaccination. The primary outcome was rate of IBD flare, defined as an increase in IBD activity, resulting in escalation of medical therapy, following vaccination. The secondary outcomes were rates of local and systemic adverse reactions after vaccination. RESULTS We identified 67 patients (28 with ulcerative colitis and 39 with Crohn's disease) who received at least one dose of RZV. The two-dose vaccine series was completed by 55 patients (82%). Median duration of follow-up after vaccination was 207 days. One case of IBD flare was identified. No cases of herpes zoster were identified. Local and systemic adverse reactions were reported in 74.6% and 56.7% of patients, respectively. CONCLUSIONS In this cohort of 67 patients, a low rate of IBD flare (1.5%) was observed after RZV administration. Rates of local and systemic adverse reactions were comparable to those seen in the RZV clinical trials.

中文翻译:

带状肠病患者重组带状疱疹疫苗的安全性。

背景技术具有炎性肠病(IBD)的患者患带状疱疹的风险增加。2017年10月,FDA批准了一种两剂量的佐剂重组带状疱疹疫苗(RZV)。从理论上讲,疫苗佐剂可能会导致免疫介导疾病的患者发作。我们旨在评估一组IBD患者中RZV给药后IBD耀斑发生率和不良反应。方法我们对2018年2月至2019年7月之间在三级IBD转诊中心接受RZV的IBD患者进行了一项前瞻性观察研究。接种疫苗后在办公室就诊或电话中从患者中收集IBD活动评分。主要结局是IBD耀斑发生率,IBD耀斑率定义为IBD活动增加,导致药物治疗升级,接种疫苗后。次要结果是接种疫苗后局部和全身不良反应的发生率。结果我们确定接受至少一剂RZV的67例患者(28例溃疡性结肠炎和39例克罗恩病)。55名患者(82%)完成了两剂疫苗系列。接种疫苗后的中位随访时间为207天。确定了1例IBD耀斑。没有发现带状疱疹病例。据报道,局部和全身不良反应分别占74.6%和56.7%。结论在这67例患者中,RZV给药后IBD耀斑发生率低(1.5%)。局部和全身不良反应的发生率与RZV临床试验中观察到的相当。次要结果是接种疫苗后局部和全身不良反应的发生率。结果我们确定接受至少一剂RZV的67例患者(28例溃疡性结肠炎和39例克罗恩病)。55名患者(82%)完成了两剂疫苗系列。接种疫苗后的中位随访时间为207天。确定了1例IBD耀斑。没有发现带状疱疹病例。据报道,局部和全身不良反应分别占74.6%和56.7%。结论在这67例患者中,RZV给药后IBD耀斑发生率低(1.5%)。局部和全身不良反应的发生率与RZV临床试验中观察到的相当。次要结果是接种疫苗后局部和全身不良反应的发生率。结果我们确定接受至少一剂RZV的67例患者(28例溃疡性结肠炎和39例克罗恩病)。55名患者(82%)完成了两剂疫苗系列。接种疫苗后的中位随访时间为207天。确定了1例IBD耀斑。没有发现带状疱疹病例。据报道,局部和全身不良反应分别占74.6%和56.7%。结论在这67例患者中,RZV给药后IBD耀斑发生率低(1.5%)。局部和全身不良反应的发生率与RZV临床试验中观察到的相当。病)至少接受一剂RZV。55名患者(82%)完成了两剂疫苗系列。接种疫苗后的中位随访时间为207天。确定了1例IBD耀斑。没有发现带状疱疹病例。据报道局部和全身不良反应分别占74.6%和56.7%。结论在这67例患者中,RZV给药后IBD耀斑发生率低(1.5%)。局部和全身不良反应的发生率与RZV临床试验中观察到的相当。病)至少接受一剂RZV。55名患者(82%)完成了两剂疫苗系列。接种疫苗后的中位随访时间为207天。确定了1例IBD耀斑。没有发现带状疱疹病例。据报道,局部和全身不良反应分别占74.6%和56.7%。结论在这67例患者中,RZV给药后IBD耀斑发生率低(1.5%)。局部和全身不良反应的发生率与RZV临床试验中观察到的相当。据报道,局部和全身不良反应分别占74.6%和56.7%。结论在这67例患者中,RZV给药后IBD耀斑发生率低(1.5%)。局部和全身不良反应的发生率与RZV临床试验中观察到的相当。据报道,局部和全身不良反应分别占74.6%和56.7%。结论在这67例患者中,RZV给药后IBD耀斑发生率低(1.5%)。局部和全身不良反应的发生率与RZV临床试验中观察到的相当。
更新日期:2020-01-04
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