Safety of the Zoster Vaccine Recombinant Adjuvanted in Rheumatoid Arthritis and Other Systemic Rheumatic Disease Patients: A Single Center's Experience With 400 Patients
Safety of the Zoster Vaccine Recombinant Adjuvanted in Rheumatoid Arthritis and Other Systemic Rheumatic Disease Patients: A Single Center's Experience With 400 Patients
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DOI：
10.1002/acr2.11150
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发表时间：
2020-06-01
影响因子：
3.4
通讯作者：
Desai, Sonali
中科院分区：
文献类型：
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作者：
Stevens, Emma;Weinblatt, Michael E.;Desai, Sonali
目的类风湿性关节炎(RA)和其他系统性风湿病(SRD)患者发生带状疱疹(HZ)的风险增加。带状疱疹重组佐剂(ZRA)是美国食品药品监督管理局于2018年批准的重组疫苗。有人担心，ZRA可能会在免疫功能受损的风湿病患者中引发疾病爆发。我们调查了ZRA疫苗对RA和SRD患者的影响，并测量了闪光和副作用的发生率。方法将闪光定义为在疫苗接种后12周内发生的闪光，通过以下两种方式之一：1)办公室笔记、电话接触或患者门户交流中的RA闪光记录；2)新剂量或增加剂量的皮质类固醇。我们测量了6.7%(n=27)的耀斑发生率。副反应发生率为12.7%(n=51)。所有的红斑和副作用都被认为是轻微的。接种后2个月、10个月和11个月有3例HZ病例发生。结论403例接种ZRA疫苗的患者中，疾病红斑发生率为7%或以下，副作用发生率为13%或以下，均低于关键试验中观察到的发生率。
ObjectivePatients with rheumatoid arthritis (RA) and other systemic rheumatic diseases (SRDs) are at increased risk of developing herpes zoster (HZ). Zoster recombinant adjuvanted (ZRA) is a recombinant vaccine approved by the Food and Drug Administration in 2018. Concern has been raised that the ZRA may trigger disease flares in rheumatology patients who are immunocompromised. We investigated the impact of the ZRA vaccine in patients with RA and SRD and measured the incidence of flares and side effects.MethodsA flare was defined as occurring within 12 weeks of vaccine administration by either 1) documentation of RA flare in office notes, telephone encounter, or patient portal communication or 2) new or increased dose of corticosteroids.ResultsWe identified 403 patients (239 patients with RA and 164 patients with SRD) who received the ZRA vaccine from February 1, 2018, to February 1, 2019. We measured a 6.7% (n = 27) incidence of flare. Side effects occurred in 12.7% (n = 51) of patients. All flares and side effects were regarded as mild. Three cases of HZ were reported as occurring 2, 10, and 11 months after the vaccination.ConclusionIn 403 patients who received the ZRA vaccine, the incidence of disease flares was 7% or less and that of side effects was 13% or less, both of which are less than the incidence rates observed in the pivotal trials.