SARS-COV-2 疫苗加强针可提高炎症性肠病患者亚最佳血清转化率。GETECCU（VACOVEII 研究）前瞻性多中心研究结果。

A booster dose of SARS-COV-2 vaccine improves suboptimal seroconversion rates in patients with inflammatory bowel disease. Results of a prospective multicenter study of GETECCU (VACOVEII study).

机构信息

Servicio de Aparato Digestivo, Hospital Universitario Miguel Servet de Zaragoza, Spain; Instituto de Investigación Sanitaria de Aragón (IIS Aragón), Spain.

Servicio de Aparato Digestivo, Hospital Universitario Miguel Servet de Zaragoza, Spain.

出版信息

Gastroenterol Hepatol. 2024 Oct;47(8):821-833. doi: 10.1016/j.gastrohep.2023.11.004. Epub 2023 Nov 23.

DOI:10.1016/j.gastrohep.2023.11.004

PMID:38007154

Abstract

BACKGROUND

The response to SARS-CoV-2 vaccination decreases in inflammatory bowel disease (IBD) patients, specially under anti-TNF treatment. However, data on medium-term effectiveness are limited, specially using new recommended seroconversion rate (>260BAU/mL). Our aim was to evaluate the 6-month>260 BAU-seroconversion rate after full vaccination and after booster-dose.

METHODS

VACOVEII is a Spanish multicenter, prospective study promoted by GETECCU. IBD patients full vaccinated against SARS-CoV-2 and without previous COVID-19 infection, treated or not with immunosuppressants, were included. The booster dose was administered 6 months after the full vaccination. Seroconversion was set at 260BAU/mL, according to most recent recommendations and was assessed 6 months after the full vaccination and 6 months after booster-dose.

RESULTS

Between October 2021 and March 2022, 313 patients were included (124 no treatment or mesalazine; 55 immunomodulators; 87 anti-TNF; 19 anti-integrin; and 28 ustekinumab). Most patients received mRNA-vaccines (86%). Six months after full vaccination, overall seroconversion rate was 44.1%, being significantly lower among patients on anti-TNF (19.5%, p<0.001) and ustekinumab (35.7%, p=0.031). The seroconversion rate after booster was 92%. Again, anti-TNF patients had a significantly lower seroconversion rate (67%, p<0.001). mRNA-vaccine improved seroconversion rate (OR 11.720 [95% CI 2.26-60.512]).

CONCLUSION

The full vaccination regimen achieves suboptimal response in IBD patients, specially among those anti-TNF or ustekinumab. The booster dose improves seroconversion rate in all patients, although it remains limited in those treated with anti-TNF. These results reinforce the need to prioritize future booster doses in patients on immunosuppressants therapy, specially under anti-TNF, and using mRNA-vaccines.

摘要

背景

在炎症性肠病（IBD）患者中，特别是在接受抗 TNF 治疗的患者中，对 SARS-CoV-2 疫苗的反应会降低。然而，关于中期疗效的数据是有限的，特别是使用新推荐的血清转化率（>260BAU/mL）。我们的目的是评估完全接种疫苗后 6 个月时>260BAU 的血清转化率，以及在加强剂量后。

方法

VACOVEII 是一项由 GETECCU 推广的西班牙多中心前瞻性研究。我们纳入了已完全接种 SARS-CoV-2 疫苗且无既往 COVID-19 感染的 IBD 患者，无论是否接受免疫抑制剂治疗。加强剂量在完全接种疫苗后 6 个月时给予。根据最新建议，将血清转化率设定为 260BAU/mL，并在完全接种疫苗后 6 个月和加强剂量后 6 个月进行评估。

结果

2021 年 10 月至 2022 年 3 月期间，共纳入 313 例患者（124 例无治疗或美沙拉嗪；55 例免疫调节剂；87 例抗 TNF；19 例抗整合素；28 例乌司奴单抗）。大多数患者接受了 mRNA 疫苗（86%）。完全接种疫苗后 6 个月时，总体血清转化率为 44.1%，接受抗 TNF（19.5%，p<0.001）和乌司奴单抗（35.7%，p=0.031）治疗的患者血清转化率显著较低。加强剂量后的血清转化率为 92%。同样，抗 TNF 患者的血清转化率显著较低（67%，p<0.001）。mRNA 疫苗可提高血清转化率（OR 11.720 [95%CI 2.26-60.512]）。

结论

在 IBD 患者中，完全接种方案的反应不佳，特别是在接受抗 TNF 或乌司奴单抗治疗的患者中。加强剂量可提高所有患者的血清转化率，但在接受抗 TNF 治疗的患者中仍有限。这些结果强调了在接受免疫抑制剂治疗的患者中，特别是在接受抗 TNF 治疗的患者中，需要优先考虑未来的加强剂量，并使用 mRNA 疫苗。