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接受度普利尤单抗治疗的患者使用疫苗的系统评价和专家 Delphi 共识推荐:美国过敏、哮喘和免疫学学会的立场文件。

A systematic review and expert Delphi Consensus recommendation on the use of vaccines in patients receiving dupilumab: A position paper of the American College of Allergy, Asthma and Immunology.

机构信息

Department of Pediatrics, The University of Tennessee Health Science Center and LeBonheur Children's Hospital, Memphis, Tennessee.

Departments of Medicine and Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada; Evidence in Allergy Group, McMaster University and The Research Institute of St. Joe's Hamilton, Hamilton, Canada.

出版信息

Ann Allergy Asthma Immunol. 2024 Sep;133(3):286-294. doi: 10.1016/j.anai.2024.05.014. Epub 2024 Jun 5.

DOI:10.1016/j.anai.2024.05.014
PMID:38848870
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11459655/
Abstract

BACKGROUND

Dupilumab is a monoclonal antibody that targets the interleukin (IL)-4 receptor alpha subunit, thus blocking the effects of IL-4 and IL-13, and has shown efficacy in treating various conditions including asthma, atopic dermatitis, eosinophilic esophagitis, and others. Because of its immune modulatory effects, clinical trials that studied dupilumab did not allow patients to receive live vaccines during the clinical trials because of an abundance of caution, and thus package inserts recommend that patients who are being treated with dupilumab should avoid live vaccines. Because dupilumab is now approved for use in patients from 6 months of age for the treatment of atopic dermatitis, this reported contraindication is now posing a clinical dilemma for patients and clinicians.

OBJECTIVE

To perform a systematic review of literature on the safety and efficacy of vaccinations in patients who are receiving dupilumab and to provide expert guidance on the use of vaccines in patients who are receiving dupilumab.

METHODS

A systematic review of the literature was performed, and an expert Delphi Panel was assembled.

RESULTS

The available literature on patients who received vaccinations while using dupilumab overall suggests that live vaccines are safe and that the vaccine efficacy, in general, is not affected by dupilumab. The expert Delphi panel agreed that the use of vaccines in patients receiving dupilumab was likely safe and effective.

CONCLUSION

Vaccines (including live vaccines) can be administered to patients receiving dupilumab in a shared decision-making capacity.

摘要

背景

度普利尤单抗是一种针对白细胞介素(IL)-4 受体 α 亚单位的单克隆抗体,可阻断 IL-4 和 IL-13 的作用,已被证明对治疗哮喘、特应性皮炎、嗜酸性食管炎等多种疾病有效。由于其免疫调节作用,研究度普利尤单抗的临床试验出于谨慎考虑不允许患者在临床试验期间接种活疫苗,因此说明书建议正在接受度普利尤单抗治疗的患者应避免接种活疫苗。由于度普利尤单抗现已批准用于 6 个月及以上年龄的特应性皮炎患者,因此目前这种禁忌对患者和临床医生来说是一个临床难题。

目的

对正在接受度普利尤单抗治疗的患者接种疫苗的安全性和有效性进行系统评价,并就正在接受度普利尤单抗治疗的患者接种疫苗提供专家指导。

方法

对文献进行系统评价,并组建专家德尔菲小组。

结果

关于正在接受度普利尤单抗治疗的患者接种疫苗的总体可用文献表明,活疫苗是安全的,并且度普利尤单抗一般不会影响疫苗的疗效。专家德尔菲小组一致认为,正在接受度普利尤单抗治疗的患者接种疫苗可能是安全且有效的。

结论

在共同决策的情况下,可以向正在接受度普利尤单抗治疗的患者接种疫苗(包括活疫苗)。

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A systematic review and expert Delphi Consensus recommendation on the use of vaccines in patients receiving dupilumab: A position paper of the American College of Allergy, Asthma and Immunology.接受度普利尤单抗治疗的患者使用疫苗的系统评价和专家 Delphi 共识推荐:美国过敏、哮喘和免疫学学会的立场文件。
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引用本文的文献

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BMJ Open. 2025 Aug 3;15(8):e101050. doi: 10.1136/bmjopen-2025-101050.
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A case series of live attenuated vaccine administration in dupilumab-treated children with atopic dermatitis.在接受度普利尤单抗治疗的特应性皮炎儿童中使用减毒活疫苗的病例系列。
Pediatr Dermatol. 2024 Mar-Apr;41(2):204-209. doi: 10.1111/pde.15518. Epub 2024 Feb 2.
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Preclinical and clinical experience with dupilumab on the correlates of live attenuated vaccines.度普利尤单抗在减毒活疫苗相关性方面的临床前和临床经验。
J Allergy Clin Immunol Glob. 2021 Dec 8;1(1):9-15. doi: 10.1016/j.jacig.2021.12.003. eCollection 2022 Feb.
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The impact of dupilumab treatment on SARS-CoV-2 T cell responses in atopic dermatitis patients.
Safety of biologics for the treatment of asthma in children and adolescents: a systematic review.
生物制剂用于治疗儿童和青少年哮喘的安全性:一项系统评价。
Eur Respir Rev. 2025 Jun 18;34(176). doi: 10.1183/16000617.0269-2024. Print 2025 Apr.
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Adverse effects of biologics used to treat asthma.用于治疗哮喘的生物制剂的不良反应。
Ther Adv Respir Dis. 2025 Jan-Dec;19:17534666251319175. doi: 10.1177/17534666251319175. Epub 2025 Mar 18.
度普利尤单抗治疗对特应性皮炎患者严重急性呼吸综合征冠状病毒2(SARS-CoV-2)T细胞反应的影响。
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SARS-CoV-2 mRNA Vaccine Antibody Response in Patients with Asthma Receiving Biologic Therapy: A Real-World Analysis.接受生物治疗的哮喘患者对SARS-CoV-2 mRNA疫苗的抗体反应:一项真实世界分析
Am J Respir Crit Care Med. 2022 Sep 1;206(5):644-648. doi: 10.1164/rccm.202203-0599LE.
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The impact of dupilumab treatment on severe acute respiratory syndrome coronavirus 2-coronavirus disease 2019 antibody responses in patients with atopic dermatitis.度普利尤单抗治疗对特应性皮炎患者严重急性呼吸综合征冠状病毒2-冠状病毒病2019抗体反应的影响。
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Recommendations for Vaccination in Children with Atopic Dermatitis Treated with Dupilumab: A Consensus Meeting, 2020.特应性皮炎患儿接受度普利尤单抗治疗后的疫苗接种推荐意见:共识会议,2020 年。
Am J Clin Dermatol. 2021 Jul;22(4):443-455. doi: 10.1007/s40257-021-00607-6. Epub 2021 Jun 2.
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Severity grading system for acute allergic reactions: A multidisciplinary Delphi study.急性过敏反应严重程度分级系统:一项多学科 Delphi 研究。
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