{"title":"生物制剂快速药物脱敏的回顾性分析：单中心经验。","authors":"Döne Gülçin Unutmaz Erkaya, Makbule Seda Bayrak Durmaz, Begüm Görgülü Akın, Sevim Bavbek","doi":"10.1002/clt2.12397","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Following the increased use of biological agents, a subset of patients experiences hypersensitivity reaction (HSR). We reported our experience with rapid drug desensitization (RDD) to nine biologics (rituximab, infliximab, cetuximab, trastuzumab, pertuzumab, nivolumab, brentuximab, tocilizumab and filgrastim) and identified risk factors for breakthrough reactions (BTRs).</p>\n </section>\n \n <section>\n \n <h3> Method</h3>\n \n <p>This was a retrospective review (2013–2022) of patients with immediate HSRs to biological agents. Initial HSRs were classified as grade 1, 2, or 3 in their severity. Skin prick tests (SPT)/intradermal tests (IDT) were performed using implicated agents. The phenotypes of HSRs were defined as Type I, cytokine-release syndrome (CRS), mixed reactions (cytokine-release + type I) based on history, clinical presentations and skin tests with implicated biologicals. A 12-step RDD protocol was used.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>The study comprised 45 patients (F/M: 31/14, median age: 55 (range: 20–69)). Majority of the patients reacted at the first infusion (<i>n</i>: 29/45, 64.4%). The majority of initial HSRs were grade 3 (<i>n</i>: 24/45, 53.3%) and grade 2 (<i>n</i>: 21/45, 46.6%); none were grade 1. Initial reactions were presented as type I (<i>n</i>: 20/45, 44.4%), CRS (<i>n</i>: 12/45, 26.6%) and mixed (<i>n</i>: 13/45, 28.8%). A total of 258 RDDs were performed and 98.4% of them were completed successfully. BTRs occurred in 36/258 (13.9%) infusions of RDDs. There was no significant association between the BTRs and age, drug cycle, SPT and IDT positivity, gender, comorbidities, or atopy.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>In our experience, 98.4% of 258 RDDs to biologics were successfully completed; RDD was safe and effective for our population.</p>\n </section>\n </div>","PeriodicalId":10334,"journal":{"name":"Clinical and Translational Allergy","volume":"14 10","pages":""},"PeriodicalIF":4.6000,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11493553/pdf/","citationCount":"0","resultStr":"{\"title\":\"Retrospective analysis of rapid drug desensitization with biologic agents: A single center experience\",\"authors\":\"Döne Gülçin Unutmaz Erkaya, Makbule Seda Bayrak Durmaz, Begüm Görgülü Akın, Sevim Bavbek\",\"doi\":\"10.1002/clt2.12397\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>Following the increased use of biological agents, a subset of patients experiences hypersensitivity reaction (HSR). We reported our experience with rapid drug desensitization (RDD) to nine biologics (rituximab, infliximab, cetuximab, trastuzumab, pertuzumab, nivolumab, brentuximab, tocilizumab and filgrastim) and identified risk factors for breakthrough reactions (BTRs).</p>\\n </section>\\n \\n <section>\\n \\n <h3> Method</h3>\\n \\n <p>This was a retrospective review (2013–2022) of patients with immediate HSRs to biological agents. Initial HSRs were classified as grade 1, 2, or 3 in their severity. Skin prick tests (SPT)/intradermal tests (IDT) were performed using implicated agents. The phenotypes of HSRs were defined as Type I, cytokine-release syndrome (CRS), mixed reactions (cytokine-release + type I) based on history, clinical presentations and skin tests with implicated biologicals. A 12-step RDD protocol was used.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>The study comprised 45 patients (F/M: 31/14, median age: 55 (range: 20–69)). Majority of the patients reacted at the first infusion (<i>n</i>: 29/45, 64.4%). The majority of initial HSRs were grade 3 (<i>n</i>: 24/45, 53.3%) and grade 2 (<i>n</i>: 21/45, 46.6%); none were grade 1. Initial reactions were presented as type I (<i>n</i>: 20/45, 44.4%), CRS (<i>n</i>: 12/45, 26.6%) and mixed (<i>n</i>: 13/45, 28.8%). A total of 258 RDDs were performed and 98.4% of them were completed successfully. BTRs occurred in 36/258 (13.9%) infusions of RDDs. There was no significant association between the BTRs and age, drug cycle, SPT and IDT positivity, gender, comorbidities, or atopy.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusion</h3>\\n \\n <p>In our experience, 98.4% of 258 RDDs to biologics were successfully completed; RDD was safe and effective for our population.</p>\\n </section>\\n </div>\",\"PeriodicalId\":10334,\"journal\":{\"name\":\"Clinical and Translational Allergy\",\"volume\":\"14 10\",\"pages\":\"\"},\"PeriodicalIF\":4.6000,\"publicationDate\":\"2024-10-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11493553/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical and Translational Allergy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/clt2.12397\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"ALLERGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical and Translational Allergy","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/clt2.12397","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ALLERGY","Score":null,"Total":0}
Retrospective analysis of rapid drug desensitization with biologic agents: A single center experience
Background
Following the increased use of biological agents, a subset of patients experiences hypersensitivity reaction (HSR). We reported our experience with rapid drug desensitization (RDD) to nine biologics (rituximab, infliximab, cetuximab, trastuzumab, pertuzumab, nivolumab, brentuximab, tocilizumab and filgrastim) and identified risk factors for breakthrough reactions (BTRs).
Method
This was a retrospective review (2013–2022) of patients with immediate HSRs to biological agents. Initial HSRs were classified as grade 1, 2, or 3 in their severity. Skin prick tests (SPT)/intradermal tests (IDT) were performed using implicated agents. The phenotypes of HSRs were defined as Type I, cytokine-release syndrome (CRS), mixed reactions (cytokine-release + type I) based on history, clinical presentations and skin tests with implicated biologicals. A 12-step RDD protocol was used.
Results
The study comprised 45 patients (F/M: 31/14, median age: 55 (range: 20–69)). Majority of the patients reacted at the first infusion (n: 29/45, 64.4%). The majority of initial HSRs were grade 3 (n: 24/45, 53.3%) and grade 2 (n: 21/45, 46.6%); none were grade 1. Initial reactions were presented as type I (n: 20/45, 44.4%), CRS (n: 12/45, 26.6%) and mixed (n: 13/45, 28.8%). A total of 258 RDDs were performed and 98.4% of them were completed successfully. BTRs occurred in 36/258 (13.9%) infusions of RDDs. There was no significant association between the BTRs and age, drug cycle, SPT and IDT positivity, gender, comorbidities, or atopy.
Conclusion
In our experience, 98.4% of 258 RDDs to biologics were successfully completed; RDD was safe and effective for our population.
期刊介绍：
Clinical and Translational Allergy, one of several journals in the portfolio of the European Academy of Allergy and Clinical Immunology, provides a platform for the dissemination of allergy research and reviews, as well as EAACI position papers, task force reports and guidelines, amongst an international scientific audience.
Clinical and Translational Allergy accepts clinical and translational research in the following areas and other related topics: asthma, rhinitis, rhinosinusitis, drug hypersensitivity, allergic conjunctivitis, allergic skin diseases, atopic eczema, urticaria, angioedema, venom hypersensitivity, anaphylaxis, food allergy, immunotherapy, immune modulators and biologics, animal models of allergic disease, immune mechanisms, or any other topic related to allergic disease.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
