{"title":"慢性自发性荨麻疹患者奥马珠单抗更新用药模式的特征及预测因素:一项前瞻性多中心观察研究。","authors":"Guillaume Pierrard, Claire Bernier, Aurélie Du-Thanh, Corina Bara, Angèle Soria, Florence Castelain, Isabelle Boccon-Gibod, Florence Hacard, Juliette Delaunay, Laurence de Montjoye, Delphine Staumont-Salle, Frédéric Dezoteux","doi":"10.1111/all.16256","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Limited information is available on the use of omalizumab (OMA) updosing since its introduction as a second-line therapy in chronic spontaneous urticaria (CSU) in 2014. Practical guidelines from health authorities are lacking, and the specific characteristics of patients requiring higher doses remain unknown. Our objectives were to characterize the patterns of OMA updosing (defined as changes in dose and/or injection intervals), to identify the predictive factors associated with updosing, and to improve CSU management.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>We conducted a prospective, multicentric, real-life observational study, including patients diagnosed with CSU and starting OMA. The data were collected at 0, 3, 6, and 9 months. The primary endpoint was the frequency of OMA updosing at 3 months. The secondary endpoints included an analysis of updosed patients' profile, and an assessment of OMA efficacy and safety.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>We included 153 patients. Twenty percent of patients were updosed at 3 months, and 27% in total during the 9-month follow-up. Practitioners mainly chose to increase the frequency of injections (66%). At baseline, the updosed patients were more likely to have more severe CSU (UCT < 4, <i>p</i> < 0.030), a lower lymphocyte count (<2000/mm<sup>3</sup>, <i>p</i> = 0.037), and low IgE levels (<70 UI/mL, <i>p</i> = 0.024). The side effects of OMA were not more frequent after updosing.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>One in five patient underwent updosing within just 3 months. OMA updosing is frequent in particular in cases of severe disease and low IgE blood levels.</p>\n </section>\n </div>","PeriodicalId":122,"journal":{"name":"Allergy","volume":null,"pages":null},"PeriodicalIF":12.6000,"publicationDate":"2024-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/all.16256","citationCount":"0","resultStr":"{\"title\":\"Characterization of omalizumab updosing patterns and predictive factors in chronic spontaneous urticaria: A prospective multicentric observational study\",\"authors\":\"Guillaume Pierrard, Claire Bernier, Aurélie Du-Thanh, Corina Bara, Angèle Soria, Florence Castelain, Isabelle Boccon-Gibod, Florence Hacard, Juliette Delaunay, Laurence de Montjoye, Delphine Staumont-Salle, Frédéric Dezoteux\",\"doi\":\"10.1111/all.16256\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>Limited information is available on the use of omalizumab (OMA) updosing since its introduction as a second-line therapy in chronic spontaneous urticaria (CSU) in 2014. Practical guidelines from health authorities are lacking, and the specific characteristics of patients requiring higher doses remain unknown. Our objectives were to characterize the patterns of OMA updosing (defined as changes in dose and/or injection intervals), to identify the predictive factors associated with updosing, and to improve CSU management.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>We conducted a prospective, multicentric, real-life observational study, including patients diagnosed with CSU and starting OMA. The data were collected at 0, 3, 6, and 9 months. The primary endpoint was the frequency of OMA updosing at 3 months. The secondary endpoints included an analysis of updosed patients' profile, and an assessment of OMA efficacy and safety.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>We included 153 patients. Twenty percent of patients were updosed at 3 months, and 27% in total during the 9-month follow-up. Practitioners mainly chose to increase the frequency of injections (66%). At baseline, the updosed patients were more likely to have more severe CSU (UCT < 4, <i>p</i> < 0.030), a lower lymphocyte count (<2000/mm<sup>3</sup>, <i>p</i> = 0.037), and low IgE levels (<70 UI/mL, <i>p</i> = 0.024). The side effects of OMA were not more frequent after updosing.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusion</h3>\\n \\n <p>One in five patient underwent updosing within just 3 months. OMA updosing is frequent in particular in cases of severe disease and low IgE blood levels.</p>\\n </section>\\n </div>\",\"PeriodicalId\":122,\"journal\":{\"name\":\"Allergy\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":12.6000,\"publicationDate\":\"2024-07-26\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1111/all.16256\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Allergy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1111/all.16256\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ALLERGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Allergy","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/all.16256","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ALLERGY","Score":null,"Total":0}
引用次数: 0
摘要
背景:自 2014 年奥马珠单抗(OMA)作为慢性自发性荨麻疹(CSU)的二线疗法推出以来,有关其更新剂量使用的信息十分有限。卫生部门缺乏实用指南,需要加大剂量的患者的具体特征仍不清楚。我们的目标是描述奥马西林更新剂量(定义为剂量和/或注射间隔的变化)的模式,确定与更新剂量相关的预测因素,并改善CSU的管理:我们开展了一项前瞻性、多中心、真实生活观察研究,研究对象包括确诊为 CSU 并开始使用 OMA 的患者。数据收集时间为 0、3、6 和 9 个月。主要终点是 3 个月时 OMA 的更新频率。次要终点包括分析更新患者的概况以及评估 OMA 的疗效和安全性:我们共纳入了 153 名患者。20%的患者在3个月时更新了OMA,在9个月的随访期间,总计有27%的患者更新了OMA。医生主要选择增加注射次数(66%)。在基线时,接受更新治疗的患者更有可能患有更严重的CSU(UCT 3,p = 0.037)和低IgE水平(结论:每五名患者中就有一名接受了更新治疗):每五名患者中就有一人在短短三个月内接受了更新治疗。在病情严重和 IgE 血液水平较低的病例中,OMA 更新治疗尤为频繁。
Characterization of omalizumab updosing patterns and predictive factors in chronic spontaneous urticaria: A prospective multicentric observational study
Background
Limited information is available on the use of omalizumab (OMA) updosing since its introduction as a second-line therapy in chronic spontaneous urticaria (CSU) in 2014. Practical guidelines from health authorities are lacking, and the specific characteristics of patients requiring higher doses remain unknown. Our objectives were to characterize the patterns of OMA updosing (defined as changes in dose and/or injection intervals), to identify the predictive factors associated with updosing, and to improve CSU management.
Methods
We conducted a prospective, multicentric, real-life observational study, including patients diagnosed with CSU and starting OMA. The data were collected at 0, 3, 6, and 9 months. The primary endpoint was the frequency of OMA updosing at 3 months. The secondary endpoints included an analysis of updosed patients' profile, and an assessment of OMA efficacy and safety.
Results
We included 153 patients. Twenty percent of patients were updosed at 3 months, and 27% in total during the 9-month follow-up. Practitioners mainly chose to increase the frequency of injections (66%). At baseline, the updosed patients were more likely to have more severe CSU (UCT < 4, p < 0.030), a lower lymphocyte count (<2000/mm3, p = 0.037), and low IgE levels (<70 UI/mL, p = 0.024). The side effects of OMA were not more frequent after updosing.
Conclusion
One in five patient underwent updosing within just 3 months. OMA updosing is frequent in particular in cases of severe disease and low IgE blood levels.
期刊介绍:
Allergy is an international and multidisciplinary journal that aims to advance, impact, and communicate all aspects of the discipline of Allergy/Immunology. It publishes original articles, reviews, position papers, guidelines, editorials, news and commentaries, letters to the editors, and correspondences. The journal accepts articles based on their scientific merit and quality.
Allergy seeks to maintain contact between basic and clinical Allergy/Immunology and encourages contributions from contributors and readers from all countries. In addition to its publication, Allergy also provides abstracting and indexing information. Some of the databases that include Allergy abstracts are Abstracts on Hygiene & Communicable Disease, Academic Search Alumni Edition, AgBiotech News & Information, AGRICOLA Database, Biological Abstracts, PubMed Dietary Supplement Subset, and Global Health, among others.