Omalizumab Implementation in Practice: Lessons Learned From the OUtMATCH Study

IF 8.2 1区医学 Q1 ALLERGY

Journal of Allergy and Clinical Immunology-In Practice Pub Date : 2024-11-01 DOI:10.1016/j.jaip.2024.08.056

Brian P. Vickery MD , J. Andrew Bird MD , R. Sharon Chinthrajah MD , Stacie M. Jones MD , Corinne A. Keet MD, PhD , Edwin H. Kim MD , Donald Y.M. Leung MD, PhD , Wayne G. Shreffler MD, PhD , Scott H. Sicherer MD , Sayantani Sindher MD , Jonathan Spergel MD, PhD , Robert A. Wood MD

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引用次数: 0

Abstract

In February 2024, omalizumab was approved by the U.S. Food and Drug Administration for the treatment of food allergy, based on data from the landmark phase 3 clinical trial, Omalizumab as Monotherapy and as Adjunct Therapy in Children and Adults (OUtMATCH). In this Rostrum, OUtMATCH investigators share their perspectives on the trial results, the implications for translation into daily practice, and on remaining gaps in the field. The study met its primary and key secondary end points, demonstrating a large effect size in multiallergen desensitization compared with placebo; yet there were some participants who did not respond, and the percentage of responders tolerating all 3 food allergens was lower than that for single foods. Clinicians are likely to have many questions about appropriate patient selection, monitoring for treatment responsiveness, and how to manage off-label considerations such as dietary incorporation or cotreatment with oral immunotherapy. Additional research is needed to answer these remaining questions and ensure that the translation of omalizumab in real-world practice leads to high-quality outcomes.

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奥马珠单抗在实践中的应用：从 OUtMATCH 研究中汲取的经验教训。

2024 年 2 月，根据具有里程碑意义的 3 期临床试验 "奥马珠单抗作为儿童和成人的单药和辅助疗法（OUtMATCH）"的数据，奥马珠单抗被美国食品和药物管理局批准用于治疗食物过敏。在本期Rostrum中，OUtMATCH研究人员分享了他们对试验结果、转化为日常实践的意义以及该领域尚存差距的看法。这项研究达到了主要终点和关键次要终点，与安慰剂相比，在多过敏原脱敏方面显示出很大的效应规模；但也有一些参与者没有反应，而且能耐受所有三种食物过敏原的反应者比例低于耐受单一食物过敏原的反应者比例......"。临床医生可能会有很多问题，如如何选择合适的患者、如何监测治疗反应、如何处理标签外的注意事项，如饮食结合或与口服免疫疗法联合治疗等。我们需要开展更多的研究来回答这些遗留问题，并确保奥马珠单抗在实际应用中能带来高质量的疗效。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Allergy and Clinical Immunology-In Practice ALLERGYIMMUNOLOGY-IMMUNOLOGY

CiteScore

11.10

自引率

9.60%

发文量

683

审稿时长

50 days

期刊介绍： JACI: In Practice is an official publication of the American Academy of Allergy, Asthma & Immunology (AAAAI). It is a companion title to The Journal of Allergy and Clinical Immunology, and it aims to provide timely clinical papers, case reports, and management recommendations to clinical allergists and other physicians dealing with allergic and immunologic diseases in their practice. The mission of JACI: In Practice is to offer valid and impactful information that supports evidence-based clinical decisions in the diagnosis and management of asthma, allergies, immunologic conditions, and related diseases. This journal publishes articles on various conditions treated by allergist-immunologists, including food allergy, respiratory disorders (such as asthma, rhinitis, nasal polyps, sinusitis, cough, ABPA, and hypersensitivity pneumonitis), drug allergy, insect sting allergy, anaphylaxis, dermatologic disorders (such as atopic dermatitis, contact dermatitis, urticaria, angioedema, and HAE), immunodeficiency, autoinflammatory syndromes, eosinophilic disorders, and mast cell disorders. The focus of the journal is on providing cutting-edge clinical information that practitioners can use in their everyday practice or to acquire new knowledge and skills for the benefit of their patients. However, mechanistic or translational studies without immediate or near future clinical relevance, as well as animal studies, are not within the scope of the journal.