Requalification of patients with severe asthma for biological therapy—Practical ‘ReQuaBi’ rate decision scheme based on the analytical model

IF 4.6 2区医学 Q2 ALLERGY

Clinical and Translational Allergy Pub Date : 2025-05-09 DOI:10.1002/clt2.70059

Alicja Majos, Anna Ben Drissi, Maciej Kupczyk, Michał Panek

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引用次数: 0

Abstract

Background

Patients with severe asthma experience decreased quality of life due to fixed airway obstruction, hospitalisations and potential fatalities. However, to date, the requalification of severe asthma patients eligible for biological therapy in daily clinical practice remains unstudied.

Objective

The aim of the study was to prepare a universal decision-making algorithm for requalifying patients for biological therapy based on available clinical data obtained from a leading reference centre in Poland.

Methods

All severe asthma patients treated with biologics since 2013 at the Internal Medicine, Asthma and Allergy Department (Medical University of Lodz, Poland), were analysed. The analysis included demographic (age, sex), pre-treatment (reported at qualification: oral glucocorticosteroids use, total IgE serum level, peripheral blood eosinophilia, co-morbidities: atopic dermatitis, chronic allergic rhinitis or sinusitis) and treatment-related data (treatment time, current treatment status, reason for early termination of therapy, year of discontinuation, rediagnostics, requalification).

Results

Rediagnostics were performed in only 4.76% of all requalifications. The following additional data were used to requalify patients: blood eosinophilia (n = 63; 100.00% of requalifications), atopic comorbidities (n = 30; 47.62%) and total IgE serum level (n = 8; 12.70%). Kaplan–Meier curve analysis of all source data revealed the longevity of maintenance as follows: the highest for mepolizumab, then omalizumab, benralizumab, dupilumab and tezepelumab (p = 0.016). Based on the results, requalification model ‘ReQuaBi’, was constructed.

Conclusion

The most important criteria for selecting a biological agent in requalification are peripheral blood eosinophilia, followed by comorbidities and IgE levels. In most cases, extensive additional re-diagnosis may not be necessary.

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查看原文本刊更多论文

重度哮喘患者生物治疗的再认证——基于分析模型的实用“ReQuaBi”率决策方案

背景：严重哮喘患者由于固定气道阻塞、住院和潜在的死亡而经历生活质量下降。然而，迄今为止，重症哮喘患者在日常临床实践中是否有资格接受生物治疗仍未得到研究。该研究的目的是根据波兰一家领先参考中心获得的现有临床数据，为重新确定患者接受生物治疗的资格准备一种通用决策算法。方法对2013年以来波兰罗兹医科大学（Lodz Medical University of Lodz）哮喘与过敏内科所有使用生物制剂治疗的重症哮喘患者进行分析。分析包括人口统计学（年龄、性别）、治疗前（确认时报告：口服糖皮质激素使用、血清总IgE水平、外周血嗜酸性粒细胞增加、合并症：特应性皮炎、慢性变应性鼻炎或鼻窦炎）和治疗相关数据（治疗时间、当前治疗状态、早期终止治疗的原因、停药年份、重新诊断、重新确认）。结果再诊断率仅为4.76%。以下附加数据用于重新评估患者：血嗜酸性粒细胞增多(n = 63；100.00%)，特应性合并症(n = 30；47.62%)和血清总IgE水平(n = 8；12.70%)。Kaplan-Meier曲线分析显示，mepolizumab的维持寿命最高，其次是omalizumab、benralizumab、dupilumab和tezepelumab （p = 0.016）。在此基础上，构建了再认证模型“ReQuaBi”。结论在再鉴定中选择生物制剂最重要的标准是外周血嗜酸性粒细胞增多，其次是合并症和IgE水平。在大多数情况下，可能不需要广泛的额外重新诊断。

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

Clinical and Translational Allergy Immunology and Microbiology-Immunology

CiteScore

7.50

自引率

4.50%

发文量

117

审稿时长

12 weeks

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.