Majos Alicja, Drissi Anna Ben, Kupczyk Maciej, Panek Michał
Department of General and Transplant Surgery, Medical University of Lodz, Łódź, Poland.
Department of Internal Medicine, Asthma and Allergy, Medical University of Lodz, Łódź, Poland.
Clin Transl Allergy. 2025 May;15(5):e70059. doi: 10.1002/clt2.70059.
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.
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.
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).
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.
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.
重度哮喘患者因气道固定性阻塞、住院治疗及潜在死亡风险而生活质量下降。然而，迄今为止，在日常临床实践中，符合生物治疗条件的重度哮喘患者重新评估的情况仍未得到研究。
本研究旨在根据从波兰一家领先参考中心获得的现有临床数据，制定一种通用的决策算法，用于重新评估患者是否适合生物治疗。
对自2013年以来在波兰罗兹医科大学内科、哮喘与过敏科接受生物制剂治疗的所有重度哮喘患者进行分析。分析内容包括人口统计学信息（年龄、性别）、治疗前信息（资格审查时报告的：口服糖皮质激素使用情况、总IgE血清水平、外周血嗜酸性粒细胞增多、合并症：特应性皮炎、慢性过敏性鼻炎或鼻窦炎）以及治疗相关数据（治疗时间、当前治疗状态、治疗早期终止原因、停药年份、重新诊断、重新评估）。
在所有重新评估中，仅4.76%进行了重新诊断。用于重新评估患者的其他数据如下：血液嗜酸性粒细胞增多（n = 63；重新评估的100. %）、特应性合并症（n = 30；47.62%）和总IgE血清水平（n = 8；12.70%）。对所有源数据进行的Kaplan-Meier曲线分析显示维持治疗的时长如下：美泊利珠单抗最长，其次是奥马珠单抗、贝那利珠单抗、度普利尤单抗和替沙贝单抗（p = 0.016）。基于这些结果，构建了重新评估模型 “ReQuaBi”。
重新评估时选择生物制剂的最重要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，可能无需进行广泛的额外重新诊断。
