Department of Biomedical and Clinical Sciences, University of Milan, Milan, Italy.
Division of Respiratory Diseases, Luigi Sacco University Hospital, ASST Fatebenefratelli-Sacco, Milan, Italy.
Ann Med. 2024 Dec;56(1):2407523. doi: 10.1080/07853890.2024.2407523. Epub 2024 Oct 7.
Patients with severe asthma frequently have comorbid chronic rhinosinusitis (CRS) with or without nasal polyps, that can increase the symptom burden and complicate treatment. Real-life clinical data on the impact of biologic treatments on CRS-specific quality-of-life questionnaires are still lacking.
In this retrospective real-life study, we collected data from patients with severe asthma with comorbid CRS with/without nasal polyposis at baseline, and after 3, 6 and 12 months of treatment with omalizumab, mepolizumab, benralizumab or dupilumab. In particular, we evaluated improvements in HRQoL as measured by SinoNasal Outcome Test-22 (SNOT-22, 0 - 110), Visual Analog Scale symptom scores (VAS, 0-10), and Asthma Control Test (ACT, 5-25) and the proportion of patients meeting the minimal clinically important difference (MCID).
Disease-specific HRQoL, as measured by SNOT 22 and VAS score improved in all patients at 3, 6, and 12 months of treatment compared with baseline (SNOT-22: 14, IQR: 0-52 vs 10, IQR:0-30 vs 0, IQR:0-15 vs 0, IQR:0-12, < 0.001, VAS score: 1, IQR: 0-5 vs 0, IQR:0-3 vs 0, IQR:0-2 vs 0, IQR 0-1, < 0.001). After 3 months of treatment >80% of patients reached the MCID for ACT, while only patients on dupilumab showed to reach a MCID in 100% of cases. The effect size depended upon the symptom burden at baseline.
The study confirms the efficacy of omalizumab, mepolizumab, benralizumab, and dupilumab in a real-life setting, with a rapid improvement in CRS-specific HRQoL and general health status. These data highlight the importance of targeting type 2 inflammation in asthmatic patients with co-existing upper and lower airways disease.The Authors disclose that preliminary data and analysis of the present study have been presented in abstract form during the "X International Workshop on Lung Health - Respiratory Disease and Immune Response", held in Nice on 19-21 January 2023.
患有严重哮喘的患者常伴有慢性鼻-鼻窦炎（CRS），伴或不伴鼻息肉，这会增加症状负担并使治疗复杂化。关于生物治疗对 CRS 特异性生活质量问卷的影响的真实临床数据仍然缺乏。
在这项回顾性真实世界研究中，我们从基线时患有伴有/不伴有鼻息肉的 CRS 的严重哮喘合并症患者中收集数据，并在接受奥马珠单抗、美泊利珠单抗、贝那利珠单抗或度普利尤单抗治疗 3、6 和 12 个月后收集数据。特别是，我们评估了 SinoNasal Outcome Test-22（SNOT-22，0-110）、视觉模拟量表症状评分（VAS，0-10）和哮喘控制测试（ACT，5-25）的 HRQoL 改善情况，以及达到最小临床重要差异（MCID）的患者比例。
与基线相比，所有患者在治疗 3、6 和 12 个月时，疾病特异性 HRQoL 均得到改善，SNOT 22 和 VAS 评分均得到改善（SNOT-22：14，IQR：0-52 比 10，IQR：0-30 比 0，IQR：0-15 比 0，IQR：0-12，<0.001，VAS 评分：1，IQR：0-5 比 0，IQR：0-3 比 0，IQR：0-2 比 0，IQR：0-1，<0.001）。治疗 3 个月后，超过 80%的患者 ACT 达到 MCID，而只有接受度普利尤单抗治疗的患者达到 100%的 MCID。治疗效果的大小取决于基线时的症状负担。
该研究在真实环境中证实了奥马珠单抗、美泊利珠单抗、贝那利珠单抗和度普利尤单抗的疗效，CRS 特异性 HRQoL 和一般健康状况迅速改善。这些数据强调了在伴有上、下呼吸道疾病的哮喘患者中靶向 2 型炎症的重要性。作者披露，本研究的初步数据和分析已在 2023 年 1 月 19 日至 21 日在尼斯举行的“第十届肺健康国际研讨会-呼吸道疾病和免疫反应”上以摘要形式呈现。
