Immunoallergology Unit, Careggi University Hospital, Florence, Italy.
Allergology and Clinical Immunology Unit, San Giovanni Di Dio Hospital, Florence, Italy.
J Asthma. 2023 Jan;60(1):158-166. doi: 10.1080/02770903.2022.2036754. Epub 2022 Feb 12.
Mepolizumab is an anti-IL-5 monoclonal antibody that has shown, in different trials, the capacity to induce a reduction of exacerbations, an improvement of asthma control and a significant oral corticosteroid (OCS)-sparing effect. At present, there is limited real-life data about its long-term effects. The aim of the study was to evaluate the long-term effects of mepolizumab in real-life. We conducted a 36-months single-center retrospective study in 51 patients suffering from severe eosinophilic asthma treated with mepolizumab 100 mg/4 weeks. Clinical outcomes (symptoms, annual asthma exacerbation rates) were monitored. Additionally, we estimated annualized OCS dosage before and after mepolizumab treatment. Mepolizumab retention rate in the follow-up period was also evaluated. A significant decrease of the annual rate of asthma exacerbations in association with significant changes in asthma control was observed. Specifically, the exacerbation rate significantly fell from 5.1 ± 4 per person/year in the pre-mepolizumab treatment period to 0.8 ± 1.2 per person/year in the 12-follow-up. The clinical benefit was maintained throughout the study follow up period of 36 months. Mepolizumab treatment induced significant changes in both ACT and ACQ5 scores. The majority of patients (65.2%) experienced a more pronounced improvement of 50% or more in SNOT-22. A mean cumulative OCS exposure reduction of 5365.5 mg over a 3-year period for patients receiving mepolizumab was estimated. The drug retention rate was: 96% at 12 months; 93.7% at 18 months, 88.9% at 24 months and 82.3% at 36 months. Our real-life results confirm that mepolizumab treatment allows to control asthma symptoms, reduce exacerbations and OCS exposure in a significant and sustained manner.
美泊利珠单抗是一种抗白细胞介素-5（IL-5）的单克隆抗体，不同试验表明其具有减少恶化、改善哮喘控制和显著减少口服皮质类固醇（OCS）的作用。目前，关于其长期效果的真实世界数据有限。本研究旨在评估美泊利珠单抗的长期真实世界效果。我们对 51 名接受美泊利珠单抗 100mg/4 周治疗的重度嗜酸性粒细胞性哮喘患者进行了为期 36 个月的单中心回顾性研究。监测了临床结局（症状、每年哮喘恶化率）。此外，我们还估计了美泊利珠单抗治疗前后的 OCS 年剂量。还评估了美泊利珠单抗在随访期间的保留率。观察到哮喘恶化的年发生率显著降低，同时哮喘控制也显著改善。具体来说，在美泊利珠单抗治疗前的 5.1±4 人/年恶化率下降到治疗后的 0.8±1.2 人/年。临床获益在 36 个月的研究随访期间得以维持。美泊利珠单抗治疗诱导了 ACT 和 ACQ5 评分的显著变化。大多数患者（65.2%）的 SNOT-22 评分改善了 50%或更多。估计接受美泊利珠单抗治疗的患者在 3 年内 OCS 累计暴露量减少了 5365.5mg。药物保留率为：12 个月时为 96%；18 个月时为 93.7%；24 个月时为 88.9%；36 个月时为 82.3%。我们的真实世界结果证实，美泊利珠单抗治疗可显著和持续地控制哮喘症状、减少恶化和 OCS 暴露。
