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从奥马珠单抗转换为美泊利珠单抗:来自意大利南部的真实临床经验。

Switching from omalizumab to mepolizumab: real-life experience from Southern Italy.

机构信息

Department of Basic Medical Sciences, Neuroscience and Sense Organs, Section of Respiratory Disease, University "Aldo Moro" of Bari, Bari, Italy.

Department of Health Sciences, Section of Respiratory Disease, University "Magna Græcia" of Catanzaro, Catanzaro, Italy.

出版信息

Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620929231. doi: 10.1177/1753466620929231.

Abstract

BACKGROUND

Current availability of several biologic treatments for severe asthma makes it possible to choose the most appropriate for each patient. Sometimes a good percentage of patients with severe asthma may be eligible for biologics that target either the allergic phenotype or the eosinophilic one, but not all respond to that selected as first choice. The aim of our real-life study was to assess whether, for patients with severe eosinophilic allergic asthma, not previously controlled by the anti-IgE omalizumab, the shift to another biologic targeting interleukin-5, such as mepolizumab, may represent a good therapeutic choice.

METHODS

A total of 41 consecutive patients with severe, persistent allergic, eosinophilic asthma, uncontrolled despite treatment with omalizumab, were enrolled in seven certified Clinical Respiratory Units of Southern Italy (Catania, Catanzaro, Foggia, Bari, Palermo, and two University Respiratory Units of Naples) and shifted to mepolizumab without a wash-out period. Data at baseline, after at least 12 months of therapy with omalizumab, and after at least 12 months of treatment with mepolizumab were collected.

RESULTS

After at least 12 months of therapy with mepolizumab, patients experienced a significant decrease in the number of exacerbations/year (5.8 ± 1.8 0.7 ± 0.9,  < 0.0001), an increment of asthma control test score (12 ± 2.7 21.9 ± 2.7,  < 0.0001), an increase in pre-bronchodilator forced expiratory volume in 1 s (1.56 ± 0.45 l 1.86 ± 0.52 l,  < 0.0001), and a reduction of blood eosinophils (584 ± 196 cells/µl 82 ± 56 cells/µl,  < 0.0001). The percentage of patients who were dependent on corticosteroids significantly decreased from 46% at baseline to 5% during treatment with mepolizumab.

CONCLUSION

Results of our real-life multicentric experience confirms that the shift to mepolizumab could be a good therapeutic strategy in severe eosinophilic allergic asthma not previously controlled by omalizumab.

摘要

背景

目前有多种生物制剂可用于治疗严重哮喘,这使得我们可以为每位患者选择最合适的治疗方案。对于有严重哮喘的患者,其中很大一部分可能适合使用靶向过敏表型或嗜酸性粒细胞表型的生物制剂,但并非所有患者对作为首选药物的生物制剂都有反应。本真实研究的目的是评估对于先前未通过抗 IgE 奥马珠单抗控制的严重嗜酸性粒细胞性变应性哮喘患者,是否可以将另一种靶向白细胞介素-5 的生物制剂(如美泊利珠单抗)作为一种更好的治疗选择。

方法

共纳入意大利南部 7 个认证的临床呼吸单位(卡塔尼亚、卡坦扎罗、福贾、巴里、巴勒莫,以及那不勒斯的两个大学呼吸单位)的 41 例严重、持续、变应性、嗜酸性粒细胞性哮喘患者,这些患者尽管接受了奥马珠单抗治疗,但仍未得到控制,然后将他们无洗脱期地转为美泊利珠单抗治疗。收集基线时、接受奥马珠单抗治疗至少 12 个月后以及接受美泊利珠单抗治疗至少 12 个月后的资料。

结果

接受美泊利珠单抗治疗至少 12 个月后,患者每年哮喘加重次数显著减少(5.8±1.8 与 0.7±0.9, <0.0001),哮喘控制测试评分增加(12±2.7 与 21.9±2.7, <0.0001),支气管扩张前用力呼气 1 秒量(FEV1)增加(1.56±0.45 与 1.86±0.52, <0.0001),血液嗜酸性粒细胞计数减少(584±196 与 82±56 细胞/µl, <0.0001)。需要皮质类固醇治疗的患者比例从基线时的 46%显著下降至美泊利珠单抗治疗期间的 5%。

结论

本真实多中心研究结果证实,对于先前未通过奥马珠单抗控制的严重嗜酸性粒细胞性变应性哮喘患者,转为美泊利珠单抗治疗可能是一种有效的治疗策略。

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