Scioscia Giulia, Tondo Pasquale, Nolasco Santi, Pelaia Corrado, Carpagnano Giovanna Elisiana, Caiaffa Maria Filomena, Valenti Giuseppe, Maglio Angelantonio, Papia Francesco, Triggiani Massimo, Crimi Nunzio, Pelaia Girolamo, Vatrella Alessandro, Foschino Barbaro Maria Pia, Crimi Claudia
Department of Medical and Surgical Sciences, University of Foggia, 71122 Foggia, Italy.
Department of Clinical and Experimental Medicine, University of Catania, 95124 Catania, Italy.
J Clin Med. 2023 Jun 28;12(13):4362. doi: 10.3390/jcm12134362.
Mepolizumab and benralizumab are monoclonal antibodies directed against anti-IL-5 and anti-IL5R, respectively, and their use reduces the exacerbation rate and maintains oral corticosteroid requirements in severe eosinophilic asthma. Previous studies have tested the therapeutic switch between two biologics with excellent results, further demonstrating the heterogeneity of asthmatic disease and the complexity of the therapeutic choice. It remains unclear if such patients may improve following a switch from mepolizumab to benralizumab.
Within a multicentre real-life setting, we decided to evaluate the potential effectiveness of a therapeutic switch to benralizumab in patients with severe eosinophilic asthma initially treated with mepolizumab, who experienced sub-optimal responses. The secondary aim was to identify the clinical factors associated with a better response to benralizumab.
We retrospectively assessed patients with severe eosinophilic asthma treated at six Italian specialist centres, who were switched from mepolizumab to benralizumab following a sub-optimal response, defined as a partial or total lack of clinical remission (i.e., frequent severe exacerbations and/or poorly controlled symptoms and/or higher OCS daily use in patients with a poor or moderate response in the global evaluation of treatment effectiveness scale), after at least 12 months of treatment.
Twenty-five patients were included in the analysis (mean age 56.76 ± 11.97 years, 65% female). At 6 months of treatment with benralizumab, the ACT score was significantly higher than the ACT score with mepolizumab (20.24 ± 3.38 vs. 16.77 ± 3.48, < 0.0001); the mean number of daily SABA inhalations was significantly lower after 6 months and 12 months of treatment with benralizumab than that after treatment with mepolizumab; OCS intake and the prednisone median dosage at 6 months of treatment with benralizumab were significantly lower than those with mepolizumab. Benralizumab treatment resulted in a marked improvement in asthma control, suppressed blood eosinophil levels and reduction in the number of exacerbations in the subgroup of patients with severe eosinophilic asthma and nasal polyposis.
Patients diagnosed with severe eosinophilic asthma who experience a partial response to mepolizumab could benefit from switching to benralizumab, and even more those who have nasal polyposis.
美泊利单抗和贝那利珠单抗分别是针对抗白细胞介素-5(IL-5)和抗IL-5受体的单克隆抗体,它们的使用可降低重度嗜酸性粒细胞性哮喘的急性加重率,并维持口服糖皮质激素的需求量。既往研究对两种生物制剂之间的治疗转换进行了测试,结果良好,进一步证明了哮喘疾病的异质性和治疗选择的复杂性。目前尚不清楚从美泊利单抗转换为贝那利珠单抗后这些患者是否会有所改善。
在多中心现实生活环境中,我们决定评估对于最初接受美泊利单抗治疗但反应欠佳的重度嗜酸性粒细胞性哮喘患者,转换为使用贝那利珠单抗治疗的潜在有效性。次要目的是确定与对贝那利珠单抗反应更好相关的临床因素。
我们回顾性评估了在六个意大利专科中心接受治疗的重度嗜酸性粒细胞性哮喘患者,这些患者在至少12个月的治疗后,因反应欠佳(定义为部分或完全缺乏临床缓解,即在治疗有效性全球评估量表中反应较差或中等的患者中频繁出现严重急性加重和/或症状控制不佳和/或每日口服糖皮质激素用量较高)而从美泊利单抗转换为贝那利珠单抗。
25例患者纳入分析(平均年龄56.76±11.97岁,65%为女性)。在使用贝那利珠单抗治疗6个月时,哮喘控制测试(ACT)评分显著高于使用美泊利单抗时的评分(20.24±3.38对16.77±3.48,<0.0001);在使用贝那利珠单抗治疗6个月和12个月后,每日吸入短效β2受体激动剂(SABA)的平均次数显著低于使用美泊利单抗治疗后;在使用贝那利珠单抗治疗6个月时,口服糖皮质激素的摄入量和泼尼松中位剂量显著低于使用美泊利单抗时。贝那利珠单抗治疗使重度嗜酸性粒细胞性哮喘合并鼻息肉患者亚组的哮喘控制得到显著改善,抑制了血液嗜酸性粒细胞水平,并减少了急性加重次数。
被诊断为重度嗜酸性粒细胞性哮喘且对美泊利单抗有部分反应的患者,转换为使用贝那利珠单抗可能会获益,尤其是那些患有鼻息肉的患者。