Sposato Bruno, Camiciottoli Gianna, Bacci Elena, Scalese Marco, Carpagnano Giovanna Elisiana, Pelaia Corrado, Santus Pierachille, Maniscalco Mauro, Masieri Simonetta, Corsico Angelo, Scichilone Nicola, Baglioni Stefano, Murgia Nicola, Folletti Ilenia, Bardi Giulio, Grosso Amelia, Cameli Paolo, Latorre Manuela, Musarra Antonino, Bargagli Elena, Ricci Alberto, Pelaia Girolamo, Paggiaro Pierluigi, Rogliani Paola
Azienda USL Toscana Sud-Est Pneumology Department, "Misericordia" Hospital, Grosseto, Italy; Experimental Medicine and Systems, "PhD Program" Department of Systems Medicine University of Rome "Tor Vergata", Italy.
Section of Respiratory Medicine, Department of Experimental and Clinical Medicine, Careggi University Hospital, University of Florence, Largo A Brambilla 3, 50134, Florence, Italy.
Pulm Pharmacol Ther. 2020 Apr;61:101899. doi: 10.1016/j.pupt.2020.101899. Epub 2020 Jan 21.
Mepolizumab (MEP) has been recently introduced to treat severe eosinophilic asthma. Trials have demonstrated a significant effectiveness in this asthma phenotype. We evaluated MEP efficacy on lung function, symptoms, asthma exacerbations, biologic markers, steroid dependence and controller treatment level in real-life.
We retrospectively analyzed 134 severe asthmatics (61 males; mean age 58.3 ± 11; mean FEV%:72 ± 21), treated with MEP for at least 6 months (mean duration:10.9 ± 3.7 months).
FEV% improved significantly after MEP. Mean FEF also increased from 37.4 ± 25.4% to 47.2 ± 27.2% (p < 0.0001). Mean baseline blood eosinophil level was 712 ± 731/μL (8.4 ± 5.2%) decreasing to 151 ± 384/μL (1.6 ± 1.6%) (p < 0.0001), FENO levels decreased likewise. MEP treatment also led to a significant ACT improvement (mean pre:14.2 ± 4.4; mean post:20.5 ± 28) and exacerbations significantly fell from 3.8 ± 1.9 to 0.8 ± 1.1 (p < 0.0001). 74% of patients were steroid-dependent before MEP. 45.4% and 46.4% of them showed a suspension and dose reduction respectively (p < 0.0001). A significant number reduced also ICS doses. Only 67% of subjects used SABA as needed before MEP, falling to 20% after MEP. About 40% of patients highlighted a maintenance therapy step-down. Subjects showing an omalizumab treatment failure before MEP had a similar positive response when compared with omalizumab untreated patients.
In real-life, MEP improved significantly all outcomes even small airway obstruction, suggesting its possible role also in distal lung region treatment. Furthermore, it demonstrated its high effectiveness in OC/ICS-sparing, in reducing SABA as needed and in stepping-down maintenance therapy. MEP is a valid alternative for patients with previous omalizumab treatment failure.
美泊利单抗(MEP)最近被用于治疗重度嗜酸性粒细胞性哮喘。试验已证明其对这种哮喘表型具有显著疗效。我们评估了MEP在实际临床中对肺功能、症状、哮喘急性发作、生物学标志物、激素依赖及控制治疗水平的疗效。
我们回顾性分析了134例重度哮喘患者(61例男性;平均年龄58.3±11岁;平均FEV%:72±21),这些患者接受MEP治疗至少6个月(平均疗程:10.9±3.7个月)。
MEP治疗后FEV%显著改善。平均FEF也从37.4±25.4%增至47.2±27.2%(p<0.0001)。平均基线血嗜酸性粒细胞水平为712±731/μL(8.4±5.2%),降至151±384/μL(1.6±1.6%)(p<0.0001),FENO水平同样下降。MEP治疗还使ACT显著改善(平均治疗前:14.2±4.4;平均治疗后:20.5±2.8),急性发作次数从3.8±1.9显著降至0.8±1.1(p<0.0001)。74%的患者在使用MEP前依赖激素。其中分别有45.4%和46.4%的患者停用或减量使用激素(p<0.0001)。也有相当数量的患者减少了ICS剂量。在使用MEP前,仅67%的患者按需使用SABA,使用MEP后降至20%。约4%的患者表示维持治疗降级。与未接受奥马珠单抗治疗的患者相比,在使用MEP前奥马珠单抗治疗失败的患者也有类似的阳性反应。
在实际临床中,MEP显著改善了所有指标,甚至包括小气道阻塞,提示其在远端肺区域治疗中也可能发挥作用。此外,它在减少OC/ICS使用、按需减少SABA使用及降低维持治疗水平方面显示出高效性。对于先前奥马珠单抗治疗失败的患者,MEP是一种有效的替代药物。