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重度哮喘与倍利珠单抗在现实生活中的长期疗效

Severe asthma and long-term Benralizumab effectiveness in real-life.

作者信息

Sposato B, Scalese M, Camiciottoli G, Carpagnano G E, Pelaia C, Santus P, Pelaia G, Palmiero G, Di Tomassi M, Ronchi M C, Cameli P, Bargagli E, Ciambellotti L, Rizzello S, Sglavo R, Coppola A, Lacerenza L G, Gabriele M, Radovanovic D, Perrella A, Ricci A, Rogliani P

机构信息

Pneumology Department, Azienda USL Toscana Sud-Est, "Misericordia" Hospital, Grosseto, Italy.

出版信息

Eur Rev Med Pharmacol Sci. 2022 Oct;26(20):7461-7473. doi: 10.26355/eurrev_202210_30016.

Abstract

OBJECTIVE

Long-term efficacy of Benralizumab in real life is not clearly known. We assessed the long-term effectiveness persistence to anti-IL-5R treatment in a group of severe eosinophilic asthmatics.

PATIENTS AND METHODS

We retrospectively analyzed 95 individuals affected by severe asthma (36 males  ̶ 37.9%; mean age 58.1 ± 12.2) treated with Benralizumab (mean time 19.7 ± 7.2 months, range 12-35). Outcomes were evaluated at the beginning and at the end of patients' treatment periods.

RESULTS

Mean baseline blood eosinophils were 897.5 ± 720.1 cells/μL (11 ± 5.6%) decreasing to 7.4 ± 20.6 cells/μL (0.97 ± 0.26%; p < 0.0001) after Benralizumab. FENO likewise decreased from 63.9 ± 68.4 to 28.4 ± 23.6 ppb, while FEV1% significantly improved (p < 0.0001). Mean FEF25-75 also increased from 45.8 ± 24.6% to 60.7 ± 24.6%, whereas RAW dropped from 202.15 ± 109.6% to 135.2 ± 54.75% (p < 0.0001). Also, lung volumes greatly decreased. ACT/ACQ significantly improved, while exacerbations number fell from 4.1 ± 2.4, before anti-IL-5R, to 0.33 ± 0.77, after treatment (p < 0.0001). Rhinitis severity levels and SNOT-22 also changed favorably. Patients that took long-term OCs were 71.6% before treatment, decreasing to 23.2% after Benralizumab (p < 0.0001), with an OCs dose reduction from 14.8 ± 8.9 to 1.45 ± 2.8 mg/day (p < 0.0001). 51.6% of subjects used SABA as needed before Benralizumab, falling to 4.2% after treatment. Several patients showed a reduction of ICS doses, SABA use and maintenance therapy step-down. Clinical/biological response with anti-IL-5R remained constant or even improved in terms of exacerbations or maintenance therapy reductions over time. On the contrary, FEF25-75% improvement slowed down in the long-term. No relationship was found between baseline blood eosinophil number and therapeutic response.

CONCLUSIONS

Long-term Benralizumab effectiveness persistence in all outcomes in real life was confirmed.

摘要

目的

在现实生活中,贝那利珠单抗的长期疗效尚不清楚。我们评估了一组重度嗜酸性粒细胞性哮喘患者接受抗IL-5R治疗的长期有效性持续性。

患者和方法

我们回顾性分析了95例重度哮喘患者(36例男性,占37.9%;平均年龄58.1±12.2岁),他们接受了贝那利珠单抗治疗(平均治疗时间19.7±7.2个月,范围为12 - 35个月)。在患者治疗期开始和结束时评估结果。

结果

基线时平均血液嗜酸性粒细胞为897.5±720.1个/μL(11±5.6%),使用贝那利珠单抗后降至7.4±20.6个/μL(0.97±0.26%;p<0.0001)。呼出一氧化氮(FENO)同样从63.9±68.4降至28.4±23.6 ppb,而第1秒用力呼气容积百分比(FEV1%)显著改善(p<0.0001)。平均用力呼气中期流速(FEF25 - 75)也从45.8±24.6%增加到60.7±24.6%,而气道阻力(RAW)从202.15±109.6%降至135.2±54.75%(p<0.0001)。此外,肺容积大幅下降。哮喘控制测试(ACT)/哮喘控制问卷(ACQ)显著改善,发作次数从抗IL-5R治疗前的4.1±2.4次降至治疗后的0.33±0.77次(p<0.0001)。鼻炎严重程度和鼻结膜炎生活质量问卷(SNOT - 22)评分也有有利变化。治疗前长期使用口服糖皮质激素(OCs)的患者为71.6%,使用贝那利珠单抗后降至23.2%(p<o.0001),OCs剂量从14.8±8.9毫克/天降至1.45±2.8毫克/天(p<0.0001)。51.6%的受试者在使用贝那利珠单抗前按需使用短效β2受体激动剂(SABA),治疗后降至4.2%。几名患者的吸入性糖皮质激素(ICS)剂量、SABA使用量减少,维持治疗降级。随着时间推移,抗IL-5R治疗的临床/生物学反应在发作或维持治疗减少方面保持稳定甚至有所改善。相反地,长期来看,FEF25 - 75%的改善速度减慢。未发现基线血液嗜酸性粒细胞数量与治疗反应之间存在关联。

结论

证实了贝那利珠单抗在现实生活中对所有结局的长期有效性持续性。

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