意大利西北部使用抗白细胞介素-5疗法的经验及与对照试验的比较。
The North-Western Italian experience with anti IL-5 therapy amd comparison with regulatory trials.
作者信息
Bagnasco Diego, Milanese Manlio, Rolla Giovanni, Lombardi Carlo, Bucca Caterina, Heffler Enrico, Canonica Giorgio Walter, Passalacqua Giovanni
机构信息
1Allergy and Respiratory Diseases, IRCCS Policlinico San Martino, University of Genoa, Genoa, Italy.
2Division of Pneumology, S.Corona Hospital, Pietra Ligure, Italy.
出版信息
World Allergy Organ J. 2018 Dec 6;11(1):34. doi: 10.1186/s40413-018-0210-7. eCollection 2018.
BACKGROUND
The severe forms of asthma represent a major burden, because of severity of symptoms, costs and impact on everyday life. Recently, Mepolizumab (MEP) was approved and marketed for the treatment of hypereosinophilic severe asthma. This anti-IL-5 monoclonal antibody reduced exacerbation rates and oral corticosteroid (OCS) use in well selected patients. The aim of this study was to evaluate the characteristics of patients receiving MEP in a real-life setting. Thus, we describe a retrospective analysis of patients treated with MEP in six centres in North Western Italy, including those who participated in the main regulatory trials.
METHODS
The baseline data, before prescription, from six North Western Italy severe asthma clinics, between June 1st 2017 and December 31st 2017, were evaluated. The collected real-life data were then compared with those of SIRUS, MENSA, DREAM and MUSCA trials.
RESULTS
Sixty-five patients were included (45% female; mean age 56 years; age range 19-84). Main observed differences with regulatory trials could be observed in eosinophils blood count at baseline, where the mean of our real-life patients (653 cells/μL) was overall higher than the one of all trials (240 cells/μL, 296 cells/μL, 253 cells/μL; < 0.0001). The incidence of polyposis was also significantly higher in our sample (72% vs. 24%, 49%, 10%, 19%; p < 0.0001). The daily average dose of OCS was lower in our real-life patients (9 mg), if compared with SIRIUS (13.7 mg), MENSA (13.2) and MUSCA (13), and similar to the data published in DREAM (10.8).
CONCLUSIONS
The comparison of real-life patients' characteristics with regulatory trials, displayed several apparent discrepancies. The demographic and clinical aspects were similar in all groups, whereas other features (eosinophil count, pulmonary function FEV1%) differed. These data, for the first time, could represent a basis for a more accurate prescription of the drug.
背景
重度哮喘因其症状严重、费用高昂以及对日常生活的影响，成为一项重大负担。最近，美泊利单抗（MEP）被批准用于治疗嗜酸性粒细胞增多性重度哮喘。这种抗白细胞介素-5单克隆抗体在精心挑选的患者中降低了急性加重率并减少了口服糖皮质激素（OCS）的使用。本研究的目的是评估在实际临床环境中接受MEP治疗的患者特征。因此，我们对意大利西北部六个中心接受MEP治疗的患者进行了回顾性分析，其中包括参与主要监管试验的患者。
方法
对2017年6月1日至2017年12月31日期间意大利西北部六个重度哮喘诊所处方前的基线数据进行评估。然后将收集到的实际临床数据与SIRUS、MENSA、DREAM和MUSCA试验的数据进行比较。
结果
共纳入65例患者（45%为女性；平均年龄56岁；年龄范围19 - 84岁）。与监管试验相比，主要观察到的差异在于基线时的嗜酸性粒细胞计数，我们实际临床患者的平均值（653个细胞/μL）总体高于所有试验中的平均值（240个细胞/μL、296个细胞/μL、253个细胞/μL；<0.0001）。我们样本中鼻息肉病的发生率也显著更高（72% 对比24%、49%、10%、19%；p<0.0001）。与SIRIUS（13.7mg）、MENSA（13.2mg）和MUSCA（13mg）相比，我们实际临床患者的OCS每日平均剂量较低（9mg），与DREAM试验中公布的数据（10.8mg）相似。
结论
实际临床患者特征与监管试验的比较显示出一些明显差异。所有组的人口统计学和临床方面相似，但其他特征（嗜酸性粒细胞计数、肺功能FEV1%）有所不同。这些数据首次可能为更准确地开具该药物处方提供依据。
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