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一项关于在意大利持续性难治性特应性哮喘中添加奥马珠单抗的成本/效用的36个月研究。

A 36-month study on the cost/utility of add-on omalizumab in persistent difficult-to-treat atopic asthma in Italy.

作者信息

Dal Negro Roberto Walter, Tognella Silvia, Pradelli Lorenzo

机构信息

Lung Unit, Orlandi General Hospital, Bussolengo, Verona, Italy.

出版信息

J Asthma. 2012 Oct;49(8):843-8. doi: 10.3109/02770903.2012.717659. Epub 2012 Sep 7.

Abstract

OBJECTIVE

Omalizumab is a biological treatment for difficult-to-treat allergic asthma. Its mechanism of action relies on impeding the binding of immunoglobulin E (IgE) to specific cellular receptors, thus blocking the inflammatory cascade. At present, no long-term data are available on its cost/effectiveness. The aim of this study is to assess long-term clinical outcomes and to measure the cost/utility of long-term omalizumab use in difficult-to-treat allergic asthmatics.

METHODS

The clinical, economic, and quality-of-life (QoL) outcomes of 36-month add-on omalizumab therapy were compared to equivalent outcomes for the year before the therapy's introduction in a cohort (n = 16) of adults with severe uncontrolled atopic asthma on chronic high-dose antiasthma treatments. The variables considered were lung function, IgE levels, health status, Asthma Control Test (ACT) score, QoL (St. George Questionnaire), general practitioner (GP) and specialist visits, number and duration of hospitalizations, emergency room admission, and pharmacological treatment (both dose and duration). Derived calculated indicators were changes in health-related QoL, total healthcare costs, and incremental cost/utility. Data from the two periods were tested for statistically significant differences according to Student's t test and p < .05 was accepted.

RESULTS

Add-on omalizumab significantly and progressively improved asthma control and patient health-related QoL. Symptomatic drug and hospital care costs for these patients dropped significantly. A €450 increase in overall monthly costs was observed; however, when health benefits were considered, this cost increase translated into an incremental cost/utility ratio of €23,880 per quality-adjusted life year gained, which is quite a favorable and convenient figure in terms of the willingness to pay for health benefits in industrialized countries.

CONCLUSIONS

The 36-month add-on omalizumab therapy persistently improved all clinical outcomes in difficult-to-treat asthmatic patients. Costs were also optimized and related to the extent of long-term health benefits achieved.

摘要

目的

奥马珠单抗是一种用于治疗难治性过敏性哮喘的生物制剂。其作用机制依赖于阻止免疫球蛋白E(IgE)与特定细胞受体的结合,从而阻断炎症级联反应。目前,尚无关于其成本效益的长期数据。本研究的目的是评估长期临床疗效,并衡量长期使用奥马珠单抗治疗难治性过敏性哮喘患者的成本/效用。

方法

将36个月的奥马珠单抗附加治疗的临床、经济和生活质量(QoL)结果与治疗引入前一年的等效结果进行比较,该队列(n = 16)为患有严重未控制的特应性哮喘且正在接受慢性高剂量抗哮喘治疗的成年人。所考虑的变量包括肺功能、IgE水平、健康状况、哮喘控制测试(ACT)评分、QoL(圣乔治问卷)、全科医生(GP)和专科医生就诊次数、住院次数和时长、急诊入院情况以及药物治疗(剂量和时长)。得出的计算指标包括与健康相关的QoL变化、总医疗费用以及增量成本/效用。根据学生t检验对两个时期的数据进行统计学显著性差异检验,p <.05被视为有统计学意义。

结果

附加奥马珠单抗显著且逐步改善了哮喘控制和患者与健康相关的QoL。这些患者的对症药物和住院护理费用显著下降。观察到每月总体费用增加了450欧元;然而,考虑到健康益处,这种成本增加转化为每获得一个质量调整生命年的增量成本/效用比为23,880欧元,就工业化国家为健康益处支付意愿而言,这是一个相当有利且合适的数字。

结论

36个月的附加奥马珠单抗治疗持续改善了难治性哮喘患者的所有临床结局。成本也得到了优化,且与所实现的长期健康益处程度相关。

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