Reduction in asthma exacerbation rate after mepolizumab treatment initiation in patients with severe asthma: A real-world database study in Japan

IF 2.8 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Hiroyuki Nagase , Jun Tamaoki , Takeo Suzuki , Yasuko Nezu , Shoko Akiyama , Ashley L. Cole , Shibing Yang , George Mu , Masayuki Katsumata , Masaki Komatsubara , Rafael Alfonso-Cristancho
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引用次数: 1

Abstract

Objective

To investigate the changes in asthma exacerbation, as well as in oral corticosteroid (OCS) use, exacerbation-related healthcare resource utilization (HRU), and healthcare costs before and after mepolizumab treatment initiation in patients with severe asthma who started treatment with mepolizumab in a real-world clinical setting in Japan.

Methods

A retrospective, observational, self-controlled study was conducted in Japan using a hospital-based administrative claims database. Patients who were diagnosed with asthma and who were new users of mepolizumab were included in the study. The primary outcome was the incidence rate of any asthma exacerbation/patient-year during the 12-month period before (baseline period) and after (follow-up period) the first mepolizumab prescription. Secondary outcome measures included the proportion of patients with ≥1 any asthma exacerbation, patients with exacerbation requiring hospitalization, the incidence rate of exacerbations requiring hospitalization/patient-year, the median daily OCS dose (OCS sparing effect), exacerbation-related HRU (hospitalization length, the proportion of patients with emergency visits, and the number of emergency/outpatient visits), and associated costs.

Results

Of the 377 patients included, 56.2% were ≥65 years of age. Following the first mepolizumab prescription, incidence rates for any asthma exacerbation were reduced by 40.6% (4.00/patient-year to 2.38/patient-year; the incidence rate ratio [95% confidence interval]: 0.60 [0.53–0.67]; p < 0.0001) from the baseline to follow-up periods. The incidence rate of exacerbations requiring hospitalization was reduced by 55.8% (0.37/patient-year to 0.16/patient-year) from the baseline to follow-up periods. The proportion of patients experiencing any exacerbation decreased from 84.4% to 57.8% and those requiring hospitalization decreased from 23.9% to 10.3% both from the baseline to follow-up periods. The median daily OCS dose decreased by 44.6% (median [interquartile range]: 6.7 [4.7–9.9] mg/day to 3.3 [0.9–5.6] mg/day) from the last baseline quarter to the 4th quarter of the follow-up period. All exacerbation-related HRUs decreased from the baseline to follow-up periods. Inpatient cost reduced by >50% (123,279 Japanese Yen [JPY]/patient-year vs. 57,283 JPY/patient-year), reducing the total cost by 80,716 JPY from the baseline to follow-up periods.

Conclusion

Mepolizumab was effective in treating patients with severe asthma by reducing the incidence rates of exacerbations and exacerbation requiring hospitalization, OCS dose, exacerbation-related HRU, and cost in routine clinical practice in Japan.

严重哮喘患者mepolizumab治疗开始后哮喘加重率降低:日本的一项真实世界数据库研究
目的调查日本现实世界临床环境中开始美polizumab治疗的严重哮喘患者在美polizumab治疗前后哮喘加重、口服皮质类固醇(OCS)使用、加重相关医疗资源利用(HRU)和医疗费用的变化。方法采用基于医院的行政索赔数据库,在日本进行回顾性、观察性、自我对照研究。被诊断为哮喘的患者和新使用mepolizumab的患者被纳入研究。主要结局是在首次使用美polizumab处方之前(基线期)和之后(随访期)的12个月期间内任何哮喘恶化/患者年的发病率。次要结局指标包括≥1次哮喘急性发作患者的比例、需要住院治疗的急性发作患者、需要住院治疗的急性发作发生率/患者-年、OCS日剂量中位数(OCS节约效应)、与急性发作相关的HRU(住院时间、急诊患者比例、急诊/门诊就诊次数)和相关费用。结果377例患者中,56.2%年龄≥65岁。在首次使用美polizumab后,任何哮喘加重的发病率降低了40.6%(4.00/患者-年至2.38/患者-年;发病率比[95%可信区间]:0.60 [0.53-0.67];p & lt;0.0001),从基线到随访期。从基线到随访期间,需要住院治疗的恶化发生率降低了55.8%(0.37/患者-年至0.16/患者-年)。从基线到随访期间,出现任何加重的患者比例从84.4%降至57.8%,需要住院治疗的患者比例从23.9%降至10.3%。从最后一个基线季度到随访期的第四个季度,OCS的中位日剂量下降了44.6%(中位数[四分位数范围]:6.7 [4.7-9.9]mg/天至3.3 [0.9-5.6]mg/天)。从基线到随访期间,所有与恶化相关的hru均下降。住院费用降低了50%(123,279日元/患者-年vs. 57,283日元/患者-年),从基线到随访期间总费用降低了80,716日元。结论在日本的常规临床实践中,mepolizumab通过降低急性发作和需要住院的急性发作发生率、OCS剂量、与急性发作相关的HRU和成本,对治疗严重哮喘患者有效。
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来源期刊
CiteScore
6.20
自引率
0.00%
发文量
41
审稿时长
42 days
期刊介绍: Pulmonary Pharmacology and Therapeutics (formerly Pulmonary Pharmacology) is concerned with lung pharmacology from molecular to clinical aspects. The subject matter encompasses the major diseases of the lung including asthma, cystic fibrosis, pulmonary circulation, ARDS, carcinoma, bronchitis, emphysema and drug delivery. Laboratory and clinical research on man and animals will be considered including studies related to chemotherapy of cancer, tuberculosis and infection. In addition to original research papers the journal will include review articles and book reviews. Research Areas Include: • All major diseases of the lung • Physiology • Pathology • Drug delivery • Metabolism • Pulmonary Toxicology.
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