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重度哮喘患者接受抗IgE或抗IL-5治疗后的临床及肺功能结果

Clinical and Lung Function Outcomes After Anti-IgE or Anti-IL5 Therapy in Severe Asthma.

作者信息

AlShareef Saad, McDonald Christine F, Lee Joy

机构信息

Department of Medicine, College of Medicine, Imam Mohammad Ibn Saud Islamic University (IMSIU), Riyadh, 13317-4233, Saudi Arabia.

Department of Respiratory and Sleep Medicine, Austin Health, Heidelberg, Australia.

出版信息

J Asthma Allergy. 2022 Feb 15;15:209-217. doi: 10.2147/JAA.S348137. eCollection 2022.

Abstract

BACKGROUND

Although there have been indirect comparisons of the relative efficacy of mepolizumab (anti-IL-5) and benralizumab (anti-IL-5Rα) in severe asthma patients, long-term direct head-to-head comparisons are lacking. Here, we (i) examined the effect of mepolizumab, benralizumab, and omalizumab on symptom control and lung function parameters over time; and (ii) compared the efficacy of mepolizumab and benralizumab on symptom control and lung function outcomes.

METHODS

This was a retrospective study of patients with severe asthma taking anti-IgE (omalizumab; n = 24), anti-IL5 (mepolizumab, n = 23), or anti-IL-Rα (benralizumab; n = 12) therapy. Data were extracted on (i) Asthma Control Questionnaire (ACQ-5) scores; (ii) forced expiratory volume over 1 second (FEV); and (iii) peak expiratory flow rate (PEFR) at 4-6 months and 1 year and documented reductions in exacerbations. Clinical and lung function outcomes were compared between patients taking mepolizumab and benralizumab and over time.

RESULTS

There were significant decreases in ACQ-5 scores (3.3 ± 0.93 to 1.7 ± 0.98 for mepolizumab, 3.5 ± 0.72 to 1.6 ±0.89 for benralizumab, and 3.5 ± 0.95 to 1.7 ± 1.1 for omalizumab; -test, all p < 0.0001) but not increases in FEV and PEFR for all three agents after 4-6 months of therapy, which persisted but did not decrease further at one year. There were trends toward a greater percentage increase in FEV and PEFR from baseline and a decrease in the number of exacerbations in patients taking benralizumab than those taking mepolizumab.

CONCLUSION

Although limited by a small sample size, this real-world, head-to-head comparison of mepolizumab and benralizumab is consistent with comparative data on asthma biologicals and indirect comparisons showing no major difference in efficacy. The study also generates new testable hypotheses about the efficacy of asthma biologicals in different patient populations.

摘要

背景

尽管已对美泊利珠单抗(抗白细胞介素-5)和贝那利珠单抗(抗白细胞介素-5受体α)在重度哮喘患者中的相对疗效进行了间接比较,但缺乏长期直接的头对头比较。在此,我们(i)研究了美泊利珠单抗、贝那利珠单抗和奥马珠单抗随时间对症状控制和肺功能参数的影响;(ii)比较了美泊利珠单抗和贝那利珠单抗在症状控制和肺功能结果方面的疗效。

方法

这是一项对接受抗IgE(奥马珠单抗;n = 24)、抗白细胞介素-5(美泊利珠单抗,n = 23)或抗白细胞介素-5受体α(贝那利珠单抗;n = 12)治疗的重度哮喘患者的回顾性研究。提取了以下数据:(i)哮喘控制问卷(ACQ-5)评分;(ii)第1秒用力呼气容积(FEV);以及(iii)4至6个月和1年时的呼气峰值流速(PEFR),并记录了病情加重次数的减少情况。比较了服用美泊利珠单抗和贝那利珠单抗的患者之间以及随时间推移的临床和肺功能结果。

结果

治疗4至6个月后,所有三种药物的ACQ-5评分均显著降低(美泊利珠单抗从3.3±0.93降至1.7±0.98,贝那利珠单抗从3.5±0.72降至1.6±0.89,奥马珠单抗从3.5±0.95降至1.7±1.1;t检验,所有p<0.0001),但FEV和PEFR未增加,这种情况在1年时持续存在但未进一步下降。与服用美泊利珠单抗的患者相比,服用贝那利珠单抗的患者FEV和PEFR从基线的百分比增加趋势更大,且病情加重次数减少。

结论

尽管受样本量小的限制,但这项美泊利珠单抗和贝那利珠单抗的真实世界头对头比较与哮喘生物制剂的比较数据一致,间接比较显示疗效无重大差异。该研究还产生了关于哮喘生物制剂在不同患者群体中疗效的新的可检验假设。

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