在持续未控制的中度至重度过敏性哮喘青少年的治疗中添加奥马珠单抗。

Adding omalizumab to the therapy of adolescents with persistent uncontrolled moderate--severe allergic asthma.

作者信息

Massanari M, Milgrom H, Pollard S, Maykut R J, Kianifard Farid, Fowler-Taylor A, Geba G P, Zeldin R K

机构信息

Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936-1080, USA.

出版信息

Clin Pediatr (Phila). 2009 Oct;48(8):859-65. doi: 10.1177/0009922809339054. Epub 2009 Jun 29.

DOI:10.1177/0009922809339054

PMID:19564449

Abstract

OBJECTIVE

This study aimed to evaluate the effectiveness of omalizumab among adolescents with moderate-severe allergic asthma inadequately controlled with inhaled corticosteroids.

PATIENTS AND METHODS

Data from patients 12 to 17 years of age were pooled from 5 placebo-controlled registration trials of omalizumab. Impact on asthma control was assessed by need for rescue bursts of oral corticosteroids, lung function, symptom scores, and unscheduled office visits.

RESULTS

In adolescents (n = 146), addition of omalizumab decreased mean number of rescue bursts (0.3 vs 0.9) versus placebo; relative risk 0.47 (95% confidence interval [CI], 0.22-0.99; P = .047). At study conclusion, mean forced expiratory volume in 1 second increased 268 mL (13.8%) in omalizumab-treated subjects versus 98 mL (5.5%) for placebo (least squares mean treatment difference 146 mL [95% CI, 19.4-272.6; P = .024]). Omalizumab significantly improved asthma symptom scores and reduced unscheduled office visits.

CONCLUSION

Omalizumab added to baseline therapy improves measures of asthma control in adolescents with persistent moderate-severe allergic asthma.

摘要

目的

本研究旨在评估奥马珠单抗对吸入糖皮质激素控制不佳的中重度过敏性哮喘青少年患者的有效性。

患者与方法

汇总来自5项奥马珠单抗安慰剂对照注册试验中12至17岁患者的数据。通过口服糖皮质激素急救使用次数、肺功能、症状评分和非计划门诊就诊情况评估对哮喘控制的影响。

结果

在青少年患者（n = 146）中，与安慰剂相比，加用奥马珠单抗使急救使用次数的平均值降低（0.3比0.9）；相对危险度0.47（95%置信区间[CI]，0.22 - 0.99；P = 0.047）。在研究结束时，奥马珠单抗治疗组患者的1秒用力呼气容积平均增加268 mL（13.8%），而安慰剂组增加98 mL（5.5%）（最小二乘均值治疗差异为146 mL [95% CI，19.4 - 272.6；P = 0.024]）。奥马珠单抗显著改善哮喘症状评分并减少非计划门诊就诊次数。