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奥马珠单抗在各年龄段重度哮喘患者中的疗效:意大利的真实病例经验

Effects of omalizumab in severe asthmatics across ages: A real life Italian experience.

作者信息

Sposato B, Scalese M, Latorre M, Scichilone N, Matucci A, Milanese M, Masieri S, Rolla G, Steinhilber G, Rosati Y, Vultaggio A, Folletti I, Baglioni S, Bargagli E, Di Tomassi M, Pio R, Pio A, Maccari U, Maggiorelli C, Migliorini M G, Vignale L, Pulerà N, Carpagnano G E, Foschino Barbaro M P, Perrella A, Paggiaro P L

机构信息

Pneumologia, Ospedale Misericordia, Grosseto, Italy.

Istituto di Fisiologia Clinica, CNR, Pisa, Italy.

出版信息

Respir Med. 2016 Oct;119:141-149. doi: 10.1016/j.rmed.2016.09.005. Epub 2016 Sep 4.

DOI:10.1016/j.rmed.2016.09.005
PMID:27692136
Abstract

BACKGROUND

This retrospective study aimed at evaluating long-term effects of Omalizumab in elderly asthmatics in a real-life setting.

METHODS

105 consecutive severe asthmatics (GINA step 4-5; mean FEV% predicted:66 ± 15.7) treated with Omalizumab for at least 1 year (treatment mean duration 35.1 ± 21.7 months) were divided into 3 groups according to their age at Omalizumab treatment onset: 18-39, 40-64 and ≥ 65 years.

RESULTS

Comorbidities, number of overweight/obese subjects and patients with late-onset asthma were more frequent among older people. A similar reduction of inhaled corticosteroids dosage and SABA on-demand therapy was observed in all groups during Omalizumab treatment; a similar FEV increased was also observed. Asthma Control Test (ACT) improved significantly (p < 0.001) in the three groups, increasing from 15 [IQR:12-18] to 24 [IQR:22-25] in younger subjects, from 14 [IQR:10-16] to 21 [IQR:20-23] in the 40-64-year-group and from 15 [IQR:12-16] to 20 [IQR:18-22] in elderly patients where improvement was lower (p = 0.039) compared to younger people. Asthma exacerbations decreased significantly after Omalizumab but the percentage of exacerbation-free patients was higher in younger people (76.9%) compared to middle aged patients (49.2%) and the elderly (29%) (p = 0.049). After Omalizumab treatment, the risk for exacerbations was lower in subjects aged 40-64 (OR = 0.284 [CI95% = 0.098-0.826], p = 0.021) and 18-39 (OR = 0.133 [CI95% = 0.026-0.678], p = 0.015), compared to elderly asthmatics. Also, a significantly reduced ACT improvement (β = -1.070; p = 0.046) passing from each age class was observed.

CONCLUSION

Omalizumab improves all asthma outcomes independently of age, although the magnitude of the effects observed in the elderly seems to be lower than in the other age groups.

摘要

背景

这项回顾性研究旨在评估在现实生活环境中奥马珠单抗对老年哮喘患者的长期影响。

方法

105例连续接受奥马珠单抗治疗至少1年(治疗平均持续时间35.1±21.7个月)的重度哮喘患者(全球哮喘防治创议第4 - 5级;预计FEV%平均值:66±15.7),根据开始使用奥马珠单抗治疗时的年龄分为3组:18 - 39岁、40 - 64岁和≥65岁。

结果

老年人中合并症、超重/肥胖受试者数量以及迟发性哮喘患者更为常见。在奥马珠单抗治疗期间,所有组吸入性糖皮质激素剂量和按需使用SABA治疗均有类似程度的减少;FEV也有类似程度的增加。三组哮喘控制测试(ACT)均显著改善(p < 0.001),年轻受试者从15[四分位间距:12 - 18]提高到24[四分位间距:22 - 25],40 - 64岁组从14[四分位间距:10 - 16]提高到21[四分位间距:20 - 23],老年患者从15[四分位间距:12 - 16]提高到20[四分位间距:18 - 22],但老年患者的改善程度低于年轻患者(p = 0.039)。奥马珠单抗治疗后哮喘发作显著减少,但无发作患者的百分比在年轻人中更高(76.9%),高于中年患者(49.2%)和老年人(29%)(p = 0.049)。奥马珠单抗治疗后,40 - 64岁受试者(OR = 0.284[95%置信区间 = 0.098 - 0.826],p = 0.021)和18 - 39岁受试者(OR = 0.133[95%置信区间 = 0.026 - 0.678],p = 0.015)的发作风险低于老年哮喘患者。此外,观察到从每个年龄组过渡时ACT改善显著降低(β = -1.070;p = 0.046)。

结论

奥马珠单抗可改善所有哮喘结局,与年龄无关,尽管在老年人中观察到的效果程度似乎低于其他年龄组。

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