Long-term safety, efficacy, pharmacokinetics and pharmacodynamics of omalizumab in children with severe uncontrolled asthma

被引：46

作者：

Odajima, Hiroshi ^{[1
]}

Ebisawa, Motohiro ^{[2
]}

Nagakura, Toshikazu ^{[3
]}

Fujisawa, Takao ^{[4
]}

Akasawa, Akira ^{[5
]}

Ito, Komei ^{[6
]}

Doi, Satoru ^{[7
]}

Yamaguchi, Koichi ^{[8
]}

Katsunuma, Toshio ^{[9
]}

Kurihara, Kazuyuki ^{[10
]}

Teramoto, Takahide ^{[11
]}

Sugai, Kazuko ^{[12
]}

Nambu, Mitsuhiko ^{[13
]}

Hoshioka, Akira ^{[14
]}

Yoshihara, Shigemi ^{[15
]}

Sato, Norio ^{[16
]}

Seko, Noriko ^{[16
]}

Nishima, Sankei ^{[1
]}

机构：

[1] Fukuoka Natl Hosp, Dept Pediat, Fukuoka, Japan

[2] Sagamihara Natl Hosp, Dept Allergy, Clin Res Ctr Allergol & Rheumatol, Sagamihara, Kanagawa, Japan

[3] Yoga Allergy Clin, Tokyo, Japan

[4] Mie Natl Hosp, Inst Clin Res, Tsu, Mie, Japan

[5] Tokyo Metropolitan Childrens Med Ctr, Div Allergy, Tokyo, Japan

[6] Aichi Childrens Hlth & Med Ctr, Dept Allergy, Obu, Japan

[7] Osaka Prefectural Med Ctr Resp & Allerg Dis, Dept Pediat, Habikino, Japan

[8] Fratern Mem Hosp, Dept Pediat, Tokyo, Japan

[9] Jikei Daisan Hosp, Dept Pediat, Tokyo, Japan

[10] Kanagawa Childrens Med Ctr, Dept Allergy, Yokohama, Kanagawa, Japan

[11] Gifu Univ, Grad Sch Med, Dept Pediat, Gifu, Japan

[12] Fukuyama Med Ctr, Dept Pediat, Fukuyama, Hiroshima, Japan

[13] Tenri Hosp, Dept Pediat, Tenri, Nara, Japan

[14] Chiba Childrens Hosp, Dept Allergy & Rheumatol, Chiba, Japan

[15] Dokkyo Med Univ, Dept Pediat, Mibu, Tochigi, Japan

[16] Novartis Pharma KK, Clin Dev, Tokyo, Japan

来源：

ALLERGOLOGY INTERNATIONAL | 2017年 / 66卷 / 01期

关键词：

Childhood asthma; Efficacy; Omalizumab; Safety evaluation; Total IgE; SEVERE ALLERGIC-ASTHMA; IGE-MEDIATED ASTHMA; TO-TREAT ASTHMA; ANTI-IGE; CHILDHOOD ASTHMA; IMPULSE OSCILLOMETRY; MONOCLONAL-ANTIBODY; JAPANESE CHILDREN; MANAGEMENT; RESPONSES;

D O I：

10.1016/j.alit.2016.06.004

中图分类号：

R392 [医学免疫学];

学科分类号：

100102 ;

摘要：

Background: Omalizumab is effective and well-tolerated in children with moderate to severe allergic asthma. However, the effects of long-term treatment with omalizumab in this population haven't been well investigated. The objective of this study is to evaluate the long-term safety, efficacy, pharmacokinetics and pharmacodynamics of omalizumab in children with uncontrolled severe asthma. Methods: Thirty-eight Japanese children (aged 7-16 years) who completed the 24-week treatment core study were included in an uncontrolled extension study, in which treatment with omalizumab continued until the pediatric indication was approved in Japan (ClinicalTrials.gov number: NCT01328886). Results: Thirty-five patients (92.1%) completed the extension study. The median exposure throughout the core and extension studies was 116.6 weeks (range, 46.9-151.1 weeks). The most common adverse events were nasopharyngitis, influenza, upper respiratory tract infection, and asthma. Serious adverse events developed in 10 patients (26.3%), but resolved completely with additional treatments. Incidence of adverse events didn't increase with extended exposure with omalizumab. Twenty-nine patients (76.3%) achieved completely- or well-controlled asthma compared with 9 patients (23.7%) at the start of the extension study. QOL scores, the rates (per year) of hospitalizations and ER visits were significantly improved compared with the baseline of the core study [39.0 vs 48.0 (median), p < 0.001 for QOL, 1.33 vs 0.16, p < 0.001 for hospitalization, 0.68 vs 0.15, p = 0.002 for ER visits]. Remarkably, the mean total IgE level showed a decreasing trend while exposure to omalizumab remained at steady-state. Conclusions: Long-term treatment with omalizumab is well-tolerated and effective in children with uncontrolled severe allergic asthma. No new safety findings were identified. Copyright (C) 2017, Japanese Society of Allergology. Production and hosting by Elsevier B.V.

引用

页码：106 / 115

页数：10

共 44 条

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