Efficacy and safety of tezepelumab in patients recruited in Japan who participated in the phase 3 NAVIGATOR study
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- Ishizuka Tamotsu
- Third Department of Internal Medicine, Faculty of Medical Sciences, University of Fukui
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- Menzies-Gow Andrew
- Royal Brompton and Harefield Hospitals
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- Okada Hiroshi
- BioPharmaceuticals TA, R&D, AstraZeneca K.K.
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- Fukushima Yasushi
- Fukuwa Clinic
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- Hayashi Nobuya
- Science & Data Analytics Division, R&D, AstraZeneca K.K.
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- Colice Gene
- Late-stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca
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- Ponnarambil Sandhia
- Late-stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca
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- Hunter Gillian
- Biometrics, Late-stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca
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- Odajima Hiroshi
- Department of Pediatrics, NHO Fukuoka National Hospital
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- Ebisawa Motohiro
- Clinical Research Center for Allergy and Rheumatology, NHO Sagamihara National Hospital
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<p>Background: Tezepelumab, a human monoclonal antibody, blocks the activity of thymic stromal lymphopoietin. In the phase 3 NAVIGATOR study (NCT03347279), tezepelumab reduced exacerbations by 56% compared with placebo in adults and adolescents with severe, uncontrolled asthma. This analysis evaluated the efficacy and safety of tezepelumab in NAVIGATOR patients recruited in Japan.</p><p>Methods: NAVIGATOR was a phase 3, multicenter, randomized, double-blind, placebo-controlled study. Patients (12-80 years old) were randomized 1:1 to receive tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks. Endpoints assessed included: the annualized asthma exacerbation rate (AAER) over 52 weeks (primary endpoint) and the change from baseline to week 52 in pre-bronchodilator forced expiratory volume in 1 s (FEV1) and Asthma Control Questionnaire (ACQ)-6 score. The safety of tezepelumab was also assessed.</p><p>Results: Overall, 97 patients recruited in Japan were randomized (tezepelumab, n = 58; placebo, n = 39). The AAER over 52 weeks was 1.54 (95% confidence interval [CI]: 0.90, 2.64) with tezepelumab compared with 3.12 (95% CI: 1.82, 5.35) with placebo (rate ratio: 0.49 [95% CI: 0.25, 0.99]; 51% reduction). For tezepelumab and placebo, the least-squares mean (standard error) change from baseline to week 52 for pre-bronchodilator FEV1 was 0.23 (0.06) L and 0.19 (0.07) L and the ACQ-6 score was −1.12 (0.15) and -0.97 (0.19), respectively. The frequency of adverse events was similar between treatment groups (tezepelumab, 86.2%; placebo, 87.2%).</p><p>Conclusions: Tezepelumab reduced exacerbations compared with placebo, and was well tolerated, in NAVIGATOR patients with severe, uncontrolled asthma recruited in Japan.</p>
収録刊行物
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- Allergology International
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Allergology International 72 (1), 82-88, 2023
一般社団法人日本アレルギー学会
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詳細情報 詳細情報について
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- CRID
- 1390013552698417408
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- ISSN
- 14401592
- 13238930
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- 本文言語コード
- en
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- データソース種別
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- JaLC
- Crossref
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- 抄録ライセンスフラグ
- 使用不可