Efficacy and safety of benralizumab in Japanese patients with severe, uncontrolled eosinophilic asthma
Background: In the Phase III CALIMA trial, benralizumab significantly reduced asthma exacerbations, increased lung function, and alleviated symptoms for patients with severe, uncontrolled eosinophilic asthma. The aim of this subgroup analysis was to evaluate the efficacy and safety of benralizumab f...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2018-04-01
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| Series: | Allergology International |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1323893017301570 |
| _version_ | 1819064753025187840 |
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| author | Ken Ohta Mitsuru Adachi Yuji Tohda Tadashi Kamei Motokazu Kato J. Mark Fitzgerald Masayuki Takanuma Tadahiro Kakuno Nobuyuki Imai Yanping Wu Magnus Aurivillius Mitchell Goldman |
| author_facet | Ken Ohta Mitsuru Adachi Yuji Tohda Tadashi Kamei Motokazu Kato J. Mark Fitzgerald Masayuki Takanuma Tadahiro Kakuno Nobuyuki Imai Yanping Wu Magnus Aurivillius Mitchell Goldman |
| author_sort | Ken Ohta |
| collection | DOAJ |
| description | Background: In the Phase III CALIMA trial, benralizumab significantly reduced asthma exacerbations, increased lung function, and alleviated symptoms for patients with severe, uncontrolled eosinophilic asthma. The aim of this subgroup analysis was to evaluate the efficacy and safety of benralizumab for Japanese patients in the CALIMA trial. Methods: CALIMA was a randomised, controlled trial of 1306 patients (aged 12–75 years; registered at ClinicalTrials.gov: NCT01914757) with severe asthma uncontrolled by medium- to high-dosage inhaled corticosteroids and long-acting β2-agonists (ICS/LABA). Patients received 56 weeks' benralizumab 30 mg either every 4 weeks (Q4W) or every 8 weeks (Q8W; first three doses Q4W), or placebo Q4W. The primary analysis population was patients receiving high-dosage ICS/LABA with blood eosinophils ≥300 cells/μL. This subgroup analysis covered Japanese patients from this group. Results: Of 83 patients randomised in Japan, 46 were receiving high-dosage ICS/LABA and had blood eosinophils ≥300 cells/μL. Compared with placebo, benralizumab reduced the annual rate of asthma exacerbations by 66% (Q4W; rate ratio 0.34, 95% CI, 0.11–0.99) and 83% (Q8W; rate ratio 0.17, 95% CI, 0.05–0.60); increased prebronchodilator FEV1 by 0.334 L (Q4W; 95% CI, 0.020–0.647) and 0.198 L (Q8W; 95% CI, −0.118 to 0.514); and decreased total asthma symptom score by 0.17 (Q4W; 95% CI, −0.82 to 0.48) and 0.24 (Q8W; 95% CI, −0.87 to 0.40). Percentages of adverse events were consistent with the overall CALIMA group. Conclusions: Benralizumab reduced annual asthma exacerbations and symptoms, increased lung function, and was well-tolerated by Japanese patients with severe, uncontrolled eosinophilic asthma. Keywords: Asthma, Biologic, Eosinophil, Exacerbation, Interleukin-5 receptor |
| first_indexed | 2024-12-21T15:35:34Z |
| format | Article |
| id | doaj.art-ada1b0cb627641cb9cc7dec4059d16a2 |
| institution | Directory Open Access Journal |
| issn | 1323-8930 |
| language | English |
| last_indexed | 2024-12-21T15:35:34Z |
| publishDate | 2018-04-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Allergology International |
| spelling | doaj.art-ada1b0cb627641cb9cc7dec4059d16a22022-12-21T18:58:39ZengElsevierAllergology International1323-89302018-04-01672266272Efficacy and safety of benralizumab in Japanese patients with severe, uncontrolled eosinophilic asthmaKen Ohta0Mitsuru Adachi1Yuji Tohda2Tadashi Kamei3Motokazu Kato4J. Mark Fitzgerald5Masayuki Takanuma6Tadahiro Kakuno7Nobuyuki Imai8Yanping Wu9Magnus Aurivillius10Mitchell Goldman11National Hospital Organization, Tokyo National Hospital, Tokyo, Japan; Corresponding author. Center for Pulmonary Diseases, National Hospital Organization, Tokyo National Hospital, 3-1-1 Takeoka, Kiyose-shi, Tokyo 204-8585, Japan.International University of Health and Welfare Sanno Hospital, Tokyo, JapanKindai University Faculty of Medicine, Osaka, JapanKamei Respiratory Clinic, Takamatsu, JapanKishiwada City Hospital, Osaka, JapanThe Lung Centre, Vancouver General Hospital, UBC Institute for Heart and Lung Health, Vancouver, BC, CanadaKyowa Hakko Kirin Co., Ltd., Tokyo, JapanKyowa Hakko Kirin Co., Ltd., Tokyo, JapanKyowa Hakko Kirin Co., Ltd., Tokyo, JapanAstraZeneca, Gaithersburg, MD, USAAstraZeneca, Mölndal, SwedenAstraZeneca, Gaithersburg, MD, USABackground: In the Phase III CALIMA trial, benralizumab significantly reduced asthma exacerbations, increased lung function, and alleviated symptoms for patients with severe, uncontrolled eosinophilic asthma. The aim of this subgroup analysis was to evaluate the efficacy and safety of benralizumab for Japanese patients in the CALIMA trial. Methods: CALIMA was a randomised, controlled trial of 1306 patients (aged 12–75 years; registered at ClinicalTrials.gov: NCT01914757) with severe asthma uncontrolled by medium- to high-dosage inhaled corticosteroids and long-acting β2-agonists (ICS/LABA). Patients received 56 weeks' benralizumab 30 mg either every 4 weeks (Q4W) or every 8 weeks (Q8W; first three doses Q4W), or placebo Q4W. The primary analysis population was patients receiving high-dosage ICS/LABA with blood eosinophils ≥300 cells/μL. This subgroup analysis covered Japanese patients from this group. Results: Of 83 patients randomised in Japan, 46 were receiving high-dosage ICS/LABA and had blood eosinophils ≥300 cells/μL. Compared with placebo, benralizumab reduced the annual rate of asthma exacerbations by 66% (Q4W; rate ratio 0.34, 95% CI, 0.11–0.99) and 83% (Q8W; rate ratio 0.17, 95% CI, 0.05–0.60); increased prebronchodilator FEV1 by 0.334 L (Q4W; 95% CI, 0.020–0.647) and 0.198 L (Q8W; 95% CI, −0.118 to 0.514); and decreased total asthma symptom score by 0.17 (Q4W; 95% CI, −0.82 to 0.48) and 0.24 (Q8W; 95% CI, −0.87 to 0.40). Percentages of adverse events were consistent with the overall CALIMA group. Conclusions: Benralizumab reduced annual asthma exacerbations and symptoms, increased lung function, and was well-tolerated by Japanese patients with severe, uncontrolled eosinophilic asthma. Keywords: Asthma, Biologic, Eosinophil, Exacerbation, Interleukin-5 receptorhttp://www.sciencedirect.com/science/article/pii/S1323893017301570 |
| spellingShingle | Ken Ohta Mitsuru Adachi Yuji Tohda Tadashi Kamei Motokazu Kato J. Mark Fitzgerald Masayuki Takanuma Tadahiro Kakuno Nobuyuki Imai Yanping Wu Magnus Aurivillius Mitchell Goldman Efficacy and safety of benralizumab in Japanese patients with severe, uncontrolled eosinophilic asthma Allergology International |
| title | Efficacy and safety of benralizumab in Japanese patients with severe, uncontrolled eosinophilic asthma |
| title_full | Efficacy and safety of benralizumab in Japanese patients with severe, uncontrolled eosinophilic asthma |
| title_fullStr | Efficacy and safety of benralizumab in Japanese patients with severe, uncontrolled eosinophilic asthma |
| title_full_unstemmed | Efficacy and safety of benralizumab in Japanese patients with severe, uncontrolled eosinophilic asthma |
| title_short | Efficacy and safety of benralizumab in Japanese patients with severe, uncontrolled eosinophilic asthma |
| title_sort | efficacy and safety of benralizumab in japanese patients with severe uncontrolled eosinophilic asthma |
| url | http://www.sciencedirect.com/science/article/pii/S1323893017301570 |
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