Dupilumab efficacy and safety in Japanese patients with uncontrolled, moderate-to-severe asthma in the phase 3 LIBERTY ASTHMA QUEST study
Background: In the LIBERTY ASTHMA QUEST (ClinicalTrials.gov: NCT02414854) study, dupilumab 200 mg and 300 mg every 2 weeks vs matched-volume placebo reduced severe asthma exacerbations and improved lung function (FEV1), asthma control, and quality of life in patients with uncontrolled, moderate-to-s...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2020-10-01
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| Series: | Allergology International |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1323893020300526 |
| _version_ | 1818522242888237056 |
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| author | Yuji Tohda Yoichi Nakamura Takao Fujisawa Motohiro Ebisawa Kazuhiko Arima Masanori Miyata Yoshinori Takahashi Megan S. Rice Yamo Deniz Paul Rowe Naimish Patel Neil M.H. Graham Ariel Teper |
| author_facet | Yuji Tohda Yoichi Nakamura Takao Fujisawa Motohiro Ebisawa Kazuhiko Arima Masanori Miyata Yoshinori Takahashi Megan S. Rice Yamo Deniz Paul Rowe Naimish Patel Neil M.H. Graham Ariel Teper |
| author_sort | Yuji Tohda |
| collection | DOAJ |
| description | Background: In the LIBERTY ASTHMA QUEST (ClinicalTrials.gov: NCT02414854) study, dupilumab 200 mg and 300 mg every 2 weeks vs matched-volume placebo reduced severe asthma exacerbations and improved lung function (FEV1), asthma control, and quality of life in patients with uncontrolled, moderate-to-severe asthma (N = 1902). Here, we examine the safety and efficacy of dupilumab in the subpopulation of Japanese patients who participated in QUEST (n = 114; 6%). Methods: Endpoints assessed were annualized severe exacerbation rates and the effect of treatment over the 52-week treatment period on FEV1, asthma control, asthma-related quality of life, and markers of type 2 inflammation. Results: In Japanese patients, dupilumab 200 and 300 mg every 2 weeks vs matched placebo reduced severe asthma exacerbation rates by 44% (P = 0.33) and 75% (P = 0.03), respectively, and improved FEV1 at Week 12 by 0.20 L (P = 0.05) and 0.17 L (P = 0.12). FEV1 improvements were rapid (by Week 2) and sustained throughout treatment. Significant and/or numerical improvements vs placebo in asthma control and quality of life were also observed throughout treatment. For each endpoint, greater efficacy was observed in patients with elevated baseline levels of type 2 inflammatory biomarkers (blood eosinophils or FeNO). Dupilumab treatment significantly reduced levels of FeNO and total IgE, but not blood eosinophils. Conclusions: In this subanalysis of QUEST, the efficacy and safety of dupilumab in Japanese patients was comparable to that observed in the overall intention-to-treat population, suggesting no variability in efficacy on the basis of Japanese ethnicity.(Funded by Sanofi and Regeneron Pharmaceuticals, Inc.; ClinicalTrials.gov number: NCT02414854) |
| first_indexed | 2024-12-11T05:30:41Z |
| format | Article |
| id | doaj.art-9cdc2eefd38c43cabfa8ef718643133b |
| institution | Directory Open Access Journal |
| issn | 1323-8930 |
| language | English |
| last_indexed | 2024-12-11T05:30:41Z |
| publishDate | 2020-10-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Allergology International |
| spelling | doaj.art-9cdc2eefd38c43cabfa8ef718643133b2022-12-22T01:19:27ZengElsevierAllergology International1323-89302020-10-01694578587Dupilumab efficacy and safety in Japanese patients with uncontrolled, moderate-to-severe asthma in the phase 3 LIBERTY ASTHMA QUEST studyYuji Tohda0Yoichi Nakamura1Takao Fujisawa2Motohiro Ebisawa3Kazuhiko Arima4Masanori Miyata5Yoshinori Takahashi6Megan S. Rice7Yamo Deniz8Paul Rowe9Naimish Patel10Neil M.H. Graham11Ariel Teper12Kindai University Hospital, Osaka, Japan; Corresponding author. Kindai University Hospital, 377-2 Ohnohigashi, Osakasayama, Osaka, 589-8511, Japan.Yokohama City Minato Red Cross Hospital, Yokohama City, JapanAllergy Center, National Hospital Organization Mie National Hospital, Tsu, JapanDepartment of Allergy, Clinical Research Center for Allergy and Rheumatology, National Hospital Organization, Sagamihara National Hospital, Sagamihara, JapanSanofi K.K., Tokyo, JapanSanofi K.K., Tokyo, JapanSanofi K.K., Tokyo, JapanSanofi, Cambridge, MA, USARegeneron Pharmaceuticals, Inc., Tarrytown, NY, USASanofi, Bridgewater, NJ, USASanofi, Bridgewater, NJ, USARegeneron Pharmaceuticals, Inc., Tarrytown, NY, USASanofi, Bridgewater, NJ, USABackground: In the LIBERTY ASTHMA QUEST (ClinicalTrials.gov: NCT02414854) study, dupilumab 200 mg and 300 mg every 2 weeks vs matched-volume placebo reduced severe asthma exacerbations and improved lung function (FEV1), asthma control, and quality of life in patients with uncontrolled, moderate-to-severe asthma (N = 1902). Here, we examine the safety and efficacy of dupilumab in the subpopulation of Japanese patients who participated in QUEST (n = 114; 6%). Methods: Endpoints assessed were annualized severe exacerbation rates and the effect of treatment over the 52-week treatment period on FEV1, asthma control, asthma-related quality of life, and markers of type 2 inflammation. Results: In Japanese patients, dupilumab 200 and 300 mg every 2 weeks vs matched placebo reduced severe asthma exacerbation rates by 44% (P = 0.33) and 75% (P = 0.03), respectively, and improved FEV1 at Week 12 by 0.20 L (P = 0.05) and 0.17 L (P = 0.12). FEV1 improvements were rapid (by Week 2) and sustained throughout treatment. Significant and/or numerical improvements vs placebo in asthma control and quality of life were also observed throughout treatment. For each endpoint, greater efficacy was observed in patients with elevated baseline levels of type 2 inflammatory biomarkers (blood eosinophils or FeNO). Dupilumab treatment significantly reduced levels of FeNO and total IgE, but not blood eosinophils. Conclusions: In this subanalysis of QUEST, the efficacy and safety of dupilumab in Japanese patients was comparable to that observed in the overall intention-to-treat population, suggesting no variability in efficacy on the basis of Japanese ethnicity.(Funded by Sanofi and Regeneron Pharmaceuticals, Inc.; ClinicalTrials.gov number: NCT02414854)http://www.sciencedirect.com/science/article/pii/S1323893020300526DupilumabExacerbationForced expiratory volumeJapaneseModerate-to-severe asthma |
| spellingShingle | Yuji Tohda Yoichi Nakamura Takao Fujisawa Motohiro Ebisawa Kazuhiko Arima Masanori Miyata Yoshinori Takahashi Megan S. Rice Yamo Deniz Paul Rowe Naimish Patel Neil M.H. Graham Ariel Teper Dupilumab efficacy and safety in Japanese patients with uncontrolled, moderate-to-severe asthma in the phase 3 LIBERTY ASTHMA QUEST study Allergology International Dupilumab Exacerbation Forced expiratory volume Japanese Moderate-to-severe asthma |
| title | Dupilumab efficacy and safety in Japanese patients with uncontrolled, moderate-to-severe asthma in the phase 3 LIBERTY ASTHMA QUEST study |
| title_full | Dupilumab efficacy and safety in Japanese patients with uncontrolled, moderate-to-severe asthma in the phase 3 LIBERTY ASTHMA QUEST study |
| title_fullStr | Dupilumab efficacy and safety in Japanese patients with uncontrolled, moderate-to-severe asthma in the phase 3 LIBERTY ASTHMA QUEST study |
| title_full_unstemmed | Dupilumab efficacy and safety in Japanese patients with uncontrolled, moderate-to-severe asthma in the phase 3 LIBERTY ASTHMA QUEST study |
| title_short | Dupilumab efficacy and safety in Japanese patients with uncontrolled, moderate-to-severe asthma in the phase 3 LIBERTY ASTHMA QUEST study |
| title_sort | dupilumab efficacy and safety in japanese patients with uncontrolled moderate to severe asthma in the phase 3 liberty asthma quest study |
| topic | Dupilumab Exacerbation Forced expiratory volume Japanese Moderate-to-severe asthma |
| url | http://www.sciencedirect.com/science/article/pii/S1323893020300526 |
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