PMID- 38268535
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240126
IS  - 1178-6965 (Print)
IS  - 1178-6965 (Electronic)
IS  - 1178-6965 (Linking)
VI  - 17
DP  - 2024
TI  - Real-World Safety and Effectiveness of Benralizumab in Japanese Patients with 
      Severe Asthma: A Multicenter Prospective Observational Study.
PG  - 45-60
LID - 10.2147/JAA.S432695 [doi]
AB  - INTRODUCTION: This study aimed to demonstrate whether benralizumab maintained the 
      safety and effectiveness profiles established in randomized controlled trials 
      among all patients with severe uncontrolled asthma initially prescribed 
      benralizumab in the real-world setting in Japan. METHODS: This was a prospective, 
      observational, multicenter post-marketing study (ClinicalTrial.gov, NCT03588546). 
      The safety and tolerability of benralizumab over 1 year were assessed by the 
      incidence of adverse events (AEs), serious AEs, adverse drug reactions (ADRs), 
      and serious ADRs. Patient background characteristics indicating a more frequent 
      onset of ADRs with benralizumab were explored. The main effectiveness assessment 
      was the change in Asthma Control Questionnaire-5 (ACQ-5) score from baseline. 
      Patients with baseline ACQ-5 scores >/=1.5 were defined as having severe 
      uncontrolled asthma. RESULTS: In total, 632 patients were evaluated for safety 
      and 274 for effectiveness; 139 patients were included in the severe uncontrolled 
      asthma subgroup. ADRs were reported in 12.7% and serious AEs in 13.0% of 
      patients. Serious infections occurred in 3.8%, serious hypersensitivity in 0.3%, 
      and malignancy in 0.3% of patients. No helminthic infections occurred. In the 
      effectiveness population, benralizumab improved the mean (standard deviation [95% 
      confidence interval]) ACQ-5 score by -1.16 (1.40 [-1.36, -0.96]) from baseline; 
      forced expiratory volume in 1 second by 0.151 (0.440 [0.09, 0.21]) L; and 
      Mini-Asthma Quality of Life questionnaire score by 1.16 (1.29 [0.94, 1.38]) at 
      the last observation. The annual asthma exacerbation rate was 0.42. A greater 
      ACQ-5 score improvement was observed among patients with eosinophilic asthma 
      characteristics. CONCLUSION: No new safety concerns were raised, and patients 
      experienced benefits consistent with previous studies of benralizumab, thus 
      supporting the use of benralizumab for the add-on maintenance treatment of 
      patients with eosinophilic severe uncontrolled asthma.
CI  - (c) 2024 Yamaguchi et al.
FAU - Yamaguchi, Masao
AU  - Yamaguchi M
AUID- ORCID: 0000-0001-6167-0591
AD  - Division of Respiratory Medicine, Third Department of Medicine, Teikyo University 
      Chiba Medical Center, Ichihara, Chiba, Japan.
FAU - Nishimura, Yoshihiro
AU  - Nishimura Y
AD  - Kita-Harima Medical Center, Ono, Hyogo, Japan.
FAU - Takumi, Yuko
AU  - Takumi Y
AD  - Patient Safety Division, Research and Development, AstraZeneca K.K., Osaka, 
      Japan.
FAU - Hayashi, Nobuya
AU  - Hayashi N
AUID- ORCID: 0000-0002-5386-5599
AD  - Data Science and Innovation Division, Research and Development, AstraZeneca K.K., 
      Osaka, Japan.
FAU - Sakamoto, Kei
AU  - Sakamoto K
AD  - Patient Safety Division, Research and Development, AstraZeneca K.K., Osaka, 
      Japan.
FAU - Tohda, Yuji
AU  - Tohda Y
AD  - Department of Respiratory Medicine and Allergology, Kindai University School of 
      Medicine, Osaka-Sayama, Osaka, Japan.
LA  - eng
PT  - Journal Article
DEP - 20240120
PL  - New Zealand
TA  - J Asthma Allergy
JT  - Journal of asthma and allergy
JID - 101543450
PMC - PMC10807277
OTO - NOTNLM
OT  - anti-interleukin-5 receptor alpha monoclonal antibody
OT  - asthma control
OT  - benralizumab
OT  - eosinophils
OT  - exacerbation
OT  - quality of life
OT  - severe uncontrolled asthma
COIS- Yamaguchi M: AstraZeneca K.K.: support for this study, consulting fees, and 
      lecture fees. Nishimura Y: AstraZeneca K.K.: support for this study and 
      consulting fees. Takumi Y, Hayashi N, and Sakamoto K: employees of AstraZeneca 
      K.K. and stock ownership in the company. Tohda Y: AstraZeneca K.K.: support for 
      this study and consulting fees; Boehringer-Ingelheim Co., Ltd., Kyorin 
      Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Factory, Taiho, Teijin Pharma 
      Co., Ltd., Astellas, GSK, Daiichi Sankyo Co., Ltd., Ono Pharmaceutical: grants or 
      contracts; AstraZeneca K.K., Kyorin Pharmaceutical Co., Ltd., Teijin Pharma Co., 
      Ltd., Boehringer Ingelheim Co., Ltd., Daiichi Sankyo Co., Ltd., Astellas, Pearl 
      Therapeutics, Inc.: payment or honoraria.
EDAT- 2024/01/25 06:43
MHDA- 2024/01/25 06:44
PMCR- 2024/01/20
CRDT- 2024/01/25 04:01
PHST- 2023/07/27 00:00 [received]
PHST- 2023/12/19 00:00 [accepted]
PHST- 2024/01/25 06:44 [medline]
PHST- 2024/01/25 06:43 [pubmed]
PHST- 2024/01/25 04:01 [entrez]
PHST- 2024/01/20 00:00 [pmc-release]
AID - 432695 [pii]
AID - 10.2147/JAA.S432695 [doi]
PST - epublish
SO  - J Asthma Allergy. 2024 Jan 20;17:45-60. doi: 10.2147/JAA.S432695. eCollection 
      2024.