PMID- 31145343
OWN - NLM
STAT- MEDLINE
DCOM- 20190607
LR  - 20221005
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 98
IP  - 22
DP  - 2019 May
TI  - Adverse events of benralizumab in moderate to severe eosinophilic asthma: A 
      meta-analysis.
PG  - e15868
LID - 10.1097/MD.0000000000015868 [doi]
LID - e15868
AB  - BACKGROUND: Benralizumab, a humanized, anti-interleukin-5 (anti-IL-5) receptor alpha 
      monoclonal antibody that directly and rapidly depletes eosinophils, has shown 
      significant efficacy in reducing asthma exacerbations and improving lung function 
      in moderate to severe eosinophilic asthma patients. However, there is some 
      controversy regarding the adverse events (AEs) of benralizumab and a 
      comprehensive analysis of these AEs has not been performed. This study aimed to 
      assess the incidence of these AEs in published randomized controlled trials 
      (RCTs). METHODS: We searched for RCTs in the Embase, PubMed and Cochrane 
      databases that compared benralizumab with placebo in moderate to severe 
      eosinophilic asthma patients. The outcome was the incidence of AEs during the 
      observation period. RESULTS: Eight RCTs were analyzed in this study. Patients 
      treated with benralizumab had a lower risk of overall AEs (risk ratio (RR) 0.94; 
      95% confidence interval (CI) 0.90-0.98), serious adverse events (SAEs) (RR 0.82; 
      95% CI 0.68-0.98), asthma exacerbation (RR 0.72, 95% CI 0.61-0.85), bronchitis 
      (RR 0.76, 95% CI 0.59-0.96) and sinusitis (RR 0.64, 95% CI 0.48-0.85), but had a 
      higher risk of headache (RR 1.42, 95% CI 1.07-1.87) and pyrexia (RR 2.26, 95% CI 
      1.32-3.87) than patients treated with placebo. No increased incidence of death, 
      hypersensitivity, injection-site reactions, nasopharyngitis, rhinitis, upper 
      respiratory tract infection, influenza, cough, nausea, back pain or arthralgia 
      was observed with benralizumab compared with placebo. CONCLUSIONS: Benralizumab 
      reduced the risk of SAEs, asthma exacerbation, bronchitis and sinusitis, and 
      aggravated the risk of headache and pyrexia. Other AEs were comparable between 
      the benralizumab group and placebo group. Therefore, benralizumab is a relatively 
      safe drug, but vigilance regarding AEs is imperative during long-term treatment.
FAU - Liu, Wanshu
AU  - Liu W
AD  - Department of Dermatology, The Affiliated Hospital of Southwest Medical 
      University, Luzhou City.
FAU - Ma, Xuesu
AU  - Ma X
AD  - Department of Dermatology, The Affiliated Hospital of Southwest Medical 
      University, Luzhou City.
FAU - Zhou, Weikang
AU  - Zhou W
AD  - Department of Dermatology, The Affiliated Hospital of Southwest Medical 
      University, Luzhou City.
AD  - Department of Allergy, Chongqing General Hospital, Chongqing, China.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Systematic Review
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (Anti-Asthmatic Agents)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 71492GE1FX (benralizumab)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-Asthmatic Agents/*adverse effects
MH  - Antibodies, Monoclonal, Humanized/*adverse effects
MH  - Asthma/*drug therapy
MH  - Child
MH  - Double-Blind Method
MH  - Female
MH  - Fever/chemically induced
MH  - Headache/chemically induced
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pulmonary Eosinophilia/*drug therapy
MH  - Randomized Controlled Trials as Topic
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC6709166
COIS- The authors have no conflicts of interests to disclose.
EDAT- 2019/05/31 06:00
MHDA- 2019/06/08 06:00
PMCR- 2019/05/31
CRDT- 2019/05/31 06:00
PHST- 2019/05/31 06:00 [entrez]
PHST- 2019/05/31 06:00 [pubmed]
PHST- 2019/06/08 06:00 [medline]
PHST- 2019/05/31 00:00 [pmc-release]
AID - 00005792-201905310-00073 [pii]
AID - MD-D-18-08973 [pii]
AID - 10.1097/MD.0000000000015868 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2019 May;98(22):e15868. doi: 10.1097/MD.0000000000015868.