PMID- 37848636
OWN - NLM
STAT- MEDLINE
DCOM- 20231023
LR  - 20231123
IS  - 2045-2322 (Electronic)
IS  - 2045-2322 (Linking)
VI  - 13
IP  - 1
DP  - 2023 Oct 17
TI  - A risk of serious anaphylatic reactions to asthma biologics: a pharmacovigilance 
      study based on a global real-world database.
PG  - 17607
LID - 10.1038/s41598-023-44973-z [doi]
LID - 17607
AB  - Asthma is a chronic inflammatory condition that affects the lung airways. Chronic 
      use of oral glucocorticoids in patients with severe asthma is associated with 
      several adverse events (AEs). Biologics (omalizumab, benralizumab, mepolizumab, 
      reslizumab, and dupilumab) have been developed as alternative therapies for the 
      treatment of asthma. In this study, we aimed to evaluate the risk of anaphylactic 
      reactions associated with these five biologics based on a large global database. 
      We utilized individual case reports from the Uppsala Monitoring Center from 
      January 1968 to December 29, 2019. A disproportionality analysis was performed 
      over all drugs and monoclonal antibodies. Anaphylactic reactions were defined 
      according to the "anaphylactic reaction" of the standardized MedDRA queries. 
      Contrary to dupilumab, omalizumab, benralizumab, and mepolizumab demonstrated 
      positive signals related to anaphylactic reactions over all drugs and monoclonal 
      antibodies. Reslizumab, which represented only 315 cases of all AEs, requires 
      more reports to determine its association with anaphylactic reactions. More 
      anaphylactic reactions have been identified than are known, and most cases 
      (96.2%) are reported to be serious. Our findings indicate that omalizumab, 
      benralizumab, and mepolizumab for asthma treatment are associated with a high 
      risk of anaphylactic reactions; thus, more careful monitoring in the 
      post-administration period is recommended.
CI  - (c) 2023. Springer Nature Limited.
FAU - Park, Sunny
AU  - Park S
AUID- ORCID: 0000-0001-9053-6930
AD  - College of Pharmacy and Research Institute of Pharmaceutical Sciences, Korea 
      University, Sejong, South Korea.
FAU - Kim, Yeju
AU  - Kim Y
AUID- ORCID: 0009-0000-2820-4644
AD  - College of Pharmacy, Korea University, Sejong, South Korea.
FAU - Lee, Geon Ho
AU  - Lee GH
AUID- ORCID: 0009-0009-6890-478X
AD  - College of Pharmacy, Korea University, Sejong, South Korea.
FAU - Choi, Soo An
AU  - Choi SA
AUID- ORCID: 0000-0002-7831-7740
AD  - College of Pharmacy and Research Institute of Pharmaceutical Sciences, Korea 
      University, Sejong, South Korea. sachoi@korea.ac.kr.
AD  - College of Pharmacy, Korea University, Sejong, South Korea. sachoi@korea.ac.kr.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20231017
PL  - England
TA  - Sci Rep
JT  - Scientific reports
JID - 101563288
RN  - 2P471X1Z11 (Omalizumab)
RN  - 0 (Anti-Asthmatic Agents)
RN  - 0 (Biological Products)
RN  - 0 (Antibodies, Monoclonal)
SB  - IM
MH  - Humans
MH  - Omalizumab/adverse effects
MH  - *Anti-Asthmatic Agents/adverse effects
MH  - *Biological Products/adverse effects
MH  - Pharmacovigilance
MH  - *Anaphylaxis/chemically induced/drug therapy
MH  - *Asthma
MH  - Antibodies, Monoclonal/therapeutic use
PMC - PMC10582024
COIS- The authors declare no competing interests.
EDAT- 2023/10/18 00:43
MHDA- 2023/10/23 01:18
PMCR- 2023/10/17
CRDT- 2023/10/17 23:40
PHST- 2023/03/28 00:00 [received]
PHST- 2023/10/13 00:00 [accepted]
PHST- 2023/10/23 01:18 [medline]
PHST- 2023/10/18 00:43 [pubmed]
PHST- 2023/10/17 23:40 [entrez]
PHST- 2023/10/17 00:00 [pmc-release]
AID - 10.1038/s41598-023-44973-z [pii]
AID - 44973 [pii]
AID - 10.1038/s41598-023-44973-z [doi]
PST - epublish
SO  - Sci Rep. 2023 Oct 17;13(1):17607. doi: 10.1038/s41598-023-44973-z.