PMID- 37256136
OWN - NLM
STAT- MEDLINE
DCOM- 20230602
LR  - 20230604
IS  - 1664-3224 (Electronic)
IS  - 1664-3224 (Linking)
VI  - 14
DP  - 2023
TI  - Adverse events with risankizumab in the real world: postmarketing 
      pharmacovigilance assessment of the FDA adverse event reporting system.
PG  - 1169735
LID - 10.3389/fimmu.2023.1169735 [doi]
LID - 1169735
AB  - BACKGROUND: Risankizumab, a humanized IgG1 monoclonal antibody that selectively 
      inhibits IL-23, is currently approved for the treatment of moderate-to-severe 
      plaque psoriasis and Crohn's disease. The real-world safety study of risankizumab 
      in a large- sample population is currently lacking. The aim of this study was to 
      evaluate risankizumab-associated adverse events (AEs) and characterize the 
      clinical priority through the data mining of the Food and Drug Administration 
      (FDA) Adverse Event Reporting System (FAERS). METHODS: Disproportionality 
      analyses were performed by calculating the reporting odds ratios (RORs), deemed 
      significant when the lower limit of the 95% confidence interval was greater than 
      1, to quantify the signals of risankizumab-related AEs from the second quarter 
      (Q2) of 2019 to 2022 Q3. Serious and non-serious cases were compared, and signals 
      were prioritized using a rating scale. RESULTS: Risankizumab was recorded in 
      10,235 reports, with 161 AEs associated with significant disproportionality. Of 
      note, 37 PTs in at least 30 cases were classified as unexpected AEs, which were 
      uncovered in the drug label, such as myocardial infarction, cataract, 
      pancreatitis, diabetes mellitus, stress, and nephrolithiasis. 74.68%, 25.32%, and 
      0% PTs were graded as weak, moderate, and strong clinical priorities, 
      respectively. A total of 48 risankizumab-related AEs such as pneumonia, 
      cerebrovascular accident, cataract, loss of consciousness, cardiac disorder, 
      hepatic cirrhosis, and thrombosis, were more likely to be reported as serious 
      AEs. The median TTO of moderate and weak signals related to risankizumab was 115 
      (IQR 16.75-305) and 124 (IQR 29-301) days, respectively. All of the 
      disproportionality signals had early failure type features, indicating that 
      risankizumab-associated AEs gradually decreased over time. CONCLUSION: Our study 
      found potential new AE signals and provided valuable evidence for clinicians to 
      mitigate the risk of risankizumab-associated AEs based on an extensive analysis 
      of a large-scale postmarketing international safety database.
CI  - Copyright (c) 2023 Shu, Chen, Ding and Zhang.
FAU - Shu, Yamin
AU  - Shu Y
AD  - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, China.
FAU - Chen, Jing
AU  - Chen J
AD  - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, China.
FAU - Ding, Yiling
AU  - Ding Y
AD  - Graduate School of Pharmaceutical Sciences, University of Tokyo, Tokyo, Japan.
FAU - Zhang, Qilin
AU  - Zhang Q
AD  - Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, China.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230515
PL  - Switzerland
TA  - Front Immunol
JT  - Frontiers in immunology
JID - 101560960
RN  - 90ZX3Q3FR7 (risankizumab)
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
SB  - IM
MH  - United States/epidemiology
MH  - Humans
MH  - *Pharmacovigilance
MH  - Adverse Drug Reaction Reporting Systems
MH  - United States Food and Drug Administration
MH  - *Drug-Related Side Effects and Adverse Reactions/diagnosis/epidemiology
MH  - Antibodies, Monoclonal
MH  - Antibodies, Monoclonal, Humanized
PMC - PMC10225532
OTO - NOTNLM
OT  - FAERS
OT  - adverse event
OT  - disproportionality
OT  - pharmacovigilance
OT  - risankizumab
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2023/05/31 13:11
MHDA- 2023/06/02 06:42
PMCR- 2023/01/01
CRDT- 2023/05/31 10:36
PHST- 2023/02/20 00:00 [received]
PHST- 2023/04/28 00:00 [accepted]
PHST- 2023/06/02 06:42 [medline]
PHST- 2023/05/31 13:11 [pubmed]
PHST- 2023/05/31 10:36 [entrez]
PHST- 2023/01/01 00:00 [pmc-release]
AID - 10.3389/fimmu.2023.1169735 [doi]
PST - epublish
SO  - Front Immunol. 2023 May 15;14:1169735. doi: 10.3389/fimmu.2023.1169735. 
      eCollection 2023.