PMID- 37310063
OWN - NLM
STAT- MEDLINE
DCOM- 20231102
LR  - 20231102
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 22
IP  - 10
DP  - 2023 Jul-Dec
TI  - Post-Marketing Safety Concerns with Upadacitinib: A Disproportionality Analysis 
      of the FDA Adverse Event Reporting system.
PG  - 975-984
LID - 10.1080/14740338.2023.2223952 [doi]
AB  - BACKGROUND: Upadacitinib was approved to treat rheumatoid arthritis, psoriasis, 
      ulcerative colitis, ankylosing spondylitis, and atopic dermatitis. This study 
      assessed the adverse events (AEs) associated with upadacitinib by mining data 
      from the US Food and Drug Administration Adverse Event Reporting System (FAERS). 
      METHODS: Disproportionality analyses, including the reporting odds ratio (ROR), 
      the proportional reporting ratio (PRR), the Bayesian confidence propagation 
      neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) 
      algorithms, were employed to quantify the signals of upadacitinib-associated AEs. 
      RESULTS: A total of 3,837,420 reports of AEs were collected from the FAERS 
      database, of which 4494 reports were identified with upadacitinib as the "primary 
      suspect (PS)". Upadacitinib-induced AEs occurrence targeted 27 system organ 
      clases (SOCs). A total of 200 significant disproportionality PTs conforming to 
      the four algorithms were simultaneously retained. Unexpected significant AEs, 
      such as arthralgia, musculoskeletal stiffness, diverticulitis, and cataract might 
      also occur. The median onset time of upadacitinib-associated AEs was 65 days 
      (interquartile range [IQR] 21-182 days), and most of the onsets occurred within 
      the first 1, 2, 3, and 4 months after initiation of upadacitinib. CONCLUSION: 
      This study found potential new AEs signals and might provide important support 
      for clinical monitoring and risk identification of upadacitinib.
FAU - Wu, Xiang-Ping
AU  - Wu XP
AD  - Department of Pharmacy, Xiangya Hospital, Central South University, Changsha, 
      China.
AD  - College of Pharmacy, Dali University, Dali, Yunnan, China.
AD  - Department of Pharmacy, Institute for Rational and Safe Medication Practices, 
      National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, 
      Central South University, Changsha, China.
FAU - Lu, Xi-Kui
AU  - Lu XK
AD  - Department of Pharmacy, Xiangya Hospital, Central South University, Changsha, 
      China.
AD  - College of Pharmacy, Dali University, Dali, Yunnan, China.
AD  - Department of Pharmacy, Institute for Rational and Safe Medication Practices, 
      National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, 
      Central South University, Changsha, China.
FAU - Wang, Zhen-Ting
AU  - Wang ZT
AD  - Department of Pharmacy, Xiangya Hospital, Central South University, Changsha, 
      China.
AD  - College of Pharmacy, Dali University, Dali, Yunnan, China.
AD  - Department of Pharmacy, Institute for Rational and Safe Medication Practices, 
      National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, 
      Central South University, Changsha, China.
FAU - Huang, Ling
AU  - Huang L
AD  - Department of Pharmacy, Xiangya Hospital, Central South University, Changsha, 
      China.
AD  - Department of Pharmacy, Institute for Rational and Safe Medication Practices, 
      National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, 
      Central South University, Changsha, China.
FAU - Cai, Ru-Wen
AU  - Cai RW
AD  - Department of Pharmacy, Xiangya Hospital, Central South University, Changsha, 
      China.
AD  - College of Pharmacy, Dali University, Dali, Yunnan, China.
AD  - Department of Pharmacy, Institute for Rational and Safe Medication Practices, 
      National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, 
      Central South University, Changsha, China.
FAU - Yu, Hui-Min
AU  - Yu HM
AD  - Department of Pharmacy, Xiangya Hospital, Central South University, Changsha, 
      China.
AD  - Department of Pharmacy, Institute for Rational and Safe Medication Practices, 
      National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, 
      Central South University, Changsha, China.
FAU - Li, Jing-Yang
AU  - Li JY
AD  - Department of Pharmacy, Xiangya Hospital, Central South University, Changsha, 
      China.
AD  - Department of Pharmacy, Institute for Rational and Safe Medication Practices, 
      National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, 
      Central South University, Changsha, China.
FAU - Xiao, Jian
AU  - Xiao J
AD  - Department of Pharmacy, Xiangya Hospital, Central South University, Changsha, 
      China.
AD  - Department of Pharmacy, Institute for Rational and Safe Medication Practices, 
      National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, 
      Central South University, Changsha, China.
LA  - eng
PT  - Journal Article
DEP - 20230620
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 4RA0KN46E0 (upadacitinib)
SB  - IM
MH  - United States/epidemiology
MH  - Humans
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology/etiology
MH  - Adverse Drug Reaction Reporting Systems
MH  - Bayes Theorem
MH  - *Arthritis, Rheumatoid
MH  - United States Food and Drug Administration
MH  - Pharmacovigilance
OTO - NOTNLM
OT  - FAERS
OT  - adverse events
OT  - data mining
OT  - pharmacovigilance
OT  - post-marketing surveillance
OT  - upadacitinib
EDAT- 2023/06/13 13:12
MHDA- 2023/06/13 13:13
CRDT- 2023/06/13 08:32
PHST- 2023/06/13 13:13 [medline]
PHST- 2023/06/13 13:12 [pubmed]
PHST- 2023/06/13 08:32 [entrez]
AID - 10.1080/14740338.2023.2223952 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2023 Jul-Dec;22(10):975-984. doi: 
      10.1080/14740338.2023.2223952. Epub 2023 Jun 20.