PMID- 32693646
OWN - NLM
STAT- MEDLINE
DCOM- 20201104
LR  - 20211204
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 19
IP  - 11
DP  - 2020 Nov
TI  - A real-world disproportionality analysis of FDA Adverse Event Reporting System 
      (FAERS) events for baricitinib.
PG  - 1505-1511
LID - 10.1080/14740338.2020.1799975 [doi]
AB  - BACKGROUND: Baricitinib is approved for the treatment of rheumatoid arthritis 
      (RA). The authors retrospectively investigated adverse events (AEs) by 
      data-mining a self-reporting database to better understand toxicities, especially 
      since it has been used during the coronavirus disease 2019 (COVID-19) pandemic. 
      METHODS: A reporting odds ratio (ROR) was used to detect the risk signals from 
      the data in the US Food and Drug Administration (FDA) adverse event reporting 
      system database (FAERS). The definition relied on system organ class (SOCs) and 
      preferred terms (PTs) by the Medical Dictionary for Regulatory Activities 
      (MedDRA). RESULTS: The search retrieved 1,598 baricitinib-associated cases within 
      the reporting period: 86 PTs with significant disproportionality were retained. 
      Infections including 'herpes zoster,' 'oral herpes,' and 'herpes virus infection' 
      were found at a similar rate to those reported in trials, and such events were 
      rare. Reports emerged for several thrombotic adverse events, while these events 
      were also rare. Unexpected safety signals as opportunistic infections were 
      detected. Serious outcomes as death and life-threatening outcomes accounted for 
      9.76% of the reported cases. CONCLUSIONS: The incidence of these AEs does not 
      appear above the background expected. These data are consistent with routine 
      clinical observations and suggest the importance of pharmacovigilance.
FAU - Peng, Ling
AU  - Peng L
AUID- ORCID: 0000-0002-1359-4982
AD  - Department of Radiotherapy, The First Affiliated Hospital, School of Medicine, 
      Zhejiang University , Hangzhou, Zhejiang Province, China.
FAU - Xiao, Kui
AU  - Xiao K
AUID- ORCID: 0000-0001-6519-713X
AD  - Department of Pulmonary and Critical Care Medicine, Tihe Second Xiangya Hospital, 
      Central South University , Changsha, Hunan Province, China.
FAU - Ottaviani, Silvia
AU  - Ottaviani S
AUID- ORCID: 0000-0002-8830-9947
AD  - Division of Cancer, Department of Surgery and Cancer, Imperial College London , 
      London, UK.
FAU - Stebbing, Justin
AU  - Stebbing J
AUID- ORCID: 0000-0002-1117-6947
AD  - Division of Cancer, Department of Surgery and Cancer, Imperial College London , 
      London, UK.
FAU - Wang, Ying-Jie
AU  - Wang YJ
AD  - State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, 
      Collaborative Innovation Center for Diagnosis and Treatment of Infectious 
      Diseases, the First Affiliated Hospital, School of Medicine, Zhejiang University 
      , Hangzhou, Zhejiang, China.
LA  - eng
GR  - NIHR-RP-011-053/DH_/Department of Health/United Kingdom
PT  - Journal Article
DEP - 20200731
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Azetidines)
RN  - 0 (Janus Kinase Inhibitors)
RN  - 0 (Purines)
RN  - 0 (Pyrazoles)
RN  - 0 (Sulfonamides)
RN  - ISP4442I3Y (baricitinib)
SB  - IM
CIN - Expert Opin Drug Saf. 2020 Oct;19(10):1367-1369. PMID: 32840116
MH  - Adult
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Aged
MH  - Aged, 80 and over
MH  - Antirheumatic Agents/*adverse effects
MH  - Azetidines/*adverse effects
MH  - Data Mining
MH  - Databases, Factual
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH  - Female
MH  - Humans
MH  - Incidence
MH  - Janus Kinase Inhibitors/*adverse effects
MH  - Male
MH  - Middle Aged
MH  - Patient Safety
MH  - *Pharmacovigilance
MH  - Purines
MH  - Pyrazoles
MH  - Retrospective Studies
MH  - Risk Assessment
MH  - Risk Factors
MH  - Sulfonamides/*adverse effects
MH  - Treatment Outcome
MH  - United States
MH  - *United States Food and Drug Administration
MH  - Young Adult
OTO - NOTNLM
OT  - Baricitinib
OT  - FAERS
OT  - JAK inhibitor
OT  - adverse event
OT  - pharmacovigilance
EDAT- 2020/07/23 06:00
MHDA- 2020/11/05 06:00
CRDT- 2020/07/23 06:00
PHST- 2020/07/23 06:00 [pubmed]
PHST- 2020/11/05 06:00 [medline]
PHST- 2020/07/23 06:00 [entrez]
AID - 10.1080/14740338.2020.1799975 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2020 Nov;19(11):1505-1511. doi: 
      10.1080/14740338.2020.1799975. Epub 2020 Jul 31.