PMID- 32639062
OWN - NLM
STAT- MEDLINE
DCOM- 20210311
LR  - 20221207
IS  - 1365-2125 (Electronic)
IS  - 0306-5251 (Linking)
VI  - 87
IP  - 3
DP  - 2021 Mar
TI  - Serious adverse events with tocilizumab: Pharmacovigilance as an aid to 
      prioritize monitoring in COVID-19.
PG  - 1533-1540
LID - 10.1111/bcp.14459 [doi]
AB  - Given its approval for the treatment of cytokine release syndrome, tocilizumab is 
      under investigation in severe coronavirus disease-2019. To characterize serious 
      adverse events (AEs) with tocilizumab, we queried the worldwide FDA Adverse Event 
      Reporting System and performed disproportionality analysis, selecting only 
      designated medical events (DMEs) where tocilizumab was reported as suspect, with 
      a focus on hepatic reactions. The reporting odds ratios (RORs) were calculated, 
      deemed significant by a lower limit of the 95% confidence interval (LL 95% CI) > 
      1. A total of 2,433 reports of DMEs were recorded with tocilizumab, mainly in 
      rheumatic diseases. Statistically significant RORs emerged for 13 DMEs, with 
      drug-induced liver injury (n = 91; LL 95% CI 3.07), pancreatitis (151; 1.41), and 
      pulmonary fibrosis (222; 7.21) as unpredictable AEs. A total of 174 cases of 
      liver-related DMEs were retrieved (proportion of deaths = 18.4%), with median 
      onset of 27.5 days. These serious unpredictable reactions occurring in chronic 
      real-world tocilizumab use may support patient care and monitoring of ongoing 
      clinical trials.
CI  - (c) 2020 The British Pharmacological Society.
FAU - Gatti, Milo
AU  - Gatti M
AUID- ORCID: 0000-0003-3018-3779
AD  - Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of 
      Bologna, Bologna, Italy.
FAU - Fusaroli, Michele
AU  - Fusaroli M
AD  - Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of 
      Bologna, Bologna, Italy.
FAU - Caraceni, Paolo
AU  - Caraceni P
AD  - Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of 
      Bologna, Bologna, Italy.
AD  - Centre for Applied Biomedical Research (CRBA), Alma Mater Studiorum, University 
      of Bologna, Bologna, Italy.
FAU - Poluzzi, Elisabetta
AU  - Poluzzi E
AD  - Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of 
      Bologna, Bologna, Italy.
FAU - De Ponti, Fabrizio
AU  - De Ponti F
AD  - Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of 
      Bologna, Bologna, Italy.
FAU - Raschi, Emanuel
AU  - Raschi E
AUID- ORCID: 0000-0003-0487-7996
AD  - Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of 
      Bologna, Bologna, Italy.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20200726
PL  - England
TA  - Br J Clin Pharmacol
JT  - British journal of clinical pharmacology
JID - 7503323
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - I031V2H011 (tocilizumab)
SB  - IM
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal, Humanized/*adverse effects/therapeutic use
MH  - COVID-19/*complications
MH  - Chemical and Drug Induced Liver Injury/epidemiology
MH  - Cytokine Release Syndrome/drug therapy/etiology
MH  - Databases, Factual
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Monitoring, Physiologic
MH  - Odds Ratio
MH  - Pancreatitis/chemically induced/epidemiology
MH  - Pharmacovigilance
MH  - Pulmonary Fibrosis/chemically induced/epidemiology
MH  - Retrospective Studies
MH  - United States
MH  - United States Food and Drug Administration
MH  - Young Adult
MH  - *COVID-19 Drug Treatment
OTO - NOTNLM
OT  - COVID-19
OT  - disproportionality
OT  - liver injury
OT  - pharmacovigilance
OT  - tocilizumab
EDAT- 2020/07/09 06:00
MHDA- 2021/03/12 06:00
CRDT- 2020/07/09 06:00
PHST- 2020/04/01 00:00 [received]
PHST- 2020/06/07 00:00 [revised]
PHST- 2020/06/16 00:00 [accepted]
PHST- 2020/07/09 06:00 [pubmed]
PHST- 2021/03/12 06:00 [medline]
PHST- 2020/07/09 06:00 [entrez]
AID - 10.1111/bcp.14459 [doi]
PST - ppublish
SO  - Br J Clin Pharmacol. 2021 Mar;87(3):1533-1540. doi: 10.1111/bcp.14459. Epub 2020 
      Jul 26.