PMID- 29714536
OWN - NLM
STAT- MEDLINE
DCOM- 20190123
LR  - 20200103
IS  - 2168-4804 (Electronic)
IS  - 2168-4790 (Linking)
VI  - 52
IP  - 3
DP  - 2018 May
TI  - Comparison of Serious Adverse Event Profiles Among Antirheumatic Agents Using 
      Japanese Adverse Drug Event Report Database.
PG  - 339-347
LID - 10.1177/2168479017728987 [doi]
AB  - BACKGROUND: The association between drugs and adverse events (AEs) has been 
      investigated using various AE databases. The aim of this study was to provide 
      useful information for risk minimization of antirheumatic agents by investigating 
      the safety profiles of antirheumatic agents using the Japanese Adverse Drug Event 
      Report database (JADER), focusing on some important serious AEs (SAEs) and their 
      relation to time. METHODS: Tumor necrosis factor-alpha inhibitors (TNF-Is), 
      interleukin-6 inhibitors (IL-6-Is), and methotrexate (MTX) were selected as 
      antirheumatic agents. Tuberculosis, malignant tumors, and bone marrow disorders 
      were focused as typical SAEs. Disproportionate reporting of these SAEs was 
      evaluated using the reporting odds ratio. Time to onset of each SAE was 
      calculated using date information. RESULTS: Increased reporting odds ratios were 
      observed in tuberculosis and malignant tumors associated with TNF-I, in 
      tuberculosis and malignant tumors associated with IL-6-I, and in tuberculosis, 
      malignant tumors, and bone marrow disorders associated with MTX. The median time 
      to onset of the focused SAEs associated with TNF-I were 501, 681, and 254 days, 
      respectively; those associated with IL-6-I were 387, 636, and 116 days; and those 
      associated with MTX were 537, 1125, and 328 days. These results suggested 
      different profiles for the focused SAEs. CONCLUSION: The time-to-onset profiles 
      of the SAEs for TNF-I, IL-6-I, and MTX as antirheumatic agent were different 
      among different SAEs, which suggests that they should be monitored carefully 
      based on the profiles. The information from JADER is expected to contribute to 
      the risk minimization of drugs in the actual clinical practice.
FAU - Matsuoka, Yomei
AU  - Matsuoka Y
AD  - 1 Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of 
      Pharmaceutical Sciences, Kitasato University, Tokyo, Japan.
FAU - Narukawa, Mamoru
AU  - Narukawa M
AD  - 1 Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of 
      Pharmaceutical Sciences, Kitasato University, Tokyo, Japan.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
DEP - 20170912
PL  - Switzerland
TA  - Ther Innov Regul Sci
JT  - Therapeutic innovation & regulatory science
JID - 101597411
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Interleukin-6)
RN  - 0 (Tumor Necrosis Factor-alpha)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems
MH  - Antirheumatic Agents/*adverse effects/pharmacology
MH  - Bone Marrow Diseases/*chemically induced
MH  - Databases, Factual
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH  - Humans
MH  - Interleukin-6/antagonists & inhibitors
MH  - Japan/epidemiology
MH  - Methotrexate/adverse effects/pharmacology
MH  - Neoplasms/*chemically induced
MH  - Odds Ratio
MH  - Time Factors
MH  - Tuberculosis/*chemically induced
MH  - Tumor Necrosis Factor-alpha/antagonists & inhibitors
OTO - NOTNLM
OT  - JADER
OT  - SAE
OT  - antirheumatic agent
OT  - reporting odds ratio
OT  - serious adverse event
OT  - time to onset
EDAT- 2017/01/01 00:00
MHDA- 2019/01/24 06:00
CRDT- 2018/05/02 06:00
PHST- 2017/01/01 00:00 [pubmed]
PHST- 2019/01/24 06:00 [medline]
PHST- 2018/05/02 06:00 [entrez]
AID - 10.1177/2168479017728987 [doi]
PST - ppublish
SO  - Ther Innov Regul Sci. 2018 May;52(3):339-347. doi: 10.1177/2168479017728987. Epub 
      2017 Sep 12.