PMID- 28260984
OWN - NLM
STAT- MEDLINE
DCOM- 20170627
LR  - 20181113
IS  - 1449-1907 (Electronic)
IS  - 1449-1907 (Linking)
VI  - 14
IP  - 2
DP  - 2017
TI  - Age-related trends in injection site reaction incidence induced by the tumor 
      necrosis factor-alpha (TNF-alpha) inhibitors etanercept and adalimumab: the Food and Drug 
      Administration adverse event reporting system, 2004-2015.
PG  - 102-109
LID - 10.7150/ijms.17025 [doi]
AB  - Tumor necrosis factor-alpha (TNF-alpha) inhibitors are increasingly being used as 
      treatment for rheumatoid arthritis (RA). However, the administration of these 
      drugs carries the risk of inducing injection site reaction (ISR). ISR gives rise 
      to patient stress, nervousness, and a decrease in quality of life (QoL). In order 
      to alleviate pain and other symptoms, early countermeasures must be taken against 
      this adverse event. In order to improve understanding of the risk factors 
      contributing to the induction of ISR, we evaluated the association between TNF-alpha 
      inhibitors and ISR by applying a logistic regression model to age-stratified data 
      obtained from the Food and Drug Administration Adverse Event Reporting System 
      (FAERS) database. The FAERS database contains 7,561,254 reports from January 2004 
      to December 2015. Adjusted reporting odds ratios (RORs) (95% Confidence 
      Intervals) were obtained for interaction terms for age-stratified groups treated 
      with etanercept (ETN) and adalimumab (ADA). The adjusted RORs for ETN* >/= 70 and 
      ADA* >/= 70 groups were the lowest among the age-stratified groups undergoing the 
      respective monotherapies. Furthermore, we found that crude RORs for ETN + 
      methotrexate (MTX) combination therapy and ADA + MTX combination therapy were 
      lower than those for the respective monotherapies. This study was the first to 
      evaluate the relationship between aging and ISR using the FAERS database.
FAU - Matsui, Toshinobu
AU  - Matsui T
AD  - Laboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4 
      Daigaku-nishi, Gifu, 501-1196, Japan.
FAU - Umetsu, Ryogo
AU  - Umetsu R
AD  - Laboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4 
      Daigaku-nishi, Gifu, 501-1196, Japan;; Clinical Research, Innovation and 
      Education Center, Tohoku University Hospital, 1-1, Seiryomachi, Aoba-ku, Sendai, 
      Miyagi, 980-8574, Japan.
FAU - Kato, Yamato
AU  - Kato Y
AD  - Laboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4 
      Daigaku-nishi, Gifu, 501-1196, Japan.
FAU - Hane, Yuuki
AU  - Hane Y
AD  - Laboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4 
      Daigaku-nishi, Gifu, 501-1196, Japan.
FAU - Sasaoka, Sayaka
AU  - Sasaoka S
AD  - Laboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4 
      Daigaku-nishi, Gifu, 501-1196, Japan.
FAU - Motooka, Yumi
AU  - Motooka Y
AD  - Laboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4 
      Daigaku-nishi, Gifu, 501-1196, Japan.
FAU - Hatahira, Haruna
AU  - Hatahira H
AD  - Laboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4 
      Daigaku-nishi, Gifu, 501-1196, Japan.
FAU - Abe, Junko
AU  - Abe J
AD  - Laboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4 
      Daigaku-nishi, Gifu, 501-1196, Japan;; Medical Database Co., LTD, 3-11-10 
      Higashi, Shibuya-ku, Tokyo, 150-0011, Japan.
FAU - Fukuda, Akiho
AU  - Fukuda A
AD  - Laboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4 
      Daigaku-nishi, Gifu, 501-1196, Japan.
FAU - Naganuma, Misa
AU  - Naganuma M
AD  - Laboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4 
      Daigaku-nishi, Gifu, 501-1196, Japan.
FAU - Kinosada, Yasutomi
AU  - Kinosada Y
AD  - United Graduate School of Drug Discovery and Medical Information Sciences, Gifu 
      University, 1-1 Yanagido, Gifu, 501-1194, Japan.
FAU - Nakamura, Mitsuhiro
AU  - Nakamura M
AD  - Laboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4 
      Daigaku-nishi, Gifu, 501-1196, Japan.
LA  - eng
PT  - Journal Article
DEP - 20170115
PL  - Australia
TA  - Int J Med Sci
JT  - International journal of medical sciences
JID - 101213954
RN  - 0 (Tumor Necrosis Factor-alpha)
RN  - FYS6T7F842 (Adalimumab)
RN  - OP401G7OJC (Etanercept)
SB  - IM
MH  - Adalimumab/*adverse effects
MH  - Adult
MH  - Age Factors
MH  - Aged
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH  - Etanercept/*adverse effects
MH  - Female
MH  - Humans
MH  - Injections/*adverse effects
MH  - Male
MH  - Middle Aged
MH  - Tumor Necrosis Factor-alpha/*antagonists & inhibitors
MH  - United States
MH  - United States Food and Drug Administration
MH  - Young Adult
PMC - PMC5332837
OTO - NOTNLM
OT  - adalimumab
OT  - adverse event reporting system.
OT  - etanercept
OT  - injection site reaction
COIS- Competing Interests: JA is an employee of Medical Database. The rest of the 
      authors have no conflict of interest.
EDAT- 2017/03/07 06:00
MHDA- 2017/06/28 06:00
PMCR- 2017/01/01
CRDT- 2017/03/07 06:00
PHST- 2016/07/29 00:00 [received]
PHST- 2016/11/24 00:00 [accepted]
PHST- 2017/03/07 06:00 [entrez]
PHST- 2017/03/07 06:00 [pubmed]
PHST- 2017/06/28 06:00 [medline]
PHST- 2017/01/01 00:00 [pmc-release]
AID - ijmsv14p0102 [pii]
AID - 10.7150/ijms.17025 [doi]
PST - epublish
SO  - Int J Med Sci. 2017 Jan 15;14(2):102-109. doi: 10.7150/ijms.17025. eCollection 
      2017.