PMID- 30092161
OWN - NLM
STAT- MEDLINE
DCOM- 20191212
LR  - 20191217
IS  - 1439-7609 (Electronic)
IS  - 1439-7595 (Linking)
VI  - 29
IP  - 5
DP  - 2019 Sep
TI  - Three-year safety and two-year effectiveness of etanercept in patients with 
      rheumatoid arthritis in Japan: Results of long-term postmarketing surveillance.
PG  - 737-746
LID - 10.1080/14397595.2018.1510759 [doi]
AB  - Objectives: To evaluate the real-world safety and effectiveness of etanercept 
      (ETN) in Japanese patients with rheumatoid arthritis. Methods: This postmarketing 
      surveillance study (NCT00503139) assessed the safety and effectiveness of ETN 
      treatment over 3 and 2 years (from June 2007 to September 2011), respectively. 
      Safety was evaluated by occurrence and seriousness of adverse drug reactions 
      (ADRs), and of adverse events (AEs) for malignancies. Effectiveness was assessed 
      using the Disease Activity Score in 28 joints based on the erythrocyte 
      sedimentation rate (ESR) with four variables (swollen and tender joint counts, 
      ESR, and patient global assessment; DAS28-4/ESR). Treatment was considered 
      effective if patients had a good/moderate response by the European League Against 
      Rheumatism response criteria. Results: ADRs occurred in 256/675 (37.9%) patients, 
      the most common being injection site reactions (4.4%) and nasopharyngitis (3.3%). 
      Serious ADRs occurred in 60/675 (8.9%) patients, the most frequent being 
      pneumonia (1.2%). The incident rate of malignancies (AEs) was 1.06 per 100 
      patient-years. Mean baseline DAS28-4/ESR for the 581 patients included in 
      effectiveness analysis was 5.42, which decreased to 3.32 at 2 years. Eighty-two 
      percent of patients achieved a moderate/good response at 2 years. Conclusion: 
      Long-term ETN treatment safety and effectiveness were sustained over 3 and 2 
      years, respectively.
FAU - Yamanaka, Hisashi
AU  - Yamanaka H
AD  - Institute of Rheumatology, Tokyo Women's Medical University , Tokyo , Japan.
FAU - Hirose, Tomohiro
AU  - Hirose T
AD  - Pfizer Japan Inc. , Tokyo , Japan.
FAU - Endo, Yutaka
AU  - Endo Y
AD  - Pfizer Japan Inc. , Tokyo , Japan.
FAU - Sugiyama, Noriko
AU  - Sugiyama N
AD  - Pfizer Japan Inc. , Tokyo , Japan.
FAU - Fukuma, Yuri
AU  - Fukuma Y
AD  - Pfizer Japan Inc. , Tokyo , Japan.
FAU - Morishima, Yosuke
AU  - Morishima Y
AD  - Pfizer Japan Inc. , Tokyo , Japan.
FAU - Sugiyama, Naonobu
AU  - Sugiyama N
AD  - Pfizer Japan Inc. , Tokyo , Japan.
FAU - Yoshii, Noritoshi
AU  - Yoshii N
AD  - Pfizer Japan Inc. , Tokyo , Japan.
FAU - Miyasaka, Nobuyuki
AU  - Miyasaka N
AD  - Department of Rheumatology, Tokyo Medical & Dental University , Tokyo, Japan.
FAU - Koike, Takao
AU  - Koike T
AD  - Hokkaido Medical Center for Rheumatic Diseases , Sapporo , Japan.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20180920
PL  - England
TA  - Mod Rheumatol
JT  - Modern rheumatology
JID - 100959226
RN  - 0 (Antirheumatic Agents)
RN  - OP401G7OJC (Etanercept)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antirheumatic Agents/*adverse effects/therapeutic use
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Etanercept/*adverse effects/therapeutic use
MH  - Female
MH  - Humans
MH  - Injection Site Reaction/epidemiology
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - *Product Surveillance, Postmarketing
OTO - NOTNLM
OT  - DAS28-ESR
OT  - etanercept
OT  - mHAQ
OT  - postmarketing surveillance study
OT  - rheumatoid arthritis
EDAT- 2018/08/10 06:00
MHDA- 2019/12/18 06:00
CRDT- 2018/08/10 06:00
PHST- 2018/08/10 06:00 [pubmed]
PHST- 2019/12/18 06:00 [medline]
PHST- 2018/08/10 06:00 [entrez]
AID - 10.1080/14397595.2018.1510759 [doi]
PST - ppublish
SO  - Mod Rheumatol. 2019 Sep;29(5):737-746. doi: 10.1080/14397595.2018.1510759. Epub 
      2018 Sep 20.