PMID- 33050760
OWN - NLM
STAT- MEDLINE
DCOM- 20210621
LR  - 20221207
IS  - 1439-7609 (Electronic)
IS  - 1439-7595 (Linking)
VI  - 31
IP  - 3
DP  - 2021 May
TI  - A pooled safety analysis of peficitinib (ASP015K) in Asian patients with 
      rheumatoid arthritis treated over a median of 2 years.
PG  - 543-555
LID - 10.1080/14397595.2020.1836789 [doi]
AB  - OBJECTIVE: To evaluate the safety of peficitinib for the treatment of rheumatoid 
      arthritis (RA) in Asian patients. METHODS: Safety data from one Phase 2b, two 
      Phase 3, and one open-label long-term extension study [data cut-off 31 May 2018] 
      were pooled into Phase 3 studies (peficitinib 100 and 150 mg/day, and placebo) 
      and Phase 2/3 studies (all peficitinib-treated patients). Incidence rates per 100 
      patient-years (PY) of adverse events (AEs) of special interest were calculated. 
      RESULTS: Overall, 1052 patients received peficitinib for 2336.3 PY of exposure 
      (median 2.1 years); four deaths occurred, including one death after the studies. 
      AE incidence was similar across peficitinib 100 and 150 mg/day groups (Phase 3 
      studies). Respective peficitinib and placebo incidence rates (95% confidence 
      interval) per 100 PY were 2.9 (1.9, 4.6) and 0.0 for serious infections, 5.7 
      (4.2, 7.9) and 2.3 (0.6, 9.4) for herpes zoster-related disease, and 0.6 (0.2, 
      1.6) and 1.2 (0.2, 8.3) for malignancies (excluding non-melanoma skin cancer) 
      (Phase 3 studies), and 0.1 (0.0, 0.3) for venous thromboembolism in all 
      peficitinib-treated patients (Phase 2/3 studies). CONCLUSION: Peficitinib was 
      well tolerated in Asian patients with RA over a median of 2 years, with no 
      observed dose or temporal dependency for AEs with prolonged administration.
FAU - Takeuchi, Tsutomu
AU  - Takeuchi T
AUID- ORCID: 0000-0003-1111-8218
AD  - Division of Rheumatology, Department of Internal Medicine, Keio University School 
      of Medicine, Tokyo, Japan.
FAU - Tanaka, Yoshiya
AU  - Tanaka Y
AUID- ORCID: 0000-0002-0807-7139
AD  - The First Department of Internal Medicine, School of Medicine, University of 
      Occupational and Environmental Health Japan, Kitakyushu, Japan.
FAU - Rokuda, Mitsuhiro
AU  - Rokuda M
AUID- ORCID: 0000-0001-5790-7146
AD  - Astellas Pharma Inc., Tokyo, Japan.
FAU - Izutsu, Hiroyuki
AU  - Izutsu H
AUID- ORCID: 0000-0002-2193-8327
AD  - Astellas Pharma Inc., Tokyo, Japan.
FAU - Kaneko, Yuichiro
AU  - Kaneko Y
AD  - Astellas Pharma Inc., Tokyo, Japan.
FAU - Fukuda, Musashi
AU  - Fukuda M
AD  - Astellas Pharma Inc., Tokyo, Japan.
FAU - Kato, Daisuke
AU  - Kato D
AUID- ORCID: 0000-0003-1710-4319
AD  - Astellas Pharma Inc., Tokyo, Japan.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
DEP - 20201109
PL  - England
TA  - Mod Rheumatol
JT  - Modern rheumatology
JID - 100959226
RN  - 0 (Antirheumatic Agents)
RN  - 25X51I8RD4 (Niacinamide)
RN  - HPH1166CKX (peficitinib)
RN  - PJY633525U (Adamantane)
SB  - IM
MH  - Adamantane/administration & dosage/adverse effects/*analogs & 
      derivatives/therapeutic use
MH  - Adult
MH  - Antirheumatic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Arthritis, Rheumatoid/*drug therapy/ethnology
MH  - Asian People
MH  - Drug Tolerance
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Niacinamide/administration & dosage/adverse effects/*analogs & 
      derivatives/therapeutic use
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Janus kinase
OT  - peficitinib
OT  - pooled safety analysis
OT  - rheumatoid arthritis
EDAT- 2020/10/15 06:00
MHDA- 2021/06/22 06:00
CRDT- 2020/10/14 08:54
PHST- 2020/10/15 06:00 [pubmed]
PHST- 2021/06/22 06:00 [medline]
PHST- 2020/10/14 08:54 [entrez]
AID - 10.1080/14397595.2020.1836789 [doi]
PST - ppublish
SO  - Mod Rheumatol. 2021 May;31(3):543-555. doi: 10.1080/14397595.2020.1836789. Epub 
      2020 Nov 9.