PMID- 30489177
OWN - NLM
STAT- MEDLINE
DCOM- 20191212
LR  - 20191217
IS  - 1439-7609 (Electronic)
IS  - 1439-7595 (Linking)
VI  - 29
IP  - 5
DP  - 2019 Sep
TI  - Efficacy and safety of tofacitinib in Japanese patients with rheumatoid arthritis 
      by background methotrexate dose: A post hoc analysis of clinical trial data.
PG  - 756-766
LID - 10.1080/14397595.2018.1553489 [doi]
AB  - Objectives: Tofacitinib is an oral JAK inhibitor for the treatment of rheumatoid 
      arthritis (RA). We investigated concomitant methotrexate (MTX) dose on 
      tofacitinib efficacy/safety in Japanese RA patients. Methods: This post hoc 
      analysis pooled data from a 3-month phase 2 study (NCT00603512) and a 24-month 
      phase 3 study (NCT00847613). Patients (N= 254) received tofacitinib (low-dose (1 
      or 3 mg), 5 mg, 10 mg) twice daily (BID) or placebo, with low-dose (>0 to 
      8 mg/week) or high-dose (>8 mg/week) MTX. Efficacy (ACR20/50/70 and DAS28-4 
      (ESR)<2.6 response rates; changes from baseline (CFB) in DAS28-4 (ESR) and 
      HAQ-DI) and safety (adverse events (AEs), discontinuations due to AEs, serious 
      AEs, and deaths) were assessed through month 3. Results: At month 3, ACR20/50/70 
      response rates, mean DAS28-4 (ESR) CFB and HAQ-DI CFB were similar across MTX 
      doses and generally greater for all tofacitinib doses versus placebo. AE rates 
      with low-dose/high-dose MTX were: placebo, 28.6%/52.9%; tofacitinib low-dose, 
      50.0%/66.7%; 5 mg BID, 56.5%/64.3%; 10 mg BID, 73.8%/67.7%. Conclusion: 
      Tofacitinib efficacy in Japanese RA patients may be unaffected by background MTX 
      dose. AE rates with low-dose versus high-dose MTX were lower with placebo, 
      tofacitinib low-dose or 5 mg BID, but not 10 mg BID, with no apparent differences 
      across system organ class/laboratory parameters.
FAU - Takeuchi, Tsutomu
AU  - Takeuchi T
AD  - Keio University , Tokyo , Japan.
FAU - Yamanaka, Hisashi
AU  - Yamanaka H
AD  - Institute of Rheumatology, Tokyo Women's Medical University , Tokyo , Japan.
FAU - Yamaoka, Kunihiro
AU  - Yamaoka K
AD  - Keio University , Tokyo , Japan.
FAU - Arai, Shoko
AU  - Arai S
AD  - Pfizer Japan Inc , Tokyo , Japan.
FAU - Toyoizumi, Shigeyuki
AU  - Toyoizumi S
AD  - Pfizer Japan Inc , Tokyo , Japan.
FAU - DeMasi, Ryan
AU  - DeMasi R
AD  - Pfizer Inc , New York , NY , USA.
FAU - Fukuma, Yuri
AU  - Fukuma Y
AD  - Pfizer Japan Inc , Tokyo , Japan.
FAU - Hirose, Tomohiro
AU  - Hirose T
AD  - Pfizer Japan Inc , Tokyo , Japan.
FAU - Sugiyama, Naonobu
AU  - Sugiyama N
AD  - Pfizer Japan Inc , Tokyo , Japan.
FAU - Zwillich, Samuel H
AU  - Zwillich SH
AD  - Pfizer Inc , Groton , CT , USA.
FAU - Tanaka, Yoshiya
AU  - Tanaka Y
AD  - The First Department of Internal Medicine, University of Occupational and 
      Environmental Health , Kitakyushu , Japan.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20190111
PL  - England
TA  - Mod Rheumatol
JT  - Modern rheumatology
JID - 100959226
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Piperidines)
RN  - 0 (Pyrimidines)
RN  - 0 (Pyrroles)
RN  - 87LA6FU830 (tofacitinib)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Adult
MH  - Antirheumatic Agents/therapeutic use
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Male
MH  - Methotrexate/administration & dosage/adverse effects/*therapeutic use
MH  - Middle Aged
MH  - Piperidines/administration & dosage/adverse effects/*therapeutic use
MH  - Pyrimidines/administration & dosage/adverse effects/*therapeutic use
MH  - Pyrroles/administration & dosage/adverse effects/*therapeutic use
OTO - NOTNLM
OT  - Janus kinase
OT  - Japan
OT  - methotrexate
OT  - rheumatoid arthritis
OT  - tofacitinib
EDAT- 2018/11/30 06:00
MHDA- 2019/12/18 06:00
CRDT- 2018/11/30 06:00
PHST- 2018/11/30 06:00 [pubmed]
PHST- 2019/12/18 06:00 [medline]
PHST- 2018/11/30 06:00 [entrez]
AID - 10.1080/14397595.2018.1553489 [doi]
PST - ppublish
SO  - Mod Rheumatol. 2019 Sep;29(5):756-766. doi: 10.1080/14397595.2018.1553489. Epub 
      2019 Jan 11.