PMID- 25496464
OWN - NLM
STAT- MEDLINE
DCOM- 20160913
LR  - 20220408
IS  - 1439-7609 (Electronic)
IS  - 1439-7595 (Print)
IS  - 1439-7595 (Linking)
VI  - 25
IP  - 4
DP  - 2015 Jul
TI  - Efficacy and safety of tofacitinib as monotherapy in Japanese patients with 
      active rheumatoid arthritis: a 12-week, randomized, phase 2 study.
PG  - 514-21
LID - 10.3109/14397595.2014.995875 [doi]
AB  - OBJECTIVES: To evaluate oral tofacitinib versus placebo for treatment of active 
      rheumatoid arthritis in Japanese patients with inadequate response to 
      disease-modifying antirheumatic drugs. METHODS: In this double-blind, 
      placebo-controlled, randomized, parallel-group, 12-week, phase 2 study 
      (clinicaltrials.gov NCT00687193), 317 patients received tofacitinib: 1, 3, 5, 10, 
      or 15 mg as monotherapy or placebo twice daily (BID). PRIMARY ENDPOINT: response 
      rate by American College of Rheumatology (ACR) >/= 20% improvement criteria (ACR20) 
      at week 12. RESULTS: ACR20 response rates: 37.7% (20/53), 67.9% (36/53), 73.1% 
      (38/52), 84.9% (45/53), and 90.7% (49/54) with tofacitinib: 1, 3, 5, 10, and 15 
      mg BID, respectively, versus 15.4% (8/52) with placebo (p < 0.01; all doses). 
      Dose-dependent ACR20 responses with tofacitinib versus placebo occurred from week 
      2 onward (p < 0.05). Changes from baseline in 28-joint disease activity score 
      using erythrocyte sedimentation rate improved with tofacitinib versus placebo 
      from week 4 (p < 0.01; all doses). Six tofacitinib patients experienced 
      treatment-related serious adverse events (AEs). Most common treatment-emergent 
      AEs: nasopharyngitis (10% vs 12%) and hyperlipidemia (5% vs 0%). Serum 
      creatinine, hemoglobin, and total-, low-, and high-density 
      lipoprotein-cholesterol levels increased with tofacitinib. CONCLUSIONS: 
      Tofacitinib produced dose-dependent ACR20 responses and reduced disease activity. 
      The safety profile was consistent with that reported from global monotherapy 
      trials.
FAU - Tanaka, Yoshiya
AU  - Tanaka Y
AD  - The First Department of Internal Medicine, School of Medicine, University of 
      Occupational and Environmental Health , Kitakyushu, Fukuoka , Japan.
FAU - Takeuchi, Tsutomu
AU  - Takeuchi T
FAU - Yamanaka, Hisashi
AU  - Yamanaka H
FAU - Nakamura, Hiroyuki
AU  - Nakamura H
FAU - Toyoizumi, Shigeyuki
AU  - Toyoizumi S
FAU - Zwillich, Samuel
AU  - Zwillich S
LA  - eng
SI  - ClinicalTrials.gov/NCT00687193
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Mod Rheumatol
JT  - Modern rheumatology
JID - 100959226
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Piperidines)
RN  - 0 (Protein Kinase Inhibitors)
RN  - 0 (Pyrimidines)
RN  - 0 (Pyrroles)
RN  - 87LA6FU830 (tofacitinib)
RN  - EC 2.7.10.2 (Janus Kinase 3)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antirheumatic Agents/administration & dosage
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Janus Kinase 3/antagonists & inhibitors
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Piperidines/*administration & dosage
MH  - Protein Kinase Inhibitors/administration & dosage
MH  - Pyrimidines/*administration & dosage
MH  - Pyrroles/*administration & dosage
MH  - Time Factors
MH  - Treatment Outcome
PMC - PMC4819568
OTO - NOTNLM
OT  - Japan
OT  - Monotherapy
OT  - Randomized controlled trial
OT  - Rheumatoid arthritis
OT  - Tofacitinib
EDAT- 2014/12/17 06:00
MHDA- 2016/09/14 06:00
PMCR- 2016/04/04
CRDT- 2014/12/16 06:00
PHST- 2014/12/16 06:00 [entrez]
PHST- 2014/12/17 06:00 [pubmed]
PHST- 2016/09/14 06:00 [medline]
PHST- 2016/04/04 00:00 [pmc-release]
AID - 995875 [pii]
AID - 10.3109/14397595.2014.995875 [doi]
PST - ppublish
SO  - Mod Rheumatol. 2015 Jul;25(4):514-21. doi: 10.3109/14397595.2014.995875.