PMID- 27748083
OWN - NLM
STAT- MEDLINE
DCOM- 20170718
LR  - 20180119
IS  - 2326-5205 (Electronic)
IS  - 2326-5191 (Linking)
VI  - 69
IP  - 4
DP  - 2017 Apr
TI  - Peficitinib, a JAK Inhibitor, in the Treatment of Moderate-to-Severe Rheumatoid 
      Arthritis in Patients With an Inadequate Response to Methotrexate.
PG  - 709-719
LID - 10.1002/art.39955 [doi]
AB  - OBJECTIVE: To evaluate the efficacy and safety of orally administered once-daily 
      peficitinib in combination with methotrexate (MTX) in patients with 
      moderate-to-severe rheumatoid arthritis (RA) who had an inadequate response to 
      MTX. METHODS: In this multinational, phase IIb, randomized, double-blind, 
      placebo-controlled, dose-ranging trial, patients with RA (n = 378) were treated 
      with peficitinib 25 mg, 50 mg, 100 mg, or 150 mg plus MTX, or matching placebo 
      plus MTX once daily for 12 weeks. The primary end point was the percentage of 
      patients who met the American College of Rheumatology 20% improvement criteria 
      (achieved an ACR20 response) at week 12. RESULTS: ACR20 response rates at week 12 
      were 43.9%, 61.5% (P < 0.05 versus placebo), 46.4%, 57.7%, and 44.4% in the 
      peficitinib 25 mg, 50 mg, 100 mg, 150 mg, and placebo groups, respectively. 
      Significant decreases from baseline in the Disease Activity Score in 28 joints 
      using the C-reactive protein level were seen in the peficitinib 50 mg (P < 0.05) 
      and 150 mg (P < 0.01) groups compared with placebo at week 12. Overall, the 
      incidence of adverse events (AEs) was similar between peficitinib and placebo. 
      The most common AEs were urinary tract infection (n = 22 [6%]), upper respiratory 
      tract infection (n = 16 [4%]), and diarrhea (n = 16 [4%]). There were 3 cases of 
      herpes zoster infection (2 in the peficitinib 100 mg group and 1 in the 150 mg 
      group) and 2 cases of serious infection (viral infection in the peficitinib 100 
      mg group and erysipelas in the 150 mg group). CONCLUSION: The ACR20 response rate 
      in the group receiving peficitinib 50 mg plus MTX was significantly different 
      compared with the rate in patients receiving placebo, but there were no apparent 
      dose-dependent responses, and the placebo response rate was high. Peficitinib 
      plus MTX in patients with moderate-to-severe RA was well tolerated, with limited 
      safety signals emerging.
CI  - (c) 2016, American College of Rheumatology.
FAU - Kivitz, A J
AU  - Kivitz AJ
AD  - Altoona Center for Clinical Research, Duncansville, Pennsylvania.
FAU - Gutierrez-Urena, S R
AU  - Gutierrez-Urena SR
AD  - Hospital Civil de Guadalajara, Guadalajara, Mexico.
FAU - Poiley, J
AU  - Poiley J
AD  - Arthritis Associates, Orlando, Florida.
FAU - Genovese, M C
AU  - Genovese MC
AD  - Stanford University, Palo Alto, California.
FAU - Kristy, R
AU  - Kristy R
AD  - Astellas Pharma Global Development, Northbrook, Illinois.
FAU - Shay, K
AU  - Shay K
AD  - Astellas Pharma Global Development, Northbrook, Illinois.
FAU - Wang, X
AU  - Wang X
AD  - Astellas Pharma Global Development, Northbrook, Illinois.
FAU - Garg, J P
AU  - Garg JP
AD  - Astellas Pharma Global Development, Northbrook, Illinois.
FAU - Zubrzycka-Sienkiewicz, A
AU  - Zubrzycka-Sienkiewicz A
AD  - ARS Rheumatica, Warsaw, Poland.
LA  - eng
SI  - ClinicalTrials.gov/NCT01554696
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Arthritis Rheumatol
JT  - Arthritis & rheumatology (Hoboken, N.J.)
JID - 101623795
RN  - 0 (Antirheumatic Agents)
RN  - 25X51I8RD4 (Niacinamide)
RN  - EC 2.7.10.2 (Janus Kinases)
RN  - HPH1166CKX (peficitinib)
RN  - PJY633525U (Adamantane)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Adamantane/*analogs & derivatives/therapeutic use
MH  - Antirheumatic Agents/*therapeutic use
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Janus Kinases/*antagonists & inhibitors
MH  - Male
MH  - Methotrexate/*therapeutic use
MH  - Middle Aged
MH  - Niacinamide/*analogs & derivatives/therapeutic use
MH  - Severity of Illness Index
MH  - Treatment Outcome
EDAT- 2016/10/18 06:00
MHDA- 2017/07/19 06:00
CRDT- 2016/10/18 06:00
PHST- 2016/04/22 00:00 [received]
PHST- 2016/10/06 00:00 [accepted]
PHST- 2016/10/18 06:00 [pubmed]
PHST- 2017/07/19 06:00 [medline]
PHST- 2016/10/18 06:00 [entrez]
AID - 10.1002/art.39955 [doi]
PST - ppublish
SO  - Arthritis Rheumatol. 2017 Apr;69(4):709-719. doi: 10.1002/art.39955.