PMID- 28923098
OWN - NLM
STAT- MEDLINE
DCOM- 20180529
LR  - 20220331
IS  - 1478-6362 (Electronic)
IS  - 1478-6354 (Print)
IS  - 1478-6354 (Linking)
VI  - 19
IP  - 1
DP  - 2017 Sep 18
TI  - Patient-reported outcomes of baricitinib in patients with rheumatoid arthritis 
      and no or limited prior disease-modifying antirheumatic drug treatment.
PG  - 208
LID - 10.1186/s13075-017-1410-1 [doi]
LID - 208
AB  - BACKGROUND: This study evaluates patient-reported outcomes (PROs) in a 
      double-blind, phase III study of baricitinib as monotherapy or combined with 
      methotrexate (MTX) in patients with active rheumatoid arthritis (RA) with no or 
      minimal prior conventional synthetic disease-modifying antirheumatic drugs 
      (DMARDs) and naive to biological DMARDs. METHODS: Patients were randomized 4:3:4 
      to MTX administered once weekly (N = 210), baricitinib monotherapy (4 mg once 
      daily (QD), N = 159), or combination of baricitinib (4 mg QD) and MTX 
      (baricitinib + MTX, N = 215). PROs included the Patient's Global Assessment of 
      Disease Activity (PtGA), patient's assessment of pain, Health Assessment 
      Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness 
      Therapy-Fatigue (FACIT-F), duration of morning joint stiffness (MJS), worst joint 
      pain, worst tiredness, Work Productivity and Activity Impairment-Rheumatoid 
      Arthritis (WPAI-RA), Short Form 36 version 2, Acute (SF-36); and EuroQol 
      5-Dimensions (EQ-5D) Health State Profile. Comparisons were assessed with 
      analysis of covariance (ANCOVA) and logistic regression models. RESULTS: Compared 
      to MTX, patients in both baricitinib groups reported greater improvement 
      (p </= 0.01) in HAQ-DI, PtGA, pain, fatigue, worst join pain, SF-36 physical 
      component score, and EQ-5D at weeks 24 and 52. For the SF-36 mental component 
      score, patients in both baricitinib groups reported statistically significant 
      improvements (p </= 0.01) at week 52 compared to MTX-treated patients. 
      Statistically significant improvements (p </= 0.05) were observed with the WPAI-RA 
      for the baricitinib groups vs. MTX at week 24 and for the WPAI-RA daily activity 
      and work productivity measures for baricitinib + MTX at week 52. CONCLUSIONS: In 
      this study, baricitinib alone or in combination with MTX, when used as initial 
      therapy, resulted in significant improvement compared to MTX in the majority of 
      the pre-specified PRO measures. TRIAL REGISTRATION: ClinicalTrials.gov, 
      NCT01711359 . Registered on 18 October 2012.
FAU - Schiff, Michael
AU  - Schiff M
AD  - University of Colorado School of Medicine, Denver, CO, 80045, USA. 
      michael.schiff@me.com.
FAU - Takeuchi, Tsutomu
AU  - Takeuchi T
AD  - Keio University, Tokyo, Japan.
FAU - Fleischmann, Roy
AU  - Fleischmann R
AD  - Metroplex Clinical Research Center, University of Texas Southwestern Medical 
      Center, Dallas, TX, 75231, USA.
FAU - Gaich, Carol L
AU  - Gaich CL
AD  - Eli Lilly and Company, Indianapolis, IN, 46285, USA.
FAU - DeLozier, Amy M
AU  - DeLozier AM
AD  - Eli Lilly and Company, Indianapolis, IN, 46285, USA.
FAU - Schlichting, Douglas
AU  - Schlichting D
AD  - Eli Lilly and Company, Indianapolis, IN, 46285, USA.
FAU - Kuo, Wen-Ling
AU  - Kuo WL
AD  - Eli Lilly and Company, Indianapolis, IN, 46285, USA.
FAU - Won, Ji-Eon
AU  - Won JE
AD  - Eli Lilly and Company, Seoul, Republic of Korea.
FAU - Carmack, Tara
AU  - Carmack T
AD  - Eli Lilly and Company, Indianapolis, IN, 46285, USA.
FAU - Rooney, Terence
AU  - Rooney T
AD  - Eli Lilly and Company, Indianapolis, IN, 46285, USA.
FAU - Durez, Patrick
AU  - Durez P
AD  - Service et Pole de Rhumatologie, Cliniques Universitaires Saint-Luc, Brussels, 
      Belgium.
AD  - Institut de Recherche Experimentale et Clinique, Universite catholique de 
      Louvain, Rheumatology, Brussels, Belgium.
FAU - Shaikh, Saeed
AU  - Shaikh S
AD  - McMaster University, Hamilton, ON, Canada.
FAU - Hidalgo, Rodolfo Pardo
AU  - Hidalgo RP
AD  - CER, San Juan, Argentina.
FAU - van Vollenhoven, Ronald
AU  - van Vollenhoven R
AD  - Amsterdam Rheumatology and Immunology Center ARC, Amsterdam, The Netherlands.
FAU - Zerbini, Cristiano A F
AU  - Zerbini CAF
AD  - Centro Paulista de Investigacao Clinica, Sao Paulo, Brazil.
LA  - eng
SI  - ClinicalTrials.gov/NCT01711359
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20170918
PL  - England
TA  - Arthritis Res Ther
JT  - Arthritis research & therapy
JID - 101154438
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Azetidines)
RN  - 0 (Purines)
RN  - 0 (Pyrazoles)
RN  - 0 (Sulfonamides)
RN  - ISP4442I3Y (baricitinib)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antirheumatic Agents/*therapeutic use
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Azetidines/*therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Methotrexate/therapeutic use
MH  - Middle Aged
MH  - Patient Reported Outcome Measures
MH  - Purines
MH  - Pyrazoles
MH  - Sulfonamides/*therapeutic use
MH  - Treatment Outcome
PMC - PMC5604362
OTO - NOTNLM
OT  - Baricitinib
OT  - HAQ-DI
OT  - Health-related quality of life
OT  - JAK inhibitor
OT  - PRO
OT  - RA
OT  - Rheumatoid
OT  - health status indicators
OT  - tsDMARD
COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: The study was conducted in accordance 
      with ethical principles of the Declaration of Helsinki and Good Clinical Practice 
      guidelines and was approved by each center's institutional review board or ethics 
      committee. All patients provided written informed consent. CONSENT FOR 
      PUBLICATION: Not applicable. COMPETING INTERESTS: Financial Support and 
      Disclosures: MS has received consulting fees from AbbVie, Amgen, Bristol-Myers 
      Squibb, Eli Lilly and Company, Johnson & Johnson, Novartis, Roche, and UCB 
      (< US$10,000 each) and speaking fees from AbbVie and Bristol-Myers Squibb 
      (> US$10,000). TT has received consulting fees from Pfizer Japan Inc., Astra 
      Zeneca K.K., Eli Lilly Japan K.K., Novartis Pharma K.K., Daiichi Sankyo Co., 
      Ltd., Nipponkayaku Co., Ltd, Janssen Pharmaceutical K.K., Merck Serono Co., Ltd., 
      Takeda Pharmaceutical Co., Ltd. (< US$10,000 each), and from Mitsubishi Tanabe 
      Pharma Co., Astellas Pharma Inc, AbbVie GK, Bristol-Myers K.K. Asahi Kasei 
      Medical K.K (> US$10,000 each), and speaking fees from Celtrion, Nipponkayaku 
      Co., Ltd, Pfizer Japan Inc., UCB Japan, Diaichi Sankyo Co., Ltd., Takeda 
      Pharmaceutical Co., Ltd., (< US$10,000 each) and from Chugai Pharmaceutical Co,. 
      Ltd., AbbVie GK., Bristol-Myers K.K., Eisai Co., Ltd., Mitsubishi Tanabe Pharma 
      Co., Janssen Pharmaceutical K.K., and Astellas Pharma Inc., (> US$10,000 each). 
      RF has received consulting fees from AbbVie, Amgen, Bristol-Myers Squibb, 
      Janssen, Eli Lilly and Company, and Sanofi-Aventis (< US$10,000 each), and 
      consulting fees from Pfizer and UCB (> US$10,000 each). CG, AD, DS, W-LK, J-EW, 
      TC, and TR are employees of Eli Lilly and Company and all, except TC and AD are 
      shareholders. PD has received consulting fees from Eli Lilly and Company. SS has 
      received consulting fees from Abbvie, Eli Lilly, Roche, and UCB. RPH has no 
      conflicts of interest related to this manuscript. RvV has received consulting 
      fees from AbbVie, Biotest, BMS, Celgene, Crescendo, GSK, Janssen, Lilly, Merck, 
      Novartis, Pfizer, Roche, UCB, and Vertex and research grants from AbbVie, Amgen, 
      BMS, GSK, Pfizer, Roche, and UCB. CAFZ has received consulting fees from Merck, 
      Pfizer, Sanofi, and Eli Lilly and Company (< US$10,000 each). PUBLISHER'S NOTE: 
      Springer Nature remains neutral with regard to jurisdictional claims in published 
      maps and institutional affiliations.
EDAT- 2017/09/20 06:00
MHDA- 2018/05/31 06:00
PMCR- 2017/09/18
CRDT- 2017/09/20 06:00
PHST- 2017/01/05 00:00 [received]
PHST- 2017/08/25 00:00 [accepted]
PHST- 2017/09/20 06:00 [entrez]
PHST- 2017/09/20 06:00 [pubmed]
PHST- 2018/05/31 06:00 [medline]
PHST- 2017/09/18 00:00 [pmc-release]
AID - 10.1186/s13075-017-1410-1 [pii]
AID - 1410 [pii]
AID - 10.1186/s13075-017-1410-1 [doi]
PST - epublish
SO  - Arthritis Res Ther. 2017 Sep 18;19(1):208. doi: 10.1186/s13075-017-1410-1.