PMID- 27859410
OWN - NLM
STAT- MEDLINE
DCOM- 20170829
LR  - 20220409
IS  - 1365-2036 (Electronic)
IS  - 0269-2813 (Print)
IS  - 0269-2813 (Linking)
VI  - 45
IP  - 2
DP  - 2017 Jan
TI  - Effects of vedolizumab on health-related quality of life in patients with 
      ulcerative colitis: results from the randomised GEMINI 1 trial.
PG  - 264-275
LID - 10.1111/apt.13852 [doi]
AB  - BACKGROUND: Health-related quality of life (HRQL) is often diminished in patients 
      with ulcerative colitis. AIM: To evaluate the effects of vedolizumab on HRQL in 
      patients with ulcerative colitis. METHODS: Using maintenance phase data from the 
      GEMINI 1 study, an analysis of covariance model was used to calculate mean 
      differences between the vedolizumab and placebo groups in changes from baseline 
      to week 52 for 3 HRQL instruments: The Inflammatory Bowel Disease Questionnaire 
      (IBDQ), 36-Item Short Form Health Survey (SF-36), and EQ-5D. Proportions of 
      patients meeting minimal clinically important difference (MCID) thresholds for 
      changes on these instruments were compared between treatment groups for the 
      overall population and for clinically important subgroups. Concordance between 
      clinical remission and remission defined using IBDQ scores was examined. RESULTS: 
      Compared with placebo-treated patients, vedolizumab-treated patients had greater 
      improvements (152-201%) in IBDQ, EQ-5D visual analogue scale (VAS), and EQ-5D 
      utility scores. Greater proportions (6.9-19.9%) of vedolizumab-treated patients 
      than placebo-treated patients met MCID thresholds for all the instruments. 
      Vedolizumab-treated patients with lower baseline disease activity and those 
      without prior tumour necrosis factor (TNF) antagonist failure had greater HRQL 
      improvements. Among 127 patients with clinical remission based on complete Mayo 
      Clinic scores, >80% also had IBDQ remission; >70% of the 150 patients with IBDQ 
      remission demonstrated clinical remission. CONCLUSIONS: Vedolizumab therapy was 
      associated with significant improvements in HRQL measures compared with placebo. 
      Benefits were greater in patients with lower disease activity and no prior TNF 
      antagonist failure.
CI  - (c) 2016 The Authors. Alimentary Pharmacology & Therapeutics published by John 
      Wiley & Sons Ltd.
FAU - Feagan, B G
AU  - Feagan BG
AD  - Robarts Clinical Trials, Robarts Research Institute, University of Western 
      Ontario, London, ON, Canada.
FAU - Patel, H
AU  - Patel H
AD  - Immensity Consulting, Inc., Chicago, IL, USA.
FAU - Colombel, J-F
AU  - Colombel JF
AD  - Icahn School of Medicine at Mount Sinai, New York, NY, USA.
FAU - Rubin, D T
AU  - Rubin DT
AD  - University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL, 
      USA.
FAU - James, A
AU  - James A
AD  - Takeda Development Centre Europe Ltd., London, UK.
FAU - Mody, R
AU  - Mody R
AD  - Takeda Development Center Americas, Inc., Deerfield, IL, USA.
FAU - Lasch, K
AU  - Lasch K
AD  - Takeda Pharmaceuticals USA, Inc., Deerfield, IL, USA.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20161117
PL  - England
TA  - Aliment Pharmacol Ther
JT  - Alimentary pharmacology & therapeutics
JID - 8707234
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Gastrointestinal Agents)
RN  - 0 (Tumor Necrosis Factor-alpha)
RN  - 9RV78Q2002 (vedolizumab)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized/*therapeutic use
MH  - Colitis, Ulcerative/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Gastrointestinal Agents/*therapeutic use
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Quality of Life
MH  - Surveys and Questionnaires
MH  - Tumor Necrosis Factor-alpha/antagonists & inhibitors
PMC - PMC5215718
EDAT- 2016/11/20 06:00
MHDA- 2017/08/30 06:00
PMCR- 2017/01/05
CRDT- 2016/11/19 06:00
PHST- 2016/07/08 00:00 [received]
PHST- 2016/08/02 00:00 [revised]
PHST- 2016/09/20 00:00 [revised]
PHST- 2016/10/10 00:00 [revised]
PHST- 2016/10/11 00:00 [accepted]
PHST- 2016/11/20 06:00 [pubmed]
PHST- 2017/08/30 06:00 [medline]
PHST- 2016/11/19 06:00 [entrez]
PHST- 2017/01/05 00:00 [pmc-release]
AID - APT13852 [pii]
AID - 10.1111/apt.13852 [doi]
PST - ppublish
SO  - Aliment Pharmacol Ther. 2017 Jan;45(2):264-275. doi: 10.1111/apt.13852. Epub 2016 
      Nov 17.