PMID- 33032771
OWN - NLM
STAT- MEDLINE
DCOM- 20210219
LR  - 20210219
IS  - 1524-4733 (Electronic)
IS  - 1098-3015 (Linking)
VI  - 23
IP  - 10
DP  - 2020 Oct
TI  - Effects of Intravenous Golimumab on Health-Related Quality of Life in Patients 
      With Psoriatic Arthritis: 24-Week Results of the GO-VIBRANT Trial.
PG  - 1286-1291
LID - S1098-3015(20)32203-8 [pii]
LID - 10.1016/j.jval.2020.06.007 [doi]
AB  - OBJECTIVES: Evaluate the effects of intravenous golimumab 2 mg/kg on multiple 
      domains of health-related quality of life (HRQoL) in adult patients with active 
      psoriatic arthritis (PsA). METHODS: In this phase III, randomized, 
      double-blinded, placebo-controlled study, adults with active PsA were randomized 
      in a 1:1 ratio to receive intravenous (IV) infusions of placebo (n = 239) or 
      golimumab 2 mg/kg (n = 241) at weeks 0, 4, 12, and 20. Physical function was 
      assessed using the Health Assessment Questionnaire-Disability Index (HAQ-DI). 
      HRQoL was assessed using the 36-item Short-Form Health Survey Physical and Mental 
      Component Summary (SF-36 PCS/MCS) scores, the Functional Assessment of Chronic 
      Illness Therapy (FACIT)-Fatigue, EQ VAS, and the Dermatology Life Quality Index 
      (DLQI). RESULTS: Patients in the golimumab group had greater mean changes from 
      baseline in HAQ-DI compared with placebo at weeks 8 (-0.52 vs -0.10), 14 (-0.60 
      vs -0.12), and 24 (-0.63 vs -0.14). Mean improvements from baseline in SF-36 PCS 
      (8.0 vs 1.7), SF-36 MCS (5.0 vs 1.2), EQ VAS (17.2 vs 3.7), FACIT-Fatigue (7.9 vs 
      2.0), and DLQI (-7.2 vs -1.7) were also greater in the golimumab group versus 
      placebo at week 8 and were maintained or increased through week 24. Greater 
      proportions of golimumab-treated patients had improvements greater than or equal 
      to the minimal clinically important difference (MCID) for HAQ-DI, SF-36 PCS/MCS, 
      EQ VAS, FACIT-Fatigue, and DLQI scores at weeks 14 and 24. CONCLUSION: 
      Improvements in HRQoL were greater in the IV golimumab group compared with 
      placebo and were evident at week 8 and sustained through week 24.
CI  - Copyright (c) 2020 ISPOR-The Professional Society for Health Economics and Outcomes 
      Research. Published by Elsevier Inc. All rights reserved.
FAU - Husni, M Elaine
AU  - Husni ME
AD  - Cleveland Clinic, Cleveland, OH, USA.
FAU - Kavanaugh, Arthur
AU  - Kavanaugh A
AD  - University of California San Diego, La Jolla, CA, USA.
FAU - Chan, Eric K H
AU  - Chan EKH
AD  - Janssen Global Services LLC, Raritan, NJ, USA.
FAU - Peterson, Steven
AU  - Peterson S
AD  - Janssen Research & Development, LLC, Spring House, PA, USA.
FAU - Li, Nan
AU  - Li N
AD  - Janssen Research & Development, LLC, Spring House, PA, USA.
FAU - Hsia, Elizabeth C
AU  - Hsia EC
AD  - Janssen Research & Development, LLC, Spring House, PA, USA; University of 
      Pennsylvania, Philadelphia, PA, USA.
FAU - Kim, Lilianne
AU  - Kim L
AD  - Janssen Research & Development, LLC, Spring House, PA, USA.
FAU - Lo, Kim Hung
AU  - Lo KH
AD  - Janssen Research & Development, LLC, Spring House, PA, USA.
FAU - Harrison, Diane D
AU  - Harrison DD
AD  - Janssen Research & Development, LLC, Spring House, PA, USA.
FAU - Han, Chenglong
AU  - Han C
AD  - Janssen Global Services, LLC, Malvern, PA, USA. Electronic address: 
      chan3@its.jnj.com.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20200918
PL  - United States
TA  - Value Health
JT  - Value in health : the journal of the International Society for Pharmacoeconomics 
      and Outcomes Research
JID - 100883818
RN  - 0 (Anti-Inflammatory Agents)
RN  - 0 (Antibodies, Monoclonal)
RN  - 91X1KLU43E (golimumab)
SB  - IM
MH  - Adult
MH  - Anti-Inflammatory Agents/administration & dosage/*therapeutic use
MH  - Antibodies, Monoclonal/administration & dosage/*therapeutic use
MH  - Arthritis, Psoriatic/*drug therapy
MH  - Double-Blind Method
MH  - Humans
MH  - Infusions, Intravenous
MH  - Quality of Life
MH  - Surveys and Questionnaires
OTO - NOTNLM
OT  - golimumab
OT  - physical function
OT  - psoriatic arthritis
OT  - quality of life
EDAT- 2020/10/10 06:00
MHDA- 2021/02/20 06:00
CRDT- 2020/10/09 05:28
PHST- 2019/09/16 00:00 [received]
PHST- 2020/03/06 00:00 [revised]
PHST- 2020/06/29 00:00 [accepted]
PHST- 2020/10/09 05:28 [entrez]
PHST- 2020/10/10 06:00 [pubmed]
PHST- 2021/02/20 06:00 [medline]
AID - S1098-3015(20)32203-8 [pii]
AID - 10.1016/j.jval.2020.06.007 [doi]
PST - ppublish
SO  - Value Health. 2020 Oct;23(10):1286-1291. doi: 10.1016/j.jval.2020.06.007. Epub 
      2020 Sep 18.