Effects of Intravenous Golimumab on Health-Related Quality of Life in Patients with Ankylosing Spondylitis: 28-Week Results of the GO-ALIVE Trial

Oct 1, 2020, 00:00 AM
10.1016/j.jval.2020.04.1837
https://www.valueinhealthjournal.com/article/S1098-3015(20)32201-4/fulltext
Section Title : BRIEF REPORT
Section Order : 1281
First Page : 1281

Objective

Evaluate the effect of intravenous golimumab on health-related quality of life (HRQoL) in patients with ankylosing spondylitis (AS) through week 28 of the phase III, multicenter, randomized, double-blind, placebo-controlled GO-ALIVE study.

Methods

Adult patients (n = 208) were randomized to IV golimumab 2 mg/kg (n = 105) at weeks 0, 4, and 12 and every 8 weeks or placebo (n = 103) at weeks 0, 4, and 12, with crossover to golimumab 2mg/kg at weeks 16, 20, and every 8 weeks. General HRQoL was evaluated using the Short Form Health Survey (SF-36) Physical Component Summary/Mental Component Summary (PCS/MCS), and the EQ VAS, and AS disease–specific HRQoL was assessed using the Ankylosing Spondylitis Quality of Life (ASQoL) instrument.

Results

Mean improvements from baseline in SF-36 PCS were greater in the golimumab group versus the placebo group at weeks 8 and 16 (6.8 vs 2.1 and 8.5 vs 2.9, respectively; P improvements in SF-36 PCS/MCS, EQ VAS, and ASQoL were maintained through week 28.

Conclusions

Golimumab-treated patients had greater mean improvements in HRQoL measures compared with placebo through week 16. Clinically meaningful improvements were observed as early as week 8 and continued through week 28.

https://www.valueinhealthjournal.com/action/showCitFormats?pii=S1098-3015(20)32201-4&doi=10.1016/j.jval.2020.04.1837
HEOR Topics :
  • Biologics & Biosimilars
  • Clinical Outcomes
  • Clinical Outcomes Assessment
  • Clinical Trials
  • Instrument Development, Validation, & Translation
  • Patient-Centered Research
  • Specialized Treatment Areas
  • Specific Diseases & Conditions
  • Study Approaches
  • Systemic Disorders/Conditions
Tags :
  • ankylosing spondylitis
  • biologic therapy
  • quality of life
  • tumor necrosis factor inhibitors
Regions :