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

John D. Reveille, Atul Deodhar, Akgun Ince, Eric K.H. Chan, Steven Peterson, Nan Li, Elizabeth C. Hsia, Lilianne Kim, Kim Hung Lo, Stephen Xu, Diane D. Harrison, Chenglong Han

Research output: Contribution to journalArticlepeer-review

Abstract

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 <.001); similar results were observed for SF-36 MCS (5.6 vs 1.7 and 6.5 vs 0.8, respectively; P <.001). Mean improvement in each of 8 subscale scores of the SF-36 were also greater for golimumab-treated patients versus placebo at weeks 8 and 16. Mean improvements in EQ VAS and ASQoL were greater in the golimumab group versus placebo at week 8 and week 16. Greater proportions of golimumab-treated patients had clinically meaningful improvement in SF-36 PCS, SF-36 MCS, EQ VAS, and ASQoL at weeks 8 and 16; 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.

Original languageEnglish (US)
Pages (from-to)1281-1285
Number of pages5
JournalValue in Health
Volume23
Issue number10
DOIs
StatePublished - Oct 2020

Keywords

  • ankylosing spondylitis
  • biologic therapy
  • quality of life
  • tumor necrosis factor inhibitors

ASJC Scopus subject areas

  • Health Policy
  • Public Health, Environmental and Occupational Health

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