SAN FRANCISCO, CA—Data presented at the 2015 ACR/ARHP Annual Meeting showed that patients with active nonradiographic axial spondyloarthritis who received golimumab showed greater improvement in quality of life and work productivity outcomes than did patients receiving placebo.
A decrease in quality of life in patients suffering from axial spondyloarthritis can result from chronic inflammation, back pain, and progressive spinal stiffness associated with the condition. Walter Maksymowych, MD, from the University of Alberta, Edmonton, Alberta, Canada, and coauthors studied whether golimumab treatment was superior to placebo in improving the quality of life in patients with nonradiographic axial spondyloarthritis.
The double-blind, randomized, placebo-controlled trial, GO-AHEAD examined the effects of golimumab in patients with active nonradiographic axial spondyloarthritis with disease duration ≤5 years, chronic back pain, high disease activity (total back pain ≥40mm on visual analog scale [VAS], and inadequate response/intolerance to non-steroidal anti-inflammatory drugs (NSAIDs), Dr. Maksymowych explained.
A total of 197 patients were randomly assigned to receive subcutaneous golimumab 50mg (n=97) or placebo (n=100) every 4 weeks, and were assessed for qulaity of life at 16 weeks. Secondary outcomes included the 36-item Short Form Health Survey (SF-36), Ankylosing Spondylitis Quality of Life (ASQoL), EuroQoL 5-Dimension (EQ-5D) Index and Health State (10cm VAS), and Work Productivity and Activity Impairment (WPAI) questionnaire scores at Week 16.
Patients treated with golimumab showed greater improvements from baseline quality of life at Week 16 than those treated with placebo, across all scales of the ASQoL (difference vs. placebo -3.5, 95% CI: -4.7, -2.2; P<0.0001), EQ-5D (Index: 0.15, 95% CI: 0.08, 0.22; P<0.0001), and SF-36 (Physical: 6.6, 95% CI: 4.3, 8.8; P<0.0001).
Improvements in percentages of WPAI overall work impairment were greater in patients treated with golimumab than placebo (P=0.0391) and WPAI activity impairment (P<0.0001).
“Improvement in WPAI work time missed was numerically higher in patients who received golimumab,” Dr. Maksymowych noted. WPAI impairment while working significantly improved among patients with objective signs of inflammation (OSI; P=0.0914), he reported.
In patients with objective signs of inflammation (OSI), quality of life and WPAI measures were similar to those seen in the overall study population, but greater improvements in percentage of impairment were higher in the golimumab treatment group vs. the placebo group (P=0.0194).
Golimumab treatment led to greater improvement in quality of life and work productivity outcomes than placebo, although “the mean values indicate that some degree of impairment remained,” he noted.