• Rheumatology Clinical Trials
• Inflammatory Disorders

The Multicenter Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFα Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis trial [GO RAISE] evaluated the efficacy and safety of golimumab in patients with active ankylosing spondylitis (AS). Objectives of this analysis, presented by D. van der Heijde, MD, Leiden University Medical Center, Leiden, The Netherlands, were to assess AS Disease Activity Score (ASDAS) major improvement and inactive disease and their association with improvements in Health Related Quality of Life (HRQoL), and work productivity in patients with AS after 2 years of treatment with golimumab.

A total of 356 patients with AS according to the modified New York criteria were randomized to golimumab 50 mg or 100 mg or placebo every 4 weeks. Patients with <20% improvement in total back pain and morning stiffness at Week 16 entered early escape (EE), with placebo-treated patients receiving golimumab 50 mg, and golimumab 50 mg patients switching to golimumab 100 mg. Improvement in HRQoL, work productivity, and employability were analyzed by ASDAS major improvement (≥2.0) and inactive disease (<1.3) status at Weeks 14, 24, 52, and 104. HRQoL was assessed using the Physical Component Summary Score (PCS) and Mental Component Summary Score (MCS) of the SF-36. Productivity was assessed by a visual analog score (VAS; 0=no impact, 10=high impact).

Median improvements in ASDAS scores were significantly greater in the combined golimumab arms compared with the placebo arm at Weeks 14 (1.6 vs 0.4; p<0.001) and 24 (1.7 vs 0.3; p<0.001). The mean ASDAS score was improved (range 1.9 to 2.3) in all arms at Weeks 52 and 104, after the placebo crossover (all patients receiving golimumab). At Weeks 52 and 104, ASDAS inactive disease was achieved by 33.9% and 41.6% and ASDAS major improvement was achieved by 49.1% and 52.9% of all patients, respectively. Among patients who achieved ASDAS inactive disease, 57.1% and 65.5% had PCS ≥50 and 64.8% and 74.4% had MCS ≥50 at Weeks 52 and 104, respectively. Among patients who achieved ASDAS major improvement, 37.9% and 48.3% had PCS ≥50 and 62.1% and 65.31% had MCS ≥50 at Weeks 52 and 104, respectively.

Patients with inactive disease versus those without inactive disease had greater improvements in productivity at Weeks 52 (5.8 vs 2.9; p<0.001) and 104 (5.8 vs 3.1; p<0.001). ASDAS responders versus nonresponders also had greater improvements in productivity at Weeks 52 (5.4 vs 2.4; p<0.001) and 104 (5.8 vs 2.6; p<0.001). At Week 52, 37.5% of patients who achieved inactive disease and 73.3% of patients who achieved major improvement regained employability. At Week 104, 38.9% of patients who achieved inactive disease and 72.2% of patients who achieved major improvement regained employability.

Patients who were treated with golimumab versus placebo had significantly improved mean change in PCS (8.8 vs 3.0; p≤0.001) and MCS (3.7 vs −0.4; p≤0.001) at Week 14, productivity at Week 16 (2.8 vs 0.4, p≤0.001), and mean change in PCS (9.4 vs 2.8; p≤0.001) and MCS (4.0 vs 0.7; p<0.05) and productivity (2.8 vs 0.4; p≤0.001) at Week 24.

Achievement of ASDAS major improvement or inactive disease in patients with AS after treatment with golimumab is associated with improved HRQoL and productivity.

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