For a post hoc analysis, researchers compared patients with early disease (ED) of ankylosing spondylitis (AS) to those with late disease (LD) to determine the effectiveness and safety of intravenous (IV) golimumab.
In phase 3, double-blind, GO-ALIVE research, patients were randomized to receive either an intravenous infusion of golimumab (2 mg/kg) at weeks 0 and 4 and then every 8 weeks through week 52, or placebo at weeks 0 and 4, with a crossover to IV golimumab at week 16. Clinical effectiveness was determined by a ≥20% improvement in the Assessment of Spondyloarthritis International Society response criteria (ASAS20), a ≥50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI 50), and a score of <1.3 for the Ankylosing Spondylitis Disease Activity Score (ASDAS) (inactive disease). Patients were divided into quartiles based on their self-reported duration of inflammatory back pain (IBP), with the first quartile being LD and the fourth being ED. A year’s worth of effectiveness and safety data were reported using descriptive statistics.
In comparison to LD patients (n=52; 21–24 years), early disease patients (n=60) were around ~10 years younger and had a median AS (IBP) symptom duration that was shorter (2–3 years). Regardless of the length of IBP, numerically more golimumab-treated patients than placebo-treated patients at week 16 achieved ASAS20 (ED: 71% vs. 32%; LD: 67% vs. 21%), BASDAI 50 (ED: 40% vs. 12%; LD: 33% vs. 7%), and ASDAS <1.3 (ED: 17% vs. 4%; LD: 8% vs. 0%). The effectiveness persisted after a year of therapy, however, response rates were numerically larger in patients with ED than LD. Adverse and major adverse events were recorded by 46% and 3% of ED patients and 61% and 2% of LD patients until week 60.
Early AS diagnosis and IV golimumab therapy may result in more significant reductions in disease activity.