Abstract
Objective Evaluate safety and efficacy of intravenous golimumab in patients with active ankylosing spondylitis (AS) through 1 year.
Methods A total of 208 patients were randomized to intravenous infusions of golimumab 2mg/kg (n=105) at weeks 0, 4, and every 8 weeks thereafter or placebo (n=103) at weeks 0, 4, and 12 and golimumab at weeks 16, 20, and every 8 weeks thereafter through week 52. Efficacy was assessed using the Assessment of Spondyloarthritis International Society (ASAS) criteria, Ankylosing Spondylitis Disease Activity Score (ASDAS), and Bath AS Disease Activity Index (BASDAI), and Bath AS Functional Index (BASFI). Health-related quality of life was assessed using the AS Quality of Life (ASQoL). Efficacy and safety were monitored through week 52 and week 60, respectively.
Results The primary endpoint (ASAS20) and all controlled endpoints at week 16 were achieved. At week 52, 69.5% and 65.0% of patients in the golimumab group and placebo crossover group respectively, achieved an ASAS20, 56.2% and 51.5% achieved an ASAS40, 56.2% and 55.3% achieved a BASDAI50, 24.8% and 24.3% achieved ASAS partial remission, and 25.7% and 26.2% met ASDAS inactive disease criteria (all last-observation-carried-forward). Mean changes from baseline to week 52 in BASFI and ASQoL scores were similar between the golimumab group and the placebo/golimumab group (BASFI: -2.7 and -2.6; ASQoL: -5.5 and -5.4). Through week 60, 55.4% of all golimumab-treated patients had ≥1AE; 3.4% had ≥1SAE.
Conclusion Efficacy was maintained through 1 year with IV golimumab 2mg/kg among patients with active AS. AEs were consistent with the known safety profile of golimumab.
