Intravenous golimumab was safe and effective through 1 year of treatment among patients with active ankylosing spondylitis (AS), according to a study recently published in The Journal of Rheumatology.
The GO-ALIVE trial evaluated the safety and efficacy of intravenous golimumab 2 mg/kg. A total of 208 patients who had been diagnosed with AS were randomly assigned to receive either intravenous infusions of golimumab 2mg/kg (n=105) at 0 and 4 weeks and every 8 weeks thereafter or placebo (n=103) at 0, 4, and 12 weeks and golimumab at 16 and 20 weeks and every 8 weeks thereafter through 52 weeks. Efficacy was assessed through 52 weeks using the Assessment of Spondyloarthritis International Society criteria, Ankylosing Spondylitis Disease Activity Score, Bath AS Disease Activity Index, and Bath AS Functional Index. Health-related quality of life was assessed using the AS Quality of Life scale. Researchers monitored for adverse events through 60 weeks.
Approximately 73.3% of patients in the golimumab group achieved the primary end point of the study, with an improvement of ≥20% in Assessment of Spondyloarthritis International Society response at 16 weeks compared with 26.2% in the placebo group. More patients in the golimumab group had an enthesitis score of 0 (resolution of enthesitis) at 16 weeks compared with placebo (43.7% vs 14.1%; P <.0001). Improvements in AS Quality of Life were greater in patients in the golimumab group compared with placebo at 16 weeks, and these improvements were maintained at week 52. A total of 8 serious adverse events occurred, including 2 in the golimumab group through week 16, but there were no opportunistic infections, demyelinating events, malignancies, or deaths related to treatment.
These findings indicate safety and effectiveness of treatment with IV golimumab 2 mg/kg in reducing the signs and symptoms of AS among adult patients with active disease, with sustained response through 1 year.
This study was supported by Janssen Research & Development, LLC. Please refer to reference for a complete list of authors’ disclosures.
Reveille JD, Deodhar A, Caldron PH, et al. Safety and efficacy of intravenous golimumab in adults with ankylosing spondylitis: Results through 1 year of the GO-ALIVE study [published online March 1, 2019]. J Rheumatol. doi:10.3899/jrheum.180718