Golimumab for the Treatment of Axial Spondyloarthritis: Integrating Clinical Outcomes with Real-World Patient Benefits.

Axial spondyloarthritis is an immune-mediated inflammatory disease that primarily affects the sacroiliac joints, the spine, and the peripheral entheses and joints. The disease is associated with reduced functional ability and quality of life due to pain, fatigue, stiffness, sleep disruption, and inflammation-induced structural damage. The pathogenesis of axial spondyloarthritis involves, among other etiologies, the activation of immune-mediated proinflammatory cytokines, including tumor necrosis factor alpha, which is inhibited by golimumab, an approved treatment for the disease. Golimumab is produced using a recombinant cell line, and the antibody was derived from genetically modified mice immunized with human tumor necrosis factor alpha. This narrative review presents the primary efficacy and safety endpoints from the pivotal randomized controlled trials of golimumab. Additionally, it presents data from the post hoc analyses and real-world studies, which demonstrated benefits including decreased back pain, sleep disruption, fatigue, and disease activity as well as improved quality of life and work productivity and prolonged drug survival. Not only was golimumab associated with improvements in quality of life, general health status, and daily productivity, but a decrease in disease activity was significantly associated with these outcomes. Furthermore, golimumab was found to have a favorable safety profile, and the adverse event pattern observed was consistent with other tumor necrosis factor alpha inhibitors. Collectively, these studies showed that golimumab is an effective and safe treatment for axial spondyloarthritis.