In 197 patients with highly active nonradiographic axial spondyloarthritis intolerant of or unresponsive to NSAIDs, 50 mg golimumab (a fully human anti-TNF antibody) administered subcutaneously every 4 weeks led to sustained and statistically significant improvements in multiple measures of disease activity, physical function and quality of life versus placebo. The primary end point—the Assessment of Spondyloarthritis International Society (ASAS) 20 response rate at 16 weeks—favoured golimumab over placebo (71% versus 40%, P <0.0001). Golimumab was safe and well-tolerated. Of note, key secondary endpoints including the ASAS 40 response rate (57% versus 23%, P <0.0001) also favoured golimumab. As observed with other anti-TNF agents in this setting, negative MRI findings and normal C-reactive protein levels at baseline predicted nonresponse to golimumab. The study continues into a preplanned 44-week extension.
References
Sieper, J. et al. A randomized, double-blind, placebo-controlled, 16-week study of subcutaneous golimumab in patients with active non-radiographic axial spondyloarthritis. Arthritis Rheumatol. 10.1002/art.39257
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Golimumab gets the green light in GO-AHEAD. Nat Rev Rheumatol 11, 502 (2015). https://doi.org/10.1038/nrrheum.2015.103
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DOI: https://doi.org/10.1038/nrrheum.2015.103