Treatment Shows Long-Term Efficacy for Nonradiographic Axial Spondyloarthritis

An open-label extension of a 16-week study of golimumab in patients with nonradiographic axial spondyloarthritis (nr-axSpA) found sustained efficacy gains through week 52. Researchers published the findings online ahead of print in the journal Rheumatology. 

The open-label extension of the GO-AHEAD study included 189 patients with nr-axSpA, or 95.5% of participants from the 16-week double-blind phase. For the open-label extension, both patients originally randomized to golimumab, and those originally randomized to placebo, received golimumab 50 mg every 4 weeks over 36 weeks. Patients were then followed an additional 8 weeks for safety monitoring. 

Between weeks 16 and 52, the proportion of responders increased among patients who received golimumab through both phases of the study (golimumab-golimumab) as well as in patients who switched from placebo to golimumab for the open-label extension (placebo-golimumab). The golimumab-golimumab group, however, had a higher proportion of responders, researchers reported. 

Specifically, the proportion of patients achieving 20% improvement in the Assessment of SpondyloArthritis International Society (ASAS20) criteria grew from 71.1% to 83.9% between weeks 16 and 52 in the golimumab-golimumab group, while the proportion of patients achieving ASAS20 in the placebo-golimumab group grew from 40% to 75%, according to the study. During the same period, the proportion of patients achieving 40% improvement, or ASAS40, increased from 56.7% to 76.3% in the golimumab-golimumab group and from 23% to 59.4% in the placebo-golimumab group.

ASAS partial remission rose from 33% to 53.8% in the golimumab-golimumab group, and from 18% to 45.8% in the placebo-golimumab group, during the open-label extension. 

Meanwhile, incidence of adverse events was 41.9% in the golimumab-golimumab group and 54.2% in the placebo-golimumab group, the study found. 

“Golimumab was well tolerated,” researchers concluded, “and provided substantial long-term benefits to patients with nr-axSpA.” 

—Jolynn Tumolo

Reference:

van der Heijde D, Dougados M, Maksymowych WP, et al. Long-term Tolerability and Efficacy of Golimumab in Active Non-Radiographic Axial Spondyloarthritis: Results From Open-Label Extension [published online ahead of print, 2021 Apr 20]. Rheumatology (Oxford). 2021;keab346. doi:10.1093/rheumatology/keab346