Continued Golimumab Superior to Withdrawal in Patients With Inactive NrAxSpa

Adults with active nonradiographic axial spondyloarthritis (NrAxSpa) who achieved inactive disease after 10 months of open-label golimumab had superior protection against disease flares with continued golimumab compared with golimumab withdrawal, according to study results published online ahead of print in Rheumatology. 

The double-blind GO-BACK study included 188 patients who achieved inactive disease during a 10-month open-label golimumab run-in. Participants were randomized to receive monthly placebo (treatment withdrawal), continued golimumab treatment administered monthly, or golimumab treatment administered every 2 months (reduced treatment). Patients who experienced a disease flare resumed monthly open-label golimumab.

Whether administered monthly or every 2 months, golimumab treatment was superior to treatment withdrawal in preventing disease flares. Compared with placebo, the treatment difference was 50.4% with continued monthly golimumab and 34.4% with golimumab every 2 months, according to the study. Golimumab treatment showed significantly longer time to first flare compared with placebo. 

Within 3 months of restarting monthly golimumab because of a disease flare, 51 of 53 patients, or 96.2%, achieved a clinical response. However, only 71.7% sustained the response over all 3 months, the study found.

“Reattainment of clinical response after retreatment with monthly golimumab for a disease flare was achievable for most participants, albeit about 25% fewer sustained the response,” researchers wrote. “Golimumab was generally well tolerated; the safety results were consistent with the known safety profile of golimumab.”

Reference: 

Weinstein CLJ, Sliwinska-Stanczyk P, Hála T, et al. Efficacy and safety of golimumab in patients with non-radiographic axial spondyloarthritis: a withdrawal and retreatment study (GO-BACK). Rheumatology. Published online March 15, 2023. doi:10.1093/rheumatology/kead112