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Changing the dose schedule for golimumab (Simponi) as an adjunct to methotrexate for RA clarifies tantalizing results from an earlier trial.
After 14 weeks of treatment, more than half of RA patients (58.5%) nonresponsive to methotrexate showed rapid and significant responses to a regimen including additional biweekly golimimab (Simponi) injections, in a Phase III trial from Boston's Brigham and Women's Hospital. Only a quarter of those randomized to placebo also achieved a 20% response according to American College of Rheumatology criteria.
The GO-FURTHER trial picks up where an earlier trial of golimumab in methotrexate non-responders left off, having failed to reach its primary endpoint of 50% improvement at week 14 with dosing only every 12 weeks. In the newer trial, patients received more frequent infusions, receiving 2 mg/kg of golimumab at baseline and four weeks, and then every eight weeks thereafter, in addition to methotrexate.
In this newer trial, significant differences between the groups in ACR20 response began to appear by the second week, and the treatment group also showed significantly better and faster responses as measured by DAS28 and HAQ disability scores and tender and swollen joints. Adverse events (primarily urinary tract and upper respiratory infections) were similar between the treatment and placebo arms.
RA patients in this trial had more severe disease at baseline than in the previous trial, the researchers noted, with more inflammation and disability. Yet the combination "rapidly and significantly improved RA signs and symptoms and generally was well tolerated," they wrote. The trial will continue through 112 weeks of treatment.