BioCentury
ARTICLE | Clinical News

Simponi golimumab: Phase III data

June 18, 2012 7:00 AM UTC

The double-blind, international Phase III GO-FURTHER trial in 592 patients with active moderate to severe RA despite methotrexate treatment showed that 2 mg/kg IV Simponi given at weeks 0 and 4 and then every 8 weeks plus methotrexate met the primary endpoint of improving ACR20 response rate at week 14 vs. placebo plus methotrexate (59% vs. 25%, p<0.001). IV Simponi also significantly improved ACR50 response rate at week 14 vs. placebo (30% vs. 9%, p<0.001). At week 2, ACR20 response rates were 33% for IV Simponi vs. 12% for placebo (p<0.001), while ACR50 response rates were 6% and 3%, respectively. At week 24, ACR20 response rates were 63% for IV Simponi vs. 32% for placebo (p<0.001), while ACR50 response rates were 35% and 13%, respectively (p<0.001).

IV Simponi also significantly improved DAS28-CRP moderate or good responses at week 14 vs. placebo (81% vs. 40%, p<0.001). Additionally, a significantly greater proportion of patients receiving IV Simponi achieved a >0.25 point improvement from baseline in HAQ-DI score at week 14 (68% vs. 43%, p<0.001) and at week 24 (68% vs. 45%, p<0.001) vs. placebo. The most common serious adverse events were serious infections. One patient receiving IV Simponi developed breast cancer. At week 16, patients receiving placebo with a <10% improvement in combined swollen and tender joint counts were entered into early escape to receive IV Simponi at weeks 16 and 20. All patients receiving placebo crossed over to IV Simponi at week 24. Data were presented at the European League Against Rheumatism meeting in Berlin and published in Annals of Rheumatic Diseases. ...