BioCentury
ARTICLE | Clinical News

Simponi golimumab: Phase III data

October 29, 2012 7:00 AM UTC

The Phase III PURSUIT maintenance study in 1,228 patients with moderately to severely active UC showed that low- and high-dose subcutaneous Simponi as maintenance therapy each met the primary endpoint of a greater proportion of patients achieving a clinical response at week 54 vs. placebo (47% and 51%, respectively, vs. 31%, p=0.01 and p<0.001). On secondary endpoints, a significantly greater proportion of patients receiving high-dose Simponi achieved clinical remission (29% vs. 15%, p=0.003) and mucosal healing (44% vs. 27%, p=0.001) at both weeks 30 and 54 vs. placebo. A non-significantly greater proportion of patients receiving low-dose Simponi achieved clinical remission (24% vs. 15%) and mucosal healing (42% vs. 27%) at both weeks 30 and 54 vs. placebo. Data were presented at the American College of Gastroenterology meeting in Las Vegas.

The maintenance study enrolled patients who responded to induction treatment with Simponi in the Phase III PURSUIT-IV and PURSUIT-SC trials. Responders to Simponi were randomized to receive placebo or 50 or 100 mg subcutaneous Simponi every 4 weeks. Johnson & Johnson previously reported data from the Phase III PURSUIT-SC trial in 774 patients showing that induction therapy with low- and high-dose subcutaneous Simponi each met the primary endpoint of a greater proportion of patients achieving a clinical response at week 6 vs. placebo (51.8% and 55%, respectively, vs. 29.7%, p<0.0001 for both). The trial enrolled patients with moderately to severely active UC who had failed to respond to or tolerate treatment with 6-mercaptopurine, azathioprine, corticosteroids and/or 5-aminosalicylate, or were corticosteroid dependent (see BioCentury, May 28). ...