Simponi golimumab: Phase III data

The double-blind, international Phase III PURSUIT trial in 774 patients showed 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). Both doses of Simponi also met the secondary endpoints of a greater proportion of patients achieving clinical remission (18.7% and 17.8%, respectively, vs. 6.3%, p<0.0001 for both) and mucosal healing vs. placebo (43.2% and 45.3%, respectively, vs. 28.5%, p=0.0005 for both). Additionally, a significantly greater proportion of patients receiving low- and high-dose Simponi reported improvements in health-related quality of life as measured by the mean change from baseline in IBDQ scores vs. placebo (27.4% and 27%, respectively, vs. 14.6%, 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. Patients received 200 mg Simponi at week 0 followed by 100 mg Simponi at week 2; 400 mg Simponi at week 0 followed by 200 mg Simponi at week 2; or placebo. Patients responding to induction treatment with Simponi were eligible to continue in the Phase III PURSUIT maintenance study. Data were presented at the Digestive Disease Week meeting in San Diego. ...