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ARTICLE | Clinical News

Itolizumab: Interim Phase III data

January 16, 2012 8:00 AM UTC

Interim data from the double-blind, placebo-controlled, Indian Phase III TREAT-PLAQ trial in 225 patients with moderate to severe plaque psoriasis showed that 0.4 and 1.6 mg/kg IV itolizumab every 2 weeks for 12 weeks met the primary endpoint of a significantly greater proportion of patients achieving a PASI 75 response at week 12 vs. placebo (36% and 27% vs. 2.3%; p<0.043 and p=0.0172). Additionally, patients in the high-dose group who received 1.6 mg/kg IV itolizumab every 4 weeks for an additional 16 weeks had a response rate of 46% at week 28. Itolizumab also met secondary endpoints of PASI50, PASI75 and PGA scores. Itolizumab had infection rates of about 10%. ...