Secukinumab: Phase II data

A double-blind, international Phase II trial in 73 patients with RRMS showed that IV secukinumab reduced the cumulative number of CUAL on brain MRI scans performed every 4th week from week 4 to 24, the primary endpoint, by 49% compared to placebo (p=0.087). Additionally, secukinumab led to a 67% reduction in cumulative new gadolinium-enhancing lesions on T1-weighted images compared to placebo (p=0.003). Furthermore, an analysis restricted to week 8-24 MRIs showed that secukinumab reduced the number of CUAL by 61% compared to placebo (p=0.014) and the number of new gadolinium-enhancing lesions by 69% (p=0.001). Novartis said the additional 4 weeks allows for the onset of action to be considered. Secukinumab led to an ARR of 0.4 vs. 0.7 for placebo. Secukinumab was well tolerated with no serious adverse events reported. Two patients receiving placebo discontinued due to adverse events. Patients received placebo or 10 mg/kg IV secukinumab at weeks 0, 2, 4, 8, 12, 16 and 20. Data were presented at the European Committee for Treatment and Research in Multiple Sclerosis meeting in Lyon. ...