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Novartis AG Announces Secukinumab (AIN457) Demonstrated Superiority To Enbrel In Head-To-Head Phase III Psoriasis Study


Monday, 8 Jul 2013 01:14am EDT 

Novartis AG announced top-line results from the head-to-head Phase III psoriasis study which showed the superiority of secukinumab (AIN457) in clearing skin to Enbrel(etanercept), an anti-tumor necrosis factor (anti-TNF) therapy. In addition, secukinumab (AIN457) met all primary and secondary endpoints. The FIXTURE trial (the Full year Investigative eXamination of secukinumab vs. eTanercept Using 2 dosing Regimens to determine Efficacy in psoriasis) was a randomized, double-blind, double-dummy, placebo-controlled, multicenter global study of subcutaneous secukinumab (AIN457) in moderate-to-severe plaque psoriasis involving 1,307 patients. It was designed to demonstrate efficacy after 12 weeks of treatment, compared to placebo and etanercept, and to assess the safety, tolerability and long-term efficacy up to 52 weeks. Established treatment measures were used to assess the efficacy of secukinumab (AIN457) including PASI 75 (Psoriasis Area and Severity Index 75) and the Investigator's Global Assessment (IGA mod 2011), a standard tool to assess the clearing of skin after treatment. Full results from the secukinumab (AIN457) Phase III study program, the largest undertaken in moderate-to-severe plaque psoriasis to date, are expected to be presented at major medical congresses later this year. 

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