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Novartis AG Announces Results From Phase III FIXTURE Study Showing Secukinumab (AIN457)


Thursday, 3 Oct 2013 01:11am EDT 

Novartis AG announced results from the head-to-head Phase III FIXTURE study showing secukinumab (AIN457), an interleukin-17A (IL-17A) inhibitor, was significantly superior to Enbrel (etanercept) in moderate-to-severe plaque psoriasis. Enbrel is a current standard-of-care anti-TNF medication approved to treat moderate-to-severe plaque psoriasis. These new results were presented on October 3, 2013 at the 22nd Congress of the European Association of Dermatology and Venereology (EADV) in Istanbul, Turkey. The pivotal FIXTURE study met all primary and pre-specified key secondary endpoints(p<0.0001 for placebo comparisons and p=0.0250 for Enbrel comparisons). Both doses of secukinumab showed improved efficacy to Enbrel throughout the 52 week study, beginning as early as Week 2 and confirmed by Week 12 when the primary endpoints were assessed. Importantly, more secukinumab patients experienced almost clear skin (described as PASI 90) and completely clear skin (PASI 100) compared to Enbrel, which are higher standards of skin clearance compared to the standard efficacy measures used in psoriasis clinical studies.