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Secukinumab (AIN457) Superior to Etanercept (Enbrel) in Head-to-Head Phase III Psoriasis Study
A head-to-head phase III psoriasis study has demonstrated the superiority of an investigational monoclonal antibody, secukinumab (AIN457, Novartis), in clearing skin compared with etanercept (Enbrel, Amgen), an anti-tumor necrosis factor (anti-TNF) therapy. In addition, secukinumab met all primary and secondary endpoints.
The FIXTURE (Full-Year Investigative EXamination of Secukinumab vs. ETanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis) trial was a randomized, double-blind, double-dummy, placebo-controlled, phase III study of subcutaneous secukinumab in 1,307 patients with moderate-to-severe plaque psoriasis. The study was designed to demonstrate the efficacy of secukinumab after 12 weeks of treatment compared with placebo and etanercept, and to assess its safety, tolerability, and long-term efficacy for up to 52 weeks. Efficacy measures included the Psoriasis Area and Severity Index 75 (PASI 75) and the Investigator's Global Assessment (IGA mod 2011), a standard tool for assessing the clearing of skin after treatment.
Secukinumab (AIN457) is a fully human monoclonal antibody that selectively binds to and neutralizes interleukin-17A, a key pro-inflammatory cytokine (protein messenger) in the development of psoriasis. Proof-of-concept and phase II studies in moderate-to-severe plaque psoriasis and arthritic conditions (i.e., psoriatic arthritis, ankylosing spondylitis, and rheumatoid arthritis) have suggested that secukinumab may provide a new mechanism of action for the treatment of immune-mediated diseases. The phase III programs for these potential indications are ongoing.
Results from the secukinumab phase III study program are expected to be presented at medical congresses later this year.
Source: Novartis; July 8, 2013.