Secukinumab Demonstrates Potential in Phase 3 Psoriasis Trials

Novartis announced results from two Phase 3 trials evaluating secukinumab in patients with moderate-to-severe plaque psoriasis. Secukinumab is a fully human monoclonal antibody (mAb) that selectively binds and inhibits the pro-inflammatory effects of interleukin-17A (IL-17A).

Both ERASURE (Efficacy of Response And Safety of two fixed secUkinumab REgimens in psoriasis) and FIXTURE (the Full year Investigative eXamination of secukinumab vs. eTanercept Using 2 dosing Regimens to determine Efficacy in psoriasis) were randomized, double-blind, placebo-controlled, multicenter, parallel-group studies in patients with moderate-to-severe plaque psoriasis. FIXTURE also had etanercept as an active control. The co-primary endpoints for both trials were assessed at Week 12 and compared secukinumab efficacy vs. placebo based on PASI 75 and IGA mod 2011 0/1 responses.

The co-primary endpoints for the ERASURE study (n=738) met statistical significance. A higher proportion of patients treated with secukinumab 300mg and 150mg achieved a PASI 75 response at Week 12 compared to placebo patients: 81.6% (300mg) and 71.6% (150mg) vs. 4.5% for placebo. A higher proportion of patients treated with secukinumab achieved an IGA mod 2011 0/1 response at Week 12 compared to placebo: 65.3% (300mg) and 51.2% (150mg), vs. 2.4% for placebo.

The co-primary endpoints for the FIXTURE study (n=1306) also met statistical significance. A higher proportion of patients treated with secukinumab 300mg and 150mg achieved a PASI 75 response at Week 12 compared to placebo and etanercept: 77.1% (300mg) and 67.0% (150mg), vs. 4.9% for placebo and 44.0% for etanercept. A higher proportion of patients treated with secukinumab also achieved an IGA mod 2011 0/1 response at Week 12 compared to placebo and etanercept: 62.5% (300mg) and 51.1% (150mg), vs. 2.8% for placebo and 27.2% for etanercept.

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