Novartis: Secukinumab outperformed Enbrel for psoriasis treatment

Secukinumab was shown to be more effective in treating patients with moderate-to-severe plaque psoriasis compared with etanercept, Novartis reported today.

In the phase 3 FIXTURE trial, secukinumab (AIN457; Novartis) displayed superiority to etanercept (Enbrel; Amgen), an anti-tumor necrosis factor (anti-TNF), in clearing skin of patients with moderate-to-severe plaque psoriasis, according to a company press release. Novartis expects to announce full results later this year at major medical congresses.

Secukinumab is a fully human monoclonal antibody that selectively binds to and neutralizes IL-17A, a pro-inflammatory cytokine that is prolific in psoriatic skin.

Researchers evaluated 1,307 patients in the randomized, double blind, double-dummy, placebo-controlled multicenter global study. Subcutaneous secukinumab treatment was compared with etanercept and placebo after 12 weeks. Safety, tolerability and long-term efficacy up to 52 weeks were assessed. Psoriasis Area and Severity Index 75 (PASI 75) and Investigator’s Global Assessment (IGA, modified 2011) assessed the efficacy of secukinumab, which met all primary and secondary endpoints, Novartis announced.

The study, that included more than 3,300 patients from more than 35 countries, assessed 150-mg and 300-mg doses of secukinumab.

“Primary endpoints for four studies related to PASI 75 and IGA, and a fifth study evaluated the proportion of patients who maintained PASI 75 after having achieved PASI 75 after 12 weeks of active treatment,” according to the release.

The safety profile of secukinumab was consistent with previously reported phase 2 plaque psoriasis studies, Novartis said.

“These results showing that secukinumab (AIN457) is superior to Enbrel, a current standard-of-care therapy, are great news for people living with moderate-to-severe plaque psoriasis,” Tim Wright, MD, global head of development, Novartis Pharmaceuticals, said in the release.

Regulatory submissions for secukinumab are scheduled for later this year, Novartis said.