Date: 2015-06-11
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the 23rd World Congress of Dermatology (WCD) in Vancouver, Canada
Company: Novartis (Switzerland)
Product: Cosentyx® - secukinumab (AIN457)
Action
mechanism: monoclonal antibody. Secukinumab (AIN457) is a fully human monoclonal antibody that selectively binds to and neutralizes interleukin-17A (IL-17A). IL-17A is a central cytokine (messenger protein) involved in the development of psoriasis and is found in high concentration in skin affected by the disease. Research shows that IL-17A plays a key role in driving the body\'s autoimmune response in disorders such as moderate-to-severe plaque psoriasis and is a preferred target for investigational therapies. Secukinumab is the first therapy selectively targeting IL-17A to publish phase III results. Regulatory submissions for secukinumab in the EU and US were completed in 2013. In January 2015, Cosentyx® (at a dose of 300 mg) became the first and only IL-17A inhibitor approved in Europe as a first-line systemic treatment of moderate-to-severe plaque psoriasis in adult patients, and in the US as a treatment for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (light therapy). In addition to the EU and the US, Cosentyx® has been approved in Switzerland, Chile, Australia, Canada and Singapore for the treatment of moderate-to-severe plaque psoriasis and in Japan for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis (PsA). Cosentyx® is also in Phase III development for PsA and ankylosing spondylitis; global regulatory applications are planned for 2015.
Disease: nail psoriasis
Therapeutic area: Autoimmune diseases - Dermatological diseases
Country: Australia, Belgium, Brazil, Czech Republic, Denmark, Germany, Greece, Spain, UK, USA
Trial
details: TRANSFIGURE is a phase 3 randomized, double-blind, placebo-controlled, multicenter, study to demonstrate the efficacy at 16 weeks of secukinumab 150 and 300 mg s.c. and to assess safety, tolerability and longterm efficacy up to 132 Weeks in subjects with moderate to severe nail psoriasis. (NCT01807520)
Latest
news: * On June 11, 2015, Novartis announced that Cosentyx® (secukinumab) met the primary endpoints in two new clinical studies, showing superior efficacy compared to placebo in patients with psoriasis of the palms, soles and nails, all difficult-to-treat locations of plaque psoriasis. Detailed findings were presented for the first time at the 23rd World Congress of Dermatology (WCD) in Vancouver, Canada. In the GESTURE study in patients with moderate-to-severe palmoplantar psoriasis, Cosentyx (300 mg) was superior to placebo at Week 16 in achieving clear or almost clear palms and soles as assessed using the Palmoplantar Investigator’s Global Assessment (33.3% vs. 1.5%; P<0.0001) (Gottlieb A B, Sullivan J, van Doorn M B A et al. Secukinumab is effective in subjects with moderate to severe palmoplantar psoriasis: 16 week results from the GESTURE study). Similarly, in the TRANSFIGURE study in patients with significant nail psoriasis, Cosentyx (300 mg) was superior to placebo at Week 16, as assessed by mean improvement (decrease) in the Nail Psoriasis Severity Index (NAPSI) compared to baseline (-45.3% vs -10.8%; P<0.0001).2 The safety profile of Cosentyx in both studies was comparable to previously reported Phase III clinical trials (Reich K, Sullivan J, Arenberger P, et al. Secukinumab is Effective in Subjects With Moderate to Severe Plaque Psoriasis with Significant Nail Involvement: 16 Week Results From the TRANSFIGURE Study).
