Date: 2015-10-10
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the 24th Annual Congress of the European Academy of Dermatology and Venereology (EADV) in Copenhagen
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: psoriasis
Therapeutic area: Autoimmune diseases - Dermatological diseases
Country:
Trial
details: A2304E1 is a multicenter, double-blind and open-label, four-year extension to the pivotal Phase III SCULPTURE and STATURE studies. In SCULPTURE 642 patients who completed 52 weeks of treatment continued into the extension. During the core study, PASI 75 responders at Week 12 were randomized to double-blind maintenance treatment of subcutaneous secukinumab 300 mg or 150 mg, administered either at a four-week fixed-interval (FI) regimen (320 patients) or in a retreatment-as-needed (RAN) regimen (322 patients). At entry into the extension, patients continued with the same blinded maintenance treatment regimen and dose that they had received in the SCULPTURE core study.
The primary objective of the extension study was to assess the long-term safety and tolerability of Cosentyx in patients with moderate-to-severe chronic plaque psoriasis. The secondary objective was to evaluate long-term efficacy of 300 mg and 150 mg Cosentyx administered in retreatment-as-needed versus fixed-interval regimens in patients who were PASI 75 responders at Week 12. Efficacy measures included proportion of patients achieving PASI 75, PASI 90 and PASI 100 as well as IGA mod 2011 0/1 responses.
Latest
news: * On October 10, 2015, Novartis announced new late-breaking data demonstrating that Cosentyx™ (secukinumab) provides high levels of skin clearance and sustained efficacy in patients with moderate-to-severe plaque psoriasis while maintaining a favorable safety profile across three years. The results of this study - the longest Phase III Cosentyx trial conducted to-date - were presented at the 24th Annual Congress of the European Academy of Dermatology and Venereology (EADV) in Copenhagen, Denmark. Cosentyx is the first fully human interleukin-17A (IL-17A) inhibitor approved to treat adult moderate-to-severe plaque psoriasis. In this extension study, 320 patients received Cosentyx in a fixed dosing schedule for three years. 69% achieved clear or almost clear skin (PASI 90) at year one. This response was extremely well maintained after three years with 64% of patients continuing to have a PASI 90 response. In addition, 43% of patients maintained completely clear skin (PASI 100) at year three (from 44% at year one). 83% achieved the standard treatment goal of PASI 75 skin clearance at three years. In this study, Cosentyx had a favorable safety profile consistent with that observed in previous Phase III studies.
