Novartis announced new late-breaking data from the head-to-head CLEAR study, demonstrating that Cosentyx (secukinumab) remains superior to Stelara (ustekinumab) in achieving sustained skin clearance (PASI 90 response) at 52 weeks for adults living with moderate-to-severe psoriasis. These findings were presented for the first time at the American Academy of Dermatology (AAD) Annual Meeting in Washington, DC.
Cosentyx is the first fully human interleukin-17A inhibitor approved for adults to treat moderate-to-severe plaque psoriasis, and was recently approved for the treatment of psoriatic arthritis and ankylosing spondylitis in the EU and US.
"Cosentyx continues to demonstrate superior and sustainable efficacy against currently available biologics and is a proven first-line treatment option for adult patients with moderate-to-severe psoriasis," said Vasant Narasimhan, global head, drug development and chief medical officer, Novartis. "Cosentyx has the potential to give more people with psoriasis than ever before the benefit of long-lasting skin clearance."
The ultimate aim of psoriasis treatment is clear skin, and the Psoriasis Area Severity Index (PASI) 90 response is considered an important measure of treatment success. Meeting all primary and secondary endpoints at Weeks Four, 16 and 52, Cosentyx demonstrated it remains consistently superior to Stelara in achieving and sustaining PASI 90 response (76.2% vs. 60.6%; P<0.0001), and significantly better in achieving PASI 100 (clear skin) response (45.9% vs. 35.8%; P=0.0103) at 52 weeks. Cosentyx also showed significantly greater and sustained Dermatology Life Quality Index (DLQI) 0/1 responses versus Stelara (71.6% vs. 59.2%; P=0.0008).
The study also demonstrated Cosentyx had a superior rapid onset of action compared to Stelara, with half of Cosentyx patients achieving PASI 75 as early as Week Four (50.0% vs. 20.6%, P<0.0001). Cosentyx had a similar safety profile to that of Stelara in the study, which was consistent with that reported in the pivotal Cosentyx phase III studies.
Affecting around 125 million people globally, psoriasis is a chronic skin condition that causes itching, scaling and pain, and can have a significant impact on physical and psychological wellbeing. Despite this, up to half of patients receive no treatment, and of those who do, many (52%) remain dissatisfied with their disease management.
CLEAR (Comparison to assess Long-term Efficacy, sAfety and toleRability of secukinumab vs. ustekinumab) is a multi-center, double-blind, parallel-group study of Cosentyx (n=334) versus Stelara (n=335) to compare efficacy, safety and tolerability in adults with moderate-to-severe plaque psoriasis. Patients were randomized to receive either Cosentyx (300 mg) by subcutaneous injection at Baseline, Weeks One, Two and Three, then every four weeks from Week Four, or Stelara (dosing per package label). Cosentyx achieved the primary objective of superior PASI 90 response at Week 16. These data were published as an e-publication in the Journal of the American Academy of Dermatology, June 17, 2015. The 52-week PASI 90 response is a secondary objective in this study. PASI 100 and DLQI responses at 52 weeks are exploratory endpoints.
Cosentyx is a fully human monoclonal antibody that selectively neutralizes circulating IL-17A. Research suggests that IL-17A may play an important role in driving the body's immune response in psoriasis, psoriatic arthritis and ankylosing spondylitis.
Cosentyx is approved in over 50 countries for the treatment of moderate-to-severe plaque psoriasis which includes the European Union countries, Japan, Switzerland, Australia, the US and Canada. In Europe, Cosentyx is the only biologic approved for the first-line systemic treatment of moderate-to-severe plaque psoriasis in adult patients. In the US, Cosentyx is approved as a treatment for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (light therapy).
In addition, Cosentyx is the first IL-17A inhibitor with positive phase III results for the treatment of active psoriatic arthritis and active ankylosing spondylitis and is now approved in Europe, the US, Ecuador, Bangladesh and the Philippines for these conditions. Cosentyx is also approved for the treatment of psoriatic arthritis and pustular psoriasis in Japan.