Novartis, a global leader in immunology & dermatology, confirmed positive 5 year efficacy and safety results for Cosentyx from a phase III long-term extension study in patients with moderate-to-severe plaque psoriasis. Data will be presented at a key medical congress in the second half of 2017. 5 year phase III data are a recognized milestone for assessing long-term efficacy and safety of innovative treatments.
"Cosentyx has consistently demonstrated sustained efficacy and safety providing psoriasis patients a new standard of long-term care," said Vas Narasimhan, global head of drug development and chief medical officer, Novartis. "With the first data from a pivotal trial with 5 years of follow up, Cosentyx continues to demonstrate it can provide what psoriasis patients want, a life with clear skin."
4 year phase III data presented at EADV 2016 showed Cosentyx delivered almost clear or completely clear skin in a majority of patients (PASI 90 - 66%, PASI 100 - 44%) after 4 years of treatment. The data showed that with Cosentyx, 97% of PASI 90 and 99% of PASI 100 response rates were maintained from Year 1 to Year.
Recently, new label updates announced for Cosentyx in Europe demonstrated long-term superiority of Cosentyx versus Stelara (ustekinumab) in moderate-to-severe plaque psoriasis on the basis of 52 week data from the CLEAR study, and expanded the use of Cosentyx for the treatment of moderate-to-severe scalp psoriasis. Cosentyx was launched in 2015 as the first and only fully-human IL-17A inhibitor to treat psoriasis and is now licenced for the treatment of psoriatic arthritis and ankylosing spondylitis as well. Novartis remains committed to investigating important scientific questions with Cosentyx that address unmet needs and could significantly enhance patients' quality of life.
The long-term extension study for Cosentyx in patients with moderate-to-severe psoriasis is designed to analyze efficacy and safety over the period of 5 years (Week 260). The current data analysis for Cosentyx includes all patients who reached a PASI 75 response at Week 12 and subsequently received continuous treatment with 300mg secukinumab until the end of Year 5. The study includes analysis of the PASI 75/90/100 response rates over the extended treatment period from Year 1 (Week 52) to the end of Year 5 (Week 260), analyses of body surface area (BSA) and absolute PASI (i.e. assessments of increasing relevance to the dermatologists), showing how many patients still on study drug had no more than 1% of their BSA covered by psoriasis, mean PASI and BSA improvement, as well as the safety profile of Cosentyx.
Launched in January 2015, Cosentyx is a targeted treatment that specifically inhibits the IL-17A cytokine. Research suggests that IL-17A may play an important role in driving auto-inflammatory conditions in enthesis and ultimately the body's immune response in psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS).
Cosentyx is approved in more than 75 countries for the treatment of moderate-to-severe plaque psoriasis, which includes the US, Canada, the European Union countries, Japan, Switzerland and Australia. In Europe, Cosentyx is 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).
Cosentyx is the first IL-17A inhibitor approved in more than 70 countries for the treatment of active PsA and AS, which includes the US and the European Union countries. Cosentyx is also approved for the treatment of PsA and pustular psoriasis in Japan.