Psoriasis Club

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Novartis, a global leader in Immunology & Dermatology, confirmed today 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 4.

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.

About the study
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.