Novartis new Cosentyx data confirms robust efficacy and quality of life improvements in scalp psoriasis

  • Majority of patients with scalp psoriasis on Cosentyx (secukinumab) achieved clear skin (PSSI 90) at Weeks 12 and 24 and improved quality of life
  • Scalp psoriasis affects 60 million people worldwide - a difficult-to-treat form of psoriasis with a substantial impact on quality of life -
  • Cosentyx data presented at AAD adds to robust evidence demonstrating sustained efficacy in plaque, nail, palmoplantar and scalp psoriasis as well as psoriatic arthritis -

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Basel, February 16, 2018 - Novartis has presented new Cosentyx (secukinumab) data from the prospective Phase III SCALP study which showed significant improvement in skin clearance with Cosentyx in patients with scalp psoriasis. Due to the presence of hair, scalp psoriasis is particularly difficult to treat with common topical and phototherapy options. These study results were presented at the 2018 American Academy of Dermatology (AAD) Annual Meeting in San Diego, California.

"Scalp psoriasis can be painful and in some cases, can lead to temporary hair loss and cause the involved area to crack and bleed," said Kristian Reich, M.D., Ph.D., Georg-August-University Göttingen and Dermatologikum Hamburg, Germany. "The data presented at AAD is encouraging for both physicians and patients, who can have greater trust in Cosentyx as a complete treatment option for patients with plaque psoriasis who want to avoid scalp and other manifestations of psoriasis."

Approximately 60 million people worldwide are impacted by scalp psoriasis , , a form of the disease which can have a substantial impact on quality of life due its highly visible nature. Additional stress may be added as many psoriasis patients will not achieve an adequate response from standard treatments.

"As a science driven company, we are committed to investigating the full potential of Cosentyx. It is our ambition to offer the best evidence to doctors, and to deliver the best treatment to patients," said Eric Hughes, Global Development Unit Head, Immunology & Dermatology. "Cosentyx is backed by a large study program including more than 10,000 patients in over 60 studies since our first Cosentyx study initiation 10 years ago. We believe that study data on specific manifestations such as scalp help doctors reach the right decisions with their patients."

Cosentyx is a fully human interleukin-17A (IL-17A) inhibitor which has demonstrated rapid and sustained long term efficacy in the treatment of moderate-to-severe psoriasis, psoriatic arthritis and ankylosing spondilytis, as well as a consistently favorable safety profile including injection site pain at rates similar to placebo - . To date, Cosentyx has been prescribed to more than 140,000 patients worldwide across all indications since launch.

About psoriasis
Psoriasis is a distressing and painful autoimmune disease that affects more than 125 million people worldwide. It is a debilitating condition associated with a significant emotional and physical daily burden. In the long-term, psoriasis can also lead to other conditions, such as diabetes, heart disease, depression and psoriatic arthritis (PsA) - which up to 30% of patients with psoriasis may develop , .

Plaque psoriasis is the most common form of the disease and appears as raised, red skin patches covered with a silvery white build-up of dead cells. Most patients with psoriasis will also develop difficult-to-treat forms of the disease which appear on the scalp, nails, palms of the hands or soles of the feet and are associated with further pain, decreased mobility and functional impairment , - .

About Cosentyx (secukinumab) and IL-17A
Cosentyx is the first and only fully human interleukin-17A (IL-17A) inhibitor approved to treat psoriasis, PsA and ankylosing spondylitis (AS) . Cosentyx is a targeted treatment that specifically inhibits IL-17A, cornerstone cytokine involved in the pathogenesis of psoriasis, and the inflammation of the entheses in PsA and AS - .

Cosentyx delivers psoriasis patients long-lasting skin clearance, with proven sustainability and safety out to 5 years. Cosentyx has been studied in dedicated trials for difficult-to-treat types of plaque psoriasis - palmoplantar psoriasis (psoriasis of the hands and feet), scalp psoriasis, and nail psoriasis.

Cosentyx has a large clinical trials program in psoriasis, PsA and AS which includes over 60 studies and over 10,000 patients.  To date, Cosentyx has been prescribed to more than 140,000 patients worldwide since launch.

About the SCALP study
This study is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Cosentyx in 102 patients with moderate-to-severe scalp psoriasis. Eligible patients were equally randomized to either subcutaneous Cosentyx 300 mg or placebo at Weeks 0, 1, 2, 3 and 4, then every four weeks for 12 weeks. At Week 12, patients in the placebo group who did not achieve at least a 90% improvement from baseline in the Psoriasis Scalp Severity Index (PSSI) score were re-randomized to Cosentyx 300 mg until study completion. The primary endpoint was the proportion of patients who achieved PSSI 90 response rate at Week 12.

In the SCALP study, PSSI 90 response rates were achieved by a significantly higher proportion of patients receiving Cosentyx vs. placebo at Week 12 (52.9% vs. 2.0%), with further improvements in those taking Cosentyx up to Week 24 (58.8%). The safety profile of Cosentyx was in line with the known safety profile for Cosentyx.

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