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 life1
- Scalp psoriasis affects 60 million people worldwide – a difficult-to-treat form of psoriasis with a substantial impact on quality of life1-5
- Cosentyx data presented at AAD adds to robust evidence demonstrating sustained efficacy in plaque, nail, palmoplantar and scalp psoriasis as well as psoriatic arthritis6-12
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 options13. 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 psoriasis4,5, 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 treatments13.
“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 placebo6-12. To date, Cosentyx has been prescribed to more than 140,000 patients worldwide across all indications since launch14.
Psoriasis is a distressing and painful autoimmune disease that affects more than 125 million people worldwide4. 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 develop4,15.
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 impairment2,16-18.
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)19. 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 AS19-22.
Cosentyx delivers psoriasis patients long-lasting skin clearance, with proven sustainability and safety out to 5 years8. 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 psoriasis19.
Cosentyx has a large clinical trials program in psoriasis, PsA and AS which includes over 60 studies and over 10,000 patients23. To date, Cosentyx has been prescribed to more than 140,000 patients worldwide since launch14.
About the SCALP study1
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 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.
About Novartis Immunology & Dermatology
Novartis is a global leader in Immunology & Dermatology. We are dedicated to transforming the lives of people living with immunologic diseases, focusing on immunodermatology, rheumatology and specialty liver diseases. Our Immunology & Dermatology pipeline includes multiple compounds in liver disease and other immunological areas where high unmet medical needs exist.
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- Reich K et al. Secukinumab Shows Sustained Efficacy in Difficult-to-Treat Palmoplantar, Nail, and Scalp Psoriasis: Long-term Results From 3 Phase III Placebo-Controlled Randomized Trials. Eposter presented at 2018 American Academy of Dermatology (AAD) Annual Meeting; February 16–20, 2018, San Diego, California. Poster #6813.
- Zampieron A et al. Quality of life in patients with scalp psoriasis. G Ital Dermatol Venereol. 2015 Jun;150(3):309-16
- American academy of dermatology. Scalp Psoriasis. Available at: https://www.aad.org/public/diseases/hair-and-scalp-problems/scalp-psoriasis#symptoms. Last accessed January 2018.
- International Federation of Psoriasis Associations (IFPA) World Psoriasis Day website. "About Psoriasis." Available at: http://www.worldpsoriasisday.com/web/page.aspx?refid=114. Last accessed January 2018.
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- Gottlieb AB et al. Secukinumab Shows High and Sustained Efficacy in Subjects with Moderate to Severe Palmoplantar Psoriasis: 2.5-Year Results From the GESTURE Study. Abstract presented at the 2017 Psoriasis Gene to Clinic Congress, London, United Kingdom. 30th November 2017.
- Braun J et al. Secukinumab demonstrates low radiographic progression and sustained efficacy through 4 years in patients with active ankylosing spondylitis. Late breaking abstract presented at the 2017 ACR/ARHP Annual Meeting, San Diego, USA. 7th November 2017.
- Bissonnette, R., Luger, T., Thaçi, D., Toth, D., Lacombe, A., Xia, S., Mazur, R., Patekar, M., Charef, P., Milutinovic, M., Leonardi, C. and Mrowietz, U. Secukinumab Demonstrates High Sustained Efficacy and a Favorable Safety Profile in Patients with Moderate to Severe Psoriasis through 5 Years of Treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol. Accepted Author Manuscript. doi:10.1111/jdv.14878
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