. Majority of patients with scalp psoriasis on Cosentyx® (secukinumab) achieved clear skin (PSSI 90) at Weeks 12 and 24 and improved quality of life[1]
? Scalp psoriasis affects 60 million people worldwide - a difficult-to-treat form of psoriasis with a substantial impact on quality of life[1]-[5]
? Cosentyx data presented at AAD adds to robust evidence demonstrating sustained efficacy in plaque, nail, palmoplantar and scalp psoriasis as well as psoriatic arthritis[6]-[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 options[13]. 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[4],[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 treatments[13].

"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[6]-[12]. To date, Cosentyx has been prescribed to more than 140,000 patients worldwide across all indications since launch[14].

About psoriasis
Psoriasis is a distressing and painful autoimmune disease that affects more than 125 million people worldwide[4]. 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[4],[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 impairment[2],[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 AS[19]-[22].

Cosentyx delivers psoriasis patients long-lasting skin clearance, with proven sustainability and safety out to 5 years[8]. 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[19].

Cosentyx has a large clinical trials program in psoriasis, PsA and AS which includes over 60 studies and over 10,000 patients[23]. To date, Cosentyx has been prescribed to more than 140,000 patients worldwide since launch[14].

About the SCALP study[1]
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.

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.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking etc. etc.
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For questions about the site or required registration, please contact media.relations@novartis.com

References
[1] 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.
[2] Zampieron A et al. Quality of life in patients with scalp psoriasis. G Ital Dermatol Venereol. 2015 Jun;150(3):309-16
[3] 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.
[4] 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.
[5] Farber EM, Nall L. Natural history and treatment of scalp psoriasis. Cutis. 1992;49:396-400.
[6] 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.
[7] 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.
[8] 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
[9] Mease PJ et al. Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Active Psoriatic Arthritis through 3 Years: Efficacy and Safety Results from a Phase 3 Trial. AnnRheum Dis. 2017;76:952-953.
[10] Baeten D et al. Secukinumab, interleukin-17A inhibition in ankylosing spondylitis. N Engl J Med. 2015; 373:2534-48.
[11] McInnes IB et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015; 386(9999):1137-1146.
[12] Reich K et al. Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, exhibits minimal immunogenicity in patients with moderate-to-severe plaque psoriasis. Br. J. Dermatol. 2017;176:752-58.
[13] Crowley JJ. Nail, Scalp, and Palmoplantar Psoriasis. Biologic and Systemic Agents in Dermatology. 2018; 160-174.
[14] Novartis Data on File. Number of Patients Prescribed Cosentyx. Novartis Pharmaceuticals Corp; Nov. 2017.
[15] National Psoriasis Foundation. Psoriatic disease: about psoriasis. Available at: www.psoriasis.org/about-psoriasis?. Last accessed January 2018.
[16] Baran R. The burden of nail psoriasis: an introduction. Dermatol. 2010:221 Suppl 1:1-5.
[17] Kumar B et al. Palmoplantar lesions in psoriasis: a study of 3065 patients. Acta Dermatol Venereol. 2002;82:192-5.
[18] Chung J et al. Palmoplantar psoriasis is associated with greater impairment of health-related quality of life compared with moderate to severe plaque psoriasis. J Am Acad Dermatol. 2014;71(4):623-32.
[19] EU Cosentyx Summary of Product Characteristics. Novartis Europharm Limited. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003729/human_med_001832.jsp&mid=WC0b01ac058001d124?. Last accessed January 2018.
[20] Smith JA et al. Review: The Interleukin 23/Interleukin 17 Axis in Spondyloarthritis Pathogenesis: Th17 and Beyond. Arthritis Rheumatol. 2014;66:231-41.
[21] Nestle FO et al. Mechanisms of disease psoriasis. N Eng J Med. 2009;361:496-509.
[22] Girolomoni G et al. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol. 2012;167:717-24.
[23] Novartis, data on file.

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Novartis new data show Cosentyx® improved quality of life over 5 years in two thirds of patients with moderate to severe plaque psoriasis
Feb 16, 2018
? Two thirds of patients on Cosentyx® (secukinumab) reported no impact of skin disease on their quality of life over 5 years, SCULPTURE study shows[1]

? Findings show absolute PASI <=1/<=2/<=3 responses were sustained in those treated with Cosentyx from Year 1 to Year 5[1]

? Cosentyx is the first and only fully human interleukin-17A (IL-17A) inhibitor that showed sustained skin clearance rates at 5 years in patients from a psoriasis Phase III study[2]

Basel, February 16, 2018 - Novartis announced today, additional results from the SCULPTURE study showing that two thirds of moderate to severe plaque psoriasis patients treated with Cosentyx® (secukinumab) reported no impact of skin disease on their quality of life through 5 years, as described by the Dermatology Life Quality Index (DLQI) 0/1 response (72.7% at Year 1 and 65.5% at Year 5) - a questionnaire used to evaluate the impact of skin disease on a patient's quality of life[1],[3]. These data were presented at the 2018 American Academy of Dermatology (AAD) Annual Meeting in San Diego, California.

Study findings also show absolute PASI <=1/<=2/<=3 scores at Year 1 (58.6%, 67.9% and 74.1%, respectively) were sustained to Year 5 (53.3%, 66.4% and 75.4%, respectively); as observed analysis[1]. Absolute PASI scores can provide an indication of disease severity after treatment. Achievement of an absolute PASI score lower than 2 or 3 has been proposed as an indication of treatment success[4].

Psoriasis is not simply a cosmetic problem, but a persistent, chronic (long-lasting), and sometimes distressing disease, which can affect even the smallest aspects of people's lives on a daily basis."There is a link between achieving skin clearance and improved quality of life, and proper management of psoriasis should address both the physical symptoms of the disease and its impact on patients' daily lives," said Craig Leonardi, MD, Adjunct Professor of Dermatology at St. Louis University School of Medicine. "Results from the SCULPTURE study show treatment with Cosentyx can deliver both over the long-term. It's encouraging to see such improvements in DLQI responses and absolute PASI scores below 3 through 5 years."

"Patients with psoriasis are looking for a treatment that not only achieves clear skin, but also addresses the negative impact psoriasis has on their lives," said Shreeram Aradhye, Chief Medical Officer and Global Head, Medical Affairs, Novartis Pharmaceuticals. "We are excited by this new evidence, showing two thirds of psoriasis patients reporting no impact on their quality of life at 5 years when treated with Cosentyx, and the possibilities this offers patients."

The most common adverse events included nasopharyngitis, upper respiratory tract infection and headache, consistent with those reported in the core study and previous Phase III studies[1].

Cosentyx is the first and only fully human IL-17A inhibitor approved to treat ankylosing spondylitis (AS), psoriatic arthritis (PsA) and moderate to severe plaque psoriasis[5]. To date, Cosentyx has been prescribed to more than 140,000 patients worldwide since launch[6].

About psoriasis
Psoriasis is a distressing and painful autoimmune disease that affects more than 125 million people worldwide[7]. 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 - which up to 30% of patients with psoriasis may develop[8].

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[9]-[12].

About Cosentyx (secukinumab) and IL-17A
Cosentyx is the first and only fully human IL-17A inhibitor approved to treat psoriasis, PsA and ankylosing spondylitis (AS)[5]. 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[5],[13]-[15].

Cosentyx delivers psoriasis patients long-lasting skin clearance, with proven sustainability and safety out to 5 years[2]. Cosentyx is also approved for the most difficult-to-treat forms of plaque psoriasis - palmoplantar psoriasis (psoriasis of the palms of the hands and soles of the feet), nail psoriasis and scalp psoriasis[5].

Cosentyx has a large clinical trials program in psoriasis, PsA and AS which includes over 60 studies and over 10,000 patients[16]. To date, Cosentyx has been prescribed to more than 140,000 patients worldwide since launch[6].

About the Cosentyx 5-year extension study (NCT01406938)[1],[2]
NCT01406938 is a multicenter, double-blind and open-label, 5-year extension to the core Phase III SCULPTURE study. The primary objective of this extension study was to assess the long-term safety and tolerability of Cosentyx in patients with moderate to severe plaque psoriasis, examining both treatment and quality of life outcomes.

Efficacy measures included proportion of patients achieving PASI 75, PASI 90 and PASI 100, and quality of life improvement as measured by Dermatology Life Quality Index (DLQI). This long-term extension study demonstrated the sustained efficacy and safety of Cosentyx. The current as observed analysis describes, PASI 75/90/100 at Year 1 (88.9%, 68.5% and 43.8%, respectively) and Year 5 (88.5%, 66.4% and 41%); absolute PASI <=1/<=2/<=3 responses at Year 1 (58.6%, 67.9% and 74.1%, respectively) and Year 5 (53.3%, 66.4% and 75.4%, respectively), DLQI 0/1 at Year 1 (72.7%) and Year 5 (65.5%), and long-term safety and tolerability.

In the core Phase III SCULPTURE study, PASI 75 responders at Week 12 were randomized to double-blind maintenance treatment of Cosentyx 300 mg or 150 mg, given either at a 4-week fixed-interval regimen or in a retreatment-as-needed regimen. Patients who completed 52 weeks of the SCULPTURE study were eligible to continue the same dose and regimen in the extension study (N=642). Patients subsequently entered the extension phase and continued the same double-blinded treatment regimen to Year 3, and thereafter un-blinded to the end of the study at Year 5 (n=126 at Week 260). No topical treatments were allowed in SCULPTURE, and only in the extension study when applied to the scalp, face, and/or genitoanal area for a maximum of 14 days. 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.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," etc. etc.

References

[1] Bissonnette R et al. Secukinumab demonstrates high sustained efficacy and a favorable safety profile through 5 years of treatment in moderate to severe psoriasis. Eposter presented at 2018 American Academy of Dermatology (AAD) Annual Meeting; February 16-20, 2018, San Diego, California. Poster #7382.
[2] 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
[3] Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)-a simple practical measure for routine clinical use. Clin Experiment Dermatol. 1994;19(3):210-216.
[4] Zheng J. Absolute Psoriasis Area and Severity Index: an additional evaluation for clinical practice. Br J Dermatol. 2017;176:563-576.
[5] Cosentyx Summary of Product Characteristics. Novartis Europharm Limited. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003729/human_med_001832.jsp&mid=WC0b01ac058001d124?. Last accessed January 2018.
[6] Novartis. Data on file.
[7] 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.
[8] National Psoriasis Foundation. Psoriatic disease: about psoriasis. Available at: www.psoriasis.org/about-psoriasis. Last accessed January 2018?.
[9] Zampieron A et al. Quality of life in patients with scalp psoriasis. G Ital Dermatol Venereol. 2015 Jun;150(3):309-16
[10] Baran R. The burden of nail psoriasis: an introduction. Dermatol. 2010:221 Suppl 1:1-5.
[11] Kumar B et al. Palmoplantar lesions in psoriasis: a study of 3065 patients. Acta Dermatol Venereol. 2002;82:192-5.
[12] Chung J et al. Palmoplantar psoriasis is associated with greater impairment of health-related quality of life compared to moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2014 Oct;71(4):623-632.
[13] Smith JA et al. Review: The Interleukin 23/Interleukin 17 Axis in Spondyloarthritis Pathogenesis: Th17 and Beyond. Arthritis Rheumatol. 2014;66:231-41.
[14] Nestle FO et al. Mechanisms of disease psoriasis. N Eng J Med. 2009;361:496-509.
[15] Girolomoni G et al. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol. 2012;167:717-24.
[16] Novartis. Data on file.

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