Novartis presented new data at WCD demonstrating significant efficacy of Cosentyx™ in patients with psoriasis of the nails, palms and soles

• Cosentyx ^TM met the primary endpoints of superiority compared to placebo in patients with difficult-to-treat psoriasis of the nails, palms and soles (palmoplantar psoriasis)^1,2
  
  
• One third of patients with moderate-to-severe palmoplantar psoriasis achieved clear or almost clear skin on their palms and soles after 16 Weeks of treatment with Cosentyx ^TM 1, severity of nail psoriasis decreased by almost a half^1,2
  
  
• Affecting 1 million Canadians³, plaque psoriasis can negatively impact daily life and is associated with increased risk for other chronic illnesses^4,5
  
  
• Psoriasis of the palms, soles and nails is estimated to affect as many as 90% of all psoriasis patients over their lifetime⁶

DORVAL, QC, June 12, 2015 /CNW/ - Novartis announced Cosentyx^TM (secukinumab) met the primary endpoints in two new clinical studies, showed superior efficacy compared to placebo in patients with psoriasis of the palms, soles and nails, all difficult-to-treat locations of plaque psoriasis.^1,2. Detailed findings were presented for the first time at the 23rd World Congress of Dermatology (WCD) in Vancouver, Canada.

Cosentyx^TM is the first interleukin-17A (IL-17A) inhibitor to show efficacy in patients with psoriasis in these locations in a dedicated clinical trial and is approved to treat adult patients with moderate-to-severe plaque psoriasis in Canada.⁷ In the GESTURE study in patients with moderate-to-severe palmoplantar psoriasis, Cosentyx^TM (300 mg) was superior to placebo at Week 16 in achieving clear or almost clear palms and soles as assessed using the Palmoplantar Investigator's Global Assessment (33.3% vs. 1.5%; P<0.0001).¹ Similarly, in the TRANSFIGURE study, in patients with significant nail psoriasis, Cosentyx^TM (300 mg) was superior to placebo at Week 16, as assessed by mean improvement (decrease) in the Nail Psoriasis Severity Index (NAPSI) compared to baseline (-45.3% vs -10.8%; P<0.0001).² The safety profile of Cosentyx^TM in both studies was comparable to previously reported Phase III clinical trials.^1-2,8 

"Patients with psoriasis in these difficult-to-treat locations endure significantly greater physical and emotional disabilities than those whose psoriasis affecting other parts of the body," said GESTURE investigator Dr. Lyn Guenther MD FRCPC, Professor and Chair of the Division of Dermatology at Western University, and president of The Guenther Dermatology Research Centre in London, Ontario. "Patients may experience pain and difficulty walking, difficulty grasping and handling objects, and embarrassment when shaking hands, making workplace and social interactions burdensome and participation in recreational activities difficult." Dr. Guenther adds, "The results from these studies represent good news for these patients with psoriasis on the palms, soles and nails, where an unmet need still exists."

"I've been living with psoriasis for over 26 years, the past 8 have been with the disease under control.  I know first-hand how painful, emotional and difficult-to-treat psoriasis can be. Before I was effectively treated, psoriasis had stolen everything from me, I was no longer living my life: I was existing," said Andrew Gosse, Founder and President of the Canadian Psoriasis Network (CPN). "There were times I wore gloves to cover my hands, or bandages on the tips of my fingers to hide the plaque build-up. More often I just didn't go out in public unless I had to. No one should ever have the course and quality of their life decided by psoriasis.  Research brings hope and new treatment options that can transform the landscape and empower the lives of Canadians living with psoriasis." The CPN is a national not-for-profit organization whose focus is on research, education and support for Canadians living with psoriatic disease.

About the GESTURE and TRANSFIGURE studies         
GESTURE has the largest sample size (N=205) and longest duration (132-week treatment period) of any biologic study in moderate-to-severe palmoplantar psoriasis and represents an important achievement in research in a patient population that has been underrepresented in psoriasis trials.^1,10-12

TRANSFIGURE is the largest (N=198) and of longest duration (132-week treatment period) randomized controlled study of a biologic in moderate-to-severe plaque psoriasis with significant nail psoriasis to report results to date.^2,13

About Cosentyx^TM (secukinumab) and interleukin-17A (IL-17A)
Secukinumab is a human monoclonal antibody that selectively neutralizes circulating interleukin-17A (IL-17A).^{14-15 -16} In the Phase III program, Cosentyx^TM demonstrated a favorable safety profile, with similar incidence and severity of adverse events between Cosentyx^TM treatment arms.⁸ Cosentyx^TM is approved by Health Canada (300 mg) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.⁷

About Psoriasis
Affecting as many as one million Canadians³ and more than 125 million people worldwide,⁴ psoriasis is a chronic autoimmune disease characterized by thick and extensive skin lesions, called plaques, known to cause itching, scaling and pain.¹⁷ People living with psoriasis reported that these symptoms can negatively impact their quality of life, both psychosocially and physically, which makes daily functioning difficult.^18-20

Additionally, people with psoriasis are at increased risk for other chronic illnesses¹⁹ such a psoriatic arthritis, a type of inflammatory arthritis, which about 30% of people who have psoriasis get.²⁰ Psoriasis symptoms can begin at any age, including in childhood, but the disease mainly affects adults.²¹ Symptoms start when a combination of environmental triggers and genetic factors disrupt the lifecycle of skin cells.¹⁷

Estimated to affect as many as 90% of all psoriasis patients over their lifetime, psoriasis of the palms, soles and nails is extremely difficult to treat and often requires biologic treatment (a protein based medicine made from cells) to control.⁶ Nail psoriasis is a significant predictor of psoriatic arthritis.²²

In Canada, the prevalence of psoriasis is estimated at approximately 2%. According to a recent Canadian database study, 85% have chronic plaque psoriasis, 28% of which are considered moderate to severe²³.

About Novartis Pharmaceuticals Canada Inc.
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2013, the company invested close to $100 million in research and development in Canada. Novartis Pharmaceuticals Canada Inc. employs more than 600 people in Canada. For further information, please consult www.novartis.ca.

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58.0 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 120,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit http://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.

Cosentyx is a trademark.

References
1.	Gottlieb A, Sullivan J, van Doorn M et al.  Secukinumab is effective in subjects with moderate to severe palmoplantar psoriasis: 16 week results from the GESTURE study. 23^rd World Congress of Dermatology. Vancouver, Canada. 11^th June, 2015.
2.	Reich K, Sullivan J, Arenberger P, et al. Secukinumab is Effective in Subjects With Moderate to Severe Plaque Psoriasis with Significant Nail Involvement: 16 Week Results From the TRANSFIGURE Study. 23^rd World Congress of Dermatology. Vancouver, Canada. 11^th June, 2015.
3.	Canadian Assocation of Psoriasis Patients "What is Psoriasis". Accessed February 16 2015.
4.	National Psoriasis Foundation. Facts about psoriasis. Accessed February 16 2015.
5.	Guenther L, Gulliver W. Psoriasis Comorbidities. J Cutan Med Surg. 2009; 13(suppl 2):S77-87.
6.	Langley RG, Saurat JH, Reich K on behalf of the Nail Psoriasis Delphi Expert Panel. Recommendations for the treatment of nail psoriasis in patients with moderate to severe psoriasis: a dermatology expert group consensus. J Eur Acad Dermatol Venereol. 2012 Mar;26(3):373-81
7.	Cosentyx ^TM Product Monograph, Novartis Pharmaceuticals Canada Inc., March 2, 2015.
8.	Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis: results of two phase three trials. N Engl J Med. 2014. Jul 9;371(4):326-38.
9.	Pettey AA, Balkrishnan R, Rapp et al. Patients with palmoplantar psoriasis have more physical disability and discomfort than patients with other forms of psoriasis: implications for clinical practice. J Am Acad Dermatol. 2003;49(2) :271-275.
10.	Au SC, Goldminz AM, Kim N, et al. Investigator-initiated, open-label trial of ustekinumab for the treatment of moderate-to-severe palmoplantar psoriasis. J Dermatolog Treat. 2013;24:179-187.
11.	Bissonnette R, Poulin Y, Guenther L, et al. Treatment of palmoplantar psoriasis with infliximab: a randomized, double-blind placebo-controlled study. J Eur Acad Dermatol Venereol. 2011;25:1402-1408.
12.	Leonardi C, Langley RG, Papp K, et al. Adalimumab for treatment of moderate to severe chronic plaque psoriasis of the hands and feet: efficacy and safety results from REACH, a randomized, placebo-controlled, double-blind trial. Arch Dermatol. 2011;147:429-436.
13.	Rich P, Griffiths CE, Reich K, et al. Baseline nail disease in patients with moderate to severe psoriasis and response to treatment with infliximab during 1 year. J Am Acad Dermatol. 2008;58:224-231.
14.	Gaffen SL. Structure and signaling in the IL-17 receptor family. Nat Rev Immunol. 2009;9(8):556-67.
15.	Ivanov S, Linden A. Interleukin-17 as a drug target in human disease. Trends Pharmacol Sci. 2009;30(2):95-103.
16.	Onishi RM, Gaffen SL. Interleukin-17 and its target genes: mechanisms of interleukin-17 function in disease. Immunology. 2010;129(3):311-21.
17.	Nestle FO, Kaplan DH, Barker J. Psoriasis. New Engl J Med. 2009; 361: 496-509
18.	Rapp SR, Feldman SR, Exum ML, Fleischer AB, Jr., Reboussin DM. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol. 1999; 41(3 Pt 1):401-7.
19.	Farley E et al. Psoriasis: comorbidities and associations. G Ital Dermatol Venereol. 2011 Feb;146(1):9-15.
20.	National Psoriasis Foundation website. "Health conditions associated with psoriasis". Accessed February 16, 2015
21.	Raval K, Lofland JH, Waters HC, Tak Piech C. Disease and treatment burden of psoriasis: Examining the impact of biologics. J Drugs Dermatol 2011; 10(2):189-96
22.	Wilson FC, Icen M, Crowson CS et al. Incidence and clinical predictors of psoriatic arthritis in patients with psoriasis: a population-based study. Arthritis Rheum. 2009 15;61(2):233-9.
23.	Petrella RJ, Gregory V, Luciani L, Barbeau M . Characteristics of chronic plaque psoriasis in Canada: a retrospective database study. (PSS7) Poster presented at ISPOR 19th Annual International Meeting, Montréal, QC, Canada, May 2014.

SOURCE Novartis Pharmaceuticals Canada Inc.

Novartis Media Relations: Elizabeth Tanguay, Manager, External Communications, Novartis Pharmaceuticals Canada Inc., [phone], [email protected]; Rob McEwan, Vice President, Argyle Communications, + 1 416 968-7311 ext. 242, [email protected]