New Novartis data presented at AAD reveals Cosentyx® is superior to Stelara® in delivering long-lasting skin clearance (PASI 90) for psoriasis patients at 52 weeks(1)

• Cosentyx^® delivered and sustained skin clearance (PASI 90) in nearly 8 out of 10 moderate-to-severe psoriasis patients after 52 weeks of treatment¹

DORVAL, QC, March 7, 2016 /CNW/ - Novartis presented new data from the head-to-head CLEAR study demonstrating that Cosentyx^® (secukinumab) remains superior to Stelara^® (ustekinumab) in achieving sustained skin clearance (PASI 90 response) at 52 weeks for adults living with moderate-to-severe psoriasis. These findings were presented for the first time at the American Academy of Dermatology (AAD) Annual Meeting in Washington, DC¹.

Cosentyx^® is the first fully human interleukin-17A inhibitor approved for adults to treat moderate-to-severe plaque psoriasis, and was recently approved for the treatment of psoriatic arthritis and ankylosing spondylitis in the EU and US.

Commenting on the significance of the study results, Dr. Ron Vender, MD FRCPC, Director of Dermatrials Research Inc. and Venderm Innovation in Psoriasis and investigator for the CLEAR study, said, "This is an important milestone in the treatment of psoriasis, a skin disease with significant physical and emotional impact on a patient's life. I am encouraged by the data from the CLEAR study as it validates Cosentyx^® as an effective treatment option for Canadians managing moderate-to-severe psoriasis whose treatment goals include long-lasting skin clearance."

The ultimate aim of psoriasis treatment is clear skin, and the Psoriasis Area Severity Index (PASI) 90 response is considered an important measure of treatment success^2,3. Meeting all primary and secondary endpoints at Weeks Four, 16 and 52, Cosentyx^® demonstrated it remains superior to Stelara^® in achieving and sustaining PASI 90 response (76.2% vs. 60.6%; P<0.0001), and significantly better in achieving PASI 100 (clear skin) response (45.9% vs. 35.8%; P=0.0103) at 52 weeks. Cosentyx^® also showed significantly greater and sustained Dermatology Life Quality Index (DLQI) 0/1 responses versus Stelara^® (71.6% vs. 59.2%; P=0.0008)¹.

The study also demonstrated Cosentyx^® had a superior rapid onset of action compared to Stelara^®, with half of Cosentyx^® patients achieving PASI 75 as early as Week Four (50.0% vs. 20.6%, P<0.0001)⁴. Cosentyx^® had a similar safety profile to that of Stelara^® in the study, which was consistent with that reported in the pivotal Cosentyx^® Phase III studies¹.

About psoriasis
Affecting as many as one million Canadians and more than 125 million people worldwide⁵, psoriasis is a chronic autoimmune disease characterized by thick and extensive skin lesions, called plaques, known to cause itching, scaling and pain.⁶ People living with psoriasis reported that these symptoms can negatively impact their quality of life, both psychosocially and physically, which makes daily functioning difficult.^5-7 Despite this, up to half of patients receive no treatment, and of those who do, many (52%) remain dissatisfied with their disease management.⁸

Additionally, people with psoriasis are at increased risk for other chronic illnesses.^9-10 such as psoriatic arthritis, a type of inflammatory arthritis, which about 30% of people who have psoriasis get.¹¹ Psoriasis symptoms can begin at any age, including in childhood, but the disease mainly affects adults.¹² Symptoms start when a combination of environmental triggers and genetic factors disrupt the lifecycle of skin cells.¹²

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 severe.¹³

About the CLEAR study
CLEAR (Comparison to assess Long-term Efficacy, sAfety and toleRability of secukinumab vs. ustekinumab) is a multi-center, double-blind, parallel-group study of Cosentyx^® (n=334) versus Stelara^® (n=335) to compare efficacy, safety and tolerability in adults with moderate-to-severe plaque psoriasis. Patients were randomized to receive either Cosentyx^® (300 mg) by subcutaneous injection at Baseline, Weeks One, Two and Three, then every four weeks from Week Four, or Stelara^® (dosing per package label). Cosentyx^® achieved the primary objective of superior PASI 90 response at Week 16. These data were published as an e-publication in the Journal of the American Academy of Dermatology, June 17, 2015⁴. The 52-week PASI 90 response is a secondary objective in this study. PASI 100 and DLQI responses at 52 weeks are exploratory endpoints. 

About Cosentyx^® and interleukin-17A (IL-17A)
Cosentyx^® is a fully human monoclonal antibody that selectively neutralizes circulating
IL-17A. Research suggests that IL-17A may play an important role in driving the body's immune response in psoriasis, psoriatic arthritis and ankylosing spondylitis^14,15.  

Cosentyx^® is approved in over 50 countries for the treatment of moderate-to-severe plaque psoriasis which includes the European Union countries, Japan, Switzerland, Australia, the US and Canada. In Europe, Cosentyx^® is the only biologic approved for the first-line systemic treatment of moderate-to-severe plaque psoriasis in adult patients. It is approved by Health Canada for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.¹⁶

In addition, Cosentyx^® is the first IL-17A inhibitor with positive Phase III results for the treatment of active psoriatic arthritis and active ankylosing spondylitis^17-21 and is now approved in Europe, the US, Ecuador, Bangladesh and the Philippines for these conditions. Cosentyx^® is also approved for the treatment of psoriatic arthritis and pustular psoriasis in Japan.

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. Novartis Pharmaceuticals Canada Inc. employs approximately 700 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 2015, the Group achieved net sales of USD 49.4 billion, while R&D throughout the Group amounted to approximately USD 8.9 billion (USD 8.7 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 119,000 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.

References

1. Blauvelt A et al. Secukinumab demonstrates superior sustained efficacy vs. ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: 52-week results from the CLEAR study. Abstract presented at the 74th Annual Meeting of the American Academy of Dermatology. 2016 March 4-8; Washington DC.
2. Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis. European Medicines Agency website. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003329.pdf Accessed September 2015. Accessed February 2016.
3. Ryan C et al. Research gaps in psoriasis: opportunities for future studies. J Am Acad Dermatol. 2014; 70:146-167.
4. Thaçi D, Blauvelt A, Reich K, et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial. J Am Acad Dermatol. June 17, 2015  [E-pub ahead of print].
5. Canadian Dermatology Association "Living with Psoriasis". http://www.dermatology.ca/skin-hair-nails/skin/psoriasis/living-with-psoriasis/ (Accessed October 23rd 2015).
6. National Psoriasis Foundation. Facts about psoriasis. Accessed February 16 2015.
7. 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.
8. Armstrong AW et al. Undertreatment, treatment trends, and treatment dissatisfaction among patients with psoriasis and psoriatic arthritis in the United States: findings from the National Psoriasis Foundation surveys, 2003-2011. JAMA Dermatol. 2013; 149(10):1180-1185.
9. Farley E et al. Psoriasis: comorbidities and associations. G Ital Dermatol Venereol. 2011 Feb;146 (1):9-15.
10. National Psoriasis Foundation website. "Health conditions associated with psoriasis". Accessed February 16, 2015
11. 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.
12. Nestle FO, Kaplan DH, Barker J. Psoriasis. New Engl J Med. 2009; 361: 496-509
13. 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.
14. Kirkham BW et al. Interleukin-17A: a unique pathway in immune-mediated diseases: psoriasis, psoriatic arthritis and rheumatoid arthritis. Immunology. 2014; 141:133-142.
15. Ivanov S, Linden A. Interleukin-17 as a drug target in human disease. Trends Pharmacol Sci. 2009; 30(2):95-103.
16. CosentyxTM Product Monograph, Novartis Pharmaceuticals Canada Inc., February 27, 2015.
17. Baeten D et al. Secukinumab, interleukin-17A inhibition in ankylosing spondylitis. N Engl J Med. 2015; 373:2534-48.
18. Mease, PJ 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. The Lancet. 2015; 386(9999):1137-1146.
19. Mease PJ et al. Secukinumab inhibition of interleukin-17A in patients with psoriatic arthritis. N Engl J Med. 2015; 373(14):1329-39.
20. Cosentyx (secukinumab) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp, 2016.
21. 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. Accessed February 2016.

SOURCE Novartis Pharmaceuticals Canada Inc.

For further information: Novartis Media Relations: Katrina Lucking, Novartis Pharmaceuticals Canada Inc., [phone], [email protected]; Rob McEwan, Argyle Public Relationships, + 1 416 968-7311 ext. 242, [email protected]