New Novartis two-year data for investigational secukinumab revealed no progression in joint damage in 84% of psoriatic arthritis patients

• New x-ray assessment data showed no further progression of joint structural damage in the majority of patients with psoriatic arthritis over two years¹
• Investigational secukinumab is the first interleukin-17A inhibitor to have demonstrated efficacy in Phase III studies of patients with psoriatic arthritis while maintaining a safety profile consistent with that observed in previous studies^1,2,3
• Psoriatic arthritis is estimated to affect as many as 30% of people with psoriasis⁴ and as many as one in four people with psoriasis may have undiagnosed psoriatic arthritis⁵

DORVAL, QC, Nov. 10, 2015 /CNW/ - Novartis presented new data for investigational secukinumab demonstrating no further progression in joint damage in 84% of patients with psoriatic arthritis (PsA). In addition, investigational secukinumab maintained a treatment response in joint and skin disease, physical function and quality of life in patients over two years of treatment while maintaining a safety profile consistent with that observed in previous studies¹. These results from the FUTURE 1 study represented the longest investigational secukinumab Phase III study in PsA to date. The study results were presented at the 2015 Annual Meeting of the American College of Rheumatology (ACR) in San Francisco, United States.

"Psoriatic arthritis is a chronic debilitating disease affecting the skin and the joints, for which there is currently no cure. If not diagnosed quickly and treated effectively, it can lead to irreversible joint damage and important disability caused by years of inflammation^2-3,7," said Dr. Proton Rahman, a rheumatologist and FUTURE 1 Study investigator. "Canadian patients living with psoriatic arthritis are in need of treatment options that can prevent the progression in joint damage to maintain quality of life over several years. The FUTURE 1 study results represent good news as they address an unmet medical need in dealing with this painful disease."

About the FUTURE 1 study
FUTURE 1 is a two year, multi-center, randomized, placebo-controlled Phase III pivotal study to evaluate the efficacy of investigational secukinumab in patients with active PsA. FUTURE 1 enrolled 606 patients with active PsA and assessed investigational secukinumab with intravenous loading (10 mg/kg) and subcutaneous (75 mg or 150 mg) maintenance dosing¹. The primary endpoint assessed superiority of investigational secukinumab against placebo in the proportion of patients achieving the ACR 20 response at Week 24. From Week 16, patients in the placebo arm of the study were re-randomized to receive investigational secukinumab 150 mg or 75 mg at either Week 16 or Week 24, based on clinical response^1-2. 67%[*] of patients (n=202) treated with investigational secukinumab 150 mg achieved the standard treatment goal of an ACR 20 response (American College of Rheumatology response criteria)¹.

About psoriatic arthritis  
Psoriatic arthritis (PsA) is part of a family of life-long inflammatory diseases that also include ankylosing spondylitis (AS). It is also closely associated with psoriasis. Approximately 30% of patients with psoriasis have PsA⁴ and as many as one in four people with psoriasis may have undiagnosed PsA⁵. It is a debilitating, chronic disease linked with significant disability, poor quality of life and reduced life expectancy⁶. Symptoms of PsA include joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful swelling of the tendons (tendonitis), and irreversible joint damage⁷. Up to 40% of people can suffer from joint destruction and permanent physical deformity⁸.

About investigational secukinumab (AIN457) and interleukin-17A
Investigational secukinumab (AIN457) is a human monoclonal antibody that selectively neutralizes circulating interleukin-17A (IL-17A)⁹. Investigational secukinumab is the first IL-17A inhibitor with positive Phase III results for the treatment of PsA and AS^2,3,10,11. Research suggests that IL-17A may play an important role in driving the body's immune response in disorders such as psoriasis, PsA and AS¹².

In March 2015, investigational secukinumab was approved by Health Canada as an IL-17A inhibitor for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (light therapy).

PsA and AS indications are still under investigation and market authorization has not yet been obtained in Canada.

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 2014, the company invested $76 million in research and development in Canada. 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 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 www.novartis.com.

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References

1.	Mease P, McInnes IB, Kirkham B, et al. Secukinumab provides sustained improvements in psoriatic arthritis: 2-year efficacy and safety results from a phase 3 randomized, double-blind, placebo-controlled trial. Presented at the 2015 ACR/ARHP Annual Meeting, San Francisco, USA, 10 November. Oral presentation number 2148.
2.	Mease, PJ, McInnes, IB, Kirkham, B, et. al. Secukinumab inhibition of interleukin-17A in patients with psoriatic arthritis. N Engl J Med. 2015; 373(14):1329–39.
3.	Mease, PJ, McInnes, IB, Kirkham, B, 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, No. 9999; p1137–1146.
4.	Zachariae H. Prevalence of joint disease in patients with psoriasis: implications for therapy. Am J Clin Dermatol. 2003; 4:441–7.
5.	National Psoriasis Foundation. Press release: Nearly one in four people with psoriasis may have undiagnosed psoriatic arthritis according to a recent study from the National Psoriasis Foundation. Last accessed October 2015 at https://www.psoriasis.org/page.aspx?pid=2197.
6.	Gladman DD, Antoni C, Mease P, et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005; 64:ii14-ii17.
7.	Mease PJ, Armstrong AW. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs. 2014; 74:423–441.
8.	Anwar AH, Diamond H. Psoriatic arthritis: practice essentials, background, pathophysiology and etiology. Medscape reference website: http://emedicine.medscape.com/article/2196539-overview#a6. Last accessed October 2015.
9.	Kirkham BW, Kavanaugh A, Reich K. Interleukin-17A: a unique pathway in immune-mediated diseases: psoriasis, psoriatic arthritis and rheumatoid arthritis. Immunology.2014; 141:133–42.
10.	Sieper J, Braun J, Baraliakos X, et al. Secukinumab, a monoclonal antibody to interleukin-17A, significantly improves signs and symptoms of active ankylosing spondylitis: results of a phase 3, randomized, placebo-controlled trial with subcutaneous loading and maintenance dosing. ACR/ARHP Annual Meeting, Boston, MA, USA, 2014. Poster presentation number 536.
11.	Sieper et al. Secukinumab significantly improves signs and symptoms of active ankylosing spondylitis: 52-Week Data from MEASURE 2. A randomized, double-blind, placebo-controlled phase 3 trial with subcutaneous loading and maintenance dosing. 2015 EULAR Annual Meeting, Rome, Italy. Presentation number 168.
12.	Van Baarsen LGM, Lebre MC, van der Coelen D, et al. IL-17 levels in synovium of patients with rheumatoid arthritis, psoriatic arthritis and osteoarthritis: Target validation in various forms of arthritis. Ann Rheum Dis. 2011;70:A79.

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* Imputed data

SOURCE Novartis Pharmaceuticals Canada Inc.

Image with caption: "Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS) (CNW Group/Novartis Pharmaceuticals Canada Inc.)". Image available at: http://photos.newswire.ca/images/download/20151110_C6083_PHOTO_EN_541039.jpg

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