Novartis announced one-year results demonstrating sustained efficacy with investigational secukinumab in ankylosing spondylitis patients at EULAR

• 74% of patients in MEASURE 2 achieved clinically significant and sustained improvement in symptoms of ankylosing spondylitis (AS) with investigational secukinumab 150 mg after one year of treatment¹
• AS is a long-term inflammatory disease that leads to excessive formation of new bone, particularly in a patient's vertebrae and joints, which can fuse together.^2,3
• AS affects between 150,000 and 300,000 Canadians and usually appears between the ages of 15 and 30. ⁴

DORVAL, QC, June 10, 2015 /CNW/ - Novartis announced one-year study results from the MEASURE 2 pivotal Phase III study of investigational secukinumab in ankylosing spondylitis (AS). Data from the study demonstrated that approximately 74% of patients achieved clinically significant improvement in their symptoms after one year of treatment, as measured by ASAS20, a standard tool used to assess clinical improvement in AS¹. Detailed study results were presented at the European League Against Rheumatism 2015 Annual Scientific Meeting (EULAR), in Rome, Italy. The safety and efficacy of investigational secukinumab are still under review for AS and market authorization has not been obtained.

In MEASURE 2, patients treated with investigational secukinumab 150 mg achieved significantly higher ASAS20 versus placebo at Week 16 (61.1% vs 28.4%; p<0.001). New data at one year show that improvements in the signs and symptoms of AS were sustained through 52 weeks of treatment, confirming data from the MEASURE 1 study. In MEASURE 2, 73.8% of patients achieved ASAS20 response at one year along with associated improvements in physical function and health-related quality of life.¹

"Ankylosing spondylitis (AS) is a painful and debilitating condition and there are few therapeutic options available to people with AS" said Dr. Michel Zummer, M.D., Chief of Rheumatology at Maisonneuve-Rosemount Hospital and Associate Professor at Université de Montréal. "It's encouraging to see the MEASURE 2 data showing secukinumab's efficacy in treating a serious inflammatory disease over a one year period," Dr. Zummer adds. "Twenty to forty percent of patients have inadequate long-term response to the current standard of care, which includes non-steroidal anti-inflammatory medications and anti-tumor-necrosis-factor (anti-TNF) medicines."

Importantly, MEASURE 2 showed investigational secukinumab clinical benefits were observed in patients without previous treatment with anti-TNFs and those with inadequate response or intolerance to anti-TNF therapy.¹

Investigational secukinumab was well tolerated in MEASURE 2, with a safety profile consistent with that observed in the psoriasis clinical trial program involving nearly 4,000 patients¹. The most common adverse events (AEs) were upper respiratory tract infection and headache.¹

About MEASURE 2
MEASURE 2 is a randomized, double-blind, Phase III study evaluating the efficacy and safety of investigational secukinumab versus placebo in subjects with active AS.¹ A total of 219 patients were randomized to receive subcutaneous investigational secukinumab (150 or 75 mg) or placebo at baseline, Week 1, 2 and 3 and every 4 Weeks starting at Week 4.¹

The trial met its primary endpoint of ASAS20 response at Week 16, which was significantly higher with investigational secukinumab 150 mg versus placebo (61.1% vs 28.4%; p<0.001), with improvements observed by Week 1, and sustained through one year of treatment (ASAS20=73.8%).¹ Investigational secukinumab 150 mg also significantly improved ASAS40, hsCRP, ASAS 5/6, BASDAI, SF-36 PCS and ASQoL compared with placebo at Week 16, with improvements sustained through 1 year. Investigational secukinumab 75 mg did not meet the pre-defined primary or secondary endpoints.¹

About ankylosing spondylitis (AS)                                                   
Ankylosing spondylitis (AS) is a common type of spondyloarthritis (SpA), a family of long-term diseases of joints (inflammatory disease), which also includes psoriatic arthritis (PsA).⁶ AS is a painful, progressively debilitating condition caused by inflammation of the spine and can have serious consequences, including irreversible spinal damage. Patients with AS can become progressively disabled and unable to work, which may add to their reduced quality of life.^2,6,7 Up to 70% of patients with severe AS can develop spinal fusion (bones grow together), significantly reducing mobility and quality of life.^3,6,7 AS occurs in up to 1% of the general population and typically affects young men and women aged 25 or older.^8,9 Certain genetic factors increase a person's risk of developing AS by more than 50%.¹⁰

About secukinumab
In March 2015, 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).

SpA 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 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.

References

1. 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. EULAR Annual Meeting, Rome Italy, 2015. Oral presentation (presentation number 168)
2. Sieper J, Braun J, Rudwaleit M, et al. Ankylosing spondylitis: an overview. Ann Rheum Dis. 2002;61(Suppl III):iii8-iii18.
3. Lories R. The balance of tissue repair and remodeling in chronic arthritis. Nat Rev Rheumatol. 2011;7:700-07.
4. The Arthritis Society website. "Ankylosing Spondylitis." http://www.arthritis.ca/page.aspx?pid=915. Accessed June 4, 2015.
5. Dougados M, Baeten D. Spondyloarthritis. Lancet. 2011; 377:2127-37.
6. American College of Rheumatology (ACR) website. "Spondylarthritis (Spondylarthropathy)."http://www.rheumatology.org/Practice/Clinical/Patients/Diseases_And_Conditions/Spondylarthritis_(Spondylarthropathy)/. Accessed December 2013.
7. Barkham N, Kong KO, & Tennant A. The unmet need for anti-tumour necrosis factor (anti-TNF) therapy in ankylosing spondylitis. Rheumatology. 2005;44:1277-81.
8. Braun J, Bollow M, Remlinger G, et al. Prevalence of spondylarthropathies in HLA-B27 positive and negative blood donors. Arthritis Rheum. 1998;41(1):58-67.
9. Feldtkeller E, Khan M, Van Der Heijde D, et al. Age at disease onset and diagnosis delay in HLA-B27 negative vs. Positive patients with ankylosing spondylitis.Rheumatology International. 2003;23(2):61-66.
10. Brown MA. Progress in studies of the genetics of ankylosing spondylitis. Arthritis Res Ther. 2009;11:254.
11. 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.
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.
13. Johansen C, Usher PA, Kjellerup RB, et al. Characterization of the interleukin-17 isoforms and receptors in lesional psoriatic skin. Brit J Dermatol. 2009; 160: 319-24.

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/20150610_C4481_PHOTO_EN_17842.jpg

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]