New two-year data for Novartis' investigational secukinumab showed sustained response and no spinal radiographic progression in up to 80% of AS patients

• An extended study showed up to 80% of ankylosing spondylitis (AS) patients treated with investigational secukinumab had no radiographic progression in the spine over two years¹
  
• Investigational secukinumab is the first interleukin-17A inhibitor to demonstrate efficacy in Phase III studies in AS patients with a safety profile consistent with that observed in previous studies across multiple conditions^2,3,4 
  
• AS is a life-long and painful inflammatory disease that can cause irreversible joint and/or spinal damage for patients if not treated effectively⁵
  
• AS affects between 150,000 and 300,000 Canadians and usually appears between the ages of 15 and 30⁶

DORVAL, QC, Nov. 10, 2015 /CNW/ - Novartis shared late-breaking two-year results for investigational secukinumab showing up to 80% of patients with ankylosing spondylitis (AS) had no radiographic progression in the spine on x-ray assessment¹. This is the first time that data on structural spinal progression in AS have been presented for an interleukin-17A (IL-17A) inhibitor.

In addition, investigational secukinumab showed a sustained response in improvements of signs and symptoms, physical function and quality of life in AS patients over two years with a safety profile consistent with that observed in previous studies across multiple indications². These results from an extension phase of the MEASURE 1 pivotal study were revealed at the 2015 Annual Meeting of the American College of Rheumatology (ACR) in San Francisco, United States.

"As a rheumatologist, I often see the substantial impact of ankylosing spondylitis on many of my patients, said Dr. Proton Rahman, a rheumatologist and MEASURE 1 Study investigator.  "The results from MEASURE 1 are important because up to 70% of patients with severe AS will develop spinal fusion over 10 to 15 years, which significantly reduces mobility⁹. Canadians living with this chronic and painful condition are looking for treatment options to help sufficiently manage their disease and stop its progression in the hope of a better quality of life."

About the MEASURE 1 study
These results are from the MEASURE 1 study and represent the longest investigational secukinumab AS Phase III study presented to date. MEASURE 1 is a two year, multi-center, randomized, placebo-controlled Phase III study assessing the efficacy and safety of investigational secukinumab in patients with active AS. The study has now entered a three-year extension period. 371 patients were enrolled and administered a investigational secukinumab intravenous loading dose of 10 mg/kg every two weeks for the first four weeks of treatment, followed by monthly subcutaneous maintenance dosing (75 mg and 150 mg)¹. Primary endpoints assessed superiority of investigational secukinumab against placebo at Week 16 in the proportion of patients achieving at least a 20% improvement in the ASAS 20 response criteria. From Week 16, patients in the placebo arm of the study were re-randomized to investigational secukinumab 75 mg or 150 mg based on ASAS 20 response, with non-responders switched at Week 16, and responders at Week 24². In total, 103/124 and 97/125 patients randomized to investigational secukinumab 75 mg and 150 mg respectively completed 104 weeks. Observed analyses included in the extension phase at 104 weeks included only data available at a given time point. Patients with missing data at that time point were not included.

Data from 125 patients presented for investigational secukinumab 150 mg showed that 74%^* achieved an ASAS 20 response (Assessment of Spondyloarthritis International Society response criteria) at two years^†. The study enrolled patients who had either never taken, or who had previously been treated with, the current standard of care biologic, anti-TNF therapy². Quality of life and physical function scores were also maintained over two years. Investigational secukinumab was well tolerated over the two-year treatment period with a safety profile consistent with that observed in previous studies across multiple indications².

About ankylosing spondylitis
Ankylosing spondylitis (AS) is part of a family of life-long inflammatory diseases that also include psoriatic arthritis (PsA).⁷ 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.^7,8,9 Up to 70% of patients with severe AS can develop spinal fusion (bones grow together), significantly reducing mobility and quality of life.^7,9,10 AS occurs in up to 1% of the general population and typically affects young men and women aged 25 or older.^11,12 Certain genetic factors increase a person's risk of developing AS by more than 50%.¹³

About investigational secukinumab (AIN457) and interleukin-17A
Investigational secukinumab (AIN457) is a human monoclonal antibody that selectively neutralizes circulating interleukin-17A (IL-17A)¹⁴. Investigational secukinumab is the first IL-17A inhibitor with positive Phase III results for the treatment of PsA and AS^3,4,15,16. Research suggests that IL-17A may play an important role in driving the body's immune response in disorders such as psoriasis, PsA and AS¹⁷.

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.

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

*	Imputed data
†	ASAS 20 is improvement of ≥20% and ≥1 unit on a 10-unit scale in at least three of the four core ASAS domains, with no worsening of ≥20% and ≥1 unit in the fourth at 104 weeks.

References

1.	Baraliakos X, Deodhar A, Braun J et al. Effect of interleukin-17A inhibition on spinal radiographic changes through 2 years in patients with active ankylosing spondylitis: results of a phase 3 study with secukinumab. Late breaking abstract presented at the 2015 ACR/ARHP Annual Meeting, San Francisco, USA, November 10. Oral presentation number 6L.
2.	Baeten D, Braun J, Sieper J et al. Secukinumab provides sustained improvements in the signs and symptoms of active ankylosing spondylitis: 2-year efficacy and safety results from a phase 3, randomized, double-blind, placebo-controlled trial. Oral poster presented at the 2015 ACR/ARHP Annual Meeting, San Francisco, USA, November Poster presentation number 2896.
3.	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. 2014 ACR/ARHP Annual Meeting, Boston, MA, USA. Poster presentation number 536.
4.	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. Oral presentation number 168.
5.	Schett et al. Structural damage in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: traditional views, novel insights gained from TNF blockade, and concepts for the future. Arthritis Res Ther. 2011;13:S4.
6.	The Arthritis Society website. "Ankylosing Spondylitis." http://www.arthritis.ca/page.aspx?pid=915. Accessed November 5, 2015.
7.	American College of Rheumatology (ACR) website. "Spondylarthritis (Spondylarthropathy)." http://www.rheumatology.org/Practice/Clinical/Patients/Diseases_And_Conditions/Spondylarthritis_(Spondylarthropathy)/. Accessed December 2013.
8.	Sieper J, Braun J, Rudwaleit M, et al. Ankylosing spondylitis: an overview. Ann Rheum Dis. 2002;61(Suppl III):iii8-iii18.3.
9.	Barkham N, Kong K O, Tennant A, et al. The unmet need for anti-tumour necrosis factor (anti-TNF) therapy in ankylosing spondylitis. Rheumatology. 2005;44:1277–1281.
10.	Lories R. The balance of tissue repair and remodeling in chronic arthritis. Nat Rev Rheumatol. 2011;7:700-07.
11.	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.
12.	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.
13.	Brown MA. Progress in studies of the genetics of ankylosing spondylitis. Arthritis Res Ther. 2009;11:254
14.	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.
15.	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.
16.	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.
17.	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.

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_C7653_PHOTO_EN_541046.jpg

For further information: 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]