Novartis announces new one-year results demonstrating sustained secukinumab efficacy in ankylosing spondylitis patients

Jun 10, 2015
  • 74% of patients in MEASURE 2 achieved clinically significant and sustained improvement in symptoms of ankylosing spondylitis (AS) with secukinumab 150 mg after one year of treatment[1] 
  • AS is a long-term, painful and debilitating disease that causes irreversible spinal damage 
  • There are few treatments available for AS and 40% of patients have poor or no response to standard of care anti-TNFs[2]

The digital press release with multimedia content can be accessed here:


Basel, June 10, 2015 - Novartis announced today new one-year study results from the MEASURE 2 pivotal Phase III study of 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 AS.[1] Detailed study results will be presented at the European League Against Rheumatism Annual Congress (EULAR 2015), in Rome, Italy.

Ankylosing spondylitis 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.[3],[4] It is a painful and progressively debilitating condition that can have serious consequences, including irreversible spinal damage that reduces patients' mobility and quality of life.[3]

In MEASURE 2, patients treated with 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 is a long-term, painful and debilitating condition with a critical need for new efficacious treatments that provide symptom relief over prolonged periods of time," said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. "We are pleased to present important data from MEASURE 2 showing that secukinumab's efficacy in treating this serious inflammatory disease is sustained through one year."

There are few therapeutic options available to people with AS and there is a significant unmet need for alternative treatment options.[2] Up to 40% of patients have an inadequate or no response to the current standard of care, anti-tumor-necrosis-factor (anti-TNF) medicines.[2] Importantly, MEASURE 2 showed 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] Secukinumab is the first biologic therapy other than anti-TNFs to demonstrate efficacy in AS Phase III studies and the first biologic to demonstrate efficacy in patients with inadequate response or intolerance to anti-TNFs.[1]

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 patients.[1] 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 secukinumab versus placebo in subjects with active AS.[1] A total of 219 patients were randomized to receive subcutaneous secukinumab (150 or 75 mg) or placebo at baseline, Week 1, 2 and 3 and every 4 Weeks starting at Week 4.[1] This differed from the MEASURE 1 study, in which patients received an intravenous loading dose of secukinumab followed by monthly subcutaneous doses. At Week 16, subjects in the placebo group were re-randomized to secukinumab 150 mg or 75 mg every 4 weeks.  In total, 181 (82.6%) of patients completed one year of treatment.[1]

The trial met its primary endpoint of ASAS20 response at Week 16, which was significantly higher with 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] 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.  Secukinumab 75 mg did not meet any of 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).[5] AS is a painful, progressively debilitating condition caused by inflammation of the spine.[5] AS occurs in up to 1% of the general population and typically affects young men and women aged 25 or older.[6],[7] Certain genetic factors increase a person's risk of developing AS by more than 50%.[8] Up to 70% of patients with severe AS can develop spinal fusion (bones grow together), significantly reducing mobility and quality of life.[4],[5],[9] Patients with AS can become progressively disabled and unable to work, which may add to their reduced quality of life.[5],[9]

About secukinumab and interleukin-17A (IL-17A)
Secukinumab is a human monoclonal antibody that selectively neutralizes circulating IL-17A.[10] Secukinumab is the first IL-17A inhibitor with positive Phase III results for the treatment of PsA and ankylosing spondylitis (AS). Research shows that IL-17A plays an important role in driving the body's immune response in psoriasis and spondyloarthritis conditions, including PsA and AS.[11]

In January 2015, Cosentyx (secukinumab) (at a dose of 300 mg) became the first and only IL-17A inhibitor approved in Europe as a first-line systemic treatment of moderate-to-severe plaque psoriasis in adult patients, and in the US as a treatment for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (light therapy). In addition to the EU and the US, Cosentyx has been approved in Switzerland, Chile, Australia, Canada and Singapore for the treatment of moderate-to-severe plaque psoriasis and in Japan for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis (PsA).

Global regulatory submissions for PsA and AS are planned for the first half of 2015.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as "will," "leads to," "can," "planned," or similar terms, or by express or implied discussions regarding potential new indications or labeling for secukinumab, or regarding potential future revenues from secukinumab. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that secukinumab will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that secukinumab will be commercially successful in the future. In particular, management's expectations regarding secukinumab could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

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.

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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] Dougados M, Baeten D. Spondyloarthritis. Lancet. 2011; 377:2127-37.
[3] Sieper J, Braun J, Rudwaleit M, et al. Ankylosing spondylitis: an overview. Ann Rheum Dis. 2002;61(Suppl III):iii8-iii18.
[4] Lories R. The balance of tissue repair and remodeling in chronic arthritis. Nat Rev Rheumatol. 2011;7:700-07.
[5] American College of Rheumatology (ACR) website. "Spondylarthritis (Spondylarthropathy).
"http://www.rheumatology.org/Practice/Clinical/Patients/Diseases_And_Conditions/Spondylarthritis_(Spondylarthropathy)/. Accessed December 2013.
[6] 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.
[7] 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.
[8] Brown MA. Progress in studies of the genetics of ankylosing spondylitis. Arthritis Res Ther. 2009;11:254.
[9] 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.
[10] 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.
[11] 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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