Novartis announced that two pivotal phase III studies (FUTURE 1 and FUTURE 2) of AIN457 (secukinumab) in psoriatic arthritis (PsA) met primary and key secondary endpoints. Endpoints included improving signs and symptoms of psoriatic arthritis (PsA), including improving peripheral joint disease and preventing joint damage versus placebo, while delivering clear or almost clear skin (PASI 90).
Secukinumab is an investigational medicine that works by stopping the action of interleukin-17A (IL-17A), a protein that is central to the development of inflammatory diseases. FUTURE 1 and FUTURE 2 enrolled a combined total of more than 1,000 patients. Detailed results of the studies will be presented at an upcoming medical congress.
PsA is a long-lasting, complex condition involving joint inflammation (arthritis), and usually occurs in combination with psoriasis. There are many different features of PsA that affect the skin, joints and tendons, resulting in irreversible joint damage in many patients. It is linked with significant disability, poor quality of life, reduced life expectancy and major economic burden for the society. Although TNF (tumour-necrosis-factor) inhibitors, the current standard of care for PsA, can improve clinical symptoms, responses may diminish over time. Furthermore, many patients with PsA do not respond to or tolerate these agents, leaving an unmet need.
"Building on the positive data previously reported in psoriasis, we are excited to present the first phase III results of secukinumab in PsA. These positive results are planned to form the basis of a filing application to regulatory authorities in this indication," said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. "Effective new therapies are urgently needed for newly PsA diagnosed patients and for nearly half of PsA patients who are dissatisfied with or not responding to their current treatments."
Global regulatory applications for secukinumab in PsA are planned for 2015. This follows the secukinumab global regulatory applications for moderate-to-severe plaque psoriasis which were filed in October 2013 with approvals anticipated in late 2014 or early 2015.
FUTURE 1 and FUTURE 2 are randomized, placebo-controlled, multicenter studies designed to demonstrate efficacy of secukinumab in PsA compared to placebo and to assess safety and tolerability. The American College of Rheumatology response criteria (ACR20) was the primary endpoint in the studies. Secukinumab was well tolerated in both studies. The observed safety profile was consistent with previously reported results from the large psoriasis clinical trial program involving nearly 4,000 patients.
Psoriatic arthritis (PsA) is closely associated with psoriasis; approximately 30 per cent of patients with psoriasis have psoriatic arthritis. It is a debilitating, long-lasting inflammatory disease linked with significant disability, poor quality of life and reduced life expectancy. PsA causes joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful tendonitis, and irreversible joint damage. Between 0.3 per cent and 1 per cent of the general population may be affected by PsA and as many as one in four people with psoriasis may have undiagnosed PsA.
AIN457 (secukinumab) is a fully human monoclonal antibody that selectively stops the action of IL-17A. Secukinumab is the first medicine selectively targeting IL-17A with positive phase III results for the treatment of PsA. IL-17A, a protein that stimulates inflammatory disease, is central to the development of psoriasis and other inflammatory arthritic diseases, including PsA.
In addition to PsA, secukinumab is also in clinical trials for the treatment of ankylosing spondylitis (AS) and rheumatoid arthritis (RA). Following the presentation of the first moderate-to-severe plaque psoriasis phase III results of secukinumab in October 2013, EU and US regulatory filings.