Novartis AIN457 (secukinumab) is the first ever IL-17A inhibitor to meet primary endpoint in two Phase III studies in psoriatic arthritis - Seite 2

"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[17].

About psoriatic arthritis (PsA)
Psoriatic arthritis (PsA) is closely associated with psoriasis; approximately 30% of patients with psoriasis have psoriatic arthritis[2]. It is a debilitating, long-lasting inflammatory disease linked with significant disability, poor quality of life and reduced life expectancy[1]. PsA causes joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful tendonitis, and irreversible joint damage[1]. Between 0.3% and 1% of the general population may be affected by PsA  and as many as one in four people with psoriasis may have undiagnosed PsA[2],[5].

About AIN457 (secukinumab) and interleukin-17A (IL-17A)
AIN457 (secukinumab) is a fully human monoclonal antibody that selectively stops the action of IL-17A[4]. 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[5].