Novartis AIN457 (secukinumab) meets primary endpoint in two Phase III studies in ankylosing spondylitis, a debilitating joint condition of the spine - Seite 2

AS is a common type of spondyloarthropathy (SpA), a family of long-term diseases impacting joints (inflammatory diseases), which includes other conditions such as psoriatic arthritis (PsA)[5]. Occurring in up to 1% of the general population - typically young men and women aged 25 or older - AS is a painful, debilitating condition primarily associated with swelling, in severe cases fusion of the spine (bones growing together), and irreversible bone formation (new bones growing)[6],[7]. It can cause persistent back pain, stiffness, fatigue and curvature of the spine that result in patients becoming progressively disabled and unable to work[1],[2]. People with AS have very few therapeutic options available to them. In case of non-response to non-steroidal anti-inflammatory drugs (NSAIDs), anti-TNF medicines are the only currently available biologic treatment alternative but are not effective for all patients, representing a substantial unmet need[1].

Joint regulatory applications for secukinumab in AS and 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 regulatory decisions anticipated in late 2014 or early 2015.

MEASURE 1 and MEASURE 2 are randomized, placebo-controlled, multicenter studies designed to demonstrate efficacy of secukinumab in AS compared to placebo and to assess safety, tolerability and long-term effectiveness. The Assessment of Spondyloarthritis International Society criterion (ASAS 20) was the primary endpoint. Secukinumab showed an acceptable safety profile in both studies which was consistent with that observed in the large psoriasis clinical trial program, involving approximately 4,000 patients[8].

About ankylosing spondylitis (AS)
Ankylosing spondylitis (AS) is a common type of spondyloarthropathy (SpA), a family of long-term diseases of joints (inflammatory disease)[5]. Up to 70% of patients with severe AS can develop spinal fusion (bones grow together), significantly reducing mobility and quality of life[2],[9],[10]. 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%[11].