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Secukinumab Meets Primary Endpoint in Two Phase III Studies in Ankylosing Spondylitis
Secukinumab (AIN457, Novartis) has met the primary and key secondary endpoints in two pivotal phase III studies (MEASURE 1 and MEASURE 2) of patients with ankylosing spondylitis (AS). Key endpoints included improvements in the signs and symptoms of the disease compared with placebo and associated improvements in physical function and quality of life.
The MEASURE 1 and MEASURE 2 trials were randomized, placebo-controlled studies designed to demonstrate the efficacy of secukinumab in AS compared with placebo and to assess the drug’s safety, tolerability, and long-term effectiveness. The Assessment of Spondyloarthritis International Society (ASAS 20) criterion was the primary endpoint. The two studies enrolled a total of approximately 600 patients with AS.
Secukinumab is a fully human monoclonal antibody that selectively neutralizes the action of the inflammatory protein interleukin-17A, which is central to the development of psoriasis and other inflammatory arthritic diseases, including AS.
AS is a common type of spondyloarthropathy (SpA), a family of long-term inflammatory diseases of the joints. Up to 70% of patients with severe AS can develop spinal fusion, which significantly reduces their mobility and quality of life. AS occurs in up to 1% of the general population and typically affects young men and women 25 years of age and older. Certain genetic factors increase a person’s risk of developing AS by more than 50%.
People with AS have few therapeutic options. In cases of a lack of response to nonsteroidal anti-inflammatory drugs (NSAIDs), anti-tumor necrosis factor (anti-TNF) agents are the only currently available biologic treatment alternative, but they are not effective for all patients, representing a substantial unmet need.
In addition to AS, secukinumab is in clinical trials for the treatment of psoriatic arthritis (PsA) and rheumatoid arthritis. Global regulatory applications for secukinumab in AS and PsA are planned for 2015.
Source: Novartis; October 23, 2014.