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Secukinumab Meets Key Objectives in Phase III Trials
Two pivotal phase III studies of secukinumab (AIN457, Novartis) in psoriatic arthritis (PsA) have met their primary and key secondary endpoints. These endpoints included improving the signs and symptoms of PsA, including improving peripheral joint disease and preventing joint damage compared with placebo while delivering clear or almost clear skin (Psoriasis Area and Severity Index 90 [PASI 90] response).
Secukinumab is an investigational fully human monoclonal antibody that selectively blocks the action of interleukin (IL)-17A, a protein that is central to the development of inflammatory diseases, including PsA. It is the first medication that selectively targets IL-17A with positive phase III results for the treatment of PsA.
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.
The FUTURE 1 and FUTURE 2 trials were randomized, placebo-controlled studies designed to demonstrate the efficacy of secukinumab compared with that of placebo in patients with PsA and to assess the treatment’s safety and tolerability. The studies enrolled a total of more than 1,000 patients. The American College of Rheumatology response criteria (ACR20) were the primary endpoints in both trials.
PsA is closely associated with psoriasis; approximately 30% of patients with psoriasis have PsA. It is a debilitating, long-lasting inflammatory disease linked to 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% and 1.0% of the general population are affected by PsA, and as many as one in four people with psoriasis may have undiagnosed PsA.
Although tumor necrosis factor (TNF) inhibitors — the current standard of care for PsA — can improve clinical symptoms, responses may diminish over time. Moreover, many patients with PsA do not respond to or tolerate these agents, leaving an unmet need.
In addition to PsA, secukinumab is in clinical trials for the treatment of ankylosing spondylitis and rheumatoid arthritis.
Source: Novartis; September 25, 2014.