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Novartis today 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)[4], a protein that is central to the development of inflammatory diseases[5]. 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.
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]
Via Krishan Maggon
Secukinumab met primary and key secondary endpoints in two pivotal Phase III studies showing superiority to placebo in patients with adult onset psoriatic arthritis (PsA)
Many people with PsA do not respond to current standard of care, with approximately 45% of people dissatisfied with current treatments[3]Secukinumab is the first interleukin-17A (IL-17A) inhibitor with positive Phase III results in PsA and regulatory submissions are planned for 2015
Global regulatory applications for secukinumab in PsA are planned for 2015.
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].
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 were submitted at the end of 2013.