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Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.
Secukinumab is the first IL-17A inhibitor to meet its primary endpoint in two Phase III trials for patients with ankylosing spondylitis.
The use of secukinumab to treat patients with ankylosing spondylitis (AS) was associated with improvements in physical function and quality of life in two trials, MEASURE 1 and MEASURE 2, Novartis announced in a press release on Oct. 23, 2014. AS is a debilitating type of arthritis characterized by inflammation of the bones and joints at the base of the spine, bone fusion, curvature of the spine, and severe pain. The condition is a member of the group of spondyloarthropathies that also includes psoriatic arthritis and juvenile rheumatoid arthritis.
Secukinumab stops the action of the protein interleukin-17A (IL-17A) that is responsible for inflammation. If approved by FDA for this indication, the drug would be the first of its kind to treat AS. The current standard of care for the treatment of AS is anti-tumor necrosis factor (TNF) drugs, such as Enbrel (entanercept), Remicade (infliximab), or Humira (adalimumab), but these biologic therapies are not effective in all patients.
"We are thrilled to see positive results with secukinumab in AS, a gravely debilitating condition with a significant remaining unmet need as up to 40% of patients do not respond to anti-TNF therapies," said Vasant Narasimhan, global head of development, Novartis Pharmaceuticals, in a press release. "With these results in AS and the recently announced positive results in psoriatic arthritis, we now have data from four Phase III trials of secukinumab in spondyloarthropathies which we look forward to presenting at a congress later this year."
The announcement also comes on the heels of the news that an FDA panel unanimously backed secukinumab for the treatment of plaque psoriasis. A decision on the psoriasis indication is expected in late 2014 or early 2015, and joint regulatory applications for secukinumab in AS and psoriatic arthritis are planned for 2015.