Secukinumab Approved for Ankylosing Spondylitis and PsA

January 19, 2016

Approval of secukinumab for ankylosing spondylitis and psoriatic arthritis marks a milestone in rheumatic disease.

The U.S. Food and Drug Administration (FDA) has approved secukinumab (Cosentyx, Novartis) to treat adult patients with ankylosing spondylitis (AS) and psoriatic arthritis (PsA). Secukinumab was previously approved by the FDA in January 2015 for adults with moderate to severe psoriasis.

“The approval of additional indications for Cosentyx represents an important milestone for AS and PsA patients, their caregivers, and their doctors,” said Christi Shaw, president of Novartis Corp., in a news release reacting to the FDA’s approval of secukinumab.[[{"type":"media","view_mode":"media_crop","fid":"45049","attributes":{"alt":"©AlilaMedicalMedia/Shutterstock.com","class":"media-image media-image-right","id":"media_crop_5756001870613","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"5091","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"font-size: 13.008px; line-height: 1.538em; float: right;","title":"©AlilaMedicalMedia/Shutterstock.com","typeof":"foaf:Image"}}]]

Secukinumab is the first and only interleukin-17A (IL-17A) antagonist approved for adult patients with active ankylosing spondylitis and psoriatic arthritis. Phase III trials, which included more than 1,500 patients, showed that secukinumab met the primary endpoints showing statistically significant improvements versus placebo in the signs and symptoms of ankylosing spondylitis and psoriatic arthritis.

In December, a study published in the New England Journal of Medicine, showed that secukinumab significantly reduced the signs and symptoms of ankylosing spondylitis, as compared with placebo, in two phase III trials (MEASURE 1,2). In June, a study (FUTURE 2) published in The Lancetdescribed subcutaneous secukinumab, at 300 mg or 150 mg, improved the signs and symptoms of patients with psoriatic arthritis.

About ankylosing spondylitis (AS):

  • Ankylosing spondylitis (AS) is a painful and often progressively debilitating disease, caused by spine inflammation that can result in irreversible damage.
  • Up to 70% of patients who go on to develop severe AS will form spinal fusions (where the bones grow together) over 10 to 15 years, which significantly reduces mobility.
  • In the United States, the prevalence of AS is estimated to be between 0.2% and 0.5%, with nearly half a million people affected.
  • Approximately 20-40% of patients do not respond well to standard of care biologic medicines, and there are few therapeutic options available to those patients.

About psoriatic arthritis (PsA):

  • Between 0.3% and 1% of the general population may be affected by psoriatic arthritis (PsA) and up to 15% of people with psoriasis may have undiagnosed PsA.
  • Symptoms of PsA include joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers and persistent painful ethesitis (inflammation of the sites where tendons or ligaments insert into the bone).
  • PsA can lead to irreversible joint damage and disability caused by years of inflammation.
  • Up to 40% of people can suffer from joint destruction and permanent physical deformity.
  • New medicines are needed as many patients do not respond to, or tolerate current therapies and approximately 45% of PsA patients are dissatisfied with treatments.

 

References:

 Prof Iain B McInnes, MDcorrespondenceemail, Prof Philip J Mease, MD, et al.

"

Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial,"

The Lancet. Volume 386, No. 9999, p1137–1146, 19 September 2015  Dominique Baeten, M.D., Joachim Sieper, M.D. et al.

"Secukinumab, an Interleukin-17A Inhibitor, in Ankylosing Spondylitis,"

New England Journal of Medicine. December 24, 2015DOI: 10.1056/NEJMoa1505066