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You are here: Home / Articles / FDA Approves Secukinumab for Non-Radiographic Axial Spondyloarthritis

FDA Approves Secukinumab for Non-Radiographic Axial Spondyloarthritis

August 5, 2020 • By Michele B. Kaufman, PharmD, BCGP

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In June, the U.S. Food & Drug Administration (FDA) approved secukinumab (Cosentyx) to treat active non-radiographic axial spondyloarthritis (nr-axSpA).1

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Secukinumab inhibits interleukin (IL) 17A, a cytokine involved in the development of psoriatic arthritis, moderate to severe plaque psoriasis and ankylosing spondylitis (AS). The agent is already FDA-approved to treat these conditions. More than 13 years of clinical data for secukinumab exist, including five years of data supporting its long-term safety and efficacy in patients with moderate to severe plaque psoriasis, psoriatic arthritis and ankylosing spondylitis.

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This new indication for secukinumab is based on efficacy and safety findings from the randomized, double-blind, placebocontrolled, phase 3 PREVENT study. This study included adults with active nr-axSpA (N=555) who were biologic naive or had an inadequate response to, or were intolerant of, tumor necrosis factor-α (TNFα) inhibitor therapy. Of the study patients, most (90%; n=501) were biologic naive.

Patients were randomized to one of three treatment groups: a 150 mg of subcutaneous secukinumab loading dose, followed by 150 mg of subcutaneous secukinumab weekly for four weeks and then maintenance with 150 mg of secukinumab monthly; 150 mg of subcutaneous secukinumab monthly; or placebo. The primary endpoint was the proportion of biologic-naive therapy patients who achieved an Assessment of Spondylo-Arthritis International Society 40 (ASAS40) response at weeks 16 and 52—defined as an improvement of at least 40% and an absolute improvement from baseline of at least 20 units on a 0–100 scale in at least three of the following domains: patient global assessment of disease activity, pain assessment, physical function as measured by the Bath Ankylosing Spondylitis Functional Index or inflammation; with no worsening in the remaining domain.

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Secondary endpoints included a change in the Bath Ankylosing Spondylitis Disease Activity Index over time and a change in the Ankylosing Spondylitis Disease Activity Score with C-reactive protein (CRP).

Secukinumab met the study’s primary endpoints, with patients receiving secukinumab achieving improvement in the signs and symptoms of nr-axSpA. These results were statistically significant.

The safety profile of secukinumab was similar to prior clinical trials. No new safety signals were identified.

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Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

Reference

  1. Novartis AG. News release: Novartis Cosentyx receives FDA approval for new indication to treat active non-radiographic axial spondyloarthritis. 2020 Jun 17.

Filed Under: DMARDs & Immunosuppressives, Drug Updates Tagged With: FDA, FDA approval, non-radiographic axial spondyloarthritis, secukinumab, U.S. Food and Drug Administration (FDA)Issue: September 2020

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