Novartis Presents Secukinumab 5-Year Data


Data from 2 phase 3 studies of secukinumab (Cosentyx) in patients with psoriatic arthritis and ankylosing spondylitis will be presented at an upcoming meeting.

New 5-year data from phase 3 studies of secukinumab (Cosentyx) in patients with psoriatic arthritis and ankylosing spondylitis show that secukinumab provides ongoing improvements in symptoms.

In FUTURE 1, 83% and 94% of patients with psoriatic arthritis (PsA) achieved a total resolution of enthesitis and dactylitis, respectively. Over 80% of patients with either psoriatic arthritis or ankylosing spondylitis (AS) in the extension phases of either FUTURE 1 or MEASURE 1 completed 5 years.

Novatris announced that the phase 3 extension data will be presented at the 2018 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in Chicago, United States.

"AS and PsA have a significant impact on the quality of patients' lives, and they require a comprehensive treatment which targets all of the manifestations of their disease," said Georg A. Schett, MD, Professor and Chair, Department of Medicine, Rheumatology and Immunology at University of Erlangen-Nuremberg. "The presentation of long-term data in PsA and AS supports the central role of Cosentyx in the long-term sustained management of these complex and multi-faceted conditions."

Allan Gibofsky, MD discusses the characteristics of psoriatic arthritis and ankylosing spondylitis. For more, see his Insights video series on psoriatic arthritis and ankylosing spondylitis.

The FUTURE 1 study enrolled 606 patients with active psoriatic arthritis who were randomized to either secukinumab (intravenous loading dose 10 mg/kg and subcutaneous 75 mg and 150 mg maintenance dosing) or placebo. Of those, 460 patients entered the three-year extension period following the two-year study.

The MEASURE 1 study assessed secukinumab in 371 patients with active ankylosing spondylitis. Of the 290 patients who completed the two-year trial, 274 continued in the three-year extension period.

Secukinumab was first approved by the US Food and Drug Administration (FDA) in 2015 for the treatment of moderate-to-sever plaque psoriasis in adults.

In June 2018, the FDA approved a label update for secukinumab, including new data showing that secukinumab impedes the progression of join structural damage in patients with active psoriatic arthritis. A few months earlier, in February 2018, the FDA updated the label to include the treatment of moderate-to-severe scalp psoriasis.

"Five-year data is often seen as a benchmark for proving long-term efficacy and safety," said Eric Hughes, MD, PhD, Global Development Unit Head, Immunology, Hepatology and Dermatology, Novartis. "By adding five-year data in PsA and AS to the already reported five-year data in psoriasis, we are reinforcing the robust profile of Cosentyx and reimagining the standard of care for patients who search for a complete treatment for spondyloarthritis and psoriatic disease."

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