Synovitis Reduction Observed With Secukinumab in Psoriatic Arthritis Trial

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The 52-week double-blind, placebo-controlled ULTIMATE study included 166 adult biologic-naive patients with active psoriatic arthritis.

Novartis announced results from a phase 3b study evaluating the time course of response to secukinumab (Cosentyx®) on joint synovitis and enthesitis in adults with psoriatic arthritis using power doppler ultrasonography (PDUS).

The 52-week multicenter, double-blind, placebo-controlled ULTIMATE study included 166 adult biologic-naive patients with active psoriatic arthritis. Patients were randomized 1:1 to receive secukinumab (300mg or 150mg according to disease severity) or placebo weekly for a month, followed by a once monthly dose for the next 11 months. 

The primary end point was the difference between secukinumab and placebo in terms of joint synovitis as measured by the PSUD Global OMERACT-EULAR Synovitis (GLOESS) at week 12. Secondary end points included American College of Rheumatology (ACR) 20 response, ACR50, and change in Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index from baseline to week 12.

Results showed that treatment with secukinumab was associated with a significant reduction in synovitis, with improvement observed as early as week 1. Additionally, improvements in key secondary end points were also observed with secukinumab vs placebo (ACR20: 68% vs 34%, respectively; ACR50: 46% vs 9%, respectively; mean change from baseline in SPARCC: -2.4 vs -1.7, respectively). The safety profile of secukinumab through 12 weeks was found to be consistent with that seen in previous studies.

“The ability to use a sensitive imaging technique to assess synovitis and enthesitis in PsA represents a breakthrough in how we conceptualize treatment goals,” said Dr Catherine Bakewell of Intermountain Medical Group in Salt Lake City, UT and an investigator in the ULTIMATE study. “In addition to other measures, PDUS helps to provide earlier insight into treatment response and that patients are more effectively treated across multiple domains of this heterogeneous psoriatic disease spectrum.” 

The 12-week study results will be presented at the ACR All-Virtual Annual Meeting held on November 5-9, 2020. The full 24-week study data will be disclosed at the European League Against Rheumatism (EULAR) annual meeting in 2021 and final analysis at ACR 2021.

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Cosentyx, an interleukin-17A antagonist, is approved for the treatment of active psoriatic arthritis, ankylosing spondylitis, active non-radiographic axial spondyloarthritis, and moderate to severe plaque psoriasis.  

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Novartis Cosentyx® shows early synovitis reduction in patients with psoriatic arthritis in first-of-its-kind study. [press release]. East Hanover, NJ: Novartis; November 5, 2020.