Novartis has announced that 12-week results from the Phase IIIb ULTIMATE trial of Cosentyx (secukinumab) showed significant treatment response on synovitis in psoriatic arthritis (PsA) over placebo.
Cosentyx is a fully-human biologic that hinders interleukin-17A (IL-17A), a cytokine involved in the inflammation.
The ongoing 52-week double-blind, placebo-controlled trial uses ultrasound to analyse the time-course of Cosentyx response on synovitis in PsA. It enrolled 166 adult biologic-naïve patients with active PsA.
They were randomly given either Cosentyx (300mg/150mg depending on skin disease severity) or placebo weekly for a month with treatment, starting at week four.
This was followed by a once-a-month dose for another 11 months.
The trial’s primary endpoint is the difference in mean change from baseline to week 12 between secukinumab and placebo in the Global Omeract-European League Against Rheumatism Ultrasound Synovitis Score (GLOESS).
Synovitis was evaluated with the help of an imaging technique called Power Doppler ultrasonography (PDUS).
Trial data showed that Cosentyx demonstrated significant benefit on synovitis over placebo at week 12, with improvements noted as early as week one.
Cosentyx also significantly improved key secondary endpoints, including ACR20, ACR50, and change in Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index from baseline.
Cosentyx’s safety profile has so far been consistent with previous trials.
ULTIMATE trial investigator Dr Catherine Bakewell said: “As a strong believer in the diagnostic and treatment monitoring benefits of ultrasound, this first large randomised double-blind placebo-controlled clinical trial in PsA with an ultrasonographic primary endpoint is incredibly exciting.”
PsA is an inflammatory disease that targets the joints associated with psoriasis. The symptoms of this disease include joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful swelling of the tendons and irreversible joint damage.
Novartis also reported positive data from two Phase III trials of Cosentyx in patients with moderate-to-severe plaque psoriasis.