Secukinumab (Cosentyx) showed early significant treatment response on synovitis in psoriatic arthritis (PsA) patients in the phase IIIb ULTIMATE trial, announced Novartis.
Secukinumab is a human IgG1κ monoclonal antibody that binds and hinders interleukin-17A (IL-17A), a cytokine involved in the inflammation.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.
The ongoing 52-week double-blind, placebo-controlled trial uses ultrasound to analyse the time-course of secukinumab response on synovitis in PsA. It enrolled 166 adult patients with active PsA. Synovitis was evaluated with the help of an imaging technique called Power Doppler ultrasonography (PDUS). Trial data showed that secukinumab demonstrated significant benefit on synovitis over placebo at week 12, with improvements noted as early as week one. Patients were randomized (1:1) to receive either secukinumab (300-mg or 150-mg according to severity of skin disease) or placebo weekly for a month with treatment starting at week 4. This was followed by a once-a-month dose for another 11 months.
The trial’s primary endpoint was 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).
Novartis also reported positive data from two phase III trials of secukinumab in patients with moderate-to-severe plaque psoriasis.