New one year results from the pivotal Phase III FUTURE 2 study of Novartis’ secukinumab in psoriatic arthritis (PsA) have been published.
Secukinumab is the first interleukin-17A (IL-17A) inhibitor to demonstrate efficacy in a Phase III study in adult patients with active PsA. PsA is a long-term, debilitating, inflammatory disease associated with joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful tendonitis and irreversible joint damage.
The new study results show improvements observed with subcutaneous secukinumab 300 mg and 150 mg were sustained over one year of treatment in the majority of patients (64% for both doses), as measured by the American College of Rheumatology response criteria (ACR 20). Moreover, ACR 50 response rates were also sustained to one year in secukinumab 300 mg and 150 mg (44% and 39% respectively). Secukinumab met the primary endpoint of the study, which was ACR 20 at Week 24 with response rates significantly higher in the secukinumab groups versus placebo, with clinical improvements observed as early as Week 3.
Secukinumab shows consistent efficacy through one year in PsA
“Secukinumab is the first IL-17A inhibitor to show consistent efficacy through one year in Psoriatic Arthritis, Psoriasis, and Ankylosing spondylitis” said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. “Novartis has recently filed global regulatory submissions for secukinumab in both psoriatic arthritis and ankylosing spondylitis and will continue to work to bring this important advance to patients with these debilitating diseases.”
Secukinumab 300 mg and 150 mg also significantly improved a key secondary endpoint which was improvement in psoriasis symptoms, as measured by 90% improvements in Psoriasis Area and Severity Index score (PASI 90). Achieving PASI 90 means that patients can attain clear to almost clear skin. This is important as the majority of people living with PsA have a history of, or concomitant, psoriasis, another long-term condition which is characterised by thick and extensive skin lesions, called plaques, known to cause itching, scaling and pain.
Although the secukinumab benefits seen in FUTURE 2 were generally higher in patients without previous treatment with standard of care anti-TNF therapy, clinical benefits were observed in both anti-TNF-naïve patients and those with an inadequate response to anti-TNFs.
The new results are published in The Lancet.
