Novartis announces publication in The Lancet showing sustained efficacy with secukinumab over one year in psoriatic arthritis patients

Novartis has announced that new one year results from the pivotal Phase III FUTURE 2 study of secukinumab in psoriatic arthritis (PsA) were published in The Lancet following fast-track review. Secukinumab is the first interleukin- 17A (IL-17A) inhibitor to demonstrate efficacy in a Phase III study in adult patients with active PsA.¹ 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.² Between 0.3 and 1% of the general population may be affected by PsA, which could mean more than 600,000 people in the UK have the condition.^3,4

The new study results published in The Lancet 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).¹ Moreover, ACR 50 response rates were also sustained to one year in secukinumab 300 mg and 150 mg treatment arms (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 300 mg (54%; p<0.0001) and 150 mg (51%; p<0.0001) groups versus placebo (15%), with clinical improvements observed as early as Week 3.¹ ACR 20 and 50 are standard tools used to assess improvement of PsA signs and symptoms, and represent a 20% and 50% improvement from baseline, respectively.⁵

Dimitrios Georgiopoulos, UK Medical Director, Novartis Pharmaceuticals said, "This is exciting data. Secukinumab is now the first IL-17A inhibitor to show consistent efficacy through one year in psoriatic arthritis, psoriasis, and ankylosing spondylitis. In the UK we have already begun to see the impact that secukinumab can have in achieving high levels of skin clearance for psoriasis patients, since it was licensed in this indication earlier this year. Following global regulatory submissions for secukinumab in both psoriatic arthritis and ankylosing spondylitis (AS), we will continue to work to bring this important advance to patients with these debilitating inflammatory conditions."

Secukinumab 300 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).¹ Achieving PASI 90 means that patients can attain almost clear skin.6 This is important as the majority of people living with PsA have a history of, or concomitant, psoriasis3, another long-term condition which is characterised by thick and extensive skin lesions, called plaques, known to cause itching, scaling and pain. ^7,8

Clinical benefits were observed in both anti-TNF-naïve patients and those with an inadequate response to anti-TNFs.¹ This is important as many patients do not respond to, or tolerate, these therapies and approximately 40% of people are dissatisfied with current treatments indicating a significant unmet need.^9,10

Secukinumab was well tolerated in FUTURE 2, with a safety profile consistent with that observed in the psoriasis clinical trial programme involving over 3,400 patients.^1,11-13 The most common adverse events (AEs) were upper respiratory tract infections and the common cold.¹

About the FUTURE 2 study

FUTURE 2 is a Phase III, multi-centre, randomised, placebo-controlled clinical trial that assessed the efficacy and safety of secukinumab, a human anti-IL-17A monoclonal antibody, in patients with PsA.¹ The study enrolled 397 patients with active PsA and compared subcutaneous loading and maintenance dosing with secukinumab 300 mg, 150 mg and 75 mg to placebo.¹

The study met its primary endpoint of ACR 20 at Week 24. In addition, significant improvements with secukinumab were also demonstrated in psoriasis symptoms that many patients with psoriatic arthritis experience.1 Compared to placebo at Week 24, secukinumab 300 mg demonstrated greater improvements as measured by Psoriasis Area-and-Severity Index score 90 (PASI 90) (49% vs 9%, P=0.005).¹

About psoriatic arthritis (PsA)

Psoriatic arthritis (PsA) is a long-term, painful inflammatory disease of the joints and skin which leads to significant disability, poor quality of life and reduced life expectancy.^2,3 PsA is closely associated with psoriasis and approximately 30% of patients with psoriasis have PsA.^3,14

About secukinumab and interleukin-17A (IL-17A)

Secukinumab is a human monoclonal antibody that selectively neutralises circulating IL- 17A.¹⁴ Secukinumab is the first IL-17A inhibitor with positive Phase III results for the treatment of PsA and AS.^1,15 Research shows that IL-17A plays an important role in driving the body's immune response in psoriasis and spondyloarthritis conditions, including PsA and AS.¹⁶

In January 2015, secukinumab, marketed as CosentyxTM, (at a dose of 300 mg) became the first and only IL-17A inhibitor approved in Europe as a first-line systemic treatment of moderate-to-severe plaque psoriasis in adult patients. Secukinumab has since received a positive final recommendation from the National Institute of Health and Care Excellence (NICE) for its use within NHS England and Wales and positive guidance from the Scottish Medicines Consortium for its use within NHS Scotland.^17,18