You are here
Secukinumab (Cosentyx) Shows Long-Term Benefits in Patients With Psoriatic Arthritis
New 1-year results from a pivotal phase III study of secukinumab (Cosentyx, Novartis) in patients with psoriatic arthritis (PsA) have been published in The Lancet following fast-track review.
Secukinumab is a human monoclonal antibody that selectively neutralizes circulating interleukin 17A (IL-17A). Research has shown that IL-17A plays an important role in driving the body’s immune response in psoriasis and in spondyloarthritic conditions, including PsA and ankylosing spondylitis.
The FUTURE 2 trial was a randomized, placebo-controlled study that assessed the efficacy and safety of secukinumab in 397 patients with PsA.
The results showed that improvements with subcutaneous secukinumab 300 mg or 150 mg were sustained during 1 year of treatment in most patients (64% for both doses), as measured by the American College of Rheumatology response criteria for 20% improvement from baseline (ACR 20). ACR 50 response rates were also sustained for 1 year in patients treated with secukinumab 300 mg or 150 mg (44% and 39%, respectively). Secukinumab was superior to placebo in achieving ACR 20 at week 24 (the trial’s primary endpoint), with response rates significantly higher in the secukinumab 300 mg (54%; P < 0.0001) and 150 mg (51%; P < 0.0001) groups compared with the placebo group (15%).
Significantly more patients treated with secukinumab 300 mg or 150 mg also achieved 90% improvement in the Psoriasis Area and Severity Index score (PASI 90) –– a key secondary endpoint –– compared with placebo. Achieving PASI 90 means that patients attained almost-clear to clear skin.
The benefits of secukinumab were observed both in patients who were naïve to anti-tumor necrosis factor (TNF) therapy and in those with an inadequate response to anti-TNF agents. The most common adverse events observed with secukinumab were upper respiratory-tract infections and the common cold.
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 disease is closely associated with psoriasis, and approximately 30% of patients with psoriasis have PsA. Between 0.3% and 1.0% of the general population may be affected by PsA and as many as one in four people with psoriasis may have undiagnosed PsA.
In January 2015, Cosentyx (secukinumab) 300 mg became the only IL-17A inhibitor approved in the U.S. as a treatment for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
Source: Novartis; June 29, 2015.