Novartis Announces NEJM Publication of Secukinumab Phase IIIOctober 1, 2015
Novartis announced on Wednesday that results from the pivotal Phase III FUTURE 1 study for Secukinumab in psoriatic arthritis (PsA) were published online in the New England Journal of Medicine.
Novartis says that Secukinumab is the first interleukin-17A (IL-17A) inhibitor to demonstrate efficacy in a Phase III study in patients with active PsA, a painful, debilitating condition causing inflammation of joints and skin. PsA is part of a family of long-term diseases impacting joints, known as spondylorarthritis. In this study, secukinumab met the primary endpoint with a 20% reduction in the American College of Rheumatology response criteria (ACR 20) at Week 24 showing rapid and significant clinical improvements versus placebo. ACR is a standard tool used to assess improvement of PsA signs and symptoms. In addition, secukinumab met all secondary endpoints, including improvements in skin and joint diseases and joint structural damage progression.
Results showed that half of patients (50.0% and 50.5%) in both secukinumab-treated dose groups (150 mg and 75 mg; p<0.001) achieved ACR 20 response compared with only 17.3% of placebo patients. Clinically significant improvements with secukinumab were observed as early as Week 1 and sustained throughout 52 weeks of treatment.
“Secukinumab is the first IL-17A inhibitor with detailed positive results for the treatment of PsA, further validating the importance of the role IL-17A plays in spondyloarthritis,” said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals.
“Novartis looks forward to advancing this important therapy to address the unmet need for patients living with PsA.”
Novartis aslo explains that PsA is a debilitating, long-lasting inflammatory disease associated with joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful tendonitis and irreversible joint damage. These all lead to significant disability, poor quality of life and reduced life expectancy. Importantly, in FUTURE 1, clinical benefits with secukinumab were observed regardless of prior exposure to anti-tumor-necrosis-factor (anti-TNF) medicines, the current standard of care. Many patients do not respond to, or tolerate these therapies and approximately 45% of people are dissatisfied with current treatments. There is therefore, a high unmet need for patients with PsA.
Secukinumab was well tolerated in the study, with a safety profile that was consistent with that observed in the large psoriasis clinical trial program involving nearly 4,000 patients. The most common adverse events (AEs) were the common cold, headache and upper respiratory tract infections.