Novartis today announced new two-year results demonstrating sustained efficacy with Cosentyx™ (secukinumab) with an acceptable safety profile for the treatment of psoriasis patients. The data comes from the extension study of the pivotal Phase III FIXTURE and ERASURE trials. Results were presented for the first time in a late-breaking session at the 73rd Annual Meeting of the American Academy of Dermatology (AAD) in San Francisco. Cosentyx is the first and only interleukin-17A (IL-17A) antagonist approved to treat adult moderate-to-severe plaque psoriasis patients.
"This two-year data is significant because it represents results from the longest continuous Phase III study to date evaluating an IL-17A antagonist in the treatment of psoriasis," said Andrew Blauvelt, MD, MBA, President of the Oregon Medical Research Center and lead study investigator. "The study not only strengthens our understanding of the efficacy and safety of Cosentyx, but reiterates that it is an important new longer-term treatment option for patients with moderate-to-severe plaque psoriasis."
In this extension of the FIXTURE and ERASURE studies, 995 patients who achieved Psoriasis Area Severity Index (PASI) 75 response after a year of therapy (Week 52) received either Cosentyx 300 mg, Cosentyx 150 mg or placebo for an additional year (Week 104). After two full years of therapy, 7 out of 10 (70.6%) patients treated with Cosentyx 300 mg had clear to almost clear skin (PASI 90); 4 out of 10 (43.9%) had clear skin (PASI 100) and almost 9 out of 10 (88.2%) patients maintained their PASI 75 response at Week 104.
For patients treated with Cosentyx 150 mg, 44.6% had clear or almost clear skin (PASI 90); 23.5% had clear skin (PASI 100) and 75.5% maintained their PASI 75 response at Week 104. PASI assesses treatment efficacy by measuring the reduction in redness, scaling and thickness of psoriatic plaques and the extent of involvement in each region of the body.
In the study, 94.8% of patients who initially received placebo (at the start of the extension) and were switched to receive Cosentyx 300 mg after relapse, were able to achieve PASI 75 and 70.3% achieved PASI 90 within 12 weeks of re-starting Cosentyx treatment.
"We are pleased to share new long-term data showing how the sustained efficacy and acceptable safety profile of Cosentyx helps psoriasis patients maintain clear or almost clear skin at the end of two years of treatment," said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. "Psoriasis is a chronic condition causing itching, scaling and pain; patients need therapies that provide relief and clear skin over a long period of time."
Cosentyx demonstrated an acceptable safety profile. The most common adverse events (AEs) for the 300 mg and 150 mg treatment arms were nasopharyngitis (24.1% and 17.0%, respectively), upper respiratory tract infection (5.3% and 5.0%), hypertension (4.3% and 5.2%), headache (5.6% and 2.9%) and arthralgia (4.0% and 4.2%). Infections and infestations were reported in 53.1% of patients receiving Cosentyx 300 mg and 41.6% of patients receiving 150 mg. There were 64 (6.0%) serious AEs (SAEs) in any Cosentyx dose and no deaths reported during the study.
FDA strengthens AI regulation to ensure patient safety and innovation in healthcare