Novartis announced new two-year results demonstrating strong and sustained efficacy with Cosentyx (secukinumab) with a favorable 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, USA. Cosentyx is the first and only interleukin-17A (IL-17A) inhibitor approved to treat adult moderate-to-severe plaque psoriasis patients.
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 (71 percent) patients treated with Cosentyx 300 mg had clear or almost clear skin (PASI 90); 4 out of 10 (44 percent) had clear skin (PASI 100) and almost 9 out of 10 (88 percent) patients maintained their PASI 75 response. 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.
“We are pleased to share new long term data showing how the sustained efficacy and favorable safety profile of Cosentyx helps psoriasis patients maintain clear or almost clear skin over 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 rapid relief and clear skin over a long period of time.”
In the study, 70 percent of patients who initially received placebo and were switched to receive Cosentyx 300 mg after losing treatment response, were able to achieve PASI 90 within 12 weeks of starting Cosentyx treatment. The safety profile of Cosentyx was favorable and consistent with previously reported Phase III clinical trials. No new or unexpected safety findings were identified during the two year extension. The most common adverse were nasopharyngitis, upper respiratory tract infection, hypertension, headache and arthralgia.
Filed Under: Drug Discovery