Novartis (NVS) Announces Strong Cosentyx Phase III SCULPTURE Trial 1 Data in Psoriasis Patients

October 3, 2016 6:36 AM EDT

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Novartis (NYSE: NVS) announced new data showing Cosentyx (secukinumab) delivers efficacy in patients with moderate to severe plaque psoriasis out to four years of treatment. These late-breaking data come from the extension study of the Phase III SCULPTURE trial.1 Results were presented for the first time at the 25th European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria.

"These impressive results show that Cosentyx keeps working year-on-year, maintaining high levels of skin clearance with a favorable safety profile," said Vasant Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. "Psoriasis patients need therapies they can use over long periods of time without loss of efficacy and we are pleased that Cosentyx is proving a sustainable choice for patients."

The ultimate aim of psoriasis treatment is clear skin, and the Psoriasis Area Severity Index (PASI) 90 response is considered an important measure of treatment success.3 SCULPTURE extension patients received the same blinded maintenance treatment regimen and dose up to the end of Year 3. In the fourth year, the study became open label. All results presented are for the Cosentyx 300 mg every 4 weeks group. Almost clear skin (PASI 90) was achieved by 68.5% of patients at Year 1 (Week 52) and 61.9% of patients at Year 3 (Week 156), and was maintained at Year 4 (Week 208) in 66.4% of patients.1

In addition, completely clear skin (PASI 100) was achieved by 43.8% of patients at Year 1 and 41.7% of patients at Year 3, and was maintained at Year 4 in 43.5% of patients. The historic standard goal of treatment, PASI 75 skin clearance, was achieved by 88.9% of patients at Year 1 and 78.4% of patients at Year 3, and was maintained by 88.5% of patients at Year 4. The most common adverse events (AEs) at Year 4 were nasopharyngitis (12.1%) and upper respiratory tract infection (3.5%) and were similar to those observed at Year 1.1

Also presented at EADV were results from the GESTURE study demonstrating the strength of Cosentyx versus placebo in patients with moderate to severe palmoplantar plaque psoriasis, which are considered difficult areas to treat on the body. At Week 16, about 40% of patients achieved clear or almost clear palms and soles with Cosentyx 300 mg every 4 weeks, which continued to improve with approximately 60% of patients achieving clear or almost clear palms and soles at Week 80 (Year 1.5). AEs were reported in 47 of the 69 patients receiving Cosentyx 300 mg and 27 of the 68 patients receiving placebo at Week 80.2 Patients with palmoplantar psoriasis are known to suffer greater disability and discomfort than those with psoriasis on other areas.4

"The four-year study adds to a growing body of evidence that Cosentyx is an important longer-term treatment option for patients with moderate to severe plaque psoriasis," said Craig Leonardi, MD, study author and adjunct professor of dermatology at St. Louis University Medical School. "Furthermore, the palms and soles of the feet are generally very difficult to treat. This new data is significant as there is still high unmet need for effective treatments for those living with palmoplantar psoriasis."

Additional data presented at EADV from a study in moderate to severe scalp psoriasis showed Cosentyx demonstrated superior efficacy compared to placebo. In the study, Psoriasis Scalp Severity Index (PSSI) 90 responses were achieved by a significantly greater percentage of patients receiving Cosentyx 300 mg (52.9%) than placebo (2.0%) at Week 12 (P<0.001). AEs were reported in 52.9% of patients receiving Cosentyx 300 mg and 49.0% of patients receiving placebo at Week 12. No serious AEs were reported with Cosentyx.5



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