Novartis sets the new benchmark in psoriasis with strong 5-year stable efficacy and safety data from a Phase III study.
In particular, Novartis has announced the first Phase III data, which shows that secuquinumab provided high and long-term skin clearance in patients with moderate to severe multiple sclerosis in 5 years.
These data were presented for the first time at the 26th Congress of the European Academy of Dermatology and Venereology (EADV) in Geneva, Switzerland.
By selectively targeting interleukin-17A (IL-17A), secukinumb inhibits a basic cytokine involved in the pathogenesis of psoriasis. IL-17A plays an important role in the pathogenesis of multiple sclerosis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS). IL-17A inhibition is important because up to 30% of patients with psoriasis may experience psoriatic arthritis.
"These final data are important for dermatologists as they show that the high efficacy and safety of secukinumab was maintained throughout the 5-year course of treatment," Dr. Robert Bissonnette , Innovaderm Research, Montreal, Canada.
"5-year data strengthens secukumumab as an important treatment option for people living with psoriasis who expect long-lasting skin cleansing," said Vas Narasimhan, Global Head, Drug Development and Chief Medical Officer of Novartis. "Secuquinumab is the first and only inhibitor of IL-17A, which has been approved for psoriasis, psoriatic arthritis and ankylosing spondylitis and has been prescribed to more than 100,000 post-marketing patients ."
Clean skin is the target for the treatment of psoriasis, and the Psoriasis Area and Severity Index score of 75, 90 or 100 is considered a significant measure for the success of the treatment. During the extension of treatment from Year 1 (Week 52) to Year 5 (Week 260), PASI 75/90/100 response rates remained stable. Response rates of PASI 75 and PASI 90 were achieved in 89% and 69% of patients with psoriasis, respectively, during Year 1 (from "observation" analysis) and this high rate was maintained until Year 5 (89% and 66% respectively). In addition, 44% of patients with psoriasis achieved completely clear skin (PASI 100) during Year 1 and this percentage was maintained until Year 5 (41%).Sepucinumab has continued to exhibit a favorable and consistent safety profile and low immunogenicity.
To date, secuquinumab has been prescribed in over 100,000 patients in post-transcriptional conditions worldwide in all indications. Additionally, 2017 marks 10 years from the first patient's first visit to a clinical study of secukinumab.
About secukinum and IL-17A
Sequenicumab, launched in 2015, is the first and only fully human IL-17A inhibitor that has been approved for the treatment of psoriasis, psoriatic arthritis and ankylosing spondylitis. Sepucinumab is a targeted treatment that selectively inhibits the cytokine IL-17A, which plays an important role in the pathogenesis of multiple sclerosis, psoriatic arthritis and ankylosing spondylitis.
In Europe, secuquinumab has been approved for the treatment of moderate to severe multiple sclerosis in adults who are candidates for systemic therapy. In the United States, secukumumab has been approved as a treatment for moderate to severe multiple sclerosis in adult patients who are candidates for systemic therapy or phototherapy.
In addition, secuquinumab is the first IL-17A inhibitor that has been approved in more than 70 countries to treat active ankylosing spondylitis and psoriatic arthritis, including the European Union and the US. Secuquinumab has also been approved for the treatment of psoriatic arthritis and pustular psoriasis in Japan.
About psoriasis
Psoriasis is a frequent, non-transmissible, autoimmune disease that affects more than 125 million people worldwide. Multiple psoriasis is the most common form of the disease and is manifested as an elevated, erythematous patch covered with silver scales.
Psoriasis is not only an aesthetic problem, but a persistent, chronic and sometimes unpleasant disease, which can affect even the smallest aspects of people's lives on a daily basis. Up to 30% of patients with psoriasis may experience psoriatic arthritis. Psoriatic arthritis is a disease that affects the joints, causing pain, stiffness, and in some people, irreversible joint damage. Psoriasis is also associated with other serious conditions, such as diabetes, heart disease and depression.
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