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Positive Long-Term Data Reported for Psoriasis Drug Secukinumab (Cosentyx)
New 2-year results have demonstrated sustained efficacy with secukinumab (Cosentyx, Novartis) with a favorable safety profile for the treatment of patients with psoriasis. The data come from an extension study of the pivotal phase III FIXTURE and ERASURE trials.
The results were presented at the 73rd annual meeting of the American Academy of Dermatology in San Francisco, California.
Secukinumab is the only interleukin-17A (IL-17A) inhibitor approved by the FDA to treat moderate-to-severe plaque psoriasis in adults.
In the extension of the FIXTURE and ERASURE studies, a total of 995 patients who had achieved a Psoriasis Area Severity Index (PASI) 75 response after 1 year of therapy (week 52) received either secukinumab (150 or 300 mg) or placebo for an additional year (week 104). After 2 years of therapy, seven out of 10 (71%) patients treated with secukinumab 300 mg had clear or almost clear skin (PASI 90); four out of 10 (44%) had clear skin (PASI 100); and almost nine out of 10 (88%) maintained their PASI 75 response. The 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, 70% of patients who initially received placebo and were switched to secukinumab 300 mg after losing their treatment response were able to achieve PASI 90 within 12 weeks of starting secukinumab. No new or unexpected safety findings were identified during the 2-year extension. The most common adverse events included nasopharyngitis, upper respiratory tract infection, hypertension, headache, and arthralgia.
Secukinumab is a human monoclonal antibody that selectively neutralizes IL-17A, which is found in high concentrations in skin affected by psoriasis and is a preferred target for investigational therapies. In the phase III program, secukinumab demonstrated a favorable safety profile, with a similar incidence and severity of adverse events between the secukinumab treatment arms (150 and 300 mg).
In January 2015, secukinumab (at a dose of 300 mg) became the only IL-17A inhibitor approved in the U.S. as a treatment for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Secukinumab is also in phase III development for the treatment of psoriatic arthritis and ankylosing spondylitis; global regulatory applications are planned for 2015.
Psoriasis affects up to 3% of the world's population, or more than 125 million people. According to an analysis of surveys conducted of 5,600 patients by the National Psoriasis Foundation between 2003 and 2011, 52% of patients with mild, moderate, or severe psoriasis were dissatisfied with their disease management. Of the patients surveyed, some were receiving no treatment (9.4% to 49.2%) or were undertreated (10.2% to 55.5%).
Source: Novartis; March 21, 2015.