The FINANCIAL — Novartis announced on March 12 that new results for Cosentyx(TM) (secukinumab) in moderate-to-severe plaque psoriasis, including detailed findings from the head-to-head CLEAR study and long-term data from the Phase III program, will be presented as late breaking research at the 73rd Annual Meeting of American Academy of Dermatology (AAD), from 20 – 24 March in San Francisco, California, USA.
In total, 25 posters from the Novartis Dermatology portfolio will be highlighted at this leading congress, according to Novartis.
New data from the CLEAR study will include results that demonstrate Cosentyx is superior to Stelara®* (ustekinumab) in clearing skin (PASI 90 and PASI 100) at Week 16[1]. CLEAR is the first Phase III psoriasis study designed with a PASI 90 objective, which is considered an important measure of treatment success by the European Medicines Agency[5] and an optimal treatment goal for patients[6].
In addition, new long-term results for Cosentyx up to two years from the Phase III program will be highlighted for the first time at the congress. The data comes from an extension of the pivotal FIXTURE and ERASURE studies. In the FIXTURE study, Cosentyx cleared the skin of 72% psoriasis patients compared to 31% for Enbrel®** (etanercept) at Week 16[7].
“We are excited to present new late-breaking research at AAD, following the back-to-back regulatory approvals received earlier this year,” said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. “Our commitment is to keep demonstrating more evidence on the ability of Cosentyx to clear psoriasis skin, to inform physicians and give hope to people living with this life-long disease who need treatments that provide long-term relief.”
In January 2015, Cosentyx (at a dose of 300 mg) became the first and only interleukin-17A (IL-17A) inhibitor approved in Europe as a first-line systemic treatment of moderate-to-severe plaque psoriasis in adult patients, and in the US as a treatment for moderate-to-severe plaque psoriasis in adult psoriasis patients who are candidates for systemic therapy (a drug that is absorbed into the bloodstream and distributed to all parts of the body) or phototherapy (light therapy)[7]. In addition to the EU and the US, Cosentyx has been approved in Switzerland, Chile, Australia and Canada for the treatment of moderate-to-severe plaque psoriasis and in Japan for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis (PsA).
Novartis dermatology highlights at AAD 2015
Cosentyx presentations
A total of 18 Cosentyx abstracts will be presented for the first time at AAD 2015, including:
Late-breaking oral presentations:
Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: 16-week results from the CLEAR study (Friday 20 March, 10:00 PST / 18:00 CET)
Secukinumab treatment maintains efficacy in moderate-to-severe plaque psoriasis through second year of treatment: a randomized extension of the ERASURE and FIXTURE studies (Friday 20 March, 11:00 PST / 19:00 CET)
Highlights of electronic posters available throughout the congress:
Secukinumab demonstrates sustained efficacy in moderate-to-severe plaque psoriasis across disease severity subgroups
Secukinumab shows efficacy in subjects regardless of previous exposure to biologic therapy: a pooled subanalysis from four Phase 3 clinical trials in psoriasis
Pooled analysis of phase 3 ERASURE and FIXTURE trials: Secukinumab 300 mg shows superior efficacy in moderate to severe plaque psoriasis vs. placebo in ERASURE vs. etanercept 50 mg and placebo in FIXTURE across subjects’ body weight groups
Secukinumab long-term self-administration by prefilled syringe or auto-injector/pen is highly acceptable to subjects with moderate-to-severe plaque psoriasis
Secukinumab, a novel anti-IL-17A antibody, exhibits low immunogenicity in clinical trials and human in vitro Assays
Other Cosentyx Phase III analyses at AAD 2015 include the efficacy and safety of Cosentyx in Asian patients and North American patients, efficacy on the head and neck, scalp psoriasis and a Phase III safety analysis.
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