• Feature

    1. Professor Christopher Griffiths

      Professor Christopher Griffiths, (University of Manchester, UK) discusses psoriasis, and the treatment options currently available for the disease.

    2. Professor Kristian Reich

      Professor Kristian Reich (Dermatologikum Hamburg, Hamburg, Germany) discusses psoriasis, and the role of interleukin-17A (IL-17A) plays in the disease.

  • Media

    1. NoImage

      Global Psoriasis Infographic

    2. NoImage

      Global IL-17A Infographic

  • Related Documents

    1. Global Psoriasis Backgrounder

    2. Global IL-17A Backgrounder

    3. Global Psoriasis Infographic

    4. Global IL-17A Infographic

    5. Image: Severe Plaque Psoriasis

    6. Image: Severe Plaque Psoriasis

  • Jul 09, 2014 11:00 PM WES

    Novartis announces NEJM publication of two phase III studies demonstrating high efficacy of secukinumab (AIN457) in psoriasis patients

    • Results of two phase III psoriasis studies consistently show rapid, very high skin clearance, sustained efficacy and an acceptable safety profile with secukinumab1

    • More than 70% of secukinumab 300 mg patients experienced clear (PASI 100) or almost clear skin (PASI 90) during the first 16 weeks of treatment1

    • If approved, secukinumab could address a high unmet need for new psoriasis treatments, as up to 50% of patients are dissatisfied with current therapies2,3

    • Secukinumab is the first IL-17A inhibitor with phase III data presented in psoriasis and regulatory submissions filed with global health authorities

    Basel, 9 July 2014 – Novartis today announced that detailed results from two pivotal phase III studies evaluating the interleukin-17A (IL-17A) inhibitor secukinumab (AIN457) were published online today in the New England Journal of Medicine (NEJM). Secukinumab met all primary and key secondary endpoints at Week 12 in the ERASURE and FIXTURE studies, showing superiority to Enbrel®* (etanercept) in improving moderate-to-severe plaque psoriasis symptoms in the FIXTURE study, and superiority over placebo in both studies1.
    Over half of secukinumab 300 mg patients experienced clear (PASI 100) or almost clear (PASI 90) skin, described as Psoriasis Area and Severity Index 90 or 100 (PASI 90/PASI 100) by Week 12 (59.2% for ERASURE and 54.2% for FIXTURE, p<0.001)
    1. In comparison, only 20.7% of Enbrel-treated patients experienced PASI 90 or 100 in FIXTURE1. Secukinumab 300 mg patients’ response continued to improve from Week 12, with more than 70% experiencing clear or almost clear skin by Week 16 (72.4% and 36.8% for PASI 90 and 100, respectively) in the FIXTURE study, which was maintained in the majority of patients up to Week 52 (with continued treatment)1.
    PASI measures the redness, scaling and thickness of psoriatic plaques and the extent of involvement in each region of the body. Treatment efficacy is assessed by the reduction of the score from baseline (i.e. a 75% reduction is known as PASI 75, a 90% reduction is known as PASI 90, and PASI 100 is completely clear skin). PASI 90 and 100 are more robust measures of the extent of skin clearance compared to standard measures
    4, such as PASI 75, that have been used in most psoriasis clinical studies.
    “The publication of two pivotal phase III studies in NEJM showing consistently high efficacy of secukinumab validates IL-17A as a preferred treatment target in psoriasis,” said David Epstein, Division Head, Novartis Pharmaceuticals. “These data, which are part of our regulatory submissions, are important as there is a high need for effective new therapies for people living with this debilitating disease.”
    Psoriasis is a chronic autoimmune disease characterized by thick and extensive skin lesions, called plaques, known to cause itching, scaling and pain
    5 that is associated with significant impairment of physical and psychological quality of life6,7. Up to 50% of patients are dissatisfied with their current psoriasis therapies, including approved biologics2,3, indicating a high need for new therapies that act rapidly with prolonged duration to relieve the debilitating symptoms8,9.
    Data published in NEJM also show that secukinumab-treated patients had their symptoms resolved faster than those treated with Enbrel in the FIXTURE study
    1. Clinically relevant differences were observed as early as Week 2, and on average secukinumab 300 mg patients had their symptoms halved by Week 3, compared to Week 7 for Enbrel patients1.
    In addition to high rates of clear to almost clear skin, secukinumab patients also reported superior improvements in itching, pain and scaling, compared to placebo at Week 12, in ERASURE
    1. Similarly, health-related quality of life (HRQoL) was significantly improved among secukinumab-treated patients at Week 12 compared to placebo in both studies, as assessed by the Dermatology Quality of Life Index (DLQI)1. The effect of psoriasis on quality of life has been shown to be similar to diseases such as cancer, heart disease, arthritis, type 2 diabetes and depression10.
    In ERASURE and FIXTURE secukinumab exhibited an acceptable safety profile consistent with phase II studies
    1. In both studies, the incidence of adverse events (AEs) was similar between both secukinumab treatment arms (300 mg and 150 mg), and were slightly higher than in the placebo group during the 12-week induction period, mostly consisting of mild to moderate upper respiratory tract infections1. Incidences of AEs in the secukinumab groups during induction and the entire 52-week treatment period in FIXTURE were comparable with Enbrel1.

  • Full Press Release

About Novartis

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 135,000 full-time-equivalent associates and sell products in more than 150 countries around the world. For more information, please visit http://www.novartis.com.

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