About Psoriasis and IL-17
Professor Kristian Reich (Dermatologikum Hamburg, Hamburg, Germany) discusses psoriasis, and the role of interleukin-17A (IL-17A) plays in the disease.
Professor Christopher Griffiths, (University of Manchester, UK) discusses psoriasis, and the treatment options currently available for the disease.
Burden of Chronic Spontaneous Urticaria Infographic
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Psoriasis: An Incurable Chronic Skin Disease Infographic
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Novartis showcases dermatology leadership on International Urticaria Day announcing new data to be presented at EADV 2014
· New data for the IL-17A inhibitor AIN457 (secukinumab) in psoriasis and Xolair® in Chronic Spontaneous Urticaria (CSU) at EADV to highlight benefit to patients’ quality of life
· Data continue to reinforce the landmark Phase III results of secukinumab in psoriasis and Xolair in CSU that showed consistent, fast efficacy and acceptable safety1-4
· Important head-to-head trial of secukinumab versus Stelara® (CLEAR), powered to evaluate superiority in clearing skin, completed patient enrolment in record time
Basel, 1 October 2014 – Novartis announced today, on the first-ever International Urticaria Day, that 15 abstracts from the Novartis specialty dermatology portfolio, will be presented at the European Association of Dermatology and Venereology (EADV) Congress, 8-12 October, in Amsterdam, Netherlands.
The abstracts include new analyses of pivotal Phase III studies for AIN457 (secukinumab) in moderate-to-severe plaque psoriasis and Xolair® (omalizumab) in Chronic Spontaneous Urticaria (CSU) highlighting benefit to patients’ quality of life. The new data to be presented at EADV continue to reinforce the previously presented landmark Phase III results of secukinumab in psoriasis and Xolair in CSU that showed consistent, fast efficacy in the treatment of these debilitating diseases1-4.
In an update on ongoing Novartis dermatology trials, the Phase IIIb CLEAR study finished full enrolment of 679 moderate-to-severe plaque patients earlier than expected after recruitment started in February 2014. CLEAR is the second head-to-head secukinumab study versus a biologic treatment and will compare the long-term safety, tolerability and efficacy of secukinumab versus Stelara®* (ustekinumab), a current standard-of-care therapy. Results are anticipated in the coming months.
“Psoriasis and CSU are serious diseases that have a significant negative impact on quality of life,” said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. “With our new data at EADV 2014 and the record-breaking enrolment timeline of the CLEAR study, we are excited to continue generating important clinical evidence of the impact of secukinumab and Xolair on patients.”
Novartis specialty dermatology portfolio highlights at EADV 2014 include:
Oral presentations of Xolair’s impact on CSU patients’ quality of life from the Phase III studies
· Omalizumab reduced symptoms and improved health-related quality of life (HRQoL) in patients with CSU: an analysis from three randomized Phase III trials (abstract FC07; 11 October, 9.45 – 11.15 CET)
· A positive correlation between changes in urticaria symptoms (UAS7) and dermatologic‐related quality of life (DLQI) and urticaria‐specific quality of life (CUQ2oL): Is it informative about the response to treatment in CSU patients? (abstract FC07; 11 October, 9.45-11.15 CET)
Highlights of electronic posters available throughout the EADV congress
· Psoriasis patients with clear or almost clear skin (categorized as Psoriasis Area and Severity Index 90 (PASI 90) to PASI 100) achieved greater health-related quality of life improvements than those with PASI 75 response, according to a sub-analysis of Phase III data
· Secukinumab shows efficacy regardless of baseline disease severity in moderate-to-severe plaque psoriasis patients, according to a pooled analysis of Phase III studies
· Secukinumab 300 mg demonstrated the highest probability of efficacy in clearing skin compared to other biologics currently approved to treat psoriasis, based on a mixed treatment comparison using data from a systematic literature review
Additional secukinumab Phase III analyses at EADV 2014 include data on sustained response, fast relief of disease burden, efficacy (at different treatment stages and in psoriatic arthritis patients), in addition to the further benefit of secukinumab treatment measured by health-related patient quality of life.
Additional analyses of Xolair pivotal Phase III studies include:
o First demonstration that improvements in urticaria symptoms result in substantial reductions in daytime sleepiness and sleep disturbance
o Pooled analyses of safety data from three pivotal Phase III studies (975 patients) with no new safety signals
o Demonstration that chronic hives, a symptom of CSU, is associated with significant burden across multiple areas of quality of life, greater impairment in work and increased utilization of health resources from the patients’ perspective
· A straight pathway for patients with chronic spontaneous urticaria (9 October, 17:00 – 18:30 CET)
· Revealing a clear path towards a new era in the management of psoriasis (10 October, 17:00 – 18:30 CET)
About AIN457 (secukinumab)
AIN457 (secukinumab) is a fully human monoclonal antibody (a special type of infection fighting cell produced in a laboratory) being investigated for diseases that affect the immune system5-7. Secukinumab stops a protein called interleukin-17A (IL-17A) from its involvement in the development of psoriasis and other inflammatory diseases, including psoriatic arthritis (PsA) and ankylosing spondylitis (AS)5-9. IL-17A is found in high concentrations in skin affected by psoriasis and is a preferred target for investigational therapies5-10.
Secukinumab is the first medicine selectively targeting IL-17A with positive Phase III results for the treatment of psoriasis and PsA. Phase III results for secukinumab in moderate-to-severe plaque psoriasis were first presented in October 2013 and March 2014. Following the presentation of the first psoriasis Phase III results in secukinumab in October 2013, EU and US regulatory filings were submitted at the end of 2013. Results from Phase III studies for arthritic conditions (PsA and AS) will be presented in late 2014.
Xolair (omalizumab) is a targeted therapy that binds to immunoglobulin E (IgE)11,12. Xolair suppresses histamine-induced skin reactions, probably through its reduction of IgE and downstream effects on cellular activation mechanisms11. Research is ongoing to understand the mechanism of action of Xolair in CSU, which could lead to a deeper understanding of how the disease develops12.
Xolair is approved for the treatment of refractory chronic spontaneous urticaria (CSU) in the EU and Switzerland, as well as in more than 25 other countries, and in the US and Canada for refractory chronic idiopathic urticaria (CIU) as it is known there. Xolair is approved for the treatment of moderate to severe persistent allergic asthma in more than 90 countries, including the US since 2003 and the EU since 2005 and has over 500,000 patient years of exposure11. In the EU, it is also approved for the treatment of severe persistent allergic asthma in children (aged six and above), adolescents and adults. In addition, a liquid formulation of Xolair in pre-filled syringes has been approved in Australia and in the EU and launched in most European countries. Novartis co-promotes Xolair with Genentech/Roche in the US and shares a portion of the operating income, but does not book US sales.
About Novartis in specialty dermatology
Novartis is committed to developing innovative, life-changing specialty dermatology therapies, redefining treatment paradigms and transforming patient care in severe skin diseases where there are remaining high unmet medical needs. The Novartis specialty dermatology portfolio includes Xolair® (omalizumab) and secukinumab (AIN457). There are also more than 10 compounds in early stage development for a wide range of severe skin diseases in the Novartis specialty dermatology portfolio. For more information about the Novartis commitment to severe skin disease care, please visit: www.skintolivein.com.
Full Press Release
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.