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.
Novartis Specialty Dermatology Data at EADV 2014
Dr John Hohneker - Senior Vice President, Global Developement Franchise Head, Integrated Hospital Care, Novartis Pharmaceuticals
Psoriasis: An Incurable Chronic Skin Disease Infographic
See below for PDF version
About Interleukin 17-A (IL-17A) Infographic
See below for PDF version
Oct 10, 2014 11:20 AM WES
Novartis data at EADV show consistent efficacy of AIN457 (secukinumab) in clearing skin of psoriasis patients
· New analyses of Phase III data show consistent efficacy in clearing psoriasis skin with AIN457 (secukinumab) regardless of how bad patients’ disease is at start of treatment1
· Significant positive responses to secukinumab seen in patients with severe psoriasis at start of treatment1
· Significant positive relationship between achieving clear to almost clear skin and psoriasis patients’ health-related quality of life, as shown by additional secukinumab analyses2
· Regulatory reviews for secukinumab are underway; a US FDA advisory committee meeting is scheduled for 20 October and CHMP recommendation is anticipated in Q4 2014
Basel, 10 October 2014 – Novartis today announced that new analyses of AIN457 (secukinumab) Phase III studies showed that treatment with secukinumab 300 mg resulted in higher rates of clear to almost clear skin at Week 12 versus placebo, regardless of patients’ psoriasis disease severity (p<0.0001)1. This data was presented at the European Association of Dermatology and Venereology (EADV) Congress, in Amsterdam, Netherlands. Secukinumab’s new mode of action stops interleukin-17A (IL-17A), which plays a central role in the development of psoriasis3-8.
In the analyses, the majority of patients across two disease severity subgroups, including those with severe psoriasis, experienced complete clear to almost clear skin measured as 100 or 90% reduction of respective baseline PASI (Psoriasis Area and Severity Index) (p<0.0001)1. Skin clearance was sustained through one year of treatment (p<0.0001)1. This is important as historically, psoriasis patients’ disease severity at the start of treatment has been shown to negatively impact their response to other therapies9,10. Disease severity subgroups were PASI ≤20 and PASI >201. PASI measures redness, scaling and thickness of psoriatic plaques and the impact in regions of the body11. These findings reconfirm the significantly better responses seen in the published FIXTURE study, where secukinumab showed superiority to Enbrel®* (etanercept), a standard of care anti-TNF medication12.
“We are excited to continue seeing new positive results for secukinumab in psoriasis, this time showing consistent high rates of skin clearance regardless of disease severity as well as the positive relationship clearing skin has on patients’ quality of life,” said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. “With global regulatory approvals anticipated shortly, we hope to bring secukinumab to patients living with this debilitating disease, which impacts much more than their skin.”
In addition to the disease severity data, another secukinumab analysis showed that significantly more patients on active treatment experienced clear or almost clear skin with no quality of life impairment, as measured by PASI 100/PASI 90 and the Dermatology Quality of Life Index (DLQI) 0/1, compared to those with PASI scores less than 90 (p<0.001)2. In the analyzed studies, more than 70% of secukinumab 300 mg patients experienced clear or almost clear skin during the first 16 weeks of treatment12.
Psoriasis’ effect on patients’ quality of life is similar to cancer, heart disease, arthritis, type 2 diabetes and depression13-15. The painful symptoms limit psoriasis patients’ ability to undertake daily activities and impact their social relationships14,15.
About the disease severity analyses
The analyses pooled data from four pivotal Phase III studies of secukinumab in moderate-to-severe plaque psoriasis: ERASURE, FIXTURE, FEATURE and JUNCTURE12,16.
ERASURE (Efficacy of Response And Safety of two fixed secUkinumab REgimens in psoriasis), FIXTURE (the Full year Investigative eXamination of secukinumab vs. eTanercept Using 2 dosing Regimens to determine Efficacy in psoriasis), FEATURE (First study of sEcukinumAb in pre-filled syringes in subjecTs with chronic plaqUe-type psoriasis REsponse) and JUNCTURE (Judging the efficacy of secUkinumab in patients with psoriasis using autoiNjector: a Clinical Trial evalUating treatment REsults) are part of the secukinumab Phase III program in moderate-to-severe plaque psoriasis, which involved more than 3,300 patients in over 35 countries12,16.
All studies assessed the efficacy, safety and tolerability of the induction period (at Week 12) and maintenance therapy (at Week 52) with secukinumab 300 mg or 150 mg in patients with moderate-to-severe plaque psoriasis. The studies were multicenter, randomized, double-blind, placebo-controlled (FIXTURE: also active controlled), parallel-group trials12,16.
Secukinumab had an acceptable safety profile consistent with Phase II studies; incidence of adverse events was similar between both secukinumab treatment arms (300 mg and 150 mg)12,16.
About the PASI 90 HRQoL analysis presented at EADV
The analysis focused on patients on active treatment in the FIXTURE and ERASURE studies2.
About secukinumab (AIN457) and interleukin-17A (IL-17A)
Secukinumab (AIN457) is a fully human monoclonal antibody being investigated for diseases that affect the immune system3-5. Secukinumab stops a protein called interleukin-17A (IL-17A) from its involvement in the development of psoriasis3-8. IL-17A is found in high concentrations in skin affected by psoriasis and is a preferred target for investigational therapies3-8.
Secukinumab is the first therapy selectively targeting IL-17A to publish Phase III results in psoriasis and to report results in psoriatic arthritis (PsA). Regulatory submissions for secukinumab in the EU and US were completed in 2013.
Phase III results for secukinumab in moderate-to-severe plaque psoriasis were first presented in October 2013 and March 2014. Phase IIIb studies are also ongoing, including the head-to-head CLEAR study of secukinumab versus Stelara®** in moderate-to-severe plaque psoriasis and studies in palmo-plantar psoriasis, nail psoriasis and palmo-plantar pustulosis. Secukinumab is also in clinical trials for the treatment of ankylosing spondylitis (AS) and rheumatoid arthritis (RA).
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.