Novartis presents new data showing that the majority of patients are able to maintain clear or almost clear skin with Cosentyx across 3 years
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Novartis International AG /
Novartis presents new data showing that the majority of patients are able to
maintain clear or almost clear skin with Cosentyx across 3 years
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The issuer is solely responsible for the content of this announcement.
* Late-breaking data at EADV show that 8 out of 10 of psoriasis patients (83%)
achieved 75% skin clearance (PASI 75) with Cosentyx(TM) after three
years[1]
* 6 out of 10 patients (64%) had clear or almost clear skin (PASI 90 to PASI
100) with Cosentyx 300 mg at year three[1]
* Favorable safety profile seen with no new or unexpected safety signals[1]
The digital press release with multimedia content can be accessed here:
Basel, October 10, 2015 - Novartis announced today new late-breaking data
demonstrating that Cosentyx(TM) (secukinumab) provides high levels of skin
clearance and sustained efficacy in patients with moderate-to-severe plaque
psoriasis while maintaining a favorable safety profile across three years[1].
The results of this study - the longest Phase III Cosentyx trial conducted to-
date - were presented at the 24(th) Annual Congress of the European Academy of
Dermatology and Venereology (EADV) in Copenhagen, Denmark. Cosentyx is the first
fully human interleukin-17A (IL-17A) inhibitor approved to treat adult moderate-
to-severe plaque psoriasis[2]-[4].
In this extension study, 320 patients received Cosentyx in a fixed dosing
schedule for three years. 69% achieved clear or almost clear skin (PASI 90) at
year one. This response was extremely well maintained after three years with
64% of patients continuing to have a PASI 90 response. In addition, 43% of
patients maintained completely clear skin (PASI 100) at year three (from 44% at
year one). 83% achieved the standard treatment goal of PASI 75 skin clearance at
three years[1].
"Psoriasis patients want therapies that maintain high levels of skin clearance
over the long-term given the impact of the disease on their physical and
psychological wellbeing," said Vasant Narasimhan, Global Head of Development,
Novartis Pharmaceuticals. "In these new data from our longest Phase III trial to
date with Cosentyx, we are pleased to show patients were able to maintain clear
or almost clear skin for up to three years."
The PASI score assesses the reduction from baseline in the redness, scaling and
thickness of psoriatic plaques and to what extent it affects each area of the
body[5],[6],[7]. PASI 75 has historically been considered the goal for psoriasis
treatment. However, with newer treatments with increased efficacy, there is now
a focus on PASI 90 (clear or almost clear skin) and PASI 100 (clear skin) as the
ultimate goal for treatment, as recommended by clinical guidelines and
regulatory authorities[5].
In this study, Cosentyx had a favorable safety profile consistent with that
observed in previous Phase III studies[1],[8]-[12].
About the A2304E1 Extension Study (Cosentyx Extension Study to SCULPTURE and
STATURE studies)
A2304E1 is a multicenter, double-blind and open-label, four-year extension to
the pivotal Phase III SCULPTURE and STATURE studies. In SCULPTURE 642 patients
who completed 52 weeks of treatment continued into the extension. During the
core study, PASI 75 responders at Week 12 were randomized to double-blind
maintenance treatment of subcutaneous secukinumab 300 mg or 150 mg, administered
either at a four-week fixed-interval (FI) regimen (320 patients) or in a
retreatment-as-needed (RAN) regimen (322 patients). At entry into the extension,
patients continued with the same blinded maintenance treatment regimen and dose
that they had received in the SCULPTURE core study[1].
The primary objective of the extension study was to assess the long-term safety
and tolerability of Cosentyx in patients with moderate-to-severe chronic plaque
psoriasis. The secondary objective was to evaluate long-term efficacy of 300 mg
and 150 mg Cosentyx administered in retreatment-as-needed versus fixed-interval
regimens in patients who were PASI 75 responders at Week 12. Efficacy measures
included proportion of patients achieving PASI 75, PASI 90 and PASI 100 as well
as IGA mod 2011 0/1 responses[1].
About psoriasis
Psoriasis affects up to 3% of the world's population, or more than 125 million
people[5]. This common and distressing condition is not simply a cosmetic
problem, even people with very mild symptoms are affected every day[8].
According to an analysis of surveys conducted on 5,600 patients by the National
Psoriasis Foundation (NPF) between 2004 and 2011, 52% of patients with mild,
moderate and severe psoriasis were dissatisfied with their disease
management[13]. Of the patients surveyed, some were receiving no treatment (9.4-
49.2%) or were undertreated[13].
About Cosentyx (secukinumab) and interleukin-17A (IL-17A)
Cosentyx is a human monoclonal antibody that selectively neutralizes circulating
interleukin-17A (IL-17A)[14],[15]. IL-17A is found in high concentrations in
skin affected by psoriasis and is a preferred target for investigational
therapies[14]-[19]. Cosentyx works by inhibiting the action of IL-17A, a protein
found in high concentrations in skin affected by the disease[14]-[19].
In January 2015, Cosentyx (secukinumab) (at a recommended dose of 300 mg in the
EU/US) became the first IL-17A inhibitor approved in Europe and the US. In
Europe, Cosentyx is the only first-line biologic approved for the systemic
treatment of moderate-to-severe plaque psoriasis in adult patients. In the US,
Cosentyx is approved as a treatment for moderate-to-severe plaque psoriasis in
adult patients who are candidates for systemic therapy or phototherapy (light
therapy). In addition to the EU and the US, Cosentyx has been approved in
Switzerland, Australia, Canada and a number of other countries for the treatment
of moderate-to-severe plaque psoriasis and in Japan for the treatment of
moderate-to-severe plaque psoriasis and psoriatic arthritis (PsA). More than
9,600 patients have been treated with Cosentyx in clinical trials across
multiple indications, and over 9,000 patients have been treated in the post-
marketing setting[8]-[12],[20].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "can," "investigational," or similar terms, or by express or
implied discussions regarding potential new indications or labeling for
Cosentyx, or regarding potential future revenues from Cosentyx. You should not
place undue reliance on these statements. Such forward-looking statements are
based on the current beliefs and expectations of management regarding future
events, and are subject to significant known and unknown risks and
uncertainties. Should one or more of these risks or uncertainties materialize,
or should underlying assumptions prove incorrect, actual results may vary
materially from those set forth in the forward-looking statements. There can be
no guarantee that Cosentyx will be submitted or approved for any additional
indications or labeling in any market, or at any particular time. Nor can there
be any guarantee that Cosentyx will be commercially successful in the future. In
particular, management's expectations regarding Cosentyx could be affected by,
among other things, the uncertainties inherent in research and development,
including unexpected clinical trial results and additional analysis of existing
clinical data; unexpected regulatory actions or delays or government regulation
generally; the company's ability to obtain or maintain proprietary intellectual
property protection; general economic and industry conditions; global trends
toward health care cost containment, including ongoing pricing pressures;
unexpected safety issues; unexpected manufacturing or quality issues, and other
risks and factors referred to in Novartis AG's current Form 20-F on file with
the US Securities and Exchange Commission. Novartis is providing the information
in this press release as of this date and does not undertake any obligation to
update any forward-looking statements contained in this press release as a
result of new information, future events or otherwise.
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 and cost-saving generic pharmaceuticals. Novartis is the only global
company with leading positions in these areas. In 2014, the Group achieved net
sales of USD 58.0 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 120,000
full-time-equivalent associates. Novartis products are available in more than
180 countries around the world. For more information, please visit
http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
References
[1] Bissonnette R., et al. Secukinumab maintains high levels of efficacy through
3 years of treatments: results from an extension to a phase 3 study (SCULPTURE).
Presented as a late breaking abstract at the European Academy of Dermatology and
Venereology 2015. October 10 2015
[2] European Medicines agency website, "Enbrel Summary of Product
Characteristics"
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/h
uman/000262/WC500027361.pdf (link is external). Accessed September 2015.
[3] European Medicines agency website, "Humira Summary of Product
Characteristics"
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/h
uman/000481/WC500050870.pdf (link is external). Accessed September 2015.
[4] European Medicines agency website, "Stelara Summary of Product
Characteristics"
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/
(link is external)
human/000958/WC500058513.pdf (link is external). Accessed September 2015.
[5] International Federation of Psoriasis Associations (IFPA) World Psoriasis
Day website. "About Psoriasis."
http://www.worldpsoriasisday.com/web/page.aspx?refid=114. Accessed September
2015
[6] Mrowietz, U. Implementing treatment goals for successful long-term
management of psoriasis. Journal of the European Academy of Dermatology and
Venereology, 26:12-20. Doi: 10.1111/j. 1468-3083.2011.04411.
[7] Guideline on clinical investigation of medicinal products indicated for the
treatment of psoriasis. European Medicines Agency Web site.
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/0
9/WC500003329.pdf. Accessed September 2015.
[8] Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in Plaque Psoriasis -
Results of Two Phase Three Trials. N Engl J Med. 2014; 371(4):326-338.
[9] Thaçi D, Humeniuk J, Frambach Y, et al. Secukinumab in Psoriasis:
Randomized, Controlled Phase 3 Trial Results Assessing the Potential to Improve
Treatment Response in Partial Responders (STATURE). Br J Dermatol.
173: 777-787. Doi: 10.1111/bjd.13814.
[10] Paul C, Lacour JP, Tedremets L, et al. Efficacy, safety, and usability of
secukinumab administration by autoinjector/pen in psoriasis: a randomized,
controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol. 2014 Sep 22 [E-pub
ahead of print].
[11] Thaçi D, Blauvelt A, Reich K, et al. Secukinumab is superior to ustekinumab
in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a
randomized controlled trial. J Am Acad Dermatol. 2015 17(th) June [E-pub ahead
of print].
[12] Papp KA, Langley RG, Sigurgeirsson B, et al. Efficacy and safety of
secukinumab in the treatment of moderate-to-severe plaque psoriasis: a
randomized, double-blind, placebo-controlled phase II dose-ranging study. Brit J
Dermatol. 2013; 168(2): 412-421.
[13] Armstrong AW, Robertson AD, Wu J, Schupp C, Lebwohl MG. Undertreatment,
treatment trends, and treatment dissatisfaction among patients with psoriasis
and psoriatic arthritis in the United States: findings from the National
Psoriasis Foundation surveys, 2003-2011. JAMA Dermatol. 2013;149(10):1180-1185.
[14] Gaffen SL. Structure and signaling in the IL-17 receptor family. Nat Rev
Immunol. 2009;9(8):556-67.
[15] Ivanov S, Linden A. Interleukin-17 as a drug target in human disease.
Trends Pharmacol Sci. 2009;30(2):95-103.
[16] Kopf M, Bachmann MF, Marsland BJ. Averting inflammation by targeting the
cytokine environment. Nat Rev Drug Discov. 2010; 9(9):703-18.
[17] Onishi RM, Gaffen SL. Interleukin-17 and its target genes: mechanisms of
interleukin-17 function in disease. Immunology. 2010;129(3):311-21.
[18] Krueger J, Fretzin S, Suárez-Fariñas M, et al. IL-17A is essential for cell
activation and inflammatory gene circuits in subjects with psoriasis. J Allergy
Clin Immunol. 2012;130(1):145-154.
[19] Johansen C, Usher PA, Kjellerup RB, et al. Characterization of the
interleukin-17 isoforms and receptors in lesional psoriatic skin. Brit J
Dermatol. 2009;160(2):319-24.
[10] Novartis data on file, September 2015.
# # #
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Datum: 10.10.2015 - 07:15 Uhr
Sprache: Deutsch
News-ID 426083
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