Novartis late-breaking data show Cosentyx delivers high and long-lasting skin clearance over 4 years for psoriasis patients
(Thomson Reuters ONE) -
Novartis International AG /
Novartis late-breaking data show Cosentyx delivers high and long-lasting skin
clearance over 4 years for psoriasis patients
. Processed and transmitted by Nasdaq Corporate Solutions.
The issuer is solely responsible for the content of this announcement.
* Cosentyx(® )delivers long-lasting clear or almost clear skin (PASI 90 to
PASI 100) in the vast majority of patients and continues to show a favorable
safety profile over 4 years[1]
* New data show that with Cosentyx almost 100% of PASI 90 and PASI 100
response rates are maintained from Year 1 to Year 4[1]
* Cosentyx significantly superior to Stelara(®) in delivering long-lasting
skin clearance in psoriasis over 52 weeks, confirms new JAAD publication[2]
The digital press release with multimedia content can be accessed here:
Basel, October 01, 2016 - Novartis announced today new data showing Cosentyx(®)
(secukinumab) delivers high and long-lasting skin clearance in patients with
moderate-to-severe plaque psoriasis out to 4 years of treatment[1]. These late-
breaking data were presented for the first time at the 25(th) European Academy
of Dermatology and Venereology (EADV) Congress in Vienna, Austria.
"These impressive results show that Cosentyx keeps working year-on-year,
maintaining high levels of skin clearance with a favorable safety profile," said
Vasant Narasimhan, Global Head, Drug Development and Chief Medical Officer,
Novartis. "Psoriasis patients need therapies they can use over long periods of
time without loss of efficacy and we are pleased that Cosentyx is proving a
sustainable choice for patients."
The aim of psoriasis treatment is clear skin, and the Psoriasis Area Severity
Index (PASI) 90 response is considered an important measure of treatment
success[3]-[6]. Clear or almost clear skin (PASI 90) was achieved by 68.5% of
patients at Year 1 and this high rate was maintained to Year 4 (66.4%)[1]. In
addition, 43.8% of psoriasis patients achieved completely clear skin (PASI 100)
at Year 1 and this rate (43.5%) was maintained to Year 4. The average
improvement of psoriasis as measured by the PASI score was maintained at over
90% after 4 years of treatment*. The standard goal of treatment, PASI 75
response, was achieved by 88.5% of patients at Year 4. In this long-term study,
Cosentyx continues to have a favorable safety profile, which was consistent with
that demonstrated in previous Phase III studies.
Also presented at EADV were results demonstrating the longer-term efficacy (1.5
years) of Cosentyx in treating psoriasis of the hands and feet (palmoplantar),
which are considered difficult areas to treat on the body[7]. Approximately 60%
of patients achieved clear or almost clear palms and soles with Cosentyx, which
continued to improve over 1.5 years[7]. This demonstrates the strength of
Cosentyx as an important treatment option for patients with psoriasis on these
parts of their body that are crucial for everyday function. These patients are
known to suffer greater disability and discomfort than those with psoriasis on
other areas[8].
Newly published data also show Cosentyx delivers superior, long-lasting skin
clearance versus Stelara(®**) (ustekinumab) for up to 1 year in patients with
moderate-to-severe psoriasis: 76% for Cosentyx vs. 61% for Stelara (P<0.0001) at
52 weeks[2]. Cosentyx has now shown superior and sustained results versus both
Stelara and Enbrel(®***), two widely used biologic treatments[2],[9]. This head-
to-head CLEAR study was published in advance of the EADV congress in the Journal
of the American Academy of Dermatology (JAAD).
About Cosentyx and interleukin-17A (IL-17A)
Cosentyx is a fully human monoclonal antibody that selectively neutralizes IL-
17A. Research suggests that IL-17A may play an important role in driving the
body's immune response in psoriasis, ankylosing spondylitis (AS) and psoriatic
arthritis (PsA)[10],[11].
Cosentyx is approved in more than 65 countries for the treatment of moderate-to-
severe plaque psoriasis which includes the European Union countries, Japan,
Switzerland, Australia, the US and Canada. In Europe, Cosentyx is approved for
the first-line systemic treatment of moderate-to-severe plaque psoriasis in
adult patients[12]. 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)[13].
In addition, Cosentyx is the first IL-17A inhibitor approved in more than 50
countries for the treatment of active AS and PsA, which includes the European
Union countries and the US. Cosentyx is also approved for the treatment of PsA
and pustular psoriasis in Japan.
More than 10,000 patients have been treated with Cosentyx in clinical trial
settings across multiple indications, and over 50,000 patients have been treated
in the post-marketing setting[14].
About the 4 year Cosentyx efficacy study (A2304E1)[1]
A2304E1 is a multicenter, double-blind and open-label, 4 year extension to the
pivotal Phase III SCULPTURE study. In SCULPTURE, PASI 75 responders at Week 12
were randomized to double-blind maintenance treatment of Cosentyx 300 mg or 150
mg, given either at a 4-week fixed-interval regimen or in a retreatment-as-
needed regimen. This same treatment regimen was applied for the 642 patients who
completed the 52 weeks of treatment and then continued into the extension.
The primary objective of this extension study was to assess the long-term safety
and tolerability of Cosentyx in patients with moderate-to-severe plaque
psoriasis. Efficacy measures included proportion of patients achieving PASI 75,
PASI 90 and PASI 100.
About the CLEAR study
CLEAR (Comparison to assess Long-term Efficacy, sAfety and toleRability of
secukinumab vs. ustekinumab) is a multi-center, double-blind, parallel-group
study of Cosentyx (n=335) versus Stelara (n=336) to compare efficacy, safety,
and tolerability in adults with moderate-to-severe plaque psoriasis. Patients
were randomized to receive either Cosentyx (300 mg) by subcutaneous injection at
Baseline, Weeks 1, 2, and 3, then every 4 weeks from Week 4, or Stelara (dosing
per package label). Cosentyx achieved the primary objective of superior PASI 90
response at Week 16. The 52 week PASI 90 response is a secondary objective in
this study. PASI 100 and PROs (including DLQI responses) at 52 weeks are
exploratory endpoints[2].
About psoriasis
Psoriasis is a common, non-contagious, autoimmune disease that affects up to 3%
of the world's population[15]. Plaque psoriasis is the most common form of the
disease and appears as raised, red patches covered with a silvery white buildup
of dead skin cells. Palmoplantar psoriasis, psoriasis involvement of the palms
and soles, occurs in up to 40% of plaque psoriasis patients[16].
Psoriasis is not simply a cosmetic problem, but a persistent, chronic (long-
lasting), and sometimes distressing disease, which can affect even the smallest
aspects of people's lives on a daily basis. Up to 30% of patients with psoriasis
have, or will develop, PsA[17]. PsA is a condition in which the joints are also
affected, causing debilitating symptoms including pain, stiffness and
irreversible joint damage[17],[18]. Psoriasis is also associated with other
serious health conditions, such as diabetes, heart disease and depression[17].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "continues," "aim," "goal," suggests," "will," 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 receive additional regulatory
approvals or 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, quality or manufacturing 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 2015, the Group achieved net
sales of USD 49.4 billion, while R&D throughout the Group amounted to
approximately USD 8.9 billion (USD 8.7 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 118,000
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
For Novartis multimedia content, please visit www.novartis.com/news/media-
library
For questions about the site or required registration, please contact
media.relations(at)novartis.com
*As observed analyses.
(**)Stelara(® )is a registered trademark of Janssen Biotech, Inc.
(***)Enbrel(®) is a registered trademark of Amgen Inc. Enbrel used in the
FIXTURE study was European sourced.
References
[1] Bissonnette R et al. Secukinumab maintains high levels of efficacy through
4 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 2016. 1(st) October 2016.
[2] Blauvelt A et al. Secukinumab is superior to ustekinumab in clearing skin of
subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the
CLEAR study. J Am Acad Dermatol. September 2016. Available from
http://dx.doi.org/10.1016/j.jaad.2016.08.008 Epub ahead of print.
[3] European Medicines Agency. Guideline on clinical investigation of medicinal
products indicated for the treatment of psoriasis. Available at:
http://www.ema.europa.eu/docs/en_GB/
document_library/Scientific_guideline/2009/09/WC500003329.pdf. Accessed
September 2016.
[4] Ryan C et al. Research gaps in psoriasis: opportunities for future studies.
J Am Acad Dermatol. 2014; 70:146-167.
[5] ACTAS Dermo-Sifiliográficas. Spanish Evidence-Based Guidelines on the
Treatment of Psoriasis With Biologic Agents. Available at:
http://www.actasdermo.org/en/spanish-evidence-based-guidelines-on-
treatment/articulo/S1578219013001789/. Accessed September 2016.
[6] Canadian Dermatology Association. Canadian Guidelines for the Management of
Plaque Psoriasis. Available at:
http://www.dermatology.ca/wp-content/uploads/2012/01/cdnpsoriasisguidelines.pdf.
Accessed September 2016.
[7] Gottlieb A et al. Secukinumab is effective in subjects with moderate to
severe palmoplantar psoriasis: 1.5 year results from the GESTURE study.
Presented as an abstract at the 25(th) European Academy of Dermatology and
Venerology. Vienna, Austria. 1(st) October 2016.
[8] Pettey A et al. Patients with palmoplantar psoriasis have more physical
disability and discomfort than patients with other forms of psoriasis:
implications for clinical practice. J Am Acad Dermatol. 2003;49(2):271-275.
[9] Langley RG et al. Secukinumab in plaque psoriasis - results of two phase
three trials. N Engl J Med. 2014;371(4):326-338.
[10] Kirkham BW, et al. Interleukin-17A: a unique pathway in immune-mediated
diseases: psoriasis, psoriatic arthritis and rheumatoid arthritis. Immunology.
2014; 141:133-142.
[11] Ivanov S, Linden A. Interleukin-17 as a drug target in human disease.
Trends Pharmacol Sci. 2009; 30(2):95-103.
[12] Cosentyx Summary of Product Characteristics. Novartis Europharm Limited.
Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/
medicines/003729/human_med_001832.jsp&mid=WC0b01ac058001d124. Accessed September
2016.
[13] Cosentyx (secukinumab) [prescribing information]. East Hanover, NJ:
Novartis Pharmaceuticals Corp, 2016.
[14] Novartis. Data on file. May 2016.
[15] International Federation of Psoriasis Associations (IFPA) World Psoriasis
Day website. "About Psoriasis." Available at:
http://www.worldpsoriasisday.com/web/page.aspx?refid=114. Accessed September
2016.
[16] Kumar B et al. Palmoplantar Lesions in Psoriasis: A Study of 3065 Patients.
Acta Dermatol Venereol. 2002;82:192-195.
[17] National Psoriasis Foundation. Psoriatic disease: about psoriasis.
Available at: www.psoriasis.org/about-psoriasis. Accessed September 2016.
[18] Mease PJ, Armstrong AW. Managing patients with psoriatic disease: the
diagnosis and pharmacologic treatment of psoriatic arthritis in patients with
psoriasis. Drugs. 2014; 74:423-441.
# # #
Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations(at)novartis.com
Eric Althoff Bhavin Vaid
Novartis Global Media Relations Novartis Global Pharma Communications
+41 61 324 7999 (direct) +41 61 324 8175 (direct)
+41 79 593 4202 (mobile) +41 79 792 7510 (mobile)
eric.althoff(at)novartis.com bhavin.vaid(at)novartis.com
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations(at)novartis.com
Central North America
Samir Shah +41 61 324 7944 Richard Pulik +1 212 830 2448
Pierre-Michel Bringer +41 61 324 1065 Sloan Pavsner +1 212 830 2417
Thomas Hungerbuehler +41 61 324 8425
Isabella Zinck +41 61 324 7188
Media Release (PDF):
http://hugin.info/134323/R/2046024/764496.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 01.10.2016 - 07:15 Uhr
Sprache: Deutsch
News-ID 498194
Anzahl Zeichen: 17106
contact information:
Town:
Basel
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 593 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Novartis late-breaking data show Cosentyx delivers high and long-lasting skin clearance over 4 years for psoriasis patients"
steht unter der journalistisch-redaktionellen Verantwortung von
Novartis International AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
