New Novartis data shows Cosentyx(TM) is significantly superior to Stelara® and clears skin (PASI 90) in nearly 80% of psoriasis patients
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Novartis International AG /
New Novartis data shows Cosentyx(TM) is significantly superior to Stelara® and
clears skin (PASI 90) in nearly 80% of psoriasis patients
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* CLEAR study at AAD showed over 21% more psoriasis patients achieved clear to
almost clear skin (PASI 90) with Cosentyx((TM)) compared to Stelara(®) at
Week 16[1]
* Cosentyx showed greater improvements to Stelara across all study endpoints
up to Week 16, including PASI 100 and onset of action[1]
* PASI 90 and PASI 100 are both considered important measures of treatment
success for psoriasis patients, demonstrating clear to almost clear
skin[2],[3]
* Cosentyx, the first and only IL-17A inhibitor approved for psoriasis, has
now shown superiority to both Stelara and Enbrel(®), widely used biologic
treatments[1],[4]
The digital press release with multimedia content can be accessed here:
Basel, March 20, 2015 - Novartis announced today results from the CLEAR study
demonstrating that Cosentyx(TM) (secukinumab) is significantly superior to
Stelara(®)* (ustekinumab), a widely used biologic, in achieving clear or almost
clear skin for psoriasis patients[1]. The detailed findings were presented in a
late-breaking research session at the 73rd Annual Meeting of the American
Academy of Dermatology (AAD) in San Francisco, USA. Cosentyx (at a dose of 300
mg) is the first and only interleukin-17A (IL-17A) inhibitor approved to treat
adult patients with moderate-to-severe plaque psoriasis.
In this Phase IIIb study, Cosentyx met the primary endpoint of showing
superiority to Stelara as assessed by the Psoriasis Area Severity Index (PASI)
90 response, known as clear to almost clear skin[2], at Week 16 (79.0% vs.
57.6%, P<0.0001)[1]. PASI 90 is considered an important measure of treatment
success by the European Medicines Agency[2] and an optimal treatment goal for
patients[3]. In addition, completely clear skin (PASI 100) at Week 16 was
achieved by significantly more patients treated with Cosentyx than those
receiving Stelara (44.3% vs. 28.4%, P<0.0001)[1].
"The robust results from the CLEAR study further demonstrate how Cosentyx is
changing the way psoriasis is treated and helping patients achieve clear skin,"
said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals.
"With Cosentyx now approved in many countries around the world, we are committed
to helping psoriasis patients significantly improve their overall quality of
life."
In addition, Cosentyx demonstrated rapid onset of action and greater efficacy at
all time points in the study up to Week 16, with 50% of Cosentyx patients
achieving PASI 75 as early as Week 4 compared to Stelara (50.0% vs. 20.6%,
P<0.0001)[1]. The safety profile of Cosentyx was comparable to Stelara and
consistent with previously reported Phase III clinical trials for
Cosentyx[1],[4]-[6].
About the CLEAR study
CLEAR (Comparison to assess Long-term Efficacy, sAfety and toleRability of
secukinumab vs. ustekinumab), a 52-week, multicenter, randomized, double-blind
study, is a head-to-head Phase IIIb study initiated with Cosentyx, and compares
the efficacy, long-term safety and tolerability of Cosentyx (secukinumab) versus
Stelara (ustekinumab), in patients with moderate-to-severe plaque psoriasis[1].
Twenty-four countries across North America, Europe, Asia and Australia
participated in the study, with enrollment reaching 679 patients in record
time[1].
The primary endpoint measured at Week 16 is PASI 90[1]. PASI 90 is considered a
more robust measure of the extent of skin clearance compared to the standard
efficacy measures used in most psoriasis clinical studies, such as PASI 75.
Additionally the secondary endpoint measured at Week 4 is PASI 75[1]. PASI 100
at Week 16 was one of the exploratory endpoints[1]. Week 52 data will follow in
due course.
The CLEAR study follows the pivotal Phase III FIXTURE study, which showed
Cosentyx was superior to Enbrel(®)** (etanercept) in clearing skin[4]. Results
from the FIXTURE study were first announced in October 2013.
About Cosentyx (secukinumab) and interleukin-17A (IL-17A)
Cosentyx is a human monoclonal antibody that selectively neutralizes
interleukin-17A (IL-17A)[7],[8]. IL-17A is found in high concentrations in skin
affected by psoriasis and is a preferred target for investigational
therapies[7]-[12]. Cosentyx works by inhibiting the action of IL-17A, a protein
found in high concentrations in skin affected by the disease[7]-[12]. In the
Phase III program, Cosentyx demonstrated a favorable safety profile, with
similar incidence and severity of adverse events between Cosentyx treatment arms
(300 mg and 150 mg)[1],[4]-[6].
In January 2015, Cosentyx (at a dose of 300 mg) became the first and only
interleukin-17A (IL-17A) inhibitor approved in Europe as a first-line systemic
treatment of moderate-to-severe plaque psoriasis in adult patients, and in the
US 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, Chile,
Australia, Canada and Singapore for the treatment of moderate-to-severe plaque
psoriasis and in Japan for the treatment of moderate-to-severe plaque psoriasis
and active psoriatic arthritis (PsA).
Cosentyx is also in Phase III development for PsA and ankylosing spondylitis
(AS); global regulatory applications are planned for 2015.
About Psoriasis
Psoriasis is a chronic immune-mediated disease characterized by thick and
extensive skin lesions, called plaques, known to cause itching, scaling and
pain; it is associated with significant impairment of physical and psychological
quality of life[13]-[15]. Psoriasis affects up to 3% of the world's population,
or more than 125 million people[16].
This common and distressing condition is not simply a cosmetic problem - even
people with very mild symptoms are affected everyday[13]. According to an
analysis of surveys conducted of 5,600 patients by the National Psoriasis
Foundation (NPF) between 2003 and 2011, 52% of patients with mild, moderate and
severe psoriasis were dissatisfied with their disease management[17]. Of the
patients surveyed, some were receiving no treatment (9.4-49.2%) or were
undertreated (10.2-55.5%)[17].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "committed," "will," "investigational," "planned," or similar
terms, or by express or implied discussions regarding potential additional
marketing authorizations 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 for sale
in any additional markets, or approved for any additional indications, 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 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 2014, the Group achieved net
sales of USD 58 billion, while R&D throughout the Group amounted to
approximately USD 9.9 billion (USD 9.6 billion excluding impairment and
amortization charges). As of December 31, 2014 Novartis Group companies employed
approximately 133,000 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.
*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] Thaci D, Blauvelt A, Reich K, et al. Secukinumab is superior to ustekinumab
in clearing skin of subjects with moderate to severe plaque psoriasis: 16 week
results from the CLEAR study. American Academy of Dermatology 73(rd) Annual
Meeitng. San Francisco, California. 20(th) March.
[2] European Medicines Agency (EMA) Committee for Medicinal Products for Human
Use (CHMP) Guidelines on clinical investigation of medicinal products indicated
for the treatment of psoriasis. 2004. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/
2009/09/WC500003329.pdf Accessed February 9, 2015.
[3] 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.x
[4] Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis:
results of two phase three trials. N Engl J Med. 2014. Jul 9;371(4):326-38.
[5] Blauvelt A, Prinz J, Gottlieb AB, et al. Secukinumab Administration by Pre-
filled Syringe: Efficacy, Safety, and Usability Results from a Randomized
Controlled Trial in Psoriasis (FEATURE). Br J Dermatol. 2014. Dec
11; 172(2): 484-493. doi: 10.1111/bjd.13348
[6] 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; doi:
10.1111/jdv.12751
[7] Gaffen SL. Structure and signaling in the IL-17 receptor family. Nat Rev
Immunol. 2009;9(8):556-67.
[8]Ivanov S, Linden A. Interleukin-17 as a drug target in human disease. Trends
Pharmacol Sci. 2009;30(2):95-103.
[9] Kopf M, Bachmann MF, Marsland BJ. Averting inflammation by targeting the
cytokine environment. Nat Rev Drug Discov. 2010; 9(9):703-18.
[10] Onishi RM, Gaffen SL. Interleukin-17 and its target genes: mechanisms of
interleukin-17 function in disease. Immunology. 2010;129(3):311-21.
[11] 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.
[12] 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.
[13] Stern RS, Nijsten T, Feldman S, et al. Psoriasis Is Common, Carries a
Substantial Burden Even When Not Extensive, and Is Associated with Widespread
Treatment Dissatisfaction. J Investig Dermatol Symp. 2004;9(2):136-9.Nestle FO,
Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009; 361(5):496-509.
[14] Rapp SR, Feldman SR, Exum ML, Fleischer AB, Jr., Reboussin DM. Psoriasis
causes as much disability as other major medical diseases. J Am Acad Dermatol.
1999; 41(3 Pt 1):401-7.
[15] Farley E et al. Psoriasis: comorbidities and associations. G Ital Dermatol
Venereol. 2011 Feb;146(1):9-15.
[16] International Federation of Psoriasis Associations (IFPA) World Psoriasis
Day website. "About Psoriasis."
http://www.worldpsoriasisday.com/web/page.aspx?refid=114. Accessed February
2014.
[17] 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.
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Datum: 20.03.2015 - 17:30 Uhr
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