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Bankleitzahlen - online.de


Novartis real-world evidence confirms efficacy and safety benefits of Cosentyx® in daily life for psoriasis patients

Novartis International AG /
Novartis real-world evidence confirms efficacy and safety benefits of Cosentyx®
in daily life for psoriasis patients
. Processed and transmitted by Nasdaq Corporate Solutions.
The issuer is solely responsible for the content of this announcement.

* Real-world evidence confirms Cosentyx(® )efficacy and safety consistent with
previously reported clinical studies[1]-[4]

* Novartis presents a large program of real-world evidence at the 27(th)
European Academy of Dermatology and Venereology (EADV) Congress, adding to
the robust body of clinical data supporting the use of Cosentyx in moderate-
to-severe psoriasis[1]-[4]

* Cosentyx 5-year data in psoriasis from a Phase III study were presented in
2017[5], proving long term efficacy and sustained safety of Cosentyx and the
importance of IL-17A inhibition - the cornerstone cytokine in the treatment
of psoriasis[6]-[8]


Basel, September 13, 2018 - Novartis, a leader in immuno-dermatology, announced
today new data from multiple real-world sources in moderate-to-severe plaque
psoriasis, which confirm Cosentyx(®) (secukinumab) efficacy and safety in
clinical practice is comparable to previously reported clinical studies[1]-[4].
Real-world evidence also confirmed the additional benefits of Cosentyx with
PROSPECT, the largest prospective real-world analysis on Cosentyx to date,
demonstrating a pronounced improvement in quality of life in a real-world
setting (59% of patients at 24 weeks experience no or little impact of their
skin disease on their quality of life)[1]. Cosentyx is the first and only fully-
human treatment that specifically inhibits IL-17A. A large program of real-world
evidence was presented for the first time at the 27(th) European Academy of
Dermatology and Venereology (EADV) Congress in Paris, France.

Additional real-world data presented at EADV showed that 87% of bio-naive
psoriasis patients remain on Cosentyx at 12 months, further supporting the use
of Cosentyx in real-world settings[2].

"Novartis commitment to well-designed Phase-IV studies and other real world
evidence is providing dermatologists around the world with an opportunity to see
how psoriasis treatments respond in everyday clinical practice," said Dr. Kim
Papp, Dermatologist and Principal Investigator of the PURE Study, Waterloo,
Ontario, Canada. "As a clinician and researcher, I find it exciting and
rewarding to contribute to this growing volume of real world evidence on
Cosentyx."

"For both psoriasis patients and doctors, these data confirm that Cosentyx
clinical data profile translates into real-world benefits," said Dr. Richard
G.B. Langley MD, RPC(C), Professor of Dermatology and Director of Research,
Dalhousie University, Halifax, Nova Scotia, Canada. "In the everyday management
of psoriasis, this provides added reassurance that with Cosentyx, patients
achieve and maintain high levels of skin clearance and improved quality of
life."

At EADV 2017, Novartis presented 5-year data from the Phase III SCULPTURE study
reinforcing Cosentyx long term skin clearance and safety[5]. Cosentyx is the
first and only fully human IL-17A inhibitor to show sustained skin clearance
rates at 5 years in Phase III in psoriasis[9]. Landmark data show that PASI 90
and PASI 100 response rates were nearly 100% maintained with Cosentyx from Year
1 to Year 5 in patients with moderate-to-severe plaque psoriasis[5].

"This large program of real-world evidence adds to the robust body of clinical
data supporting the use of Cosentyx for psoriasis," said Eric Hughes, Global
Development Unit Head, Immunology, Hepatology and Dermatology. "As a leader in
immuno-dermatology, we are reimagining the lives of psoriasis patients by
providing doctors with the best evidence possible, including in real-world
settings."

These data add to the growing body of evidence showing the unique position of
Cosentyx as the first and only fully-human IL-17A inhibitor[5]. To date,
Cosentyx has been prescribed to more than 160,000 patients worldwide[10].The
clinical Phase III program has demonstrated long-term efficacy and a proven
safety profile of Cosentyx to treat moderate-to-severe psoriasis[5], psoriatic
arthritis (PsA)[11] and ankylosing spondylitis (AS)[12]. In May, Novartis
announced its plan to initiate the ARROW trial to assess the mechanistic
superiority of direct IL-17A inhibition (Cosentyx) over IL-23 inhibition
(Tremfya(®)*) as the 100(th) study with Cosentyx[13],[14].

About XPOSE, PROSPECT, CORRONA, and PURE
These findings are from analysis of real-world data from 2 non-interventional
studies and 2 registries across multiple countries: Data from the Canadian
patient support program XPOSE (3,020 patients with moderate-to-severe psoriasis)
were analysed for the patients where efficacy data was reported by a physician
(192 patients)[2]; PROSPECT is the largest real-world study of Cosentyx in
psoriasis, involving 2,002 patients in Germany (905 patients followed up for 24
weeks to date)[1]; CORRONA(®) is an independently run registry of patients with
psoriasis from the United States (306 patients initiated Cosentyx at enrollment,
with effectiveness data available to date for 118 patients for 6 months, and 56
patients for 12 months)[4]; and PURE a prospective, international,
observational, two cohort registry of adult patients with moderate-to-severe
chronic plaque psoriasis in Latin America and Canada (397 patients, with
efficacy data available to date for 124 patients for 12 months, and 59 patients
for 18 months)[3].

Real-world evidence (RWE) is clinical evidence based upon data taken from a
variety of sources in daily life, outside of the clinical trial setting. RWE
helps to bridge the gap in knowledge that exists between clinical trials and
clinical practice, making it an important complement to long-term data from
clinical trials.

About Cosentyx
Cosentyx is the first and only fully-human biologic that specifically inhibits
interleukin-17A (IL-17A), a cornerstone cytokine involved in the inflammation
and development of psoriasis, AS, and PsA[6]-[8]. IL-17A is produced by both IL-
23 dependent and IL-23 independent pathways, by various cells from both the
innate immune system (which can be triggered by mechanical stress) and the
adaptive immune system[15]. By acting directly on IL-17A, Cosentyx inhibits this
cornerstone cytokine irrespective of where the IL-17A comes from[6]. Cosentyx
has been used by more than 160,000 patients worldwide across all indications and
is used in many countries as first-line therapy in biologic-naïve patients[10].

Cosentyx has a broad head-to-head study program that includes FIXTURE, CLEAR,
CLARITY, SURPASS and EXCEED clinical superiority trials[16]-[20]. In May 2018,
Novartis announced its plan to initiate the ARROW trial to assess the
mechanistic superiority of direct IL-17A inhibition (Cosentyx) over IL-23
inhibition (Tremfya(®)*) in treating recalcitrant plaques resistant to
ustekinumab[13]. This study is the 100(th) trial with Cosentyx in the last 10
years, adding to the wealth of data[14]. The clinical Phase III program of
Cosentyx has demonstrated long term efficacy and a proven safety profile of
Cosentyx to treat moderate-to-severe psoriasis[5], PsA[11] and AS[12].

Disclaimer
This press release contains forward-looking statements within the meaning of the
United States Private Securities Litigation Reform Act of 1995. Forward-looking
statements can generally be identified by words such as "potential," "can,"
"will," "plan," "expect," "anticipate," "look forward," "believe," "committed,"
"investigational," "pipeline," "launch," or similar terms, or by express or
implied discussions regarding potential marketing approvals, new indications or
labeling for the investigational or approved products described in this press
release, or regarding potential future revenues from such products. You should
not place undue reliance on these statements. Such forward-looking statements
are based on our current beliefs and expectations 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 the
investigational or approved products described in this press release will be
submitted or approved for sale or for any additional indications or labeling in
any market, or at any particular time. Nor can there be any guarantee that such
products will be commercially successful in the future. In particular, our
expectations regarding such products could be affected by, among other things,
the uncertainties inherent in research and development, including clinical trial
results and additional analysis of existing clinical data; regulatory actions or
delays or government regulation generally; global trends toward health care cost
containment, including government, payor and general public pricing and
reimbursement pressures; our ability to obtain or maintain proprietary
intellectual property protection; the particular prescribing preferences of
physicians and patients; general political and economic conditions; safety,
quality or manufacturing issues; potential or actual data security and data
privacy breaches, or disruptions of our information technology systems, 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 is reimagining medicine to improve and extend people's lives. As a
leading global medicines company, we use innovative science and digital
technologies to create transformative treatments in areas of great medical need.
In our quest to find new medicines, we consistently rank among the world's top
companies investing in research and development. Novartis products reach nearly
1 billion people globally and we are finding innovative ways to expand access to
our latest treatments. About 125 000 people of more than 140 nationalities work
at Novartis around the world. Find out more at www.novartis.com.

Novartis is on Twitter. Sign up to follow @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@novartis.com

*Tremfya(®) is a registered trademark of Janssen Biotech, Inc.

References

    [1]   Thaçi D et al. Secukinumab real-world effectiveness data on plaque
psoriasis treatment in Germany corroborate pivotal clinical trial results:
Analysis of the first 2,000 subjects enrolled in the PROSPECT study. Presented
as eposter P1994 at 27(th) EADV Congress 2018. 12(th) September 2018.

    [2]   Ho V et al. Secukinumab demonstrates improvement of disease activity
in Canadian psoriasis patients in a real world setting. Presented as eposter
P2083 at 27(th) EADV Congress 2018. 12(th) September 2018.

    [3]   Papp K et al. Secukinumab-Treated Patients in the PURE Registry
(Patients with moderate to severe chronic plaqUe psoRiasis) in Latin AmErica and
Canada-18 Month Follow-Up Data. Presented as eposter P1970 at 27(th) EADV
Congress 2018. 12(th) September 2018.

    [4]   Bagel J et al. Secukinumab clinical and patient-reported outcomes
after 1 year of follow-up: Real-world analyses from the Corrona Psoriasis
Registry. Presented as eposter P1850 at 27(th) EADV Congress 2018. 12(th)
September 2018.

    [5]   Bissonnette, R., Luger, T., Thaçi, D., Toth, D., Lacombe, A., Xia, S.,
Mazur, R., Patekar, M., Charef, P., Milutinovic, M., Leonardi, C. and Mrowietz,
U. Secukinumab Demonstrates High Sustained Efficacy and a Favorable Safety
Profile in Patients with Moderate to Severe Psoriasis through 5 Years of
Treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol. 2018.

    [6]   Smith JA et al. Review: The Interleukin 23/Interleukin 17 Axis in
Spondyloarthritis Pathogenesis: Th17 and Beyond. Arthritis Rheumatol.
2014;66:231-41.

    [7]   Nestle FO et al. Mechanisms of disease psoriasis. N Eng J Med.
2009;361:496-509.

    [8]   Girolomoni G et al. Psoriasis: rationale for targeting interleukin-
17. Br J Dermatol. 2012;167:717-24.

    [9]   EU Cosentyx Summary of Product Characteristics. Novartis Europharm
Limited. Available at:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/0037
29/human_med_001832.jsp&mid=WC0b01ac058001d124. Last accessed September 2018.

    [10] Novartis, data on file.

    [11] Mease PJ et al. Secukinumab Provides Sustained Improvements in the
Signs and Symptoms of Active Psoriatic Arthritis through 3 Years: Efficacy and
Safety Results from a Phase 3 Trial. Presented at the American College of
Rheumatology 2016. Presentation number 961.

    [12] Braun J et al. Secukinumab demonstrates low radiographic progression
and sustained efficacy through 4 years in patients with active ankylosing
spondylitis. Late breaking abstract presented at the 2017 ACR/ARHP Annual
Meeting, San Diego, USA. 7th November 2017

    [13] Comparison of Secukinumab Versus Guselkumab in Clearing Psoriatic
Plaques Refractory to Ustekinumab (ARROW). Available at
https://clinicaltrials.gov/ct2/show/NCT03553823. Last accessed September 2018.

    [14] Clinicaltrials.gov. Active trials include all those that are listed as
recruiting, active but not recruiting, enrolling by invitation and not yet
recruiting and completed. This list excludes all trials listed as suspended,
terminated and withdrawn.

    [15] Schett G et al. Enthesitis: from pathophysiology to treatment. Nat Rev
Rheumatol. 2017 Nov 21;3(12):731-741.

    [16] Langley RG et al. Secukinumab in Plaque Psoriasis - Results of Two
Phase 3 Trials. N Engl J Med 2014;371:326-38.

    [17] 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. 2017 Jan;76(1):60-69.

    [18] Bagel J et al. Secukinumab is Superior to Ustekinumab in Clearing Skin
of Patients with Moderate to Severe Plaque Psoriasis: CLARITY, a Randomized,
Controlled, Phase 3b Trial. Presented as poster 98 at The Winter Clinical
Dermatology Conference - Hawaii. January 13, 2018.

    [19] Effect of Secukinumab on Radiographic Progression in Ankylosing
Spondylitis as compared to GP2017 (Adalimumab Biosimilar) (SURPASS). Available
at: https://www.clinicaltrials.gov/ct2/show/NCT03259074. Last accessed September
2018.

    [20] Efficacy of Secukinumab Compared to Adalimumab in Patients With
Psoriatic Arthritis (EXCEED 1). Available at:
https://clinicaltrials.gov/ct2/show/NCT02745080. Last accessed September 2018.

# # #

Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations@novartis.com

Eric Althoff Novartis Global Media Friedrich von Heyl Novartis Global Pharma
Relations +41 61 324 7999 (direct) Communications +41 61 324 8984 (direct)
+41 79 593 4202 (mobile) +41 79 749 0286 (mobile)
eric.althoff@novartis.com friedrich.vonheyl@novartis.com

Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com

Central   North America

Samir Shah +41 61 324 7944 Richard Pulik +1 212 830 2448

Pierre-Michel Bringer +41 61 324 1065 Cory Twining +1 212 830 2417

Thomas Hungerbuehler +41 61 324 8425

Isabella Zinck +41 61 324 7188

Media release (PDF):
http://hugin.info/134323/R/2215815/865220.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



 
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