-
Two thirds of patients on
Cosentyx® (secukinumab)
reported no impact of skin disease on their quality of life over 5
years, SCULPTURE study shows[1]
-
Findings show absolute PASI
<=1/<=2/<=3 responses were sustained in those treated with
Cosentyx from Year 1 to Year 5[1]
-
Cosentyx is the first and only
fully human interleukin-17A (IL-17A) inhibitor that showed
sustained skin clearance rates at 5 years in patients from a
psoriasis Phase III study[2]
The digital press release
with multimedia content can be accessed here:
Basel, February 16, 2018 -
Novartis announced today, additional results from the SCULPTURE
study showing that two thirds of moderate to severe plaque
psoriasis patients treated with Cosentyx® (secukinumab)
reported no impact of skin disease on their quality of life through
5 years, as described by the Dermatology Life Quality Index (DLQI)
0/1 response (72.7% at Year 1 and 65.5% at Year 5) - a
questionnaire used to evaluate the impact of skin disease on a
patient's quality of life[1],[3]. These data were presented at the
2018 American Academy of Dermatology (AAD) Annual Meeting in San
Diego, California.
Study findings also show absolute PASI
<=1/<=2/<=3 scores at Year 1 (58.6%, 67.9% and 74.1%,
respectively) were sustained to Year 5 (53.3%, 66.4% and 75.4%,
respectively); as observed analysis[1]. Absolute PASI scores can
provide an indication of disease severity after treatment.
Achievement of an absolute PASI score lower than 2 or 3 has been
proposed as an indication of treatment success[4].
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."There is a link between achieving skin
clearance and improved quality of life, and proper management of
psoriasis should address both the physical symptoms of the disease
and its impact on patients' daily lives," said Craig Leonardi, MD,
Adjunct Professor of Dermatology at St. Louis University School of
Medicine. "Results from the SCULPTURE study show treatment with
Cosentyx can deliver both over the long-term. It's encouraging to
see such improvements in DLQI responses and absolute PASI scores
below 3 through 5 years."
"Patients with psoriasis are looking for a
treatment that not only achieves clear skin, but also addresses the
negative impact psoriasis has on their lives," said Shreeram
Aradhye, Chief Medical Officer and Global Head, Medical Affairs,
Novartis Pharmaceuticals. "We are excited by this new evidence,
showing two thirds of psoriasis patients reporting no impact on
their quality of life at 5 years when treated with Cosentyx, and
the possibilities this offers patients."
The most common adverse events included
nasopharyngitis, upper respiratory tract infection and headache,
consistent with those reported in the core study and previous Phase
III studies[1].
Cosentyx is the first and only fully human IL-17A
inhibitor approved to treat ankylosing spondylitis (AS), psoriatic
arthritis (PsA) and moderate to severe plaque psoriasis[5]. To
date, Cosentyx has been prescribed to more than 140,000 patients
worldwide since launch[6].
About psoriasis
Psoriasis is a distressing and painful autoimmune disease that
affects more than 125 million people worldwide[7]. It is a
debilitating condition associated with a significant emotional and
physical daily burden. In the long-term, psoriasis can also lead to
other conditions, such as diabetes, heart disease, depression and
psoriatic arthritis - which up to 30% of patients with psoriasis
may develop[8].
Plaque psoriasis is the most common form of the
disease and appears as raised, red skin patches covered with a
silvery white build-up of dead cells. Most patients with psoriasis
will also develop difficult-to-treat forms of the disease which
appear on the scalp, nails, palms of the hands or soles of the feet
and are associated with further pain, decreased mobility and
functional impairment[9]-[12].
About Cosentyx (secukinumab) and IL-17A
Cosentyx is the first and only fully human IL-17A inhibitor
approved to treat psoriasis, PsA and ankylosing spondylitis
(AS)[5]. Cosentyx is a targeted treatment that specifically
inhibits IL-17A, cornerstone cytokine involved in the pathogenesis
of psoriasis, and the inflammation of the entheses in PsA and
AS[5],[13]-[15].
Cosentyx delivers psoriasis patients long-lasting
skin clearance, with proven sustainability and safety out to 5
years[2]. Cosentyx is also approved for the most difficult-to-treat
forms of plaque psoriasis - palmoplantar psoriasis (psoriasis of
the palms of the hands and soles of the feet), nail psoriasis and
scalp psoriasis[5].
Cosentyx has a large clinical trials program in
psoriasis, PsA and AS which includes over 60 studies and over
10,000 patients[16]. To date, Cosentyx has been prescribed to more
than 140,000 patients worldwide since launch[6].
About the Cosentyx 5-year
extension study (NCT01406938)[1],[2]
NCT01406938 is a multicenter, double-blind and open-label, 5-year
extension to the core Phase III SCULPTURE study. 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, examining both treatment and quality of
life outcomes.
Efficacy measures included proportion of patients
achieving PASI 75, PASI 90 and PASI 100, and quality of life
improvement as measured by Dermatology Life Quality Index (DLQI).
This long-term extension study demonstrated the sustained efficacy
and safety of Cosentyx. The current as observed analysis describes,
PASI 75/90/100 at Year 1 (88.9%, 68.5% and 43.8%, respectively)
and Year 5 (88.5%, 66.4% and 41%); absolute PASI
<=1/<=2/<=3 responses at Year 1 (58.6%, 67.9% and 74.1%,
respectively) and Year 5 (53.3%, 66.4% and 75.4%,
respectively), DLQI 0/1 at Year 1 (72.7%) and Year 5 (65.5%), and
long-term safety and tolerability.
In the core Phase III SCULPTURE study, 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.
Patients who completed 52 weeks of the SCULPTURE study were
eligible to continue the same dose and regimen in the extension
study (N=642). Patients subsequently entered the extension phase
and continued the same double-blinded treatment regimen to Year 3,
and thereafter un-blinded to the end of the study at Year 5 (n=126
at Week 260). No topical treatments were allowed in SCULPTURE, and
only in the extension study when applied to the scalp, face, and/or
genitoanal area for a maximum of 14 days. The safety profile of
Cosentyx was in line with the known safety profile for
Cosentyx.
About Novartis Immunology &
Dermatology
Novartis is a global leader in Immunology & Dermatology. We are
dedicated to transforming the lives of people living with
immunologic diseases, focusing on immunodermatology, rheumatology
and specialty liver diseases. Our Immunology & Dermatology
pipeline includes multiple compounds in liver disease and other
immunological areas where high unmet medical needs exist.
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
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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
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release as of this date and does not undertake any obligation to
update any forward-looking statements contained in this press
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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, cost-saving generic and
biosimilar pharmaceuticals and eye care. Novartis has leading
positions globally in each of these areas. In 2017, the Group
achieved net sales of USD 49.1 billion, while R&D throughout
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References
[1] Bissonnette R et al. Secukinumab
demonstrates high sustained efficacy and a favorable safety profile
through 5 years of treatment in moderate to severe psoriasis.
Eposter presented at 2018 American Academy of Dermatology (AAD)
Annual Meeting; February 16-20, 2018, San Diego, California. Poster
#7382.
[2] 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. Accepted Author Manuscript.
doi:10.1111/jdv.14878
[3] Finlay AY, Khan GK. Dermatology Life Quality Index
(DLQI)-a simple practical measure for routine clinical use. Clin
Experiment Dermatol. 1994;19(3):210-216.
[4] Zheng J. Absolute Psoriasis Area and Severity
Index: an additional evaluation for clinical practice. Br J
Dermatol. 2017;176:563-576.
[5] 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.
Last accessed January 2018.
[6] Novartis. Data on file.
[7] International Federation of Psoriasis Associations
(IFPA) World Psoriasis Day website. "About Psoriasis." Available
at: http://www.worldpsoriasisday.com/web/page.aspx?refid=114. Last
accessed January 2018.
[8] National Psoriasis Foundation. Psoriatic disease:
about psoriasis. Available at: www.psoriasis.org/about-psoriasis.
Last accessed January 2018.
[9] Zampieron A et al. Quality of life in patients with
scalp psoriasis. G Ital Dermatol Venereol. 2015
Jun;150(3):309-16
[10] Baran R. The burden of nail psoriasis: an introduction.
Dermatol. 2010:221 Suppl 1:1-5.
[11] Kumar B et al. Palmoplantar lesions in psoriasis: a study of
3065 patients. Acta Dermatol Venereol. 2002;82:192-5.
[12] Chung J et al. Palmoplantar psoriasis is associated with
greater impairment of health-related quality of life compared to
moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2014
Oct;71(4):623-632.
[13] Smith JA et al. Review: The Interleukin 23/Interleukin 17 Axis
in Spondyloarthritis Pathogenesis: Th17 and Beyond. Arthritis
Rheumatol. 2014;66:231-41.
[14] Nestle FO et al. Mechanisms of disease psoriasis. N Eng J Med.
2009;361:496-509.
[15] Girolomoni G et al. Psoriasis: rationale for targeting
interleukin-17. Br J Dermatol. 2012;167:717-24.
[16] Novartis. Data on file.
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