-
Majority of patients with
scalp psoriasis on Cosentyx® (secukinumab)
achieved clear skin (PSSI 90) at Weeks 12 and 24 and improved
quality of life[1]
-
Scalp psoriasis affects 60
million people worldwide - a difficult-to-treat form of psoriasis
with a substantial impact on quality of life[1]-[5]
-
Cosentyx data presented at AAD
adds to robust evidence demonstrating sustained efficacy in plaque,
nail, palmoplantar and scalp psoriasis as well as psoriatic
arthritis[6]-[12]
The digital press release
with multimedia content can be accessed here:
Basel, February 16, 2018 -
Novartis has presented new Cosentyx®
(secukinumab) data from the prospective Phase III SCALP study which
showed significant improvement in skin clearance with Cosentyx in
patients with scalp psoriasis. Due to the presence of hair, scalp
psoriasis is particularly difficult to treat with common topical
and phototherapy options[13]. These study results were presented at
the 2018 American Academy of Dermatology (AAD) Annual Meeting in
San Diego, California.
"Scalp psoriasis can be painful and in some
cases, can lead to temporary hair loss and cause the involved area
to crack and bleed," said Kristian Reich, M.D., Ph.D.,
Georg-August-University Göttingen and Dermatologikum Hamburg,
Germany. "The data presented at AAD is encouraging for both
physicians and patients, who can have greater trust in Cosentyx as
a complete treatment option for patients with plaque psoriasis who
want to avoid scalp and other manifestations of psoriasis."
Approximately 60 million people worldwide are
impacted by scalp psoriasis[4],[5], a form of the disease which can
have a substantial impact on quality of life due its highly visible
nature. Additional stress may be added as many psoriasis patients
will not achieve an adequate response from standard
treatments[13].
"As a science driven company, we are committed to
investigating the full potential of Cosentyx. It is our ambition to
offer the best evidence to doctors, and to deliver the best
treatment to patients," said Eric Hughes, Global Development Unit
Head, Immunology & Dermatology. "Cosentyx is backed by a large
study program including more than 10,000 patients in over 60
studies since our first Cosentyx study initiation 10 years ago. We
believe that study data on specific manifestations such as scalp
help doctors reach the right decisions with their patients."
Cosentyx is a fully human interleukin-17A (IL-17A)
inhibitor which has demonstrated rapid and sustained long term
efficacy in the treatment of moderate-to-severe psoriasis,
psoriatic arthritis and ankylosing spondilytis, as well as a
consistently favorable safety profile including injection site pain
at rates similar to placebo[6]-[12]. To date, Cosentyx has been
prescribed to more than 140,000 patients worldwide across all
indications since launch[14].
About psoriasis
Psoriasis is a distressing and painful autoimmune disease that
affects more than 125 million people worldwide[4]. 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 (PsA) - which up to 30% of patients with
psoriasis may develop[4],[15].
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[2],[16]-[18].
About Cosentyx (secukinumab) and IL-17A
Cosentyx is the first and only fully human interleukin-17A (IL-17A)
inhibitor approved to treat psoriasis, PsA and ankylosing
spondylitis (AS)[19]. 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[19]-[22].
Cosentyx delivers psoriasis patients long-lasting
skin clearance, with proven sustainability and safety out to 5
years[8]. Cosentyx has been studied in dedicated trials for
difficult-to-treat types of plaque psoriasis - palmoplantar
psoriasis (psoriasis of the hands and feet), scalp psoriasis, and
nail psoriasis[19].
Cosentyx has a large clinical trials program in
psoriasis, PsA and AS which includes over 60 studies and over
10,000 patients[23]. To date, Cosentyx has been prescribed to
more than 140,000 patients worldwide since launch[14].
About the SCALP
study[1]
This study is a randomized, double-blind, placebo-controlled study
to evaluate the efficacy and safety of Cosentyx in 102 patients
with moderate-to-severe scalp psoriasis. Eligible patients were
equally randomized to either subcutaneous Cosentyx 300 mg or
placebo at Weeks 0, 1, 2, 3 and 4, then every four weeks for 12
weeks. At Week 12, patients in the placebo group who did not
achieve at least a 90% improvement from baseline in the Psoriasis
Scalp Severity Index (PSSI) score were re-randomized to Cosentyx
300 mg until study completion. The primary endpoint was the
proportion of patients who achieved PSSI 90 response rate at Week
12.
In the SCALP study, PSSI 90 response rates were
achieved by a significantly higher proportion of patients receiving
Cosentyx vs. placebo at Week 12 (52.9% vs. 2.0%), with further
improvements in those taking Cosentyx up to Week 24 (58.8%). 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
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 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
the Group amounted to approximately USD 9.0 billion. Novartis Group
companies employ approximately 122,000 full-time-equivalent
associates. Novartis products are sold in approximately 155
countries around the world. For more information, please visit
http://www.novartis.com.
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References
[1] Reich K et al. Secukinumab Shows Sustained
Efficacy in Difficult-to-Treat Palmoplantar, Nail, and Scalp
Psoriasis: Long-term Results From 3 Phase III Placebo-Controlled
Randomized Trials. Eposter presented at 2018 American Academy of
Dermatology (AAD) Annual Meeting; February 16-20, 2018, San Diego,
California. Poster #6813.
[2] Zampieron A et al. Quality of life in
patients with scalp psoriasis. G Ital Dermatol Venereol. 2015
Jun;150(3):309-16
[3] American academy of dermatology. Scalp
Psoriasis. Available at:
https://www.aad.org/public/diseases/hair-and-scalp-problems/scalp-psoriasis#symptoms.
Last accessed January 2018.
[4] 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.
[5] Farber EM, Nall L. Natural history and
treatment of scalp psoriasis. Cutis. 1992;49:396-400.
[6] Gottlieb AB et al. Secukinumab Shows High and
Sustained Efficacy in Subjects with Moderate to Severe Palmoplantar
Psoriasis: 2.5-Year Results From the GESTURE Study. Abstract
presented at the 2017 Psoriasis Gene to Clinic Congress, London,
United Kingdom. 30th November 2017.
[7] 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.
[8] 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
[9] 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. AnnRheum Dis. 2017;76:952-953.
[10] Baeten D et al. Secukinumab, interleukin-17A inhibition
in ankylosing spondylitis. N Engl J Med. 2015;
373:2534-48.
[11] McInnes IB et al. Secukinumab, a human
anti-interleukin-17A monoclonal antibody, in patients with
psoriatic arthritis (FUTURE 2): a randomised, double-blind,
placebo-controlled, phase 3 trial. Lancet. 2015;
386(9999):1137-1146.
[12] Reich K et al. Secukinumab, a fully human
anti-interleukin-17A monoclonal antibody, exhibits minimal
immunogenicity in patients with moderate-to-severe plaque
psoriasis. Br. J. Dermatol. 2017;176:752-58.
[13] Crowley JJ. Nail, Scalp, and Palmoplantar Psoriasis.
Biologic and Systemic Agents in Dermatology. 2018;
160-174.
[14] Novartis Data on File. Number of Patients Prescribed
Cosentyx. Novartis Pharmaceuticals Corp; Nov. 2017.
[15] National Psoriasis Foundation. Psoriatic disease: about
psoriasis. Available at: www.psoriasis.org/about-psoriasis. Last
accessed January 2018.
[16] Baran R. The burden of nail psoriasis: an introduction.
Dermatol. 2010:221 Suppl 1:1-5.
[17] Kumar B et al. Palmoplantar lesions in psoriasis: a
study of 3065 patients. Acta Dermatol Venereol.
2002;82:192-5.
[18] Chung J et al. Palmoplantar psoriasis is associated with
greater impairment of health-related quality of life compared with
moderate to severe plaque psoriasis. J Am Acad Dermatol.
2014;71(4):623-32.
[19] EU 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.
[20] Smith JA et al. Review: The Interleukin 23/Interleukin
17 Axis in Spondyloarthritis Pathogenesis: Th17 and Beyond.
Arthritis Rheumatol. 2014;66:231-41.
[21] Nestle FO et al. Mechanisms of disease psoriasis. N Eng
J Med. 2009;361:496-509.
[22] Girolomoni G et al. Psoriasis: rationale for targeting
interleukin-17. Br J Dermatol. 2012;167:717-24.
[23] Novartis, data on file.
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