- Results from CLARITY study show
Cosentyx® (secukinumab) was significantly more effective than
Stelara®*
(ustekinumab) in delivering clear and almost clear skin at 12 weeks
and at 16 weeks[1]
- Data support findings from the
CLEAR study, which found Cosentyx was superior to Stelara®* in
achieving sustained skin clearance (PASI 90) at 52 weeks[2]
- 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[3]
Basel, January 16, 2018 -
Novartis announced today results from the head-to-head CLARITY
study demonstrating the superiority of Cosentyx®
(secukinumab) compared to Stelara®*
(ustekinumab) in delivering clear and almost clear skin in adults
with moderate-to-severe plaque psoriasis at 12 weeks. The study
results show 66.5% and 72.3% of patients treated with Cosentyx
(p < 0.0001) achieved
both co-primary endpoints PASI 90 and IGA mod 2011 0/1,
respectively, compared to 47.9% and 55.4% patients, respectively,
treated with Stelara®* (p < 0.0001)[1]. At Week 12, patients receiving
Cosentyx had significantly greater PASI 100 responses (key
secondary objective) compared to those taking Stelara®* (38.1% vs.
20.1%, respectively; p < 0.0001)[1]. The
study findings, which support previously presented data from the
CLEAR study demonstrating the superiority of Cosentyx to Stelara®*
in achieving sustained skin clearance (PASI 90 response rates) at
52 weeks[2], were presented as an abstract today at the Winter
Clinical Dermatology Conference in Hawaii.
Clear skin is the aim of psoriasis treatment, and
a Psoriasis Area and Severity Index (PASI) 75, 90 or 100 response
is considered an important measure of treatment success[4]-[7]. All
key secondary endpoints in the CLARITY study were met. At Week 4,
PASI 75 response rates were significantly superior with Cosentyx
compared to Stelara®* (40.2% vs. 16.3%; p <
0.0001). At Week 16, Cosentyx demonstrated significantly
superior response rates compared to Stelara for PASI 75 (91.7% vs.
79.8%; p < 0.0001), PASI 90 (76.6% vs.
54.2%; p < 0.0001), PASI 100 (45.3% vs.
26.7%; p < 0.0001), and IGA mod 2011 0/1
(78.6% vs. 59.1%; p < 0.0001)[1].
"These data add to the robust body of evidence
supporting the use of Cosentyx to treat moderate to severe plaque
psoriasis," said Mark Lebwohl, MD and Chairman of the Waldman
Department of Dermatology at the Icahn School of Medicine at Mount
Sinai Hospital in New York City. "With these findings, clinicians
can have even greater confidence including Cosentyx in their
treatment plans."
Cosentyx continued to have a favorable and
consistent safety profile[1]. To date, Cosentyx has been used by
more than 125,000 patients worldwide[8].
About Cosentyx (secukinumab) and IL-17A
Cosentyx is the first and only fully human IL-17A inhibitor
approved to treat psoriasis, psoriatic arthritis (PsA) and
ankylosing spondylitis (AS)[9]. Cosentyx is a targeted treatment
that specifically inhibits the IL-17A cytokine which plays a
significant role in the pathogenesis of plaque psoriasis, PsA and
AS[10],[11]. Cosentyx is also approved for the most hard-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[9].
Cosentyx delivers psoriasis patients long-lasting
skin clearance, with proven sustainability, safety out to 5 years
and convenient once-monthly dosing in a patient-friendly
autoinjector[9].
Cosentyx is approved in 80 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[9]. 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)[12].
In addition, Cosentyx is the first IL-17A
inhibitor approved in more than 70 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[13].
About the CLARITY
study[1],[14]
CLARITY (NCT02826603) is a 52-week, multicenter, randomized,
double-blind study to demonstrate the superiority of Cosentyx
(secukinumab) 300 mg vs. Stelara®* (ustekinumab) in
moderate-to-severe plaque psoriasis patients. Co-primary endpoints
were 90% or more improvement from Baseline Psoriasis Area and
Severity Index (PASI 90) and Investigator's Global Assessment (IGA)
mod 2011 0/1 (clear or almost clear) response rates at Week 12. Key
secondary objectives included demonstrating superiority of
secukinumab vs. ustekinumab with respect to PASI 75 at Week 4; PASI
75 and 100 at Week 12; PASI 75, 90, 100 and IGA mod 2011 0/1 at
Week 16. Missing values were handled by multiple imputation.
Patients were randomized 1:1 to receive
subcutaneous secukinumab 300 mg (n = 550) at Baseline, Weeks 1, 2
and 3, then every 4 weeks from Week 4 to 48, or ustekinumab (n =
552) 45 mg or 90 mg subcutaneously (depending upon body weight at
randomization), according to approved label.
About psoriasis
Psoriasis is a common, non-contagious, autoimmune disease that
affects more than 125 million people worldwide[15]. Plaque
psoriasis is the most common form of the disease and appears as
raised, red patches covered with a silvery white build-up of dead
skin cells. Palmoplantar psoriasis, which appears on the palms of
the hands and soles of the feet, occurs in up to 40% of plaque
psoriasis patients and is frequently resistant to
treatment[16],[17].
During their lifetime, approximately 90% of
psoriasis patients will develop scaling on their nails[18]. Often
hard-to-treat, nail psoriasis is associated with decreased finger
mobility, functional impairment, pain and reduced quality of
life[18]. Furthermore, nail psoriasis is an important predictor of
PsA which affects up to 30% of patients with psoriasis[19]. PsA is
a condition in which the joints are also affected, causing
debilitating symptoms including pain, stiffness and for some
people, irreversible joint damage[19],[20].
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. Psoriasis is also associated with other
serious health conditions, such as diabetes, heart disease and
depression[19].
About Novartis Immunology &
Dermatology
Novartis is a global leader in Immunology & Dermatology. We are
transforming the lives of people living with immunologic diseases,
focusing on specialty dermatology, rheumatology, auto-inflammatory,
transplant and specialty liver diseases where high unmet medical
needs exist. Our leading brand Cosentyx® (secukinumab)
is an innovative biologic approved in more than 70 markets for the
treatment of moderate-to-severe psoriasis (PsO), ankylosing
spondylitis (AS) and psoriatic arthritis (PsA). Other key brands
include Xolair®**
(omalizumab) in chronic spontaneous urticaria (CSU),
Zortress®/Certican®
(everolimus) and Myfortic® (mycophenolic
acid ) in transplant and Ilaris®
(canakinumab), approved to treat several rare diseases including
some Periodic Fever Syndromes. Our I&D pipeline includes
multiple compounds in liver disease.
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; our ability to obtain or maintain
proprietary intellectual property protection; the particular
prescribing preferences of physicians and patients; global trends
toward health care cost containment, including government, payor
and general public pricing and reimbursement pressures; general
economic and industry conditions, including the effects of the
persistently weak economic and financial environment in many
countries; 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, cost-saving generic and
biosimilar pharmaceuticals and eye care. Novartis has leading
positions globally in each of these areas. In 2016, the Group
achieved net sales of USD 48.5 billion, while R&D throughout
the Group amounted to approximately USD 9.0 billion. Novartis Group
companies employ approximately 121,000 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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* Stelara® is a registered trademark of Janssen
Biotech, Inc.
** In the US, Novartis Pharmaceuticals Corporation and Genentech,
Inc. work together to develop and co-promote Xolair.
References
[1] 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.
[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. 2017;76(1).
[3] Bissonnette R et al. Secukinumab demonstrates high
sustained efficacy and a favorable safety profile through 5 years
of treatment in moderate to severe psoriasis. Presented as eposter
P2223 at 26th EADV Congress 2017. September 13, 2017.
[4] 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.
Last accessed January 2018.
[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/.
Last accessed January 2018.
[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.
Last accessed January 2018.
[7] Langley RG et al. The 5-point Investigator's Global
Assessment (IGA) Scale: a modified tool for evaluating plaque
psoriasis severity in clinical trials. J Dermatolog Treat.
2015;26(1):23-31.
[8] Novartis Data on file. Number of Patients
Prescribed Cosentyx. November 2017.
[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/003729/human_med_001832.jsp&mid=WC0b01ac058001d124.
Last accessed January 2018.
[10] Nestle FO et al. Mechanisms of disease psoriasis. N Eng J Med.
2009;361:496-509.
[11] Girolomoni G et al. Psoriasis: rationale for targeting
interleukin-17. Br J Dermatol. 2012;167:717-24.
[12] Cosentyx (secukinumab) [prescribing information]. East
Hanover, NJ: Novartis Pharmaceuticals Corp, 2016.
[13] Pharmaceuticals and Medical Devices Agency. Review Report.
Available at: http://www.pmda.go.jp/files/000216877.pdf. Last
accessed January 2018.
[14] Novartis Data on file. Clinical Trial Protocol. December,
2017.
[15] 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.
[16] Kumar B et al. Palmoplantar lesions in psoriasis: a study of
3065 patients. Acta Dermatol Venereol. 2002;82:192-5.
[17] 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.
[18] Baran R. The burden of nail psoriasis: an introduction.
Dermatol. 2010:221(Suppl I):1-5.
[19] National Psoriasis Foundation. Psoriatic disease: about
psoriasis. Available at: www.psoriasis.org/about-psoriasis. Last
accessed January 2018.
[20] Mease PJ and Armstrong AW. Managing patients with psoriatic
disease: the diagnosis and pharmacologic treatment of psoriatic
arthritis in patients with psoriasis. Drugs. 2014;74:423-41.
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