- 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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