Sep 13, 2018
  • 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 27th 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 27th 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 100th 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 100th 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.
 
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*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 27th EADV Congress 2018. 12th 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 27th EADV Congress 2018. 12th 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 27th EADV Congress 2018. 12th 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 27th EADV Congress 2018. 12th 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/003729/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.

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