- Data from five real-world evidence (RWE) and observational studies being conducted in North America, Latin America and Europe provide extensive cumulative insights for Cosentyx (secukinumab) clinical practice among more than 13,000 patients [1-6]
- The studies report on the real-world sustained efficacy, favorable safety profile, and impact on quality of life of Cosentyx over the long-term up to 2.5 years [1-6]
- Cosentyx is backed by robust clinical evidence, including 5-year sustained efficacy and safety data across psoriasis, psoriatic arthritis and ankylosing spondylitis, and dedicated studies in the persistent manifestations of psoriasis, namely nails, scalp, palms and soles [7-10]
- Cosentyx has a broad head-to-head study program that includes FIXTURE, CLEAR, CLARITY, SURPASS and EXCEED clinical superiority trials [11-16]
Basel, October 9, 2019 – “These extensive results confirm what has been previously observed in Phase 3 clinical trials, and support our continued use of Cosentyx in psoriatic disease, to offer patients improved symptom control and quality of life,” said Prof. Matthias Augustin, Director of the Institute for Health Services Research in Dermatology and Nursing. “Real-world evidence and observational studies help to bridge the gap in knowledge that exists between clinical trials and clinical practice. They provide important insights about patient characteristics, disease severity and management. Moreover, they also support the evidence of the treatment effectiveness in the routine clinical practice.”
These data are being presented at the 28th Congress of the European Academy of Dermatology and Venereology (EADV), 9-13 October 2019, Madrid, Spain.
This media update 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 media update, 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 media update 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 and requirements for increased pricing transparency; 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 media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.
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[1.] Augustin M et al. Secukinumab treatment resulted in normalization of quality of life in moderate-to-severe psoriasis patients with and without previous systemic therapy: Dermatology Life Quality Index results from the PROSE study. Presented at the 38th Congress of the European Academy of Dermatology and Venereology (EADV); 9-13 October 2019; Madrid, Spain.
[2.] Papp KA et al. Sociodemographic and Baseline Disease Profile of Patients with Moderate-to-severe Chronic Plaque Psoriasis Treated with Secukinumab vs Other Treatments: 30 months update from the PURE Registry. Presented at the 38th Congress of the European Academy of Dermatology and Venereology (EADV); 9-13 October 2019; Madrid, Spain.
[3.] Thaçi D et al. Secukinumab real-world effectiveness and safety data on plaque psoriasis treatment in Germany from 2,502 patients: Final results of the PROSPECT study. Presented at the 38th Congress of the European Academy of Dermatology and Venereology (EADV); 9-13 October 2019; Madrid, Spain.
[4.] Papp KA et al. Secukinumab treated Patients in the PURE Registry (Patients with moderate-to-severe chronic plaque psoriasis in Latin America and Canada): 30-month Follow-up Data. Presented at the 38th Congress of the European Academy of Dermatology and Venereology (EADV); 9-13 October 2019; Madrid, Spain.
[5.] Augustin M et al. Effectiveness and safety of secukinumab in a real-world clinical setting in Europe: 1-year results from an interim analysis of the SERENA study. Presented at the 38th Congress of the European Academy of Dermatology and Venereology (EADV); 9-13 October 2019; Madrid, Spain.
[6.] Alavi A et al. Effectiveness of secukinumab at 18 months in Canadian psoriasis patients in a real world setting. Presented at the 38th Congress of the European Academy of Dermatology and Venereology (EADV); 9-13 October 2019; Madrid, Spain.
[7.] Mease PJ et al. Secukinumab Provides Sustained Improvements in the Signs and Symptoms in Psoriatic Arthritis: Final 5 Year Efficacy and Safety Results from a Phase 3 Trial. Abstract presented at the American College of Rheumatology Annual Meeting, 2018.
[8.] Baraliakos X et al. Long-term Evaluation of Secukinumab in Ankylosing Spondylitis: 5 Year Efficacy and Safety Results from a Phase 3 Trial. Presented as a late-breaking abstract at the American College of Rheumatology Annual Meeting, 2018.
[9.] Bissonnette, R et al. 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;32: 1507-1514
[10.] 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. Presented as a Late Breaking Poster #6 at the 3rd Inflammatory Skin Disease Summit (ISDS), Vienna. December 2018.
[11.] Langley RG et al. Secukinumab in Plaque Psoriasis — Results of Two Phase 3 Trials. N Engl J Med 2014;371:326-38.
[12.] 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.
[13.] 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.
[14.] 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 2019.
[15.] Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis (EXCEED 1). Available at: https://clinicaltrials.gov/ct2/show/NCT02745080. Last accessed September 2019.
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