Novartis presents latest Phase III data reinforcing Cosentyx® as a first-line systemic treatment in pediatric psoriasis

Novartis presents latest Phase III data reinforcing Cosentyx® as a first-line systemic treatment in pediatric psoriasis

• Latest data show Cosentyx^® provides fast and strong skin clearance, significant improvement in quality of life and a favorable safety profile^1,2
   
• Moderate-to-severe psoriasis affects more than 350,000 children worldwide³, with the physical and psychological burden disrupting important formative years⁴
   
• FDA has accepted a submission for Cosentyx in moderate-to-severe plaque psoriasis in children and adolescents aged 6 to <18 years
   
• Cosentyx is backed by 5-year efficacy and safety data across moderate-to-severe psoriasis, psoriatic arthritis (PsA), ankylosing spondylitis (AS), with 400,000+ patients treated across four indications worldwide since launch^5-10

Basel, October 29, 2020 – Novartis, a leader in immuno-dermatology and rheumatology, today announced data from two pivotal international Phase III studies, which show Cosentyx^® (secukinumab) provides fast and strong skin clearance and significant improvement in quality of life in children and adolescents aged 6 to <18 years with moderate-to-severe plaque psoriasis.

“Pediatric psoriasis is negatively associated with physical and emotional quality of life, with lasting impact into adulthood, yet there are limited biologic treatment options available,” said Professor Christine Bodemer, Head of the Department of Dermatology, Necker-Enfants Malades Hospital, Paris. “The results from these studies are encouraging as they show Cosentyx rapidly reduces symptom burden with a favorable safety profile in this vulnerable patient group, providing us with a much-needed treatment option.”

“These new data add to the wealth of evidence Cosentyx has across four indications,” said Todd Fox, Global Head of Medical Affairs for Immunology, Hepatology and Dermatology, Novartis. “Cosentyx is already approved as a first-line systemic treatment for children in Europe and next year we are expecting a response on our recently accepted submission to the US Food and Drug Administration.”

Plain Language Media Summaries for the two pediatric psoriasis Phase III trials and other key abstracts presented at EADV 2020 are available from the Novartis website: https://www.novartis.com/our-focus/immunology-dermatology/abstract-summaries-eadv

About psoriasis

Psoriasis is a life-long debilitating systemic inflammatory disease that significantly impacts patients’ quality of life, both physically and emotionally¹¹. One third of psoriasis cases begin in childhood and, of these, the onset is most common during adolescence¹². Moderate-to-severe psoriasis affects more than 350,000 children worldwide and may impact children beyond the skin, with the physical and psychological burden of psoriasis disrupting important formative years³. The incidence of pediatric psoriasis has more than doubled between 1970 and 2000 in the US, and an upward trend in incidence of psoriasis has been observed in several countries^11,12. There are only a few approved treatment options available, and the unmet medical need remains high⁴.

About the study data

The two Phase III international studies in children and adolescents aged 6 to <18 years consisted of one open‑label, two-arm, parallel‑group, multicenter study in children with moderate-to-severe plaque psoriasis and one randomized, double-blind, placebo and etanercept-controlled study in children with severe plaque psoriasis. Dosing regimens of Cosentyx^® were stratified by weight groups.

In children with moderate-to-severe plaque psoriasis, the low dose of Cosentyx provided fast and strong skin clearance, with 93% achieving Psoriasis Area Severity Index (PASI) 75 as early as Week 12, 69% achieving PASI 90 at Week 12 and 88% at Week 24, 59.5% achieving completely clear skin (PASI 100) by Week 12 and 67% by Week 24¹. In patients with severe psoriasis, the low dose of Cosentyx ensured sustained skin clearance through Week 52, with PASI 90 achieved in 75% of patients². Differences in PASI 75 in patients with severe psoriasis treated with Cosentyx were seen as early as Week 4 and in patients with moderate-to-severe psoriasis as early as Week 2¹³.

Half of children with moderate-to-severe plaque psoriasis treated with the low dose of Cosentyx reported complete relief from symptom burden of psoriasis on their quality of life as early as Week 12, as measured by Children's Dermatology Life Quality Index (CDLQI) 0/1 responses¹. In children with severe plaque psoriasis treated with the low dose of Cosentyx, 44.7% reported complete relief by Week 12, with 60.6% by Week 52².

Cosentyx safety profile for both the low dose and high dose is comparable and consistent with the established adult psoriasis indication. No new safety signals were observed in children^1,2.

Cosentyx^® (secukinumab)
Cosentyx is the first and only fully-human biologic that directly inhibits interleukin-17A (IL-17A), an important cytokine involved in the systemic inflammation and development of moderate-to-severe plaque psoriasis, psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)^14-16.

Cosentyx is backed by more than 12 years of clinical experience and long-term five-year data across three indications of psoriasis, PsA and AS, as well as data from real world evidence^5-10,17. These data strengthen the unique position of Cosentyx as a rapid and long-lasting comprehensive treatment across axial spondyloarthritis, PsA and psoriatic disease, with more than 400,000 patients treated worldwide with Cosentyx since launch¹⁸ and plans to expand to 10 indications over the next 10 years.

Disclaimer

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,” “may,” “could,” “would,” “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, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity 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.

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 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

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References

1.    Magnolo N, Kingo K, Laquer V, et al. Secukinumab is highly efficacious and has a favorable safety profile in pediatric patients with moderate to severe plaque psoriasis: 24-Week results. Presented as an e-poster presentation at the European Academy of Dermatology and Venereology Virtual Meeting; October 29–31, 2020.

2.    Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab demonstrated high efficacy and a favorable safety profile in pediatric patients with severe chronic plaque psoriasis: One-year results. Presented as an oral presentation at the European Academy of Dermatology and Venereology Virtual Meeting; October 29–31, 2020.

3.    Paller AS, Singh R, Cloutier M, et al. Prevalence of Psoriasis in Children and Adolescents in the United States: A Claims-Based Analysis. J Drugs Dermatol. 2018;17(2):187-94.

4.    Menter A, Cordoro KM, Davis DMR, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis in pediatric patients. J Am Acad Dermatol. 2020;82(1):161-201.

5.    Data on file. CAIN457F2310 (MEASURE 2): 5 year report. Novartis Pharmaceuticals Corp; September 15, 2015.

6.    Data on file. Data analysis report: study CAIN457A2302E1. Novartis Pharmaceuticals Corp; November 30, 2015.

7.    Data on file. CAIN457F2310 and CAIN457F2305 summary of 5-year clinical safety in (ankylosing spondylitis). Novartis Pharmaceuticals Corp; May 2019.

8.    Data on file. CAIN457F2312 (FUTURE 2): 5 year-interim report. Novartis Pharmaceuticals Corp; May 2019.

9.    Data on file. CAIN457F2312 data analysis report. Novartis Pharmaceuticals Corp; November 2008.

10.  Data on file. CAIN457F2310 (MEASURE 1 and 2): pooled safety data. Novartis Pharmaceuticals Corp; July 23, 2018.

11. World Health Organization. Global report on psoriasis [online] 2016. Available from: https://apps.who.int/iris/handle/10665/204417 [Last accessed: October 2020].

12.  Tollefson MM, Crowson CS, McEvoy MT, et al. Incidence of psoriasis in children: a population-based study. J Am Acad Dermatol. 2010;62(6):979-87.

13.  Novartis data on file.

14.  Girolomoni G, Mrowietz U, Paul C, et al. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol. 2012;167:717-24.

15.  Sieper J, Poddubnyy D, Miossec P. The IL-23–IL-17 pathway as a therapeutic target in axial spondyloarthritis. Nat Rev Rheumatol. 2019;15:747-57.

16.  Jansen DT, Hameetman M, van Bergen J, et al. IL-17-producing CD4+ T cells are increased in early, active axial spondyloarthritis including patients without imaging abnormalities. Rheumatology (Oxford). 2015;54(4):728-35.

17.  Marzo-Ortega H, Sieper J, Kivitz A. 5-year efficacy and safety of secukinumab in patients with ankylosing spondylitis: end-of-study results from the phase 3 MEASURE 2 trial. Lancet Rheumatol. 2020;2:e339-46.

18.  Data on file. COSENTYX access. Novartis Pharmaceuticals Corp; October 2020.