Novartis presents positive Phase III results for Cosentyx® in children with active enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) at ACR 2021

Nov 08, 2021
  • Treatment with Cosentyx® (secukinumab) resulted in a 72% reduced flare risk versus placebo, with improvement in disease activity over two years across both enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA)1. Safety in this pediatric population was consistent with the known safety profile of Cosentyx1
  • Novartis has filed regulatory submissions for Cosentyx in ERA and JPsA [categories of juvenile idiopathic arthritis (JIA)] in the US and Europe with decisions anticipated in the coming months. The US Food and Drug Administration (FDA) granted a Priority Review for both indications
  • There are approximately 2 million children worldwide who are currently diagnosed with JIA2,3. The categories of JPsA and ERA are progressive, chronic, debilitating diseases and, if approved, Cosentyx would be the first biologic for ERA patients in the US4,5

Basel, November 08, 2021 — Novartis, a leader in rheumatology and immuno-dermatology, today announced new analyses from the two-year positive Phase III JUNIPERA study, which demonstrated the treatment response of Cosentyx® (secukinumab) in children and adolescents with enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) – two categories of juvenile idiopathic arthritis (JIA). The safety profile was consistent with that of Cosentyx in adults with plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis1. These data will be highlighted as an oral presentation at the American College of Rheumatology (ACR) Convergence all-virtual annual meeting, November 3–10, 20211. Initial results from the Phase III JUNIPERA trial were previously presented at the European Alliance of Associations for Rheumatology (EULAR) 2021 European Congress of Rheumatology in June6.

Two-year results from JUNIPERA demonstrated that patients treated with Cosentyx had a significantly longer time to flare, showing a 72% reduction in the risk of flare (P<.001) versus placebo, in children and adolescents ages two to 17 years old with active ERA (n=52; mean age: 13.7) and active JPsA (n=34; mean age: 12.2)1. At Week one, over 30% of patients showed improvement with Cosentyx (JIA American College of Rheumatology [ACR] 30) and nearly 90% achieved JIA ACR 30 by the end of the first treatment period (12 weeks)1. Additionally, by Week 12, nearly 35% of patients (N=86) achieved JIA ACR inactive disease status. Improvements in disease activity, as measured by the mean juvenile arthritis disease activity score (JADAS 27), were observed at Week one, reaching low disease activity from Week 12 through Week 1041. Safety in this pediatric population was consistent with the known safety profile of Cosentyx1.  

“If left untreated, ERA and JPsA can have a substantial negative impact on quality of life and may lead to deformities and long-term disability for children and adolescents who live with these conditions,” said Dr. Hermine Brunner, Cincinnati Children's Hospital Medical Center and lead investigator of the JUNIPERA study. “It is promising that the JUNIPERA study shows that secukinumab demonstrated marked responses in patients with ERA and JPsA, a population that currently has limited treatment options available to help improve joint inflammation, dactylitis and enthesitis.”

Novartis has filed regulatory submissions for Cosentyx in ERA and JPsA in Europe and the US. Final decisions by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) are anticipated in the coming months. If approved, Cosentyx would be the first biologic treatment for children living with ERA in the US.

“With more than 500,000 patients treated worldwide since launch, these JUNIPERA data further reinforce the known efficacy and safety of Cosentyx for children and adults living with rheumatologic and dermatologic conditions,” said Todd Fox, Global Head of Medical Affairs Immunology, Hepatology and Dermatology at Novartis. “We are committed to bringing Cosentyx to young people living with inflammatory rheumatic diseases as quickly as possible, as part of our ambition to expand Cosentyx to 10 indications.”

In July 2020, Cosentyx received EU approval as a first-line systemic treatment for pediatric psoriasis and recently received approval in the US and China7-9. In Japan, Cosentyx has also been approved to treat psoriatic arthritis as well as psoriasis in pediatric patients aged 6 years or older, as well as generalized pustular psoriasis10.

About the JUNIPERA Study
JUNIPERA is a two-year, three-part, double-blind, placebo-controlled, randomized-withdrawal, Phase III study that enrolled 86 children and adolescents aged 2 to 17 years with a confirmed diagnosis of JPsA or ERA according to the International League of Associations for Rheumatology classification criteria11. Patients were given open-label secukinumab 75 mg/150 mg (prefilled syringe at doses of 75 mg in patients <50 kg and 150 mg in patients ≥50 kg) up until Week 1211. In this treatment period 1, patients achieving at least JIA ACR 30 response then progressed onto treatment period 2 where patients were allocated to one of two arms: secukinumab 75 mg/150 mg (depending on bodyweight) or placebo and responses observed up until Week 10411. The primary endpoint of the study was time to flare in the treatment period 2 (Week 12 to Week 104)11. Secondary endpoints in treatment period 1 (up to Week 12) included evaluation of JIA ACR 30/50/70/90/100 responses and each JIA ACR core component, change from baseline of the JADAS, and total enthesitis and dactylitis count11.

About Cosentyx® (secukinumab)
Cosentyx is the first and only fully-human biologic that directly inhibits interleukin-17A (IL-17A), an important cytokine involved in the inflammation of psoriatic arthritis, (PsA), moderate to severe plaque psoriasis, (PsO), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)12,13. Cosentyx is a proven medicine and has been studied clinically for more than 14 years. The medicine is backed by robust evidence, including five years of clinical data in adults supporting long-term safety and efficacy across moderate to severe PsO, PsA and AS14-20. These data strengthen the position of Cosentyx as a treatment across AS and nr-axSpA, PsA and moderate to severe PsO, supported by more than 500,000 patients treated worldwide since launch in 20157,21,22

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 108,000 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.  Brunner H, Foeldvari I, Alexeeva E, et al. Secukinumab Treatment In Children And Adolescents with Enthesitis-Related Arthritis And Juvenile Psoriatic Arthritis: Efficacy And Safety Results From A Phase 3 Study. Presented at ACR 2021. Abstract 1424.
2.  Dave M, Rankin J, Pearce M, et al. Global prevalence estimates of three chronic musculoskeletal conditions: club foot, juvenile idiopathic arthritis and juvenile systemic lupus erythematosus. Pediatr Rheumatol Online J. 2020;18:49.
3.  Momah T and Ray L. Juvenile idiopathic arthritis: Old disease, new tactics. J Fam Pract. 2019;68:E8-E13.
4.  Basra HAS and Humphries PD. Juvenile idiopathic arthritis: what is the utility of ultrasound? Br J Radiol. 2017;90:20160920.
5.  Weiss PF, Beukelman T, Schanberg LE, et al. Enthesitis-related arthritis is associated with higher pain intensity and poorer health status in comparison with other categories of juvenile idiopathic arthritis: the Childhood Arthritis and Rheumatology Research Alliance Registry. J Rheumatol. 2012;39:2341-51.
6.  Ruperto N, Foeldvari I, Alexeeva E, et al. Efficacy and Safety of Secukinumab in Enthesitis-related Arthritis and Juvenile Psoriatic Arthritis: Primary Results from a Randomised, Double-blind, Placebo-controlled, Treatment Withdrawal, Phase 3 Study (JUNIPERA). Presented as a late-breaking abstract at EULAR 2021. Abstract LB0004.
7.  Cosentyx [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021.
8.  Magnolo N, Kingo K, Laquer V, et al. Secukinumab treatment demonstrated high efficacy and safety in pediatric patients with moderate to severe plaque psoriasis: 52-week results from a randomized trial. Presented at the American Academt of Dermatology (AAD) Virtual Meeting Experience (VMX) 2021; 23-25 April 2021. Poster 26680.
9.  Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab efficacy and safety profile in pediatric patients with severe chronic plaque psoriasis up to one year. Presented at AAD VMX 2021; 23-25 April 2021.
10.  Ministry of Health, Labor and Welfare approves additional indications for 12 products Enrest's "hypertension" is also added. Mix Online. September 28, 2021. Accessed November 2021. https://www.mixonline.jp/tabid55.html?artid=71852.
11.  Clinical Trials.gov. Secukinumab Safety and Efficacy in Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA). Available from: https://clinicaltrials.gov/ct2/show/NCT03031782. Last accessed: November 2021.
12.  Novartis Europharm Limited. Cosentyx® (secukinumab): Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/documents/product-information/cosentyx-epar-product-information_en.pdf [Last accessed: November 2021].
13.  Girolomoni G, Mrowietz U and Paul C. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol. 2012;167:717-24.
14.  Bissonnette R, Luger T, Thaçi D, et al. Secukinumab demonstrates high sustained efficacy and a favourable 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.
15.  Data on file. Data Analysis Report: Study CAIN457A2302E1. Novartis Pharmaceuticals Corp; November 30, 2015.
16.  Data on file. CAIN457F2310 and CAIN457F2305 summary of 5-year clinical safety in (ankylosing spondylitis). Novartis Pharmaceuticals Corp; May 2019.
17.  Data on file. CAIN457F2312 Data Analysis Report. Novartis Pharmaceuticals Corp; November 2008.
18.  Data on file. CAIN457F2310 (MEASURE 1 and 2): Pooled Safety Data. Novartis Pharmaceuticals Corp; July 23, 2018.
19.  McInnes IB, Mease PJ, Kirkham B, et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015;386:1137-46.
20.  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.
21.  Data on file. COSENTYX Access. Novartis Pharmaceuticals Corp; June 2021.
22.  Data on file. AIN457A2102 Clinical Study Report. Novartis Pharmaceuticals Corp; December 2008.

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