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Home » Long Term Weight Loss » Novartis Cosentyx shows early synovitis reduction in patients with psoriatic arthritis in first-of-its-kind study – BioSpace

EAST HANOVER, N.J., Nov. 5, 2020 /PRNewswire/ -- Novartis, a leader in rheumatology and immuno-dermatology, today announced 12-week results from the first-of-its-kind Phase IIIb ULTIMATE randomized controlled trial, which demonstrated the significant treatment response of Cosentyx (secukinumab) on synovitis (joint lining inflammation) in psoriatic arthritis (PsA) versus placebo. Synovitis was assessed using an advanced and sensitive imaging technique called Power Doppler ultrasonography (PDUS). These data are being presented at the American College of Rheumatology (ACR) All-Virtual Annual Meeting, November 5-9, 2020.

"Psoriatic arthritis can have a significant impact on a patient's joints. Joint lining inflammation, also known as synovitis, if left untreated, can cause pain to worsen, joint damage and may decrease physical function," said Dr. Maria A. D'Agostino, Professor of Rheumatology at the Catholic University of Rome. "These data are highly encouraging, showing Cosentyx can significantly reduce synovitis at Week 12 versus placebo with results seen as early as Week 1, and that ultrasound is a sensitive and objective tool to monitor joint inflammation in PsA patients."

The use of a standardized ultrasound synovitis score (GLOESS) as the primary endpoint showed objectively the significant benefit of Cosentyx versus placebo on synovitis at Week 12 with an early improvement observed from Week one. Treatment with Cosentyx also significantly improved key secondary endpoints versus placebo, including ACR20 (68% vs 34%, respectively), ACR50 (46% vs 9%, respectively) and enthesitis (mean change from baseline in Spondyloarthritis Research Consortium of Canada enthesitis index score [SPARCC] of -2.4 vs -1.7 respectively)1. The safety profile of Cosentyx through 12 weeks was consistent with previous studies1.

Novartis anticipates disclosing full 24-week data from the ongoing ULTIMATE trial at the European League Against Rheumatism (EULAR) annual meeting in 2021 and final analysis at ACR 2021.

"As a strong believer in the diagnostic and treatment monitoring benefits of ultrasound, this first large randomized double-blind placebo-controlled clinical trial in PsA with an ultrasonographic primary endpoint is incredibly exciting. The ability to use a sensitive imaging technique to assess synovitis and enthesitis in PsA represents a breakthrough in how we conceptualize treatment goals," said Dr. Catherine Bakewell of Intermountain Medical Group in Salt Lake City, UT and an investigator in the ULTIMATE study. "In addition to other measures, PDUS helps to provide earlier insight into treatment response and that patients are more effectively treated across multiple domains of this heterogeneous psoriatic disease spectrum."

PsA is a complex disease with multiple manifestations driving patient symptoms3,4. In PsA, synovitis may lead to joint damage and if left untreated, the joint damage can be irreversible5,6. In addition to reducing synovitis, Cosentyx has been proven to provide long-lasting inhibition of radiographic progression in PsA, limiting joint damage and helping to improve outcomes for patients with this debilitating condition7,8.

About Psoriatic Arthritis (PsA)PsA is estimated to affect up to 50 million people worldwide9,10. It is part of a family of life-long inflammatory diseases (spondyloarthritis) that target the joints and is closely associated with psoriasis10. Up to 40% of patients with psoriasis may develop PsA10. Symptoms of PsA include joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful swelling of the tendons and irreversible joint damage10.

About ULTIMATE ULTIMATE is the first ongoing 52-week double-blind, placebo-controlled Phase IIIb study using ultrasound to assess time-course of response of Cosentyx on synovitis in psoriatic arthritis. The study enrolled 166 adult biologic-nave patients with active Psoriatic arthritis. Patients were randomized (1:1) to receive either secukinumab (300-mg or 150-mg according to severity of skin disease) or placebo weekly for a month with treatment starting at Week 4, followed by a once-a-month dose for the next 11 months.

The primary endpoint is the difference in mean change from baseline to Week 12 between secukinumab and placebo in Global Omeract-European League Against Rheumatism Ultrasound Synovitis Score (GLOESS). GLOESS is a standardized composite score that has shown to be sensitive to change and able to detect and score synovitis11. Secondary endpoints include ACR20, ACR50 and change in Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index from baseline to Week 12 compared with placebo.

ACR20 and ACR50 are composite measures defined as both improvement of 20% or 50% in the number of tender and number of swollen joints, and a 20% or 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, Health Assessment Questionnaire, visual analog pain scale and erythrocyte sedimentation rate or C-reactive protein12. The SPARCC enthesitis index is a validated clinical tool for evaluation of enthesitis13,14.

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 and development of psoriatic arthritis (PsA), moderate to severe plaque psoriasis (PsO), ankylosing spondylitis (AS) and nr-axSpA15,16. Cosentyx has been studied clinically for more than 13 years. The medicine is backed by robust investigational evidence, including five years of clinical data supporting long-term safety and efficacy across moderate to severe plaque psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS)17-22,23. These data strengthen the unique position of Cosentyx as a comprehensive treatment across axial spondyloarthritis, psoriatic arthritis and psoriatic disease, supported by more than 400,000 patients treated worldwide since launch2,23,24.

IMPORTANT SAFETY INFORMATIONDo not use COSENTYX if you have had a severe allergic reaction to secukinumab or any of the other ingredients in COSENTYX. See the Medication Guide for a complete list of ingredients.

COSENTYX is a medicine that affects your immune system. COSENTYX may increase your risk of having serious side effects such as:

InfectionsCOSENTYX may lower the ability of your immune system to fight infections and may increase your risk of infections.

Before starting COSENTYX, tell your doctor if you:

After starting COSENTYX, call your doctor right away if you have any signs of infection listed above. Do not use COSENTYX if you have any signs of infection unless you are instructed to by your doctor.

Inflammatory Bowel DiseaseNew cases of inflammatory bowel disease or "flare-ups" can happen with COSENTYX, and can sometimes be serious. If you have inflammatory bowel disease (ulcerative colitis or Crohn's disease), tell your doctor if you have worsening disease symptoms during treatment with COSENTYX or develop new symptoms of stomach pain or diarrhea.

Serious Allergic ReactionsSerious allergic reactions can occur. Get emergency medical help right away if you get any of the following symptoms: feeling faint; swelling of your face, eyelids, lips, mouth, tongue, or throat; trouble breathing or throat tightness; chest tightness; or skin rash. If you have a severe allergic reaction, do not give another injection of COSENTYX.

Before starting COSENTYX, tell your doctor if you:

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of your medicines to show your doctor and pharmacist when you get a new medicine.

How should I use COSENTYX?See the detailed Instructions for Use that comes with your COSENTYX for information on how to prepare and inject a dose of COSENTYX, and how to properly throw away (dispose of) used COSENTYX Sensoready pens and prefilled syringes.

The most common side effects of COSENTYX include: cold symptoms, diarrhea, and upper respiratory infections. These are not all of the possible side effects of COSENTYX. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information, including Medication Guide.

DisclaimerThis 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," "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 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 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 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 NovartisLocated in East Hanover, NJ Novartis Pharmaceuticals Corporation an affiliate of 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 employs more than 15,000 people in the United States. For more information, please visit https://www.novartis.us.

Novartis and Novartis US is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews and @NovartisUS at https://twitter.com/NovartisUS.For Novartis multimedia content, please visit https://www.novartis.com/news/media-libraryFor questions about the site or required registration, please contact media.relations@novartis.com.

References

1.

D'Agostino MA, Schett G, Lpez-Rdz A, et al. Secukinumab significantly decreased joint synovitis measured by power Doppler ultrasonography in biologic nave patients with active psoriatic arthritis: primary (12-week) results from a randomized, placebo-controlled Phase III study. Abstract presented at the American College of Rheumatology (ACR) Convergence 2020: The ACR's All-Virtual Annual Meeting.

2.

Data on file. COSENTYX access. Novartis Pharmaceuticals Corp; July 2020.

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Ritchin CT, Colbert RA, Gladman DD. Psoriatic arthritis. N Engl J Med. 2017;376(10):957-970.

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Kavanaugh A, Helliwell P, Ritchlin CT. Psoriatic arthritis and burden of disease: patient perspectives from the population-based Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) survey. Rheumotol Ther. 2016;3(1):91-102.

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Van Kuijk A, Tak P. Synovitis in psoriatic arthritis: immunochemistry, comparisons with rheumatoid arthritis and effects of therapy. Curr Rheumatol Rep. 2011;13:353-359.

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Celis R, Cuervo A, Ramirez J, et al. Psoriatic synovitis: singularity and potential clinical implications. Frontiers in Medicine. 2019;6:1-7

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Mease P, van der Heijde D, Landew R, et al. Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study Annals of the Rheumatic Diseases 2018;77:890-897.

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Van Der Heijde D, Mease PJ, Landewe R, et al. Secukinumab provides sustained low rates of radiographic progression in psoriatic arthritis: 52-week results from a phase 3 study, FUTURE 5. Rheumatology. 2020;59:13251334

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National Psoriasis Foundation. Psoriasis statistics. Available from: https://www.psoriasis.org/content/statistics. Last accessed: October 2020.

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Mease PJ, Armstrong AW. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs. 2014;74:423-441.

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D'Agostino MA, Terslev L, Aegerter P, et al. Scoring ultrasound synovitis in rheumatoid arthritis: a EULAR-OMERACT ultrasound taskforce-Part 1: definition and development of a standardised, consensus-based scoring system. RMD Open. 2017;3:e000428.

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Eprovide. American College of Rheumatology 20/50/70 criteria (ACR20/50/70). Available from: https://eprovide.mapi-trust.org/instruments/american-college-of-rheumatology-20-50-70-criteria#:~:text=The%20ACR20%20is%20a%20composite,Health%20Assessment%20Questionnaire%20(HAQ)%5D%2C. Last accessed: October 2020.

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Maksymowych WP, Mallon C, Morrow S, et al. Development and validation of the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index. Ann Rheum Dis. 2009;68(6):948-953.

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Mease PJ, Van den Bosch F, Sieper J, Xia Y, Pangan AL, Song IH. Performance of 3 Enthesitis Indices in Patients with Peripheral Spondyloarthritis During Treatment with Adalimumab. J Rheumatol. 2017 May;44(5):599-608.

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Novartis Europharm Limited. Cosentyx (secukinumab): Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/cosentyx Last accessed: August 2019.

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Girolomoni G, et al. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol 2012;167:717724.

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

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Data on file. Data Analysis Report: Study CAIN457A2302E1. Novartis Pharmaceuticals Corp; November 30, 2015.

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Data on file. CAIN457F2310 and CAIN457F2305 Summary of 5-Year Clinical Safety in (Ankylosing Spondylitis). Novartis Pharmaceuticals Corp; May 2019.

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Data on file. CAIN457F2312 (FUTURE 2): 5 Year- Interim Report. Novartis Pharmaceuticals Corp; May 2019.

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Data on file. CAIN457F2312 Data Analysis Report. Novartis Pharmaceuticals Corp; November 2008.

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Data on file. CAIN457F2310 (MEASURE 1 and 2): Pooled Safety Data. Novartis Pharmaceuticals Corp; July 23, 2018.

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Cosentyx [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2020.

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Data on file. AIN457A2102 Clinical Study Report. Novartis Pharmaceuticals Corp; December 2008.

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Novartis Cosentyx shows early synovitis reduction in patients with psoriatic arthritis in first-of-its-kind study - BioSpace

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Home » Long Term Weight Loss » Novartis Cosentyx shows early synovitis reduction in patients with psoriatic arthritis in first-of-its-kind study – BioSpace