-
Almost 90% of patients had no
radiographic progression of psoriatic arthritis (PsA) at 2 years
with Cosentyx (secukinumab) 300mg[1]
-
Data at 2 years demonstrate
over 50% of adults with active PsA achieved ACR50, and almost 50%
achieved PASI 100 response with Cosentyx
300mg[1]
-
Results strengthen unique
position of Cosentyx as a rapid and long-lasting comprehensive
treatment of spondyloarthritis and psoriatic disease, with over
200,000 patients treated worldwide
Basel, June 12, 2019
- Novartis, a global leader in rheumatology
and immuno-dermatology, announced today new data from the FUTURE 5
trial showing no radiographic progression (mTSS <0.5) in almost
90% of psoriatic arthritis (PsA) patients treated with
Cosentyx®
(secukinumab) 300mg over 2 years.
"Half of patients with psoriatic arthritis
experience bone erosion within approximately two years. Left
untreated, this can lead to irreversible joint damage and
disability, having a substantial impact on quality of life," said
Dr. Philip J. Mease, Director of Rheumatology Research, Swedish
Medical Center/Providence St Joseph Health and Clinical Professor,
University of Washington School of Medicine, Seattle, WA. "The
availability of a treatment that is proven to inhibit progression
of psoriatic arthritis through two years gives physicians and
patients more choice in the management of this debilitating
condition."
The trial investigated the effect of Cosentyx on
the signs and symptoms of PsA, in addition to inhibition of
radiographic progression of PsA. These data demonstrate that 89.5%
(300mg), 82.3% (150mg) and 81.1% (150mg no loading dose [LD]) of
PsA patients treated with Cosentyx found no radiographic
progression at 2 years. Clinical responses, such as American
College of Rheumatology criteria (ACR20/50) and Psoriasis Area and
Severity Index (PASI 90/100) were also maintained through 2 years,
with 77% of Cosentyx 300mg patients achieving ACR20, 51.9% ACR50,
70.1% PASI 90 and 49.5% PASI 100. Results were also achieved at the
lowest dose of Cosentyx 150mg (79.4% ACR20, 52.6% ACR50, 59.2% PASI
90 and 44.2% PASI 100)[1]. These data are being presented at the
Annual European Congress of Rheumatology (EULAR) on 12-15 June in
Madrid, Spain.
"We are continuing to reimagine psoriatic
arthritis therapy to improve patients' lives and provide a
treatment option that addresses multiple manifestations and
inhibits disease progression," said Eric Hughes, Global Development
Unit Head, Immunology, Hepatology and Dermatology. "These data
further reinforce Cosentyx as a comprehensive treatment that's
backed by over 100 studies, including five-year data across
psoriasis, psoriatic arthritis and ankylosing spondylitis."
PsA is a complex disease with multiple
manifestations driving patient symptoms[2],[3]. It is estimated to
affect up to 50 million people worldwide[4]-[7] and
is part of a family of long-term inflammatory diseases
(spondyloarthritis) that target the joints. If left untreated, PsA
patients can go on to develop irreversible radiographic structural
damage[8]. Radiographic damage is defined by joint inflammation,
erosion and joint space narrowing, particularly in the hands and
feet[9]. PsA with radiographic progression is reported in more than
half of patients[8].
About FUTURE 5
FUTURE 5 is a Phase III, randomized, double-blind,
placebo-controlled study reporting on the effect of Cosentyx on
radiographic progression across 2 years in PsA patients. In the
study, 996 adults with active PsA were randomized to receive
subcutaneous Cosentyx 300 mg (with LD of 300 mg), 150 mg (LD 150
mg), 150 mg with no LD or placebo at baseline at Weeks 1, 2, 3, 4
and every 4 weeks thereafter. Patients could have the Cosentyx dose
escalated from 150 to 300 mg, starting from Week 52, based on
physicians' judgement. The primary endpoint was ACR20 at Week 16.
Radiographic progression as measured by mean change at Week 24 in
van der Heijde-modified total Sharp score and its components
erosion and joint space narrowing measured by hand/foot/wrist
X-rays was a key secondary endpoint. Other endpoints included
ACR50, PASI75/90/100 and resolution of dactylitis and
enthesitis[1].
About Cosentyx
(secukinumab)
Cosentyx is the first and only fully-human biologic that directly
inhibits interleukin-17A (IL-17A), a cornerstone cytokine involved
in the inflammation and development of PsA, psoriasis (PsO), and
ankylosing spondylitis (AS)[10].
Cosentyx is backed by robust clinical evidence,
including dedicated studies in the persistent manifestations of
psoriasis, namely nails, scalp, palms and soles, as well as PsA and
AS[11]-[13]. Cosentyx has shown long-lasting efficacy and a
favorable safety profile while addressing psoriatic disease,
therefore offering a complete treatment[13]. It has shown sustained
safety and long-lasting efficacy in three 5-year Phase III
extension studies in PsO, PsA and AS[12]-[14]. Today, more than
200,000 patients worldwide have been treated with Cosentyx since
launch[15].
Disclaimer
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actual results may vary materially from those set forth in the
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providing the information in this press release as of this date and
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References
[1]
Mease P, et al. Subcutaneous secukinumab 300mg and 150mg provides
sustained inhibition of radiographic progression in psoriatic
arthritis over 2 years: Results from the Phase 3 FUTURE-5 trial.
Presented at the Annual European Congress of Rheumatology (EULAR);
June 12-15, 2019; Madrid, Spain.
[2]
Ritchin CT, et al. N Engl J Med 2017;376:957-970.
[3]
Kavanaugh A, et al. Rheumotol Ther 2016;3;91-102.
[4]
Statistics. National Psoriasis Foundation. Available from:
https://www.psoriasis.org/content/statistics [Last accessed: June
2019].
[5]
Mease PJ, et al. Drugs 2014;74:423-441.
[6]
Liu JT, et al. World JOrthop 2014;5:537-543.
[7]
Scotti L, et al. Science Direct 2018;48:28-34.
[8]
Gladman D, et al. Arthritis Res Ther 2010;12:R113.
[9]
Landewe R, et al. Radiographic progression in rheumatoid. Available
from: arthritishttps://www.clinexprheumatol.org/article.asp?a=2688
[Last accessed: June 2019].
[10]
Novartis Europharm Limited. Cosentyx (secukinumab): Summary of
Product Characteristics. Available from:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003729/human_med_001832.jsp&mid=WC0b01ac058001d124
[Last accessed: June 2019].
[11]
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.
[12]
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.
[13]
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.
[14]
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
[15]
Novartis, data on file. June 2019.
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