-
First-of-its-kind data shows
efficacy and safety of a biologic in the management of axial
manifestations of psoriatic arthritis (PsA), which affect up to an
estimated 35 million people worldwide[1]
-
66.3% of patients treated with
secukinumab 150 mg achieved rapid and significant improvements in
the signs and symptoms of psoriatic arthritis with axial
manifestations at Week 12
-
Cosentyx bridges for the first
time treatment of psoriasis, psoriatic arthritis and axial
manifestations
-
Results strengthen unique
position of Cosentyx as a rapid, comprehensive treatment of
spondyloarthritis and psoriatic disease, with over 200,000 patients
treated worldwide
Basel, June 12, 2019 -
Novartis, a leader in rheumatology and immuno-dermatology, today
announced new data from the MAXIMISE trial evaluating the efficacy
and safety of Cosentyx (secukinumab) in the management of axial
manifestations of psoriatic arthritis (PsA).
The ongoing 52-week Phase IIIb trial met both its
primary and key secondary endpoint with 63.1% of Cosentyx 300 mg
and 66.3% of Cosentyx 150 mg patients achieving ASAS20 at Week 12
(versus 31.3% for placebo) respectively. Rapid onset of relief was
seen as early as week four, with the trial demonstrating a
favorable safety profile consistent with previous clinical
trials[2].
"Up to two thirds of patients with psoriatic
arthritis experience inflammatory back pain, which can limit
mobility," said Dr. Laura Coates, NIHR Clinician Scientist and
Senior Clinical Research Fellow at Nuffield Department of
Orthopedics, Rheumatology and Musculoskeletal Sciences, University
of Oxford, UK. "This study provides clinicians with the evidence to
help them choose a comprehensive treatment for psoriatic arthritis
that addresses diverse patient phenotypes."
PsA is a complex disease with multiple
manifestations driving patient symptoms[3],[4]. It is estimated to
affect up to 50 million people wordwide[5-8] and is part of a
family of long-term inflammatory diseases (spondyloarthritis) that
target the joints. It is closely associated with psoriasis; up to
40% of patients with psoriasis have PsA[6].
"This is the first time we've seen the efficacy of
a biologic in the axial manifestations of psoriatic arthritis at 12
weeks," said Dr. Antonio Mera Varela, Head of Rheumatology,
Hospital Clínico Universitario de Santiago de Compostela, Spain.
"As a physician, it's highly important that there is something that
can help manage all aspects of my patients' psoriatic arthritis,
including inflammation of the spine, joints, enthesitis, dactylitis
and psoriasis of the skin and nails."
These data, which add to the existing evidence
supporting Cosentyx as a treatment across multiple psoriatic
disease manifestations, will be presented at the Annual European
Congress of Rheumatology (EULAR) on 12-15 June in Madrid,
Spain.
About MAXIMISE
MAXIMISE is a 52-week, double-blind, randomized, placebo-controlled
Phase IIIb study to evaluate the efficacy and safety of Cosentyx in
the management of axial manifestations of PsA. MAXIMISE enrolled
498 patients with PsA, clinician-diagnosed axial involvements,
spinal pain rated as >40/100 on a visual analog scale (VAS) and
BASDAI >4 despite trial of at least two non-steroid
anti-inflammatory drugs. Patients were treated with subcutaneous
Cosentyx 300 mg or 150 mg given weekly for 4 weeks and every 4
weeks thereafter. The primary endpoint was the proportion of
patients achieving an ASAS20 response with Cosentyx 300 mg at Week
12. The key secondary endpoint was ASAS20 response with Cosentyx
150 mg at Week 12 after superiority of Cosentyx 300 mg was
established. At Week 12, placebo patients were re-randomized to
subcutaneous Cosentyx 300 mg or 150 mg2.
ASAS20 is achieved when there is a measure of an
improvement of at least 20% and an improvement of at least 10 units
on a 0-100 scale in at least three of the following domains:
Patient global assessment, Pain assessment, Function (Bath
Ankylosing Spondylitis Functional Index (BASFI)), and
Inflammation[9].
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].,13,
Today, more than 200,000 patients worldwide have been treated with
Cosentyx since launch[15].
Disclaimer
This 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," "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
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are based on our current beliefs and expectations regarding future
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materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those set forth in the
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investigational or approved products described in this press
release will be submitted or approved for sale or for any
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providing the information in this press release as of this date and
does not undertake any obligation to update any forward-looking
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References
[1] Field J. et al. What Is
Axial Psoriatic Arthritis? Rheum Rev. 2018; 14:363
[2] Braliakos X. et al. OP0235
Secukinumab improves axial manifestations in patients with
psoriatic arthritis and inadequate response to NSAIDS: primary
analysis of the MAXIMISE trial. Presented at the annual European
League Against Rheumatism (EULAR) 2019.
[3] Ritchin CT et al. Psoriatic
Arthritis. N Engl J Med. 2017; 376(10): 957-970.
[4] Kavanaugh A et al. 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.
[5] Statistics. National
Psoriasis Foundation. Available at:
https://www.psoriasis.org/content/statistics. Last accessed: May
2019.
[6] Mease PJ et al. Managing
patients with psoriatic disease: the diagnosis and pharmacologic
treatment of psoriatic arthritis in patients with psoriasis. Drugs
2014;74:423-41.
[7] Liu J.T et al. Psoriatic
arthritis: Epidemiology, diagnosis, and treatment. World JOrthop.
2014; 5(4): 537-543.
[8] Scotti L et al. Prevalence
and incidence of psoriatic arthritis: A systematic review and
meta-analysis. Science Direct. 2018;48:28-34.
[9] Landewe R and Van Tubergen
A. Clinical tools to assess and monitor spondyloarthritis. Curr
Rhen Rep 2015;17(7):47
[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: May
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. May 2019
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