Novartis presents new Cosentyx data showing long-lasting efficacy in psoriatic arthritis over 3 years including patient-reported pain
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Novartis International AG /
Novartis presents new Cosentyx data showing long-lasting efficacy in psoriatic
arthritis over 3 years including patient-reported pain
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* Cosentyx(®) data show sustained improvements in the signs and symptoms of
psoriatic arthritis (PsA) in approximately 80% of patients over 3 years[1]*
* New data show that with Cosentyx the high ACR response rates are
consistently maintained in PsA, with no reduction from Year 1 to Year 3[1]
* New head-to-head clinical trials planned in ankylosing spondylitis (AS) and
PsA to compare Cosentyx versus Humira(®)[2](**/***)
The digital press release with multimedia content can be accessed here:
Basel, November 14, 2016 - Novartis announced today new data showing Cosentyx(®)
(secukinumab) delivers sustained improvements in the signs and symptoms of
psoriatic arthritis (PsA) over three years - including patient-reported
pain[1],[3]. These findings were presented at the 2016 Annual Meeting of the
American College of Rheumatology (ACR) in Washington DC, United States, at which
Novartis presented 28 abstracts in total.
Cosentyx is the first approved fully human interleukin-17A (IL-17A) inhibitor to
demonstrate three-year efficacy in patients with PsA[1],[4], a life-long
inflammatory disease that affects the skin and joints. Cosentyx is also the only
IL-17A inhibitor indicated for ankylosing spondylitis (AS), PsA, and
psoriasis[4] - this is significant as up to eight in 10 patients diagnosed with
PsA already have psoriasis[5].
"Joint pain severely impacts the lives of many people living with psoriatic
arthritis. The knowledge that Cosentyx delivers lasting pain relief, reduces
swelling and helps keep joints moving is important as it means it could help
improve both patient overall quality of life and mobility," said Vasant
Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis.
"Cosentyx provides much-needed pain relief and also delivers high and long-
lasting skin clearance for psoriasis, which the majority of people with
psoriatic arthritis also suffer from."
In the first year of the three-year open-label extension study, which is a
continuation of the two-year double-blind study previously reported, 77% of PsA
patients achieved an ACR 20 response (American College of Rheumatology response
criteria) with Cosentyx[1]*. Completion rates for the extension study were high
with 95% patients completing the first year of the extension trial[1]. These new
data show that response rates were consistent from Year 1 (69.4%) to Year 3
(76.8%) and this was independent of whether patients received an anti-TNF prior
to receiving Cosentyx[1]. Importantly, a component of this measure includes
patient-reported pain. Cosentyx has previously shown 79% of AS patients achieved
an ASAS 20 response (Assessment of Spondyloarthritis International Society
response criteria) at two years[6](§). Previous data also show up to 80% of AS
and 84% of PsA patients treated with Cosentyx at two years had no radiographic
progression in the spine or joints respectively, as shown by X-ray
assessment[7],[8]. Cosentyx continues to have a favorable safety profile, which
was consistent with that shown in Phase III studies[9]-[12].
In addition, analyses, using Matching-Adjusted Indirect Comparison (MAIC)
presented at ACR show Cosentyx may improve the signs and symptoms of AS and PsA
more than Humira(®) (adalimumab)(**). In a new MAIC for AS, the ASAS 20 response
rates at Week 52 were higher for Cosentyx (74%) than for Humira(®) (65%)[13].
Likewise, in the MAIC for PsA patients, ACR 20 response rates at Week 48 were
higher for Cosentyx (72%) than for Humira(® )(56%)[14].
Following these MAIC analyses, Novartis plans to initiate new head-to-head
clinical trials to directly compare Cosentyx versus Humira(®) in patients with
AS and PsA[2]***. These will include 850 patients and will be the first ever
adequately powered head-to-head studies with biologic medicines to differentiate
the effectiveness of treatment in these conditions.
About Cosentyx and interleukin-17A (IL-17A)
Cosentyx is a fully human monoclonal antibody that selectively neutralizes IL-
17A. Research suggests that IL-17A may play an important role in driving
autoinflammatory conditions in enthesis and ultimately the body's immune
response in psoriasis, AS and PsA[15],[16].
Cosentyx is the first IL-17A inhibitor approved in more than 55 countries for
the treatment of active AS and PsA, which includes the European Union countries,
Switzerland, and the US. Cosentyx is also approved for the treatment of PsA and
pustular psoriasis in Japan.
For patients with PsA in the US, Cosentyx may be administered with or without
loading dosage by subcutaneous injection. With loading dosage, the recommended
dose is Cosentyx 150 mg by subcutaneous injection with initial dosing at
Weeks 0, 1, 2 and 3, followed by monthly maintenance dosing starting at Week 4.
Without loading dosage, the recommended dose is 150 mg every 4 weeks. If a
patient continues to have active PsA, a dosage of 300 mg should be considered.
Cosentyx may be administered with or without methotrexate. For PsA patients with
concomitant moderate-to-severe plaque psoriasis the dosing and administration
recommendations for plaque psoriasis apply.
Cosentyx is approved in more than 65 countries for the treatment of moderate-to-
severe plaque psoriasis which includes the European Union countries, Japan,
Switzerland, Australia, the US and Canada. In Europe, Cosentyx is approved for
the first-line systemic treatment of moderate-to-severe plaque psoriasis in
adult patients[4]. In the US, Cosentyx is approved as a treatment for moderate-
to-severe plaque psoriasis in adult patients who are candidates for systemic
therapy or phototherapy (light therapy)[17].
More than 10,000 patients have been treated with Cosentyx in clinical trial
settings across multiple indications, and over 50,000 patients have been treated
in the post-marketing setting[2].
About the FUTURE 1 study
FUTURE 1 is a two-year, multi-center, randomized, placebo-controlled Phase III
pivotal study to evaluate the efficacy of Cosentyx in patients with active PsA.
FUTURE 1 enrolled 606 patients with active PsA and assessed Cosentyx with
intravenous loading (10 mg/kg) and subcutaneous (75 mg and 150 mg) maintenance
dosing. The primary endpoint assessed superiority of Cosentyx against placebo in
the proportion of patients achieving the ACR 20 response at Week 24[12]. From
Week 16, patients in the placebo arm of the study were re-randomized to receive
Cosentyx 75 mg or 150 mg at either Week 16 or Week 24, based on clinical
response. At Week 104, patients could enter the extension phase of the study[1].
About MAIC and limitations of these studies
While these MAIC analyses have been performed using data from randomized
controlled trials, there are limitations to these analyses due to differences in
study designs and lower effective sample size for Cosentyx. In addition, only
publicly available data has been used for Humira(®). This impacts availability
of comparative data and matching of patient populations in these studies. The
PsA MAIC is based on 150 mg Cosentyx dosage. MAIC is a valid and accepted method
for comparative effectiveness research[18],[19]. Further details on the MAIC
analyses are available in the presented scientific abstracts and
posters[18],[19].
About ankylosing spondylitis and psoriatic arthritis
AS is part of a family of life-long inflammatory diseases that also includes
PsA. It generally results in serious impairment of movement in the spine and
physical function, which has an impact on quality of life. People in their teens
and twenties, particularly males, are affected most often. Family members of
those with AS are at higher risk[20],[21].
PsA is also closely associated with psoriasis. Approximately 30% of patients
with psoriasis have PsA and as many as one in four people with psoriasis may
have undiagnosed PsA[22],[23]. 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 damage[5]. Up to 40% of people can suffer
from joint destruction and permanent physical deformity[24].
About ASAS 20 and ACR 20
Improvements in the symptoms of AS are measured by the ASAS response criteria
(ASAS 20), which is defined as an improvement of at least 20% and absolute
improvement of at least 10 units on a 0-100mm scale in at least three of the
following criteria: improvement in flexibility, night time pain, ability to
perform specific tasks, morning stiffness, and no further deterioration in the
condition. The percentage of patients reaching an ASAS 20 response is an
accepted way of measuring the efficacy of treatments in AS[25].
Improvements in the symptoms of PsA are measured by the ACR response criteria,
which has three levels - ACR 20, 50, 70. In ACR 20 there is an improvement of
20% or greater of the following criteria: reduction in the number of tender
joints; reduction in the number of swollen joints; and a reduction in three of
five additional criteria, which are the patient's assessment of pain and/or the
patient's assessment of how active his or her PsA is, the physician's assessment
of disease activity, levels of disability measured by the Stanford Health
Assessment Questionnaire, and laboratory tests showing if inflammation is
active. The ACR 50 and ACR 70 use the same criteria as ACR 20, but are looking
for a higher percentage improvement (50% and 70%) instead of 20%[26].
*In PsA 77% of patients achieved ACR 20 response; this includes both the anti-
TNF naïve and anti-TNF inadequate response arms of the study.
(**)Humira is a registered trademark of AbbVie Inc.
***In AS, a biosimilar of Humira(®) (adalimumab) will be used and in PsA the
originator, Humira(®), will be used to directly compare against Cosentyx.
(§)In AS, 79% of patients achieved ASAS 20 response; this includes both the
anti-TNF naïve and anti-TNF inadequate response arms of the study.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "planned," "could," "may," "plans," "will," "suggests," or
similar terms, or by express or implied discussions regarding potential new
indications or labeling for Cosentyx, or regarding potential future revenues
from Cosentyx. You should not place undue reliance on these statements. Such
forward-looking statements are based on the current beliefs and expectations of
management 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 Cosentyx will be submitted or
approved for any additional indications or labeling in any market, or at any
particular time. Nor can there be any guarantee that Cosentyx will be
commercially successful in the future. In particular, management's expectations
regarding Cosentyx could be affected by, among other things, the uncertainties
inherent in research and development, including unexpected clinical trial
results and additional analysis of existing clinical data; unexpected regulatory
actions or delays or government regulation generally; the company's ability to
obtain or maintain proprietary intellectual property protection; general
economic and industry conditions; global trends toward health care cost
containment, including ongoing pricing pressures; unexpected safety, quality or
manufacturing issues, 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 Novartis
Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye care and cost-saving generic pharmaceuticals. Novartis is the only global
company with leading positions in these areas. In 2015, the Group achieved net
sales of USD 49.4 billion, while R&D throughout the Group amounted to
approximately USD 8.9 billion (USD 8.7 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 118,000
full-time-equivalent associates. Novartis products are available in
approximately 180 countries around the world. For more information, please visit
http://www.novartis.com.
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References
[1] Mease PJ et al. Secukinumab Provides Sustained Improvements in the Signs and
Symptoms of Active Psoriatic Arthritis through 3 Years: Efficacy and Safety
Results from a Phase 3 Trial. Presented at the American College of Rheumatology
2016. Presentation number 961.
[2] Novartis. Data on file. May 2016.
[3] American College of Rheumatology Committee to Reevaluate Improvement
Criteria. A Proposed Revision to the ACR20: The Hybrid Measure of American
College of Rheumatology Response. Arthritis Rheum. 2007;57(2):193-202.
[4] Cosentyx Summary of Product Characteristics. Novartis Europharm Limited.
Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines
/human/medicines/003729/human_med_001832.jsp&mid=WC0b01ac058001d124. Last
accessed November 2016.
[5] 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.
[6] Baeten D et al. Secukinumab provides sustained improvements in the signs and
symptoms of active ankylosing spondylitis: 2-year efficacy and safety results
from a phase 3, randomized, double-blind, placebo-controlled trial. Oral poster
presented at the 2015 ACR/ARHP Annual Meeting, San Francisco, USA, November 10.
Poster presentation number 2896.
[7] Braun J et al. Effect of secukinumab, an interleukin-17a inhibitor, on
spinal radiographic changes through 2 years in patients with active ankylosing
spondylitis: results of the phase 3 study, MEASURE 1. Abstract #3177 presented
at the 25(th) European League Against Rheumatism Congress. 2016, June 8-11;
London.
[8] Kavanaugh A et al. Secukinumab provides sustained improvements in the signs
and symptoms of active psoriatic arthritis: 2-year efficacy and safety results
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Abstract #3565 presented at the 25(th) European League Against Rheumatism
Congress. 2016, June 8-11; London.
[9] Bissonnette R et al. Secukinumab maintains high levels of efficacy through
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[10] Baeten D et al. Secukinumab, interleukin-17A inhibition in ankylosing
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[11] McInnes IB 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. The Lancet. 2015; 386(9999):1137-1146.
[12] Mease PJ et al. Secukinumab inhibition of interleukin-17A in patients with
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[13] Maksymowych W et al. Comparative effectiveness of secukinumab and
adalimumab in ankylosing spondylitis as assessed by matching-adjusted indirect
comparison: an analysis based on all pivotal phase 3 clinical trial data.
Abstract #1739 for presentation at the American College of Rheumatology 2016
available at http://acrabstracts.org/abstract/comparative-effectiveness-of-
secukinumab-and-adalimumab-in-
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[14] Nash P et al. Secukinumab for the treatment of psoriatic arthritis:
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comparison. Abstract #1738 for presentation at the American College of
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[15] Kirkham BW et al. Interleukin-17A: a unique pathway in immune-mediated
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[16] Ivanov S, Linden A. Interleukin-17 as a drug target in human disease.
Trends Pharmacol Sci. 2009; 30(2):95-103.
[17] Cosentyx (secukinumab) [prescribing information]. East Hanover, NJ:
Novartis Pharmaceuticals Corp, 2016.
[18] Ndirangu K et al. Trends in the use of Matching-Adjusted Indirect
Comparisons in published literature and NICE technology assessments: A
systematic review. PRM161. Value in Health. 2016; A99 (19).
[19] Thom H et al. Matching Adjusted Indirect Comparisons to assess comparative
effectiveness of therapies: Usage in scientific literature and health technology
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[20] Dean LE et al. Global prevalence of ankylosing spondylitis. Rheumatology
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[21] American College of Rheumatology (ACR) website. Spondyloarthritis.
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Conditions/Spondyloarthritis. Last accessed October 2016.
[22] National Psoriasis Foundation. Psoriatic disease: about psoriasis.
Available at: www.psoriasis.org/about-psoriasis. Last accessed November 2016.
[23] National Psoriasis Foundation. Could You Have Psoriatic Arthritis? Know the
Signs. Available at https://www.psoriasis.org/psoriatic-arthritis/know-the-
signs. Last accessed November 2016
[24] Anwar AH, Diamond H. Psoriatic arthritis: practice essentials, background,
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http://emedicine.medscape.com/article/2196539-overview#a6. Last accessed
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[25] Committee for Medicinal Products for Human Use. Guideline on clinical
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9/WC500003424.pdf Last accessed November 2016.
[26] Committee for Medicinal Products for Human Use. Guideline on clinical
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