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Novartis to reveal landmark Phase III data for AIN457 (secukinumab) in psoriatic arthritis and ankylosing spondylitis at ACR 2014

Novartis to reveal landmark Phase III data for AIN457 (secukinumab) in psoriatic arthritis and ankylosing spondylitis at ACR 2014 | Rheumatology-Rhumatologie | Scoop.it
From www.novartis.com - November 18, 2014 1:26 PM

Via Krishan Maggon
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Krishan Maggon 's curator insight, November 13, 2014 7:21 AM
Detailed results of four pivotal Phase III studies of secukinumab in psoriatic arthritis (PsA) and ankylosing spondylitis (AS) to be presented for the first time at ACR 2014Secukinumab is the first selective interleukin-17A (IL-17A) inhibitor with Phase III data to demonstrate efficacy and improve symptoms in patients with PsA and ASData will include study results from FUTURE 1 and FUTURE 2 in PsA and MEASURE 1 and MEASURE 2 in AS; data to be presented include joint structural damage progression in PsA and symptoms, quality of life/physical function in PsA and ASPsA and AS are part of a family of long-term diseases impacting joints, known as spondyloarthritis (SpA); high unmet treatment need exists for patients living with SpA[1]
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Secukinumab (Novartis) IL-17A inhibitor safe and effective in two Phase III studies psoriatic arthritis

Secukinumab (Novartis) IL-17A inhibitor safe and effective in two Phase III studies psoriatic arthritis | Rheumatology-Rhumatologie | Scoop.it
From www.novartis.com - October 31, 2014 7:38 AM

Novartis today announced that two pivotal Phase III studies (FUTURE 1 and FUTURE 2) of AIN457 (secukinumab) in psoriatic arthritis (PsA) met primary and key secondary endpoints. Endpoints included improving signs and symptoms of psoriatic arthritis (PsA), including improving peripheral joint disease and preventing joint damage versus placebo, while delivering clear or almost clear skin (PASI 90). Secukinumab is an investigational medicine that works by stopping the action of interleukin-17A (IL-17A)[4], a protein that is central to the development of inflammatory diseases[5]. FUTURE 1 and FUTURE 2 enrolled a combined total of more than 1,000 patients. Detailed results of the studies will be presented at an upcoming medical congress.

 

FUTURE 1 and FUTURE 2 are randomized, placebo-controlled, multicenter studies designed to demonstrate efficacy of secukinumab in PsA compared to placebo and to assess safety and tolerability. The American College of Rheumatology response criteria (ACR20) was the primary endpoint in the studies. Secukinumab was well tolerated in both studies. The observed safety profile was consistent with previously reported results from the large psoriasis clinical trial program involving nearly 4,000 patients[17]

 

 


Via Krishan Maggon
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Krishan Maggon 's curator insight, September 25, 2014 4:10 AM

Secukinumab met primary and key secondary endpoints in two pivotal Phase III studies showing superiority to placebo in patients with adult onset psoriatic arthritis (PsA)

 

Many people with PsA do not respond to current standard of care, with approximately 45% of people dissatisfied with current treatments[3]Secukinumab is the first interleukin-17A (IL-17A) inhibitor with positive Phase III results in PsA and regulatory submissions are planned for 2015
Global regulatory applications for secukinumab in PsA are planned for 2015. 

AIN457 (secukinumab) is a fully human monoclonal antibody that selectively stops the action of IL-17A[4]. Secukinumab is the first medicine selectively targeting IL-17A with positive Phase III results for the treatment of PsA. IL-17A, a protein that stimulates inflammatory disease, is central to the development of psoriasis and other inflammatory arthritic diseases, including PsA[5].

In addition to PsA, secukinumab is also in clinical trials for the treatment of ankylosing spondylitis (AS) and rheumatoid arthritis (RA). Following the presentation of the first moderate-to-severe plaque psoriasis Phase III results of secukinumab in October 2013, EU and US regulatory filings were submitted at the end of 2013.
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Novartis AIN457 (secukinumab) meets primary endpoint in two Phase III studies in ankylosing spondylitis, a debilitating joint condition of the spine

Novartis AIN457 (secukinumab) meets primary endpoint in two Phase III studies in ankylosing spondylitis, a debilitating joint condition of the spine | Rheumatology-Rhumatologie | Scoop.it
From www.novartis.com - October 23, 2014 3:16 PM

Novartis today announced that AIN457 (secukinumab) met primary and key secondary endpoints in two pivotal Phase III studies (MEASURE 1 and MEASURE 2) in patients with ankylosing spondylitis (AS). Key endpoints included improvements in signs and symptoms of the disease versus placebo and associated improvements in physical function and quality of life. Secukinumab is an investigational medicine that works by stopping the action of interleukin-17A (IL-17A)[3], a protein that is central to the development of inflammatory diseases[4], including AS. MEASURE 1 and MEASURE 2 enrolled a combined total of approximately 600 patients. Detailed results of the studies will be presented at an upcoming medical congress.

 

Joint regulatory applications for secukinumab in AS and PsA are planned for 2015. This follows the secukinumab global regulatory applications for moderate-to-severe plaque psoriasis which were filed in October 2013 with regulatory decisions anticipated in late 2014 or early 2015.

 

Secukinumab showed an acceptable safety profile in both studies which was consistent with that observed in the large psoriasis clinical trial program, involving approximately 4,000 patients[8].

 

 

About secukinumab (AIN457) and interleukin-17A (IL-17A)


Secukinumab (AIN457) is a fully human monoclonal antibody that selectively neutralizes the action of IL-17A[3]. Secukinumab is the first medicine selectively targeting IL-17A with positive Phase III results for the treatment of AS. IL-17A, a protein that stimulates inflammation, is central to the development of psoriasis and other inflammatory arthritic diseases, including AS[4].

In addition to AS, secukinumab is also in clinical trials for the treatment of psoriasis arthritis (PsA) and rheumatoid arthritis (RA). Global regulatory applications for secukinumab in AS and PsA are planned for 2015. This follows the secukinumab global regulatory applications for moderate-to-severe plaque psoriasis which were filed in October 2013 with approvals anticipated in late 2014 or early 2015.

 


Via Krishan Maggon
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Krishan Maggon 's curator insight, October 23, 2014 4:40 AM
Secukinumab is the first selective IL-17A inhibitor to meet primary endpoint in two pivotal Phase III studies showing improvement in active ankylosing spondylitis (AS) patients' symptoms versus placebo
AS is a painful, progressively debilitating condition associated with inflammation of the spine, causing irreversible consequences that significantly reduce patients' mobility and quality of life[1],[2]
Up to 40% of patients have an inadequate or no response to standard of care anti-TNF (tumor-necrosis-factor) medicines, currently the only biologic therapies available for patients with AS[1]
The secukinumab results in AS follow positive topline data in psoriatic arthritis (PsA) announced in September; joint regulatory filing of secukinumab in AS and PsA planned for 2015
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