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Recent News and Articles on the Keywords: psoriatic arthritis + new indication + enbrel  Related to the article below (Last Update: 7/1/2008)

Amgen and Wyeth Statement on Outcome of Dermatologic and ...
WELT ONLINE, Germany - Jun 18, 2008
People with an immune disease, such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis, ...AMGN - WYE
Enbrel (etanercept) Application for the Treatment of Pediatric ...
PharmaLive.com (press release), PA - Jun 18, 2008
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Golimumab also has been studied successfully in patients with psoriatic arthritis and ankylosing spondylitis. The firms submitted a marketing application in ...
Golimumab rheumatoid arthritis data excites at EULAR Pharma Times (subscription)
all 39 news articles »  JNJ - SGP
Abbott′s HUMIRA (adalimumab) Recommended By NICE For The Treatment ...
Medical News Today (press release), UK - Jun 26, 2008
Adalimumab is indicated for the treatment of active and progressive psoriatic arthritis (PsA) in adults when the response to previous disease-modifying anti ...
New Data Demonstrates Joint Damage Is Inhibited With Wyeth's ...
Medical News Today (press release), UK - Jun 13, 2008
Enbrel has not been studied in children aged less than 4 years. Treatment of active and progressive psoriatic arthritis in adults when the response to ...WYE

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Source: Google News

New Indications for Treatment of Chronic Inflammation by TNF-[alpha] Blockade. -
AM Reimold - The American Journal of the Medical Sciences, 2003 - amjmedsci.com
... of the relatively large phase III trial, the FDA has recently granted a new indication
for etanercept in the treatment of psoriatic arthritis, making this the ...

[CITATION] Etanercept treatment of psoriatic arthritis -
PJ Mease, AJ Kivitz, FX Burch, EL Siegel, SB Cohen … - Arthritis Rheum, 2004
... oral therapy with a new retinoid ... in rheumatoid arthritis: confounding by indication,
and the ... Young G, Salonen D. Radiological assessment in psoriatic arthritis. ...

Etanercept (Enbrel): update on therapeutic use -
G Spencer-Green - British Medical Journal, 2000 - ard.bmj.com
... study of 60 patients with severe psoriatic arthritis (PsA) who ... FURTHER INDICATIONS
FOR ETANERCEPT TNF is an important ... and is an important new treatment option ...

… of the pathogenesis of psoriasis vulgaris and psoriatic arthritis: a personal appraisal of their … -
JP Callen - Journal of the American Academy of Dermatology, 2003 - Elsevier
... Drug Administration (FDA) for other indications but which ... garis (alefacept: Amevive)
and psoriatic arthritis (et- anercept ... the potential for new, possibly safer ...

Differentiating the efficacy of the tumor necrosis factor inhibitors -
B Haraoui - Seminars in Arthritis and Rheumatism, 2005 - Elsevier
... Trial Evaluating Infliximab in a New Long-Term ... 19 Enbrel ? (etanercept) Prescribing
Information, Immunex ... in the treatment of psoriatic arthritis and psoriasis ...

Effectiveness of psoriatic arthritis therapies -
DD Gladman - Seminars in Arthritis and Rheumatism, 2003 - Elsevier
... recently received FDA approval for this indication, is the ... Efficacy and safety of
the new DMARD leflunomide ... R75, and sIL-2R in psoriatic arthritis synovial fluid ...

[CITATION] Life-threatening histoplasmosis complicating immunotherapy with tumor necrosis factor antagonists … -
JH Lee, NR Slifman, SK Gershon, ET Edwards, WD … - Arthritis Rheum, 2002
... 1999, the FDA extended the indication for use ... State University Health Sciences Center,
New Orleans ... in 1999, and for treatment of psoriatic arthritis in January ...

[CITATION] Etanercept for the treatment of psoriasis and psoriatic arthritis -
AB Gottlieb - Dermatologic Therapy, 2004 - Blackwell Synergy
... with the FDA for this indication in June ... the treatment of psoriasis with new biologic
agents. ... necrosis factor (TNF) in psoriatic arthritis: Pathophysiology and ...

Psoriatic arthritis treatment: biological response modifiers -
PJ Mease, CE Antoni - British Medical Journal, 2005 - ard.bmj.com
... psoriasis and is approved for that indication in the ... Interleukin-15: a new cytokine
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[PDF] Etanercept, a TNF antagonist for treatment for psoriatic arthritis and psoriasis -
PJ Mease - Skin Therapy Lett, 2003 - skintherapyletter.com
... approved by the US FDA for this indication. ... Controlled, Double-Blind Studies of DMARDs
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Source: Google Scholar
 
 

Psoriatic arthritis, new indication for Enbrel

 

 
FDA ( Food and Drug Administration ) approved an expanded indication for Enbrel ( Etanercept ) to improve physical function in patients with psoriatic arthritis.

In addition, the FDA approved an update to the Enbrel label to include new radiographic data demonstrating that the drug continued to inhibit the progression of joint destruction for two years among most psoriatic arthritis patients who received ongoing therapy.

Enbrel received its approval to treat signs and symptoms of psoriatic arthritis in 2002.
With this expanded approval, Enbrel is now indicated for reducing signs and symptoms, inhibiting the progression of joint destruction of active arthritis associated with psoriatic arthritis, and improving physical function in patients with psoriatic arthritis.
Enbrel is also approved to treat moderate-to-severe rheumatoid arthritis and juvenile rheumatoid arthritis, ankylosing spondylitis and moderate-to-severe plaque psoriasis.

The expanded approval of Enbrel was based on significant improvements in physical function as assessed by the disability index of the Health Assessment Questionnaire ( HAQ ), a test used to evaluate a patient's ability to perform daily activities such as dressing, walking and grooming, and the Medical Outcomes Study Short-Form Health Survey ( SF-36 ), a measurement tool that also assesses the physical impact of a disease.

Almost 40 percent of psoriatic arthritis patients taking Enbrel in this study achieved a HAQ score of zero, indicating no functional disability at 24 weeks.
In addition, the SF-36 found that many patients treated with Enbrel experienced a greater improvement from baseline, compared to placebo, in their ability to participate in physical activities such as walking, carrying groceries, or climbing a flight of stairs.

Psoriatic arthritis is a chronic, often destructive disease characterized by both joint inflammation and erosion, and is associated with psoriatic skin lesions. The progressive joint pain and swelling, which is often coupled with painful, scaly, red skin lesions, can disrupt a person's ability to perform activities of daily life that most people take for granted such as getting dressed, eating or walking. Approximately one million people suffer from psoriatic arthritis in the United States.

Enbrel is the only soluble tumor necrosis factor ( TNF ) receptor approved to reduce signs and symptoms, induce major clinical response, improve physical function, and inhibit the progression of structural damage in patients with moderately to severely active rheumatoid arthritis ( RA ). Enbrel can be used alone or in combination with Methotrexate.

Enbrel is the only treatment indicated to reduce the signs and symptoms, inhibit the progression of structural damage of active arthritis, and improve physical function in patients with psoriatic arthritis. It is approved to reduce the signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis ( JRA ) in patients four years of age or older who have had an inadequate response to one or more disease-modifying antirheumatic drugs ( DMARDs ). It is also the first biologic approved to reduce the signs and symptoms in patients with active ankylosing spondylitis ( AS ). Enbrel is indicated for the treatment of adult patients ( 18 years or older ) with chronic moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Etanercept acts by binding TNF, one of the dominant inflammatory cytokines or regulatory proteins that play an important role in both normal immune function and the cascade of reactions involved in the inflammatory process of rheumatoid arthritis, juvenile rheumatoid arthritis, psoriasis, psoriatic arthritis, and ankylosing spondylitis. The binding of Enbrel to TNF renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory activity.

Possible side effects of Enbrel include: serious infections, serious nervous system disorders such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes, Rare reports of serious blood disorders ( some fatal ).

In medical studies of all TNF blockers, including Enbrel, a higher rate of lymphoma was seen compared to the general population. The risk of lymphoma may be up to several fold higher in rheumatoid arthritis and psoriasis patients.
The role of TNF blockers, including Enbrel, in the development of lymphoma is unknown.

Source: Amgen and Wyeth Pharmaceuticals, 2005
 
 
 
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