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


XagenaMedicine2005