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FDA Recommends Enbrel® for Early Rheumatoid Arthritis

  [ 261 votes ]   [ Discuss This Article ]
By Arthritissupport staff • • July 7, 2000

The U.S. Food and Drug Administration's Arthritis Advisory Committee unanimously recommended approval of Enbrel ® (etanercept) for use to delay progression of joint damage in patients with early rheumatoid arthritis (RA), and voted in favor of approval of Enbrel for use to improve signs and symptoms of patients with early stage disease.

Enbrel’s effectiveness in delaying joint damage characteristic of RA was validated by quantifying progression (or lack of progression) of joint destruction. X-rays of the hands/wrists and feet of each patient were obtained at baseline and at six and 12 months.

New Class of Drug

The first in a new class of rheumatoid arthritis (RA) drugs known as biologic response modifiers, Enbrel is an entirely new approach to the management of rheumatoid arthritis. Enbrel acts by binding tumor necrosis factor (TNF) which results in significant reduction in inflammatory activity.

In a study involving 234 people (56% for Enbrel, 4% for placebo), most of the subjects experienced significantly less pain after using the drug.

In a separate juvenile rheumatoid arthritis (JRA) study, side effects of the drug included: infections, headache, abdominal pain, vomiting, and nausea. The types of infections reported in JRA patients were generally mild and consistent with those commonly seen in outpatient pediatric populations. Serious adverse reactions reported rarely were chicken pox, gastroenteritis, depression/personality disorder, cutaneous ulcer, and esophagitis/gastritis.

High Cost a Downside

Unfortunately, there is a drawback to this drug. A one-month supply costs about $1,000, and arthritis sufferers may have difficulty convincing their insurance companies to cover it. There is an Ebrel assistance program through which a patient or doctor can apply for the help to pay for it, but there is a waiting list. For more information call (800)282-7704.

Sources: Immunex Corporation.
Hitti, Miranda. (May/June 2000). Finding a Way; How to Handle Prescription Drug Costs. Arthritis Today. 55-58

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