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FDA Advisers Support Expanding the Role of Enbrel

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By Ori Twersky
WebMD Health News

April 11, 2000 (Washington) -- After playing the position of a second-line treatment for two years, the rheumatoid arthritis (RA) drug Enbrel (etanercept) may soon get a shot at leading off as a first-line therapy. An FDA advisory committee recommended Tuesday that Enbrel's drug label say the medicine can treat patients with earlier stages of RA who have yet to try other treatment options.

The committee also said that the makers of Enbrel should be permitted to claim the drug can delay the structural damage of arthritic joints as a result of RA. The FDA usually follows its advisory recommendations, but it doesn't have to.

Approved in 1998, Enbrel currently is approved to treat patients with moderately to severely active RA when other anti-rheumatoid medications have not been successful.

Rheumatoid arthritis is more common in women than men. The disease attacks many areas of the body, but seems to concentrate mostly on the joints of the hands and feet. The involvement of the joint tissues progresses over time, leading to deformity of the joints and disability of the sufferer.

The proposed labeling change was supported by a study that compared Enbrel with another drug called methotrexate -- considered the gold standard in treating RA. The trial was conducted at 69 sites in the U.S. and Canada and included more than 600 patients who had either swollen or tender joints. The goal was to compare the deterioration or erosion of the joint tissue between the patients who took the two different medicines.

Previous studies have suggested that many patients with early RA treated with methotrexate develop few, if any, erosions of their joints. The analysis of this study showed that Enbrel is comparable to methotrexate.

The study raised little concern about how safe Enbrel is to use. The primary safety issue centered on the possibility of serious infections when using Enbrel. But in this trial, Enbrel appeared to be generally safe and well tolerated. In fact, a higher proportion of people on methotrexate reported side effects than those on Enbrel.

Some of the most commonly reported events were headache, nausea, rash, runny nose, diarrhea, bleeding at the injection site, abdominal pain, and dizziness. Bleeding at the injection site was the only event more commonly associated with Enbrel therapy.

Doctors note they still don't have the full picture of using Enbrel as a first-line treatment of RA. "I think that there is still some concern that we don't have enough long-term follow up," FDA committee chairman David Yocum, MD, tells WebMD. However, the professor of medicine at the University of Arizona says that although Enbrel wasn't convincingly superior, it did appear to have a distinct benefit during the first month of therapy. Over time, he says, it also seems to be building a much better safety profile.

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