FDA Advisers Support Expanding the Role of Enbrel
WebMD News Archive
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
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
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
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.