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FDA Panel Back New Arthritis Drug
Associated Press Online - September 16, 1998 16:47
By LAURAN NEERGAARD
AP Medical Writer
GAITHERSBURG, Md. (AP) - A novel, genetically engineered drug significantly helps sufferers of
advanced rheumatoid arthritis combat the crippling disease, government scientists concluded
Wednesday.
Immunex Inc.'s Enbrel should be approved for sale to patients who get no relief from current drugs,
advisers to the Food and Drug Administration unanimously voted.
Enbrel also appeared to cause far fewer side effects than currently available drugs, which can attack
patients' livers and cause vomiting and other problems. Enbrel patients, in contrast, so far seem to
suffer just mild irritation at the spot where they inject the drug.
While recommending sale of Enbrel, however, the FDA advisers demanded that Immunex study
long-term side effects because the drug works in a unique way that changes the immune system in a
manner that theoretically could risk infections or possibly even cancer.
So far, experts say there are no early problems, but only 192 patients have been studied for a full
year.
Enbrel does not cure rheumatoid arthritis; patients who stopped taking the drug saw their disease
immediately rebound. Nobody yet knows if it can slow rheumatoid's worsening, something now
being studied.
Clinical trials showed the genetically engineered drug significantly, and in some cases dramatically,
improved patients' symptoms - painful, swollen joints that go so stiff that patients sometimes can't
move - by attacking rheumatoid in a way totally different from other treatments.
"One time I was taking 16 pills a day," Gloria Baswell of Gadsden, Ala., told the panel. "Nothing
worked," until she joined an Enbrel study two years ago. Now she no longer needs even
over-the-counter painkillers.
"It's my miracle," she said. "I know what hell is like, and I know how good it is to come out of it."
Other patients urged the FDA to approve Enbrel quickly so they can try it.
"When can I get this?" Margaret Crowley of Huntsville, Ala., demanded of the panel.
The FDA is not bound by its advisers' recommendations, but usually follows them. A final decision is
expected by early November.
Rheumatoid arthritis afflicts more than 2 million Americans. This is not the type of arthritis common in
the elderly, which comes on because of the wear-and-tear of aging. Instead, rheumatoid arthritis
occurs when patients' immune systems go awry and attack their joints, causing inflammation and
stiffness as rogue immune cells eat away cartilage and eventually erode bone.
The disease mostly strikes women, usually between ages 25 and 50. Within 10 years, about half the
patients are too disabled to work.
Today's best treatment is methotrexate, a drug that attacks certain immune cells responsible for much
of rheumatoid's inflammation. The FDA last week approved a similar drug called Arava, the first new
option in over a decade.
Enbrel, known chemically as etanercept, works very differently. It targets tumor necrosis factor, or
TNF, an immune system protein that also causes rheumatoid inflammation.
Enbrel is a genetically engineered copy of a cell "receptor," the spot where TNF normally hooks onto
cells to do its damage. Patients inject Enbrel twice a week, and the drug literally sops up excess TNF
in their blood before the substance can make its way to joints to do damage.
In a study of 234 advanced patients, about 60 percent who took Enbrel for 6 months improved
significantly, compared with 11 percent who took placebos. About 40 percent of Enbrel patients saw
their disease symptoms cut in half, compared with 5 percent of placebo patients. Patient surveys
reported a 40-50 percent improvement in physical function and overall health.
Then Immunex added Enbrel to standard methotrexate in another study of 89 patients. Some 71
percent of those who took both drugs experienced significant improvement, compared with just 27
percent of patients who took methotrexate alone. By a 12-5 vote, the FDA panel said Enbrel should
be allowed to be used together with methotrexate.
Injection site irritation in about 40 percent of patients was the only apparent side effect.
But because TNF is an important immune system component, FDA advisers warned that Enbrel
could increase patients' susceptibility to infections, just as methotrexate can, or even make them more
vulnerable to certain cancers.
Immunex is studying 1,200 patients to uncover the drug's long-term safety effects. It also is studying
whether Enbrel can help fight early-stage rheumatoid arthritis and help children with juvenile
rheumatoid.
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