11/09 12:00 Positive results on [Centocor's] arthritis drug reported
By Mark Egan
LOS ANGELES, Nov 9 (Reuters) - A drug already being used to treat
Crohn's disease, an inflammation of the bowel, also reduces symptoms and pain
in rheumatoid arthritis patients, researchers said on Monday.
Researchers said that the drug infliximad, made by Centocor Inc <CNTO.O>.
and marketed under the brand name Remicade, reduced pain and symptoms of
the chronic joint condition by 52 percent in patients receiving the drug
compared to those not taking it.
More than 2.5 million Americans suffer from rheumatoid arthritis, one of the
most severe forms of the disease.
Results of the phase III trial of 428 patients, usually the last step before a drug
seeks regulatory approval, were presented at the American College of
Rheumatology conference in San Diego.
The trial, which followed the effects of Remicade when taken in conjunction
with the standard drug methotrexate, revealed that 52 percent of patients
experienced at least a 20 percent drop in inflammation and pain.
About 28 percent of patients showed a 50 percent decrease in inflammation
and pain with 12 percent experiencing a 70 percent improvement.
"We were really struck by the really positive outcome of this trial," Dr. Peter
Lipsky, of the University of Texas Southwestern Medical Center in Dallas and a
principal investigator in the trial told Reuters.
"What struck us the most was that all doses that we tested were effective and
even the lowest dose (3mg/kg) that was tested was comparably effective as all
the others."
If approved, patients may find the drug, which is given intravenously once every
eight weeks, more convenient to use that the recently approved rheumatoid
arthritis drug Enbrel which has to be self-injected twice a week, Lipsky said.
"In general the trial results look pretty much comparable (with Enbrel)," Lipsky
said. "The major issue is convenience -- whether or not the patients would
choose to have subcutaneous medicine twice a week or intravenous medicine
one every eight weeks."
The drug may also be cheaper than Enbrel, which is made by Seattle-based
biotechnology company Immunex Corp <IMNX.O>. Enbrel will cost about
$220 a week while analysts expect Remicade will cost between $96 and $156
a week.
Remicade is a monoclonal antibody which binds to a protein that is central to
inflammation in rheumatoid arthritis, called the tumor necrosis factor, and
neutralizes it.
All patients in the trial had long-standing rheumatoid arthritis. Lipsky said that he
expects the drug will have a more pronounced effect on those with less
advanced problems, although further trials would be needed to prove that point.
Rheumatoid arthritis occurs when the body's immune system mistakenly turns
against the joints. No one knows why this happens but scientists suspect an
infection may be to blame.
It usually strikes young people between the ages of 20 and 50 and can cripple a
person as the joints are destroyed.
Centocor said in a statement it will file an application with regulators to approve
the drug within the next few months. The U.S. Food and Drug Administration
approved Remicade for the treatment of Crohn's disease in August.
If approved for rheumatoid arthritis, the drug will compete with Enbrel which
was approved by regulators, also for use in conjunction with methotrexate,
earlier this month. Enbrel, known generically as etanercept, has been shown to
help reduce the symptoms of moderate to severe rheumatoid arthritis.
New data on the long-term effects of Enbrel will be presented at the conference
later this week. |
