Monday, November 10, 1997
Immunex Corp. on Sunday presented positive data from a Phase
III trial of its Enbrel soluble tumor necrosis factor receptor in patients with
rheumatoid arthritis, providing another round of evidence that TNF-alpha inhibition
is an attractive strategy for treating RA.
IMNX plans to file a BLA for FDA approval in 1998, based on
the results of this and other clinical studies. It's likely competition will
be Centocor Inc.'s Avakine, another TNF inhibitor which is nearing the end of
enrollment in its Phase III trial, with a BLA filing planned by year-end in
With both products nearing their regulatory filings, it's now
possible to project the impact of TNF approaches to RA, as well as to make some
comparisons between the agents.
As discussed at the meeting of the
American College of Rheumatology, the primary end point of the IMNX trial was a 20 percent
improvement in the American College of Rheumatology composite of RA symptoms, ACR20, at
three months. A total of 62 percent of the patients in the 25 mg group reached 20 percent
improvement by the ACR criteria, versus 23 percent of the placebo group (p£0.003).