Found it!
SEATTLE, April 11 -- Immunex Corp said today that preliminary results from an ongoing safety trial for ENBREL(TM) suggest that the drug can be safely administered to patients with rheumatoid arthritis for a period of six months.ENBREL is a soluble (free-floating) tumor necrosis factor receptor (TNFR) and part of a new class of biologic drugs aimed at inhibiting the biological effects of TNF.
Study results were reported today at the regional American College of Rheumatology Meeting in Chicago by Investigator Larry
W. Moreland, MD, of the University of Alabama at Birmingham.
"This trial has so far shown that TNF receptor can be given safely to patients for six months with infrequent and tolerable side
effects," said Dr. Moreland. "This is important for patients with a chronic disease like rheumatoid arthritis."
The ongoing, open-label, multi-center study is designed to measure the long-term safety of Enbrel and clinical effects as
determined by improvements in tender and swollen joints. Improvements in clinical endpoints were consistent with previously
reported results. Forty-one patients received the drug for at least six months in this trial. All patients had previously received the
drug for a maximum of 3 months in earlier clinical trials. Injection site reactions, which are seen with some biologic drugs, were
relatively mild and infrequent (146 injection site reactions out of a total 3,708 injections given). Sixteen of 41 patients reported
infections (including colds) during 260 patient months of treatment. All infections resolved and no patient withdrew from the
study due to injection site reactions or infections. No antibodies against the drug were detected.
This long-term safety study continues. Patients on the study are scheduled to receive the drug for a minimum of one year. This
study is part of the company's clinical development program in rheumatoid arthritis. |
