This article is part of the Arthritis Archives.
Editor note: On November 2, 1998, the FDA announced the approval of Enbrel for the treatment of rheumatoid arthritis (RA).
Dateline: September 24, 1998
Enbrel Unanimously Recommended
On September 16, 1998, Enbrel (etanercept) was unanimously recommended for FDA approval for the treatment of active rheumatoid arthritis by the FDA Arthritis Advisory Committee. Enbrel, made by Immunex Corp. will be the first "entirely new approach" to treating rheumatoid arthritis approved in the last 15 years if the FDA acts on the committee's recommendation.
The FDA Arthritis Advisory Committee recommended that Enbrel be approved for use alone in patients who have not gotten satisfactory results from other disease-modifying anti-rheumatic drugs (DMARDs). The committee, by a 12-5 vote, also recommended that Enbrel be approved for use in combination with methotrexate.
There have been 1,039 rheumatoid arthritis patients who have used Enbrel in clinical trials. Results have indicated greater reduction in joint pain and swelling in patients receiving Enbrel compared to those receiving placebo. Patients treated with Enbrel also improved:
- health-related quality of life measurements
- mental health
Many patients responded to Enbrel, which is injected twice a week, within just weeks following initiation of the treatment. The most common side effect, which was observed in about 40% of patients, was mild injection-site reactions but generally not significant enough to interrupt treatment.
More than 100 patients have been treated with Enbrel for a period of at least 15 months. Sustained relief of symptoms was experienced by 80% of these patients. Conclusions from clinical trials revealed that patients have had a positive response to Enbrel even after failing other treatments. It was also concluded from studies that Enbrel can be given along with methotrexate without increasing side effects.
Enbrel is a genetically engineered copy of a cell receptor. The biotech drug works by binding TNF, tumor necrosis factor, which is one of the cytokines or proteins playing a major role in the reactions that cause the inflammatory process of rheumatoid arthritis. By preventing TNF from binding to TNFR sites, Enbrel causes cytokine to be inactive. The result is reduced inflammation.
There are fears that Enbrel might interfere with normal immune responses which would allow infections to develop. The advisory committee insisted that Immunex study long-term side effects of Enbrel. There is no certainty that such problems will exist but only 192 patients have been studied for a full year thus far.
Final approval by the FDA could come within two months and is expected in early November. Enbrel is NOT a CURE for arthritis. It has been shown that symptoms recur when the drug is stopped.
Sources: Immunex Drug Recommended For Approval By FDA Advisory Committee For Treatment of Rheumatoid Arthritis, 9/16/98, PRNewswire; FDA Panel Backs New Arthritis Drug, AP Online, 9/16/98, by Lauran Neergaard
First published: 9/24/1998