This article is part of the Arthritis Archives.
Editor note: In January 2002, Enbrel was approved by the FDA for treatment of people with psoriatic arthritis.
Dateline: August 29, 1999
Psoriatic Arthritis Trial
Results were recently announced from a clinical trial of Enbrel (etanercept) used to treat patients with severe psoriatic arthritis. The results indicated improvement in the signs and symptoms of psoriatic arthritis as well as an increase in functional ability compared to patients given placebo.
The three month clinical trial was a double-blind study of 60 patients with severe psoriatic arthritis. The efficacy of Enbrel as a possible treatment for psoriatic arthritis was assessed in the study.
Psoriatic Arthritis
Psoriatic arthritis, a specific type of arthritis, is said to occur in about 5 to 7 percent of the 2.5-5 million Americans who suffer with psoriasis. The signs and symptoms of psoriatic arthritis include pain, swelling, and stiffness in the hands and feet primarily, or in larger joints such as the:
About The Study
During the three month study, the 60 patients were randomly given either 25 mg. twice-weekly subcutaneous injections of Enbrel or placebo. The study endpoint was defined as a 30 percent improvement of at least two of four criteria: physician and patient global assessment and joint tenderness and swelling without a 30 percent worsening of any of the criteria.
There are currently no therapies which are FDA approved for the treatment of psoriatic arthritis. The lack of approved therapies specifically for psoriatic arthritis makes the news of the aforementioned trial results obviously significant. The study of Enbrel use for psoriatic arthritis was lead by rheumatologist Philip Mease M.D. and dermatologist Ben Goffe M.D. The results, which will be discussed at future scientific meetings, may eventually serve as the basis for filing of a supplemental biologics license application for an expanded label for Enbrel including indications for the treatment of psoriatic arthritis. Immunex has not yet asked the FDA for the label expansion however.
Related Resources
Source: First Trial Results Of Enbrel In Psoriatic Arthritis Announced, PRNewswire, August 16,1999
First published: 08/29/1999
