This article is part of the Arthritis Archives.
Dateline: January 16, 2002
Enbrel For Psoriatic Arthritis
Enbrel (etanercept) has been approved by the FDA (the United States Food and Drug Administration) for treatment of people with psoriatic arthritis. Actually, Enbrel is the first therapy to receive approval for reducing the signs and symptoms of active arthritis in people suffering with psoriatic arthritis. No other treatment had been specifically approved for the treatment of psoriatic arthritis.
Psoriatic Arthritis
Psoriatic arthritis is a painful, chronic, inflammatory disease with both joint and skin manifestations.
- Joint pain and swelling
- Scaly, red skin lesions
- Typically skin plaque symptoms occur first, followed by joint involvement
Because skin symptoms often precede joint involvement, many psoriatic arthritis patients receive conflicting diagnoses before being accurately diagnosed. The approval of Enbrel for psoriatic arthritis hopefully brings forth more effective treatment for this group of arthritis sufferers.
Enbrel can be used without methotrexate or can be used in combination with methotrexate in patients who have failed methotrexate alone.
Study Results
In a 24-week, multicenter, randomized, double-blind, placebo-controlled phase III study, there were 205 patients with psoriatic arthritis serving as clinical trial participants. They were either given 25 mg. subcutaneous injections twice-weekly of Enbrel, or they received placebo. After 12 weeks:
- 59% of 101 patients receiving Enbrel achieved an ACR20 response compared to 15% of 104 patients receiving placebo.
- 38% of 101 patients receiving Enbrel achieved an ACR50 response compared to 4% of 104 patients receiving placebo.
- 11% of 101 patients receiving Enbrel achieved an ACR70 response compared to 0% receiving placebo.
- Similar results were observed after 24 weeks.
- What is the ACR Criteria?
In a subset of patients with a pre-defined severity of psoriasis, responses increased over time and at 6 months the proportions of patients achieving a 50% or 75% improvement in the Psoriasis Area and Severity Index (PASI) were:
- 47% and 23% respectively for the Enbrel group
- 18% and 3% respectively for the placebo group
These study results were similar to a previous, single-center, randomized, placebo-controlled study of 60 patients with psoriatic arthritis.
The adverse events reported in the psoriatic arthritis trial were comparable to those reported in previous clinical trials for Enbrel involving patients with rheumatoid arthritis. Enbrel was first approved in 1998 for reducing the signs of symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis, and in 1999 for reducing the signs and symptoms in patients four years of age and older with moderately to severely active polyarticular juvenile rheumatoid arthritis who had an inadequate response to one or more DMARDs (disease-modifying anti-rheumatic drugs).
Related Resources
Source: Enbrel Is First Therapy Approved For Treatment Of Psoriatic Arthritis, January 16, 2002 PRESS RELEASE
First published: 1/16/2002
