Psoriatic arthritis (PsA) patients have a new therapy option to inhibit bone and joint damage following the Food and Drug Administration’s recent expanded indication for etanercept (Enbrel) in stopping the progression of structural damage of active arthritis in patients with PsA.

Approval was based on a phase 3 study evaluating 205 PsA patients. Enbrel was found to conclusively limit joint damage over a one-year period. Conversely, patients taking placebo showed continued progressive joint deterioration.

Adverse side effects were similar to those in previous clinical trials of the anti-tumor necrosis factor-alpha (TNF-a) blocker. There was no increase in instances of serious adverse effects in those taking Enbrel compared to those receiving placebo. The rate of injection site reactions was the only statistical difference. Up to 36 percent of those taking Enbrel reported injection site complications compared to just 9 percent of those in the placebo group.

Enbrel is not FDA-approved for psoriasis patients without arthritic symptoms. Since Amgen and Wyeth Pharmaceuticals (Enbrel's manufacturer) have studied Enbrel's use in two large studies of psoriasis patients, they will be seeking FDA-approval for Enbrel in the treatment of psoriasis.

Roughly one-seventh of the 7 million people in the U.S. with the chronic inflammation of the skin condition known as psoriasis have moderate to severe plaque psoriasis. The inflammation drives the formation of red, itchy skin plaques that are painful and potentially disfiguring. TNF is found at high levels in psoriatic plaques and plays a critical role in their formation and maintenance.