The US Food and Drug Administration has approved an expanded label for Amgen and Wyeth’s biologic drug, Enbrel (etanercept), with the firms now able to market the product to improve physical function in patients with psoriatic arthritis. The agency has also approved an update to the drug’s label to include new radiographic data showing that it continued to inhibit the progression of joint destruction for two years among most psoriatic arthritis patients who received ongoing therapy.
Enbrel, which Amgen and Wyeth say is the first and only treatment to receive the expanded indication, first won the US green light to treat the signs and symptoms of psoriatic arthritis back in 2002 [[17/01/02c]], and with this expanded approval, is now indicated for reducing signs and symptoms, inhibiting the progression of joint destruction of active arthritis associated with psoriatic arthritis, and improving physical function in patients with psoriatic arthritis [[04/05/04b]]. Enbrel is also cleared for the treatment of moderate-to-severe rheumatoid arthritis and juvenile rheumatoid arthritis, ankylosing spondylitis and moderate-to-severe plaque psoriasis [[04/08/03e]], [[28/07/03e]], [[29/09/04g]].
Almost 40% of psoriatic arthritis patients taking Enbrel in a clinical trial showed no functional disability at 24 weeks, with many patients receiving the drug experiencing a greater improvement from baseline, compared to placebo, in their ability to participate in physical activities such as walking, carrying groceries, or climbing a flight of stairs.
Psoriatic arthritis is a chronic, often destructive disease characterised by both joint inflammation and erosion. It is associated with psoriatic skin lesions and can disrupt a person’s ability to perform activities of daily life, such as getting dressed, eating or walking. Approximately one million people suffer from psoriatic arthritis in the US alone.