In addition, the FDA has approved an update to the Enbrel (etanercept) label to include new radiographic data demonstrating that Enbrel continued to inhibit the progression of joint destruction for two years among most psoriatic arthritis patients who received ongoing therapy.
Enbrel received approval to treat signs and symptoms of psoriatic arthritis in 2002. With this expanded approval, Enbrel 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. Enbrel is also approved to treat moderate-to-severe rheumatoid arthritis and juvenile rheumatoid arthritis, ankylosing spondylitis and moderate-to-severe plaque psoriasis.
The expanded approval was based on significant improvements in physical function as assessed by the disability index of the health assessment questionnaire (HAQ), a test used to evaluate a patient’s ability to perform daily activities such as dressing, walking and grooming, and the medical outcomes study short-form health survey (SF-36), a measurement tool that also assesses the physical impact of a disease.
Almost 40% of psoriatic arthritis patients taking Enbrel in this study achieved a HAQ score of zero, indicating no functional disability at 24 weeks. In addition, the SF-36 found that many patients treated with Enbrel experienced 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.
“No other treatment has been FDA-approved to provide efficacy for psoriatic arthritis patients using these multiple clinical measures,” said Dr Will Dere, chief medical officer and senior vice president of global development at Amgen. “Enbrel is unique because it has received ten FDA approvals in five distinct diseases and has been used by more than 280,000 patients worldwide across indications.”