FDA Expands Approval of Enbrel for Rheumatoid Arthritis Patients

The U.S. Food and Drug Administration (FDA) has expanded its approval of the use of the drug Enbrel® to include improving physical function for patients with moderate-to-severe rheumatoid arthritis.

Enbrel (etanercept) is the only biologic therapy approved for the first-line treatment of rheumatoid arthritis. The expanded approval was based on three clinical trials involving 955 rheumatoid arthritis patients who generally showed improvements in function and disability measures with the drug and maintained them for up to four years.

Patients with early rheumatoid arthritis treated with Enbrel alone for six months achieved a mean improvement of 0.7 units in their Health Assessment Questionnaire (HAQ) scores in which zero indicates no disability. At one year 29 percent of patients had achieved a zero.

Many patients with late-stage rheumatoid arthritis treated with Enbrel alone or in combination with methotrexate had significant improvement in their Health Assessment Questionnaire disability scores, compared to patients who received a placebo or methotrexate alone.

"This approval demonstrates the ability of Enbrel to help patients resume normal daily activities, which can be the patients' ultimate goal of therapy," said Kevin Young, a vice president at Amgen, which markets Enbrel in conjunction with Wyeth Pharmaceuticals

The most frequent adverse events in the clinical trials were injection site reactions, infections and headache. Only the rate of injection site reactions was higher than that of patients taking the placebo.

Other sources: Amgen