This article is part of the Arthritis Archives.
Dateline: August 9, 1999
Application Filed
Immunex Corporation has filed a supplemental biologics license application with the U.S Food and Drug Administration (FDA) for Enbrel (etanercept). The purpose of the application is to obtain a new label for Enbrel which would include an indication for slowing structural damage and for improving the signs and symptoms of early, active rheumatoid arthritis.
In recent years, early diagnosis and early treatment of rheumatoid arthritis has been emphasized by the medical community. An early course of treatment is considered important because irreversible damage can develop within the first two years following the initial diagnosis of rheumatoid arthritis. Results from a phase III clinical trial, which were announced in May 1999, pointed toward the potential benefit of Enbrel use for the treatment of early rheumatoid arthritis.
About The Study
The primary endpoints studied in the phase III clinical trial included the ability of Enbrel to slow the progression of rheumatoid arthritis utilizing digitized x-rays to assess changes in the joints, and the ability of Enbrel to reduce signs and symptoms of rheumatoid arthritis over a six month period utilizing ACR response criteria for the determination. The desired results served as the basis for the new application and were submitted to the FDA along with the application.
In the study, 632 rheumatoid arthritis patients were followed for a one year period. All of the study participants had rheumatoid arthritis for less than three years and had never been treated with methotrexate. Participants were randomly given either 25 mg. or 10 mg. of Enbrel or methotrexate in a dose up to 20 mg. per week. To ensure that the study was a blind trial participants received both Enbrel or placebo twice a week by injection and methotrexate or placebo once a week orally.
Prior Approvals For Enbrel
Enbrel was approved by the FDA on November 2, 1998 for the treatment of moderately to severely active rheumatoid arthritis in adult patients having a prior inadequate response to one or more DMARDs (disease-modifying anti-rheumatic drugs). On May 28, 1999 the FDA also approved the use of Enbrel for the treatment of moderately to severely active polyarticular JRA (juvenile rheumatoid arthritis).
Related Resources
Sources: PRNewswire, Enbrel Application For Early, Active Rheumatoid Arthritis Filed With The U.S. Food And Drug Administration; PRNewswire, Positive Results of Pivotal Phase III Trial With Enbrel in Patients With Early, Active Rheumatoid Arthritis, 5/10/99
First published: 08/09/1999
