Abbott has received US FDA approval to market Humira (adalimumab) for first-line treatment of recent onset moderate to severe rheumatoid arthritis (RA). The approval offers RA patients an important therapeutic option early in the course of their disease, when there is a critical window of opportunity to intervene before the potential crippling effects of joint destruction and long-term disability set in, according to a company release.
In 2002, Humira was approved to treat patients with moderately to severely active RA, who have had insufficient response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
The approval for the expanded indication is based on clinical and radiographic data from the two-year premier study of 799 methotrexate (MTX)-naive patients with active recent onset moderate to severe RA. In this trial, Humira in combination with MTX significantly improved the signs and symptoms of RA, claims the release.
"Humira (adalimumab) has been shown to slow the progression of RA when initiated in patients early in their treatment. For many patients, this means reduction in signs and symptoms, but more importantly, significant inhibition of joint damage," said Arthur Kavanaugh, UCSD Center for Innovative Therapy, La Jolla.
More than five million people worldwide suffer from RA, a chronic autoimmune disease that causes pain, swelling and stiffness in the joints of the hands, feet and wrists, and often leads to the destruction of joints.