In 2002, Humira was approved to treat patients with moderately to severely active rheumatoid arthritis (RA), who have had insufficient response to one or more disease-modifying anti-rheumatic drugs.
The approval offers rheumatoid arthritis 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.
The approval for the expanded rheumatoid arthritis indication is based on clinical and radiographic data from a two-year trial, known as the PREMIER study, in 799 methotrexate (MTX)-naive patients with active recent onset moderate to severe forms of the disease (defined as disease of less than three years duration).
The study showed Humira in combination with MTX was superior to MTX alone on several efficacy endpoints, including the two primary endpoints – inhibition of joint damage and improvement in signs and symptoms at one year – and a secondary endpoint of achievement of clinical remission at one year.
“Humira 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 Dr Arthur Kavanaugh, UCSD Center for Innovative Therapy, La Jolla, California, and PREMIER investigator.
The Humira approval in psoriatic arthritis, a chronic disease that combines the symptoms of arthritis with those of psoriatic skin disease, is based on results of a trial known as ADEPT that studied 313 adult patients with moderately to severely active psoriatic arthritis who had an inadequate response to NSAID (non-steroidal anti-inflammatory drug) therapy.
Humira patients experienced significantly greater improvement in both joint and skin disease symptoms than placebo-treated patients at 24 weeks. Improvements in both skin lesions and joint symptoms were seen as early as two weeks after initiation of treatment and continued to improve over time.