Bristol-Myers Squibb announces results of phase III Orencia analyses

Bristol-Myers Squibb has announced the results of three analyses of two pivotal phase III clinical trials of Orencia (abatacept) as a treatment for patients with rheumatoid arthritis who have exhibited an inadequate response to methotrexate, tumour necrosis factor antagonists or other disease-modifying anti-rheumatic drugs.

The study showed that patients receiving Orencia showed improved daily activity participation, such as work or household chores, in addition to enhanced sleep quality and social-role independence.

Data for these analyses was gleaned from the pivotal abatacept in inadequate responders to methotrexate and abatacept trial in treatment of anti-TNF inadequate responders studies.

The compound is administered as a fixed-dose via a 30-minute intravenous infusion at 10 mg/kg of body weight at day zero and at two weeks, four weeks and every four weeks after this date.

George Wells, professor of the Department of Epidemiology and Community Medicine at the University of Ottawa, said: “The chronic nature of [rheumatoid arthritis] can have a significant impact on a person’s health-related quality of life, including independence, ability to perform daily activities and sleep quality.”

In November 2006, Bristol-Myers Squibb reported trial results showing that the administration of Orencia results in improvements in children with active cases of juvenile idiopathic arthritis.