AbbVie Announces Positive Results from Concerto Trial

AbbVie

today announced the results from the CONCERTO trial, the first randomized, controlled trial assessing different predefined doses of methotrexate (MTX) in combination with HUMIRA® (adalimumab) for the treatment of moderate to severe rheumatoid arthritis (RA). CONCERTO shows that at week 26 of treatment, a statistically significant increasing trend was observed in the proportion of patients achieving low disease activity with an increasing dose of MTX when used with open-label HUMIRA®. Results were presented at the European League Against Rheumatism (EULAR) 2013 Congress in Madrid, Spain. The primary objective of CONCERTO was to determine a dose-response pattern of MTX in combination with HUMIRA® in MTX and biologic-naive patients with active moderate to severe RA for less than 1 year. Patients were randomized into four treatment arms, receiving 40 mg of open-label HUMIRA® every other week in combination with weekly oral MTX at 2.5 mg, 5 mg, 10 mg or 20 mg. For all four treatment groups, the primary endpoint was the achievement, at week 26, of low disease activity, defined by a Disease Activity Score 28 (DAS28) of <3.2. Percentages of patients achieving low disease activity were as follows: 43 percent (n=98)