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AbbVie Inc Announces First Study Assessing the Role of Predefined Doses of Methotrexate When Used in Combination with HUMIRA (adalimumab) for Rheumatoid Arthritis


Thursday, 13 Jun 2013 01:01am EDT 

AbbVie Inc 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. 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% (n=98) of patients in the 2.5 mg per week MTX group; 44% (n=100) of patients in the 5 mg per week MTX group; 57% (n=99) of patients in the 10mg per week MTX group; and 60% (n=98) of patients in the 20 mg per week MTX group (P <0.005 for the trend). 

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