AbbVie (ABBV), a research-based biopharmaceutical company formed this year following separation from Abbott Laboratories (ABT), announced CONCERTO trial results, the first randomized, controlled study evaluating assessing different predefined doses of methotrexate or MTX in combination with HUMIRA, for the treatment of moderate to severe rheumatoid arthritis or 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 aim 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 a 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 or DAS28 of <3.2, the company stated.
DAS28 measurement is a composite index that includes variables such as tender and swollen joint counts, a patient's visual analog scale for disease activity and C-reactive protein as a measure of inflammation. CONCERTO was double-blind for the MTX dose and open-label for the use of HUMIRA.
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