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AbbVie Presents First Study Assessing The Role Of Predefined Doses Of Methotrexate When Used In Combination With HUMIRA® (adalimumab) For Rheumatoid Arthritis

MADRID, June 13, 2013 /PRNewswire/ -- AbbVie (NYSE:ABBV) 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) of patients in the 2.5 mg per week MTX group;
  • 44 percent (n=100) of patients in the 5 mg per week MTX group;
  • 57 percent (n=99) of patients in the 10mg per week MTX group; and
  • 60 percent (n=98) of patients in the 20 mg per week MTX group (P<0.005 for the trend).

"In general, anti-tumor necrosis factor biologic medications, or anti-TNFs, need methotrexate to achieve better clinical and radiological outcomes versus these medications alone," said Gerd R. Burmester, M.D., Professor of Medicine, Department of Rheumatology and Clinical Immunology, Charite-University Medicine Berlin, Berlin, Germany. "The CONCERTO trial describes the extent to which the methotrexate dose affects clinical responses when implementing the combination therapy of adalimumab and methotrexate." AbbVie Inc. +1 (847) 938-9190 1 North Waukegan Road abbvie.com North Chicago, IL 60064

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 (CRP) 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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