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Abbott Announces Results of Analysis Exploring the Use of HUMIRA

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Abbott today announced results from a post-hoc analysis of HUMIRA^® (adalimumab) data in early and long-standing moderate-to-severe rheumatoid arthritis (RA) patients from three randomized, controlled trials—DE019, OPTIMA and PREMIER. The analysis evaluated the simultaneous achievement of three key treatment goals: low disease activity, normal physical function and the absence of radiographic progression at one year. These results are being presented at the American College of Rheumatology Annual Scientific Meeting (ACR) in Washington, D.C.

In the analysis, low disease activity was measured by the Disease Activity Score 28 based on C reactive protein [DAS28 (CRP)], less than 3.2; normal function was measured by the Health Assessment Questionnaire for RA Disability Index [HAQ-DI], less than 0.5; and the absence of radiographic progression was demonstrated by a change in modified Total Sharp Score [mTSS], less than or equal to 0.5 at one year.

- Reduction of disease activity, prevention of further joint damage and preservation of physical function were the three goals evaluated

- Data analysis for long-standing RA patients showed 19 percent of patients taking HUMIRA plus methotrexate (MTX) simultaneously achieved all three goals at one year, versus 5 percent of patients treated with placebo plus MTX

- Data analysis for early RA patients —those who received open label HUMIRA plus MTX following inadequate response to 26 weeks of MTX monotherapy—showed 29 percent simultaneously achieved all three goals at one year

Posted-In: News FDA


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