ABBOTT PARK, Ill., Nov. 12, 2012 /PRNewswire/ -- 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.
Study ResultsFor long-standing RA patients in the DE019 trial, 19 percent (40/207) of patients taking HUMIRA plus methotrexate (MTX) simultaneously achieved all three key treatment goals at one year, versus 5 percent (10/200) of placebo plus MTX-treated patients in the study. DE019 enrolled patients with long-standing moderate-to-severe RA (mean=11 years) and an inadequate response to MTX.
For early RA patients in the OPTIMA trial – those who were given open label HUMIRA plus MTX following inadequate response to 26 weeks of MTX monotherapy – 29 percent (102/348) of patients simultaneously achieved all three key treatment goals at one year. This rate was comparable to what was observed in the PREMIER trial with MTX-naïve early RA patients who were treated with HUMIRA plus MTX (32 percent; 87/268). OPTIMA and PREMIER enrolled early moderate-to-severe RA (mean=0.4 and 0.7 years, respectively) and MTX-naïve patients.