Abbott presents new Humira data at ACR

US pharma major Abbott Laboratories (NYSE: ABT) today announced results from a post-hoc analysis of its blockbuster drug Humira (adalimumab) data in early and long-standing moderate-to-severe rheumatoid arthritis (RA) patients from three randomized, controlled trials - DE019, OPTIMA and PREMIER, at the American College of Rheumatology Annual Scientific Meeting (ACR) in Washington DC.

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. 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.

For long-standing RA patients in the DE019 trial, 19% (40/207) of patients taking Humira plus methotrexate simultaneously achieved all three key treatment goals at one year, versus 5% (10/200) of placebo plus methotrexate-treated patients in the study. DE019 enrolled patients with long-standing moderate-to-severe RA (mean=11 years) and an inadequate response to methotrexate. For early RA patients in the OPTIMA trial - those who were given open label Humira plus methotrexate following inadequate response to 26 weeks of methotrexate monotherapy – 29% (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 methotrexate-naïve early RA patients who were treated with HUMIRA plus methotrexate (32%, 87/268). OPTIMA and PREMIER enrolled early moderate-to-severe RA (mean=0.4 and 0.7 years, respectively) and methotrexate-naïve patients.