Positive results for Humira (Abbott) in one of longest trials in patients with Rheumatoid Arthritis

Abbott announced results from two long-term, open-label studies evaluating Humira (adalimumab) treatment for up to 10 years in patients with long-standing, moderate-to-severe Rheumatoid Arthritis (RA). These 10-year studies, DE019 and DE020, are among the longest, open-label trials in RA. In both studies, patients were assessed for improvements in signs and symptoms of the disease, such as joint pain, swelling and stiffness, as well as physical function and achievement of clinical remission. Patients continued to maintain improvements: in both DE019 and DE020, a DAS28 (CRP) greater than 2.6, a measure of clinical remission, was observed in more than half of patients who continued on Humira for up to 10 years (59.6 percent and 57.2 percent, respectively). DE019 also assessed the ability of Humira to inhibit radiographic progression. Patients who completed 10 years of treatment and also had X-rays available at baseline and year 10 demonstrated an average change of 2.8 in modified total Sharp score (mTSS), a measure of radiographic inhibition. In DE019, patients who were initially treated with Humira plus methotrexate (MTX) for the first year had less radiographic progression at year 10 compared with patients who received placebo plus MTX. No new saftey issues were identified. Results were presented at the European League Against Rheumatism (EULAR) 2012 Congress.