Abbott has reported the results from Premier and DE019 Phase 3 studies, which evaluated Humira (adalimumab) plus methotrexate (MTX) in patients with early moderate to severe rheumatoid arthritis (RA).
Humira, a TNF blocker used alone, with methotrexate, or with certain other medicines, will help prevent further damage to bones and joints.
The randomised controlled Premier trial involved MTX-naïve patients with early moderate to severe RA, who received MTX, Humira or Humira plus MTX for two years of blinded treatment, and reported the radiographic, clinical and functional superiority of initial combination therapy over the individual monotherapies.
The randomised controlled DE019 trial enrolled patients with long-standing RA and demonstrated the clinical and radiographic superiority of Humira plus MTX over placebo plus MTX.
In both studies, patients were evaluated for disease activity, improvement in physical function and inhibition of radiographic progression and percentage of patients with no further radiographic progression.