Abbott has announced the data from Premier and DE019 Phase III studies that investigated Humira (adalimumab) plus methotrexate for up to eight years in patients with early moderate to severe rheumatoid arthritis and up to ten years in patients with long-standing moderate to severe rheumatoid arthritis.
Humira, a TNF blocker used alone, with methotrexate, or with certain other medicines, helps to prevent further damage to bones and joints.
The randomised and controlled Premier trial involved methotrexate-naive patients with early moderate to severe rheumatoid arthritis, who received methotrexate, Humira or Humira plus methotrexate 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.
University of California San Diego Division of Rheumatology Allergy and Immunology professor Arthur Kavanaugh said DE019 and Premier studies provide additional longer term data that support the ability of Humira to treat both early and long-standing moderate to severe rheumatoid arthritis.