SOUTH SAN FRANCISCO (dpa-AFX) - Genentech, a part of the Roche Group (RHHBY.PK), Saturday announced positive results from a study of its arthritis drug ACTEMRA and said that results will be presented during a presentation at the 2012 American College of Rheumatology Annual Scientific Meeting in Washington D.C.
Results from the study showed ACTEMRA (tocilizumab) improved signs and symptoms of rheumatoid arthritis (RA) significantly more than adalimumab when used alone as a single-agent therapy (without other disease-modifying antirheumatic drugs (DMARDs), including methotrexate).
RA patients are often treated with a combination of medicines that typically include a biologic medicine, such as ACTEMRA or adalimumab, plus methotrexate. However, about one in three patients on a biologic treatment such as ACTEMRA or adalimumab receive it as a single-agent therapy, largely due to intolerance to methotrexate.
In addition to data from the ADACTA study, long-term follow-up of patients from AMBITION, a large Phase III study, will be presented at ACR. Together, these studies support the use of ACTEMRA alone as a single-agent therapy for RA patients who are either intolerant to methotrexate or in whom methotrexate use would not be appropriate.
ADACTA (ADalimumab ACTemrA) is a Phase IV multi-center, randomized, double-blind, parallel group study designed to compare the reduction in signs and symptoms of RA in adult patients treated with either ACTEMRA or adalimumab as a single-agent therapy.
Patients participating in the study had severely active RA and either an intolerance to methotrexate or were not appropriate candidates for continued methotrexate treatment. Of note, patients participating in the study had not previously received a biologic medicine for RA.
In the study, 326 patients were randomized to receive ACTEMRA 8 mg/kg intravenously (IV) every four weeks (plus placebo adalimumab) or adalimumab 40 mg subcutaneously (SC) every two weeks (plus placebo ACTEMRA) for 24 weeks.
The study met its primary endpoint of a significantly greater reduction in the mean change from baseline in the DAS28 score in patients receiving ACTEMRA as a single-agent therapy compared to those receiving adalimumab as a single-agent therapy at 24 weeks.
RA is an autoimmune disease estimated to affect up to 70 million people worldwide, including children. Joints become chronically inflamed, painful and swollen, and patients can become increasingly disabled as cartilage and bone is damaged.
ACTEMRA is the first humanized IL-6 receptor-inhibiting monoclonal antibody approved for the treatment of adult patients with moderately to severely active RA who have had an inadequate response to one or more disease-modifying antirheumatic drugs.
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