Roche announced that new two-year data from the LITHE study1 demonstrate that Actemra (tocilizumab, known as RoACTEMRA within the EU) continues to be highly effective at inhibiting joint structural damage and maintaining consistently high remission rates. Reducing the structural damage to joints in patients with rheumatoid arthritis (RA) is a critical measure of effectiveness of an RA treatment.
William M Burns, CEO Roche Pharmaceuticals Division, outlined the implications of the results, "These new data build on the one-year results, demonstrating that, in most patients, Actemra inhibited the progression of structural joint damage which is a major cause of disability and loss of physical function for RA patients. LITHE is the fifth large study from a comprehensive development programme and demonstrates that Actemra offers rheumatoid arthritis patients the chance of achieving a long-lasting remission from the disease."
The two-year data showed that a greater proportion of patients treated with Actemra in combination with methotrexate (MTX), the current standard therapy, benefited from a significant inhibition of structural damage during 24 months of therapy, compared to patients in the control arm. The outcome was determined by x-ray evidence of the progression of bone erosions and narrowing of joint spaces. This benefit is important to patients as damage to the joints caused by the disease leads to the disability and pain associated with RA.
Additionally, patients on Actemra reported they improved in their ability to perform normal daily activities, as assessed by Health Assessment Questionnaire (HAQ) scores. In the study, Actemra was generally well tolerated and the overall safety profile after two years of treatment was consistent with previously reported trial data. Full data from this two-year trial will be used to support global regulatory filings for labelling claims of inhibition of the progression of structural damage and improvement of physical function. It will also be submitted for presentation at a future international scientific meeting.
Actemra is the result of research collaboration by Chugai and is being co-developed globally with Chugai.