Roche announced that the innovative new therapy ACTEMRA (tocilizumab) can significantly inhibit structural damage to joints in patients with rheumatoid arthritis (RA) this is a critical measure of effectiveness of an RA treatment. ACTEMRA was also found to improve the patients' physical function after one year of therapy and to significantly increase the disease remission rate.
The results from the LITHE1 trial, being presented at the American College of Rheumatology (ACR) Annual Scientific Meeting in San Francisco, showed that:
- A greater proportion of patients treated with ACTEMRA in combination with a commonly used RA drug called methotrexate (MTX) benefited from a significant inhibition of structural damage during 12 months of therapy compared to patients treated with MTX alone. 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.
- ACTEMRA improved the patients' ability to perform normal daily activities, as assessed by the Health Assessment Questionnaire (HAQ)2, leading to a better quality of life.
- Significantly more patients treated with ACTEMRA achieved remission* than those treated with MTX alone (47% vs. 8%). The improvement in remission at one year reinforces the strong remission data seen at 6 months in four additional ACTEMRA phase III trials across multiple RA patient populations.
"The outcome of this study is good news for RA patients as presently many either fail to achieve an adequate response or cannot tolerate therapies currently available," said William M. Burns, Head of the Roche Pharma Division. "New treatment options are needed, particularly those that can target different pathways to bring relief and inhibit joint damage in patients suffering from RA."
"The LITHE study demonstrated that treatment with ACTEMRA inhibited structural joint damage, which is a major cause of disability and loss of physical function for RA patients," said
Joel Kremer, M.D., investigator in the LITHE study and Director of Research at The Center for Rheumatology in Albany, New York. "It is critical to stop joint damage as quickly as possible to avoid joint deformity and to help patients maintain their quality of life." In the LITHE study, ACTEMRA was generally well tolerated and the overall safety profile after 12 months of treatment was consistent with previously reported 6 month trial data.
ACTEMRA is the first of a new class of drug with a novel mechanism of action that brings new hope to RA patients. It is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody which works by suppressing the activity of IL-6, an important trigger of the inflammatory process. This novel mode of action reduces inflammation of the joints and relieves the systemic effects of RA.