Patients with rheumatoid arthritis hopes have been raised with Roche announcing that its new drug showed positive results and was safe without any side effects according to its key study. Drug maker Roche Holding AG will file the drug Actemra for regulatory approval in Europe and the U.S. later this year.
Actemra was developed by Japanese pharmaceutical company Chugai Pharmaceutical Co. (4519.TO), which is controlled by Roche. Roche owns the rights to market Actemra outside Japan.
Two other drugs rituximab (Rituxan), abatacept (Orencia) are already there to reduce signs and symptoms of RA, improve physical function and health status, and slow joint damage progression.
Sufferers of rheumatoid arthritis, or RA, begin to experience progressive joint damage early in the disease. The disease differs from what is popularly known as arthritis, typically associated with age-related joint pain; RA is a far more serious inflammatory disease that leads to destruction of cartilage and bone, and can lead to disability.
The new treatment option Actemra in combination with traditional drugs achieved a significant improvement in disease signs and symptoms after 24 weeks, compared to those treated with the traditional drugs alone.
The heterogeneity of the disease is one of the reasons why no single therapy is effective for all patients or for one patient at all times. Disease-modifying anti-rheumatic drugs such as the anti-tumor necrosis factor (TNF) agents etanercept (Enbrel), infliximab (Remicade), and adalimumab (Humira), in combination with methotrexate, have significant anti-inflammatory and joint-protecting activity.
Abatacept, rituximab, and tocilizumab all achieved better clinical results in combination with methotrexate than when used as monotherapy.
Currently available drugs that target a protein called tumour necrosis factor, or TNF, have helped revolutionise treatment for rheumatoid arthritis, but up to 40 percent of patients do not get an adequate response. TNF blockers can also have significant side effects, including serious infections, tuberculosis and increased cancer risk.
"If active disease prevails despite anti-TNF treatment, rituximab or abatacept constitute novel alternatives, although abatacept could be administered before use of a TNF inhibitor (such practice is not currently licensed in Europe). The minimum therapeutic aim is low disease activity, but remission should constitute the ultimate goal." said Josef S. Smolen, M.D., of the Medical University of Vienna, and colleagues.