Study boost for Roche’s Actemra
pharmafile | October 30, 2008 | News story | Research and Development, Sales and Marketing |Â Â RA, RocheÂ
New data shows Roche's Actemra (tocilizumab) increases the disease remission rate in rheumatoid arthritis (RA) sufferers.
The company says the LITHE trial, a fifth phase III study, proves its novel interleukin-6 (IL-6) receptor also inhibits the progression of joint destruction.
This is significant because inflammation, particularly in the small joints of the hands and feet, is a major cause of disability and fewer than 50% of patients can work or function normally after ten years.
Actemra also improves patients' physical function after one year of therapy.
US regulators recently recommended Actemra be approved to treat adults with moderate to severe RA, but the FDA has since asked for more information on the drug's manufacture and labelling.
Co-developed with Chugai, Actemra was approved for RA in Japan earlier this year.
Roche is pinning a great deal of its hopes for growth on autoimmune diseases including RA and in MabThera (rituximab) it already has the first B-cell therapy for RA. Additionally ocrelizumab, a humanised anti-CD20 antibody, has entered phase III development for RA.
Actemra is entering a highly RA competitive market dominated by Schering-Plough's Remicade, Wyeth's Enbrel and Abbot's Humira – although the Actemra trial was against commonly-used RA drug methotrexate rather than these newer agents.
Actemra is a humanised monoclonal antibody that inhibits the activity of IL-6, a protein that causes inflammation in the membrane that lines joints.
William Burns, head of the Roche Pharma Division, said: "New treatment options are needed, particularly those that can target different pathways to bring relief and inhibit joint damage in patients suffering from RA."
Joel Kremer, LITHE investigator and director of research at the Center for Rheumatology in Albany, New York, said: "It is critical to stop joint damage as quickly as possible to avoid joint deformity and to help patients maintain their quality of life."
The LITHE study ran across nearly 1,200 patients with moderate to severe RA in 15 countries. They received one infusion every four weeks of either Actemra 4 mg/kg or 8 mg/kg every four weeks in combination with methotrexate or methotrexate alone.
RA effects around 21 million people worldwide and is characterised by joint pain, stiffness and swelling.
The progressive autoimmune disease ultimately causes irreversible damage of the joints and can shorten life expectancy by affecting major organ systems.
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