Roche Pharmaceuticals (BASEL, Switzerland) announced that Actemra^® (tocilizumab), a humanized interleukin-6 receptor-inhibiting monoclonal antibody, can significantly inhibit structural damage to joints in patients with rheumatoid arthritis (RA).

One year results from the LITHE (tociLIzumab safety and THE prevention of structural joint damage) trial showed that the drug was generally well tolerated and the overall safety profile after 12 months of treatment was consistent with previously reported 6 month trial data. LITHE, the fifth global phase III trial on Actemra, successfully met its primary endpoints in patients with moderate-to-severe RA. First-year data from the 2-year trial will be submitted for presentation at upcoming international scientific meetings.

The LITHE trial comprised 15 countries and 1196 RA patients who had an inadequate response to methotrexate (MTX). Patients were randomized to receive either Actemra (4 mg/kg or 8 mg/kg, one infusion every 4 weeks) in combination with MTX, or MTX alone. Results showed that a greater proportion of patients treated with the drug in combination with MTX benefited from a significant inhibition of structural damage during 12 months of therapy compared with patients treated with MTX alone, as demonstrated by changes in radiographic parameters. Additionally, Actemra improved the patients’ ability to perform normal daily activities, as assessed by Health Assessment Questionnaire scores.

Roche and Chugai Pharmaceutical Co, Ltd are codeveloping the drug in collaboration with Osaka University. The five phase III trials were designed to evaluate clinical findings of Actemra, all of which have reported meeting their primary endpoints. In Japan, the drug was launched by Chugai in June 2005 as a therapy for Castleman's disease; in April 2008, additional indications for RA, juvenile idiopathic arthritis, and systemic-onset juvenile idiopathic arthritis were also approved in Japan. Actemra is awaiting approval in the US and Europe.