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New RA drug shows efficacy over methotrexate alone in phase 3 trial
Upper respiratory tract infection and headache were the most common side effects reported, with a similar incidence of infection reported across treatment arms.
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NUTLEY, N.J. — Results from a phase 3 study show that a monoclonal antibody drug administered in conjunction with methotrexate significantly improved signs and symptoms of rheumatoid arthritis compared to treatment with methotrexate alone, according to a press release from Roche, developers of the new drug.
The company announced the results from the OPTION (TOcilizumab Pivotal Trial in Methotrexate Inadequate respONders) trial, a three-arm, randomized, double-blind and controlled study evaluating the safety and efficacy of Actemra (Roche) plus methotrexate compared to placebo plus methotrexate in patients with rheumatoid arthritis (RA) who inadequately responded to methotrexate alone.
Actemra is a humanized interleukin-6 (IL-6) receptor-blocking monoclonal antibody. In the study, patients received either 4-mg/kg or 8-mg/kg intravenous injections of the drug, or placebo injections, every 4 weeks in addition to weekly methotrexate.
The study enrolled 623 patients at 73 sites in 17 countries outside the United States. Investigators measured patients' responses using the American College of Rheumatology (ACR) system, in which a 20% reduction in RA signs and symptoms is represented as ACR20, according to the release.
Researchers found that more patients treated with Actemra plus methotrexate achieved a 20% improvement in disease signs and symptoms at 24 weeks' follow-up compared with those treated with placebo plus methotrexate.
Actemra also showed a safety profile consistent with earlier development studies. Upper respiratory tract infection and headache were the most common side effects reported, with a similar incidence of infection reported across treatment arms, according to the press release.
Data from the OPTION trial will be submitted for presentation at upcoming international scientific meetings. In addition, four other phase 3 trials exploring Actemra in RA are ongoing, with three trials expected to report in 2007, according to the release.
For more information:
- Roche Web site: www.roche.com.