Roche's Actemra shows promise in RA trial

22 July 2007

Swiss drug major Roche says that its developmental rheumatoid arthritis treatment Actemra (tocilizumab) has met its primary efficacy endpoint, defined as a significant reduction in the disease signs and symptoms, in a Phase III study in patients with moderate-to-severe forms of the illness who had previously failed to respond to anti-tumor necrosis factor-based therapy.

The assessment, known as RADIATE, sought to examine the drug in combination with one of two doses of methotrexate (4mg/kg or 8mg/kg), in comparison with placebo, in the treatment 498 RA sufferers at 13 sites across the world. The results showed that the combined regimen brought about a greater symptom reduction than methotrexate plus placebo.

In addition, the drug was generally well-tolerated, with most commonly reported adverse events including nausea, headache, nasopharyngitis, diarrhea and upper respiratory tract infection. Full data will be presented at an upcoming scientific meeting.

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