Roche Holdings AG (manufacturer of MabThera® (rituximab) ) announced on July 10 that its new RA drug Actemra has proved successful in a phase III clinical study. The study, called RADIATE (Research on Actemra Determining effIcacy after Anti-Tnf FailurEs) evaluated the effectiveness of the drug in patients whose disease has not responded to at least one TNF-inhibitor drug.
Actemra works by inhibiting interleukin-6 (IL-6) receptors. Interleukin-6 (IL-6) is a key molecule involved in rheumatoid arthritis as well as other inflammatory diseases and malignancies. Roche reported that Actemra is generally well tolerated with the most frequent adverse reactions being upper respiratory tract infections, headache, nasopharyngitis and hypertension. Serious infections have also been reported, similar to other DMARDs and TNF-inhibitors.
The Radiate study is the third Phase III trial for the drug. It was conducted over 24 weeks with 498 patients with difficult-to-treat RA. The results showed that patients treated with Actemra plus methotrexate, were more likely to have a significant improvement in disease signs and symptoms following 24 weeks of treatment, compared to patients treated with placebo plus methotrexate.
Published On: July 13, 2007