The results from a study conducted by Josef Smolen, professor of medicine at the Medical University of Vienna, et al. show that new drug Actemra is indeed effective in treating rheumatoid arthritis. The findings were presented in June 2007 at the annual European Congress of Rheumatology in Barcelona.
The study, called TOWARD, was the second multinational Phase III data on the drug. Earlier trials conducted in Japan had suggested Actemra might be better than other, leading therapies. The TOWARD study treated 1216 patients with moderate to severe RA; the study was conducted at 130 study sites in 18 countries, including America. For this randomized, double-blind study, patients received either 8mg/kg Actemra intravenously every 4 weeks or placebo in combination with stable anti-rheumatic therapy, including traditional DMARDs but excluding biologics.
The results showed a greater proportion of patients treated with Actemra in combination with traditional DMARDs (e.g. methotrexate) achieved a significant improvement in disease signs and symptoms by the 24th week, compared to those treated with DMARDs alone. Percentage-wise, the study reported 44 percent of patients given the higher dose of Actemra, in combination with the older drug methotrexate, experienced a 50% improvement in disease symptoms and 22% achieved a 70% improvement.
As for side effects of the drug, Actemra does increase cholesterol levels, which might lead to an increased risk of a heart attack. In practice, however, researchers assure that the effect is “modest”: while lipid levels do increase, there was no pronounced shift in HDL/LDL ratios.
In addition, there was also an increase in severe infections. Again, however, the researchers qualified this result by establishing that no particular type of infection was dominant and there was no incidence of tuberculosis in any of the patients.
“Roche’s Actemra helps arthritis, side effects okay”, site accessed on 06/17/07