MONDAY, June 16 (HealthDay News) -- Treating rheumatoid arthritis patients with tocilizumab combined with methotrexate is safe and effective, regardless of previous failed anti-tumor necrosis factor (TNF) treatment, according to a study presented at the European League Against Rheumatism Congress 2008, held June 11 to 14 in Paris.
Paul Emery, M.D., of Leeds General Infirmary in Leeds, U.K., and colleagues performed a randomized, double-blind study in which 499 patients who had moderate to severe rheumatoid arthritis and who had previously experienced failed anti-TNF treatment were randomized to receive placebo or tocilizumab (4 mg/kg or 8 mg/kg) every four weeks plus methotrexate for 24 weeks. The primary endpoint was at least a 20 percent improvement in arthritis symptoms.
The researchers found that dose response favored the 8 mg/kg tocilizumab group. Fifty percent of patients in this group achieved the primary endpoint, compared with 30.4 percent of patients in the 4 mg/kg tocilizumab group and 10.1 percent of patients in the control group. Serious adverse events were seen in 6 percent, 7 percent and 11 percent of the 8 mg/kg, 4 mg/kg and control groups, respectively, and serious infections occurred in 5 percent, 2 percent and 3 percent, respectively.
"Tocilizumab plus methotrexate therapy showed clinical improvements in efficacy and safety in this refractory population, irrespective of the number of, or most recently failed, anti-TNF treatment," the authors conclude.
The study received funding from Roche, which is developing tocilizumab, and Emery disclosed having financial ties to Roche.
Abstract
More Information
