Chugai Pharmaceutical Co., Ltd. and F. Hoffmann-La Roche Ltd. announced that the humanized anti-human IL-6 (interleukin-6) receptor monoclonal antibody, Actemra (generic name: tocilizumab -genetical recombination- injection), globally co-developed by Chugai and Roche, has shown efficacy as a combination therapy with DMARDs (Disease Modifying Antirheumatic Drugs) in rheumatoid arthritis patients in a double-blinded phase III trial.
This is a second phase III trial outside of Japan, and evaluated the efficacy on patients with inadequate response to DMARDs. The results will be presented on November 10, 2007, at the American College of Rheumatology (ACR) Annual Congress held in Boston, USA.
The objective of the study was to investigate Actemra's efficacy and safety for rheumatoid arthritis patients with inadequate response to DMARDs treatment.
The study was a double-blinded trial evaluating 1,216 patients with moderate to severe active rheumatoid arthritis despite treatment with DMARDs. Patients were allocated to receive Actemra 8mg/kg, or placebo every four weeks (intravenous infusion), in combination with traditional DMARDs.
ACR response rates were used to determine the anti-rheumatic efficacy, and at the end of the 24 weeks (or at the last observation), Actemra group achieved statistically significantly higher response rates versus placebo.
The most common adverse events reported more frequently in the Actemra arm were upper respiratory tract infections, headache and nasopharyngitis and hypertension. As with other DMARDs, serious infections have been reported in some patients treated with Actemra.
Actemra is currently marketed in Japan under the trade name "Actemra 200 for Intravenous Infusion" after approval as a therapy for Castleman's disease in April 2005. In April 2006, additional indications were filed in Japan for rheumatoid arthritis and systemic-onset juvenile idiopathic arthritis.
Outside of Japan, Roche and Chugai are investigating Actemra in five phase III international trials, of which the TOWARD trial is the second to report, following the OPTION trial which was the first to report in June 2007 at European League Against Rheumatism. In those trials, Actemra is being tested in rheumatoid arthritis patients with inadequate response to DMARDs (Disease Modifying Antirheumatic Drugs), including MTX and anti-TNF preparations, and patients who have not been treated with MTX before. Roche plans to file Actemra with regulatory authorities in Europe and in the United States, in the fourth quarter of 2007.