Chugai Pharmaceutical Co, Ltd, of Tokyo, Japan, and its strategic partner, F. Hoffmann-La Roche of Switzerland, will jointly present phase III clinical trial results on MRA (tocilizumab) for the treatment of rheumatoid arthritis (RA) at the American College of Rheumatology Annual Scientific Meeting, to be held in San Diego, California, November 12–17.
The trial results demonstrated that tocilizumab, a humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody, reduced joint damage in patients with active early RA, and was superior to conventional disease-modifying anti-rheumatic drugs (DMARDs) in antirheumatic efficacy and in inhibiting radiographic progression.
The phase III trial randomly assigned 306 patients with active early RA of <e;5 years duration to tocilizumab 8 mg/kg every 4 weeks with either a single or combination administration of conventional DMARDs, primarily methotrexate. (Tumor necrosis factor-alpha antagonists and leflunomide were excluded.)
Patients in the tocilizumab arm showed statistically significant less radiographic joint destruction compared to the control group as measured by total Sharp score, erosion score, and joint space narrowing. In addition, ACR response rates in patients taking tocilizumab were statistically higher than those in the control arm.
Currently, the two companies are conducting phase III trials targeting RA in over 20 countries. In Japan, tocilizumab is available under the trade name ACTEMRA 200 for Intravenous Injection for the treatment of Castleman's disease.
—A. Techman