FDAnews

CHUGAI REPORTS DATA ON ACTERMA

Chugai Pharmaceutical has announced that the humanized anti-human IL-6 (interleukin-6) receptor monoclonal antibody, Actemra, has shown efficacy as a monotherapy in rheumatoid arthritis patients in a double-blinded Phase III trial conducted in Japan.

This is a double-blinded trial evaluating 125 patients. Sixty-one patients were allocated to receive Actemra 8 mg/kg with MTX placebo (Actemra group) and 64 patients were allocated to receive Actemra placebo with MTX 8mg (placebo group). Actemra was administered every four weeks for total of six times, and MTX was administered every week for a total of 24 weeks.