Key ACTEMRA/RoACTEMRA publication summaries
Nishimoto N, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, Azuma J, Kishimoto T.
Mod Rheumatol 2009; 19:12-19.
The SATORI study was a double-blind, randomised, placebo-controlled Phase III study, conducted in Japan and designed to investigate the safety and efficacy of tocilizumab (TCZ) monotherapy in patients with active RA and an inadequate response to methotrexate (MTX) 8 mg/week (the maximum dosage approved in Japan).
Patients were randomised to receive TCZ 8 mg/kg + placebo (n=61) or MTX + placebo (n=64) every 4 weeks for 24 weeks. Demographics and baseline characteristics were comparable between groups.
Key study results are summarised below.
The authors suggest that the observed decrease in VEGF may be an important part of the mechanism of how TCZ exerts its therapeutic efficacy in RA, and conclude that this study demonstrates that TCZ monotherapy in patients who had an inadequate response to MTX treatment has excellent efficacy with a positive benefit–risk ratio.