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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 proportion of patients achieving an ACR20 response at Week 24 was significantly higher with TCZ monotherapy than with MTX monotherapy (80.3% vs. 25.0%; p<0.001).
• DAS28 remission rate at Week 24 was also significantly higher in the TCZ group vs. the MTX group (43.1% vs. 1.6%; p<0.001).
  • ACR50 and ACR70 response rates in the TCZ group were superior to the MTX group from Week 4 onwards.

• Mean levels of vascular endothelial growth factor (VEGF – an important modulator of angiogenesis, which is implicated in the formation and maintenance of the pannus in RA) were significantly decreased from baseline in the TCZ group compared with the control group at Week 24 (–346.9 pg/ml vs. –74.0 pg/ml; p<0.001).
• TCZ was well tolerated and the safety profile was comparable between both groups.

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.

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