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Nishimoto N, Yoshizaki K, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, Hashimoto J, Azuma J, Kishimoto T.

Arthritis Rheum 2004; 50:1761–1769.

This study was a double-blind, placebo-controlled trial, conducted in Japan to evaluate the safety and efficacy of MRA (subsequently named tocilizumab and referred to as TCZ here) in patients with refractory RA. Patients were randomly assigned to receive TCZ 4 mg/kg (n=54) or 8 mg/kg (n=55) or placebo (n=53) for 12 weeks. Baseline characteristics were similar among the groups. Median disease duration at baseline was 7.6 years.

Key study results are summarised below.

• At Week 12, an ACR20 response was achieved by 78% in the TCZ 8 mg/kg group (p<0.001 vs. placebo), 57% in the 4 mg/kg group and 11% in the placebo group.
  • The proportion of patients achieving a good or moderate EULAR response was 91% in the TCZ 8 mg/kg group, 72% in the TCZ 4 mg/kg group and 19% in the placebo group.
  • At Week 12, complete normalisation of CRP was observed in 76% and 26% of patients in the TCZ 8 mg/kg and 4 mg/kg groups, respectively.
  • A significant reduction in C-reactive protein was apparent as early as Week 4 and became more pronounced as the study progressed.

• The incidence of adverse events was 51%, 59% and 56% in the TCZ 8 mg/kg, 4 mg/kg and placebo groups, respectively.
  • Five serious adverse events were reported: three in patients in the TCZ group (2.8%) and two in patients in the placebo group (3.8%).

• Dose-dependent increases in total cholesterol, HDL cholesterol and triglycerides were observed in the TCZ groups.

In conclusion, this study provided early evidence for a rapid reduction in disease activity in response to TCZ in patients with active RA. The efficacy was dose-related and an acceptable safety profile relative to clinical benefit was indicated.

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