Nishimoto N, Hashimoto J, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, Murata N, van der Heijde D, Kishimoto T.
Ann Rheum Dis 2007; 66:1162–1167.
The SAMURAI study was a double-blind, randomised, placebo-controlled Phase III study, conducted in Japan and designed to evaluate the ability of tocilizumab (TCZ) monotherapy to inhibit progression of structural joint damage in patients with active RA (N=306). Patients were randomly assigned to receive either TCZ 8 mg/kg (n=158) or DMARD (n=148) therapy for 52 weeks. At baseline, patients had a mean disease duration of 2.3 years, a mean DAS28 of 6.5 and a total Sharp score (TSS) of 29.4.
Key study results are summarised below.
- At Week 52, fewer patients in the TCZ group showed radiographic progression than those in the DMARD group.
- 56% of TCZ patients had no radiographic progression compared with 39% of DMARD patients (p<0.01).
- More TCZ patients had negative TSS scores compared with DMARD patients (n=24 vs. n=18).
- Mean changes in erosion (0.9 vs. 3.2; p<0.001) and joint space narrowing (1.5 vs. 2.9; p<0.05) scores were significantly more favourable in the TCZ vs. DMARD groups, respectively, at Week 52.
- Proportions of patients achieving ACR20/50/70 at Week 52 were 78%, 64% and 44% in the TCZ group and 34%, 13% and 6% in the DMARD group (p<0.001 for each comparison).
- TCZ patients with a higher ACR response showed less radiographic progression.
- DAS28 remission (<2.6) was achieved in 59% of TCZ patients vs. 3% of DMARD patients (p<0.001).
- A major clinical response (ACR70 for 6 consecutive months) was achieved in 24% of TCZ patients and 2% of DMARD patients.
- Patient reports of adverse events and serious adverse events were comparable between the TCZ and DMARD groups.
In conclusion, this study demonstrated that TCZ monotherapy in patients with active RA significantly inhibited the progression of structural joint damage compared with conventional DMARD therapy.
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