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Study of active controlled monotherapy used for rheumatoid arthritis, an IL-6 inhibitor (SAMURAI): evidence of clinical and radiographic benefit from an x ray reader-blinded randomised controlled trial of tocilizumab
  1. Norihiro Nishimoto1,
  2. Jun Hashimoto1,
  3. Nobuyuki Miyasaka2,
  4. Kazuhiko Yamamoto3,
  5. Shinichi Kawai4,
  6. Tsutomu Takeuchi5,
  7. Norikazu Murata6,
  8. Désirée van der Heijde7,
  9. Tadamitsu Kishimoto1
  1. 1Osaka University, Osaka, Japan
  2. 2Tokyo Medical & Dental University, Tokyo, Japan
  3. 3University of Tokyo, Tokyo, Japan
  4. 4Toho University Omori Medical Center, Tokyo, Japan
  5. 5Saitama Medical Center/School, Saitama, Japan
  6. 6Kyowakai Hospital, Osaka, Japan
  7. 7University Hospital Maastricht, Maastricht, The Netherlands
  1. Correspondence to:
    Norihiro Nishimoto
    MD, Laboratory of Immune Regulation, Graduate School of Frontier Biosciences, Osaka University 1–3, Yamada-oka, Suita, Osaka, 565-0871, Japan; norihiro{at}


Objective: To evaluate the ability of tocilizumab (a humanised anti-IL-6 receptor antibody) monotherapy to inhibit progression of structural joint damage in patients with RA.

Methods: In a multi-centre, x ray reader-blinded, randomised, controlled trial, 306 patients with active RA of <5 years’ duration were allocated to receive either tocilizumab monotherapy at 8 mg/kg intravenously every 4 weeks or conventional disease-modifying antirheumatic drugs (DMARDs) for 52 weeks. Radiographs of hands and forefeet were scored by the van der Heijde modified Sharp method.

Results: Patients had a mean disease duration of 2.3 years and a disease activity score in 28 joints of 6.5 at baseline. Mean total modified Sharp score (TSS) was 29.4, which was very high despite the relatively short disease duration. At week 52, the tocilizumab group showed statistically significantly less radiographic change in TSS (mean 2.3; 95% CI 1.5 to 3.2) than the DMARD group (mean 6.1; 95% CI 4.2 to 8.0; p<0.01). Tocilizumab monotherapy also improved signs and symptoms. The overall incidences of AEs were 89% and 82% (serious AEs: 18% and 13%; serious infections: 7.6% and 4.1%) in the tocilizumab and DMARD groups, respectively.

Conclusion: Tocilizumab monotherapy was generally well tolerated and provided radiographic benefit in patients with RA.

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  • Published Online First 8 June 2007

  • Competing interests: NN has served as a consultant to and/or received honoraria from Chugai Pharmaceutical, the manufacture of tocilizumab. TK holds a patent for tocilizumab. The other authors have no competing interests.