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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 Randomized Controlled Trial of Tocilizumab
  1. Norihiro Nishimoto (norihiro{at}
  1. Graduate School of Frontier Biosciences, Osaka University, Japan
    1. Jun Hashimoto (junha{at}
    1. Osaka University, Japan
      1. Nobuyuki Miyasaka (miya.rheu{at}
      1. Tokyo Medical and Dental University, Japan
        1. Kazuhiko Yamamoto (yamamoto-tky{at}
        1. University of Tokyo, Japan
          1. Shinichi Kawai (skawai{at}
          1. Toho University Omori Medical Center, Japan
            1. Tsutomu Takeuchi (tsutake{at}
            1. Saitama Medical Center/School, Japan
              1. Norikazu Murata (nmurata{at}
              1. Kyowakai Hospital, Japan
                1. DMFM van der Heijde (d.vanderheijde{at}
                1. University Hospital Maastricht, Netherlands
                  1. Tadamitsu Kishimoto (kishimot{at}
                  1. Graduate School of Frontier Biosciences, Osaka University, Japan


                    Objective. To evaluate the ability of tocilizumab (a humanized anti-IL-6 receptor antibody) monotherapy to inhibit progression of structural joint damage in patients with RA. Methods. In the multi-center, X-ray reader-blinded, randomized, 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. This trial was registered in clinical trials. gov ( NCT00144508). Results. Patients had a mean disease duration of 2.3 years and DAS28 score of 6.5 at baseline. Mean total modified Sharp score (TSS) was 29.4, which was very high despite 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, 3.2) than DMARDs group (mean 6.1; 95%CI 4.2, 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 DMARDs groups, respectively. Conclusion. Tocilizumab monotherapy was generally well tolerated and provided radiographic benefit in patients with RA.

                    • clinical trial
                    • interleukin-6
                    • radiography
                    • rheumatoid arthritis
                    • tocilizumab

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