Vol.19 No.1

Original Article

Study of active controlled tocilizumab monotherapy for rheumatoid arthritis patients with an inadequate response to methotrexate (SATORI): significant reduction in disease activity and serum vascular endothelial growth factor by IL-6 receptor inhibition therapy

Authors

Norihiro Nishimoto1,6 , Nobuyuki Miyasaka2 , Kazuhiko Yamamoto3 , Shinichi Kawai4 , Tsutomu Takeuchi5 , Junichi Azuma1 , Tadamitsu Kishimoto1

  • Osaka University, Osaka, Japan
  • Tokyo Medical and Dental University, Tokyo, Japan
  • University of Tokyo, Tokyo, Japan
  • Toho University Omori Medical Center, Tokyo, Japan
  • Saitama Medical Center/School, Saitama, Japan
  • Laboratory of Immune Regulation, Graduate School of Frontier Biosciences, Osaka University, 1-3 Yamada-oka, Suita, Osaka 565-0871, Japan
Received:

12 May 2008

Accepted:

21 August 2008

Published online:

1 November 2008

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Abstract

We investigated the clinical efficacy and safety of tocilizumab (a humanized anti-IL-6 receptor antibody) monotherapy in active rheumatoid arthritis (RA) patients with an inadequate response to low dose methotrexate (MTX). In a multicenter, double-blind, randomized, controlled trial, 125 patients were allocated to receive either tocilizumab 8 mg/kg every 4 weeks plus MTX placebo (tocilizumab group) or tocilizumab placebo plus MTX 8 mg/week (control group) for 24 weeks. The clinical responses were measured using the American College of Rheumatology (ACR) criteria and the Disease Activity Score in 28 joints. Serum vascular endothelial growth factor (VEGF) levels were also monitored. At week 24, 25.0% in the control group and 80.3% in the tocilizumab group achieved ACR20 response. The tocilizumab group showed superior ACR response criteria over control at all time points. Additionally, serum VEGF levels were significantly decreased by tocilizumab treatment. The overall incidences of adverse events (AEs) were 72 and 92% (serious AEs: 4.7 and 6.6%; serious infections: 1.6 and 3.3%) in the control and the tocilizumab groups, respectively. All serious adverse events improved by adequate treatment. Tocilizumab monotherapy was well tolerated and provided an excellent clinical benefit in active RA patients with an inadequate response to low dose MTX.

Key words

Clinical trial - Interleukin-6 - Rheumatoid arthritis - Tocilizumab - Vascular endothelial growth factor