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Randomized Controlled Trial
. 2009;19(1):12-9.
doi: 10.1007/s10165-008-0125-1. Epub 2008 Nov 1.

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

Norihiro Nishimoto  1 , Nobuyuki Miyasaka, Kazuhiko Yamamoto, Shinichi Kawai, Tsutomu Takeuchi, Junichi Azuma, Tadamitsu Kishimoto
Affiliations
Randomized Controlled Trial

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

Norihiro Nishimoto et al. Mod Rheumatol. 2009.

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.

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Figures

Fig. 1
Fig. 1
Randomization, reasons for withdrawal, and numbers of patients who completed the trial. Tocilizumab humanized anti-interleukin-6 receptor antibody
Fig. 2
Fig. 2
Percentage of responders according to the American College of Rheumatology (ACR) improvement criteria and the Disease Activity Score in 28 joints (DAS28) as well as mean change in Modified Health Assessment Questionnaire (MHAQ) scores. Percentage of responders according to the ACR improvement criteria (a) and the DAS28 (b) according to the ITT analysis over 24 weeks. Mean change in MHAQ scores from baseline to week 24 (c). Last OBS = last observation. *P < 0.05; †P < 0.01; ‡P < 0.001 versus MTX by paired t-test
Fig. 3
Fig. 3
Change from baseline in serum levels of VEGF. Values are the mean for each group at each time point. VEGF was measured at three points (0, 12 and 24 weeks) over the study period. Last OBS = last observation. ‡P < 0.001 versus MTX by paired t-test
Fig. 4
Fig. 4
Change from baseline in serum levels of aspartate transaminase (AST), alanine transaminase (ALT), total bilirubin (T-BIL). Values are the mean for each group at each time point
See this image and copyright information in PMC

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