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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
Open accessAbstract
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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Cited by
Genetics of rheumatoid arthritis contributes to biology and drug discovery
the RACI consortium, Okada, Y., the GARNET consortium, Wu, D., Trynka, G., Raj, T., Terao, C., Ikari, K., Kochi, Y., Ohmura, K., et al. (2014) · Nature · doi:10.1038/nature12873 · Cited by 2,310
Self-citationGabay, C., Emery, P., van Vollenhoven, R., Dikranian, A., Alten, R., Pavelka, K., Klearman, M., Musselman, D., Agarwal, S., Green, J., et al. (2013) · The Lancet · doi:10.1016/s0140-6736(13)60250-0 · Cited by 672
Ogata, A., Tanimura, K., Sugimoto, T., Inoue, H., Urata, Y., Matsubara, T., Kondo, M., Ueki, Y., Iwahashi, M., Tohma, S., et al. (2014) · Arthritis Care & Research · doi:10.1002/acr.22110 · Cited by 140
Genovese, M. C., Fleischmann, R., Furst, D., Janssen, N., Carter, J., Dasgupta, B., Bryson, J., Duncan, B., Zhu, W., Pitzalis, C., et al. (2014) · Annals of the Rheumatic Diseases · doi:10.1136/annrheumdis-2013-204760 · Cited by 132
Kaneko, Y., Atsumi, T., Tanaka, Y., Inoo, M., Kobayashi-Haraoka, H., Amano, K., Miyata, M., Murakawa, Y., Yasuoka, H., Hirata, S., et al. (2016) · Annals of the Rheumatic Diseases · doi:10.1136/annrheumdis-2015-208426 · Cited by 96
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Metadata
- Authors
- Nishimoto, N., Miyasaka, N., Yamamoto, K., Kawai, S., Takeuchi, T., Azuma, J., & Kishimoto, T.
- Venue
- Modern Rheumatology
- Publisher
- Oxford University Press (OUP)
- Published
- 2009-02
- Volume
- 19
- Issue
- 1
- Pages
- 12-19
- ISSN
- 1439-7595 (ISSN-L)
- 1439-7609
- OpenAlex
- W4253469911
- Cited by
- 268
- References
- 0
- FWCI
- 18.18
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- CoChat. (2026). Citation check: 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. https://app.cochat.ai/papers/10.3109/s10165-008-0125-1
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- Nishimoto, N., Miyasaka, N., Yamamoto, K., Kawai, S., Takeuchi, T., Azuma, J., & Kishimoto, T. (2009). 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. Modern Rheumatology. https://doi.org/10.3109/s10165-008-0125-1
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