TY - JOUR
T1 - Study of active controlled tocilizumab monotherapy for rheumatoid arthritis patients with an inadequate response to methotrexate (SATORI)
T2 - Significant reduction in disease activity and serum vascular endothelial growth factor by IL-6 receptor inhibition therapy
AU - Nishimoto, Norihiro
AU - Miyasaka, Nobuyuki
AU - Yamamoto, Kazuhiko
AU - Kawai, Shinichi
AU - Takeuchi, Tsutomu
AU - Azuma, Junichi
AU - Kishimoto, Tadamitsu
N1 - Funding Information:
Acknowledgments The authors wish to thank the SATORI investigators for the treatment and Takahiro Kakehi, B·Sc., Yuji Kimura, M.Sc., Kenichi Yamada, B·Sc. and Karsten Kissel, MD for their valuable assistance with the design and analysis of the study and preparation of this manuscript. This work was financially supported by Chugai Pharmaceutical Co., Ltd., Tokyo, Japan. The SATORI investigators were as follows: Tatsuya Atsumi, M.D. (Hokkaido University, Hokkaido, Japan); Takeshi Sasaki, M.D. (Tohoku University, Miyagi, Japan); Takayuki Sumida, M.D. (University of Tsukuba, Ibaraki, Japan); Masahiro Iwamoto, M.D. (Jichi Medical University, Tochigi, Japan); Tsutomu Takeuchi, M.D. (Saitama Medical Center/School, Saitama, Japan); Nobuyuki Miyasaka, M.D. (Tokyo Medical and Dental Unversity, Tokyo, Japan); Michito Hirakata, M.D. (Keio University, Tokyo, Japan); Kazuhiko Yamamoto, M.D. (University of Tokyo, Tokyo, Japan); Akio Yamada, M.D. (Jikei University, Tokyo, Japan); Shigeto Tohma, M.D. (Sagamihara National Hospital, Kanagawa, Japan); Hirahito Endo, M.D. (Kitasato University, Kanagawa, Japan); Yoshiaki Ishigatsubo, M.D. (Yokohama City University, Kanagawa, Japan); Takeshi Kuroda, M.D. (Niigata University, Niigata, Japan); Shogo Banno, M.D., Yoshihito Hayami, M.D. (Nagoya City University, Aichi, Japan); Masao Tanaka, M.D. (Kyoto University, Kyoto, Japan); Tadao Miyake, M.D. (Osaka General Medical Center, Osaka, Japan); Masaki Suemura, M.D. (Nissay Hospital, Osaka, Japan); Shiro Ohshima, M.D. (Osaka University, Osaka, Japan); Masato Matsushita, M.D. (Osaka Second Police Hospital, Osaka, Japan); Yukihiko Saeki, M.D. (Osaka Minami Medical Center, Osaka, Japan); Hiroshi Uda, M.D. (Sakai-Onshinkai Hospital, Osaka, Japan); Kiyoshi Takasugi, M.D. (Dogo Spa Hospital, Ehime, Japan); Takahiko Horiuchi, M.D. (Kyushu University, Fukuoka, Japan); Kazuyoshi Saito, M.D. (University of Occupational and Environmental Health, Fukuoka, Japan); Katsumi Eguchi, M.D. (Nagasaki University, Nagasaki, Japan).
PY - 2009
Y1 - 2009
N2 - 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.
AB - 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.
KW - Clinical trial
KW - Interleukin-6
KW - Rheumatoid arthritis
KW - Tocilizumab
KW - Vascular endothelial growth factor
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U2 - 10.1007/s10165-008-0125-1
DO - 10.1007/s10165-008-0125-1
M3 - Article
C2 - 18979150
AN - SCOPUS:60149105639
SN - 1439-7595
VL - 19
SP - 12
EP - 19
JO - Japanese Journal of Rheumatology
JF - Japanese Journal of Rheumatology
IS - 1
ER -