PMID- 18979150
OWN - NLM
STAT- MEDLINE
DCOM- 20090630
LR  - 20220331
IS  - 1439-7595 (Print)
IS  - 1439-7609 (Electronic)
IS  - 1439-7595 (Linking)
VI  - 19
IP  - 1
DP  - 2009
TI  - 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.
PG  - 12-9
LID - 10.1007/s10165-008-0125-1 [doi]
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.
FAU - Nishimoto, Norihiro
AU  - Nishimoto N
AD  - Laboratory of Immune Regulation, Graduate School of Frontier Biosciences, Osaka 
      University, Osaka, Japan. norihiro@fbs.osaka-u.ac.jp
FAU - Miyasaka, Nobuyuki
AU  - Miyasaka N
FAU - Yamamoto, Kazuhiko
AU  - Yamamoto K
FAU - Kawai, Shinichi
AU  - Kawai S
FAU - Takeuchi, Tsutomu
AU  - Takeuchi T
FAU - Azuma, Junichi
AU  - Azuma J
FAU - Kishimoto, Tadamitsu
AU  - Kishimoto T
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20081101
PL  - England
TA  - Mod Rheumatol
JT  - Modern rheumatology
JID - 100959226
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Receptors, Interleukin-6)
RN  - 0 (Vascular Endothelial Growth Factor A)
RN  - I031V2H011 (tocilizumab)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal/administration & dosage/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Antirheumatic Agents/administration & dosage/*therapeutic use
MH  - Arthritis, Rheumatoid/blood/diagnosis/*drug therapy
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Male
MH  - Methotrexate/administration & dosage/*therapeutic use
MH  - Middle Aged
MH  - Receptors, Interleukin-6/*antagonists & inhibitors/blood
MH  - Treatment Outcome
MH  - Vascular Endothelial Growth Factor A/blood
MH  - Young Adult
PMC - PMC2638601
EDAT- 2008/11/04 09:00
MHDA- 2009/07/01 09:00
PMCR- 2009/02/10
CRDT- 2008/11/04 09:00
PHST- 2008/05/12 00:00 [received]
PHST- 2008/08/21 00:00 [accepted]
PHST- 2008/11/04 09:00 [pubmed]
PHST- 2009/07/01 09:00 [medline]
PHST- 2008/11/04 09:00 [entrez]
PHST- 2009/02/10 00:00 [pmc-release]
AID - 125 [pii]
AID - 10.1007/s10165-008-0125-1 [doi]
PST - ppublish
SO  - Mod Rheumatol. 2009;19(1):12-9. doi: 10.1007/s10165-008-0125-1. Epub 2008 Nov 1.