PMID- 20221663
OWN - NLM
STAT- MEDLINE
DCOM- 20100913
LR  - 20221207
IS  - 1439-7609 (Electronic)
IS  - 1439-7595 (Linking)
VI  - 20
IP  - 3
DP  - 2010 Jun
TI  - Safety and efficacy profiles of tocilizumab monotherapy in Japanese patients with 
      rheumatoid arthritis: meta-analysis of six initial trials and five long-term 
      extensions.
PG  - 222-32
LID - 10.1007/s10165-010-0279-5 [doi]
AB  - We present safety and efficacy data from Japanese clinical studies on monotherapy 
      with tocilizumab (TCZ), a humanized anti-interleukin 6 receptor monoclonal 
      antibody, in which 601 patients with moderate to severe rheumatoid arthritis, 
      with a total of 2188 patient-years (pt-yr) exposure, were enrolled. The median 
      treatment duration was 3.8 years. The incidence of adverse events (AEs), 
      including abnormal laboratory test results, was calculated as 465.1 per 100 
      pt-yr. The most common serious adverse events (SAEs) were infections (6.22 per 
      100 pt-yr). There was no increase in the frequency of AEs or SAEs with long-term 
      treatment. Abnormalities in the laboratory test results, such as increases in 
      lipid parameters or abnormal liver function parameters, were common, but most 
      were mild and there were no SAEs related to them. At baseline, 546 patients 
      (90.8%) were taking corticosteroids; of these, 77.8% were able to decrease their 
      corticosteroid dose during the study period, while 35.2% discontinued 
      corticosteroids altogether. In the patients treated longer than 5 years, 91.3, 
      73.0, and 51.3% met the ACR20, ACR50, and ACR70 response criteria, respectively, 
      and 59.7% met the DAS remission criterion (DAS28 <2.6) at 5 years. In conclusion, 
      based on these results, TCZ has shown good tolerability and high efficacy during 
      long-term treatment.
FAU - Nishimoto, Norihiro
AU  - Nishimoto N
AD  - Wakayama Medical University, 811-1 Kimiidera, Wakayama, Wakayama 641-8509, Japan. 
      norichan@wakayama-med.ac.jp
FAU - Ito, Kyoko
AU  - Ito K
FAU - Takagi, Nobuhiro
AU  - Takagi N
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
DEP - 20100311
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 (interleukin-6 receptor alpha)
RN  - I031V2H011 (tocilizumab)
SB  - IM
MH  - Antibodies, Monoclonal/*adverse effects/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Antirheumatic Agents/adverse effects/therapeutic use
MH  - Arthritis, Rheumatoid/immunology/*therapy
MH  - Asian People
MH  - Humans
MH  - Receptors, Interleukin-6/antagonists & inhibitors
MH  - Treatment Outcome
EDAT- 2010/03/12 06:00
MHDA- 2010/09/14 06:00
CRDT- 2010/03/12 06:00
PHST- 2009/12/09 00:00 [received]
PHST- 2010/01/26 00:00 [accepted]
PHST- 2010/03/12 06:00 [entrez]
PHST- 2010/03/12 06:00 [pubmed]
PHST- 2010/09/14 06:00 [medline]
AID - 10.1007/s10165-010-0279-5 [doi]
PST - ppublish
SO  - Mod Rheumatol. 2010 Jun;20(3):222-32. doi: 10.1007/s10165-010-0279-5. Epub 2010 
      Mar 11.