PMID- 21078627
OWN - NLM
STAT- MEDLINE
DCOM- 20120221
LR  - 20220321
IS  - 1462-0332 (Electronic)
IS  - 1462-0324 (Linking)
VI  - 50
IP  - 3
DP  - 2011 Mar
TI  - Risk of adverse events including serious infections in rheumatoid arthritis 
      patients treated with tocilizumab: a systematic literature review and 
      meta-analysis of randomized controlled trials.
PG  - 552-62
LID - 10.1093/rheumatology/keq343 [doi]
AB  - OBJECTIVE: To assess the risk of adverse events (AEs) in patients with RA treated 
      with tocilizumab, an IL-6 receptor antibody, in published randomized controlled 
      trials (RCTs). METHODS: A systematic literature search was conducted using the 
      Cochrane library, PUBMED and EMBASE for all RCTs (of the use of tocilizumab for 
      RA) until September 2009. Fixed effect meta-analyses were conducted to compare 
      the incidence of AEs after treatment with tocilizumab 8 and 4 mg/kg in 
      combination with MTX, and 8 mg/kg tocilizumab monotherapy, with controls. Pooled 
      summary odds ratios (ORs) were calculated using the Mantel-Haenszel method. 
      RESULTS: Six trials were analysed (four trials included 8 mg/kg tocilizumab and 
      MTX combination therapy, three of which also assessed the 4 mg/kg dose). Three 
      studies assessed tocilizumab monotherapy at 8 mg/kg. Pooled ORs revealed 
      statistical significance for an increased risk of AEs in the 8 mg/kg combination 
      group compared with controls (OR = 1.53; 95% CI 1.26, 1.86). The risk of 
      infection was significantly higher in the 8 mg/kg combination group compared with 
      controls (OR = 1.30; 95% CI 1.07, 1.58). No increased incidence of malignancy, 
      tuberculosis reactivation or hepatitis was seen. CONCLUSION: Tocilizumab in 
      combination with MTX as a treatment for RA is associated with a small but 
      significantly increased risk of AEs, which is comparable with that of other 
      biologics. Vigilance for untoward effects is, therefore, imperative in any 
      patient treated with these immuno-suppressive agents.
FAU - Campbell, Laura
AU  - Campbell L
AD  - Department of Medicine, Clinical School, University of Cambridge, Cambridge CB2 
      0QQ, UK.
FAU - Chen, Chen
AU  - Chen C
FAU - Bhagat, Shweta S
AU  - Bhagat SS
FAU - Parker, Richard A
AU  - Parker RA
FAU - Ostor, Andrew J K
AU  - Ostor AJ
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
PT  - Systematic Review
DEP - 20101114
PL  - England
TA  - Rheumatology (Oxford)
JT  - Rheumatology (Oxford, England)
JID - 100883501
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antirheumatic Agents)
RN  - I031V2H011 (tocilizumab)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Antibodies, Monoclonal, Humanized/administration & dosage/*adverse effects
MH  - Antirheumatic Agents/administration & dosage/*adverse effects
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Male
MH  - Methotrexate/administration & dosage/adverse effects
MH  - Middle Aged
MH  - Randomized Controlled Trials as Topic
MH  - Risk Assessment
MH  - Risk Factors
MH  - Treatment Outcome
EDAT- 2010/11/17 06:00
MHDA- 2012/02/22 06:00
CRDT- 2010/11/17 06:00
PHST- 2010/11/17 06:00 [entrez]
PHST- 2010/11/17 06:00 [pubmed]
PHST- 2012/02/22 06:00 [medline]
AID - keq343 [pii]
AID - 10.1093/rheumatology/keq343 [doi]
PST - ppublish
SO  - Rheumatology (Oxford). 2011 Mar;50(3):552-62. doi: 10.1093/rheumatology/keq343. 
      Epub 2010 Nov 14.