title: Efficacy and safety of induction therapy with alemtuzumab in kidney transplantation: a meta-analysis.
abstract: BACKGROUND
  Alemtuzumab, a humanized CD52 monoclonal antibody, with its profound lymphocyte depletion property, was expected to be a promising induction therapy agent for kidney transplantation (KTx). However, currently no consensus is available about its efficacy and safety. The aim of this meta-analysis was to make a profound review and an objective appraisal of this issue.
  
  
  METHODS
  Relevant papers were searched, essentially in the PubMed database and the Cochrane library. After a thorough review, randomized controlled trials (RCTs) comparing the outcome of KTx using alemtuzumab induction therapy (test group) with a control group were collected according to the inclusion criteria. Data of general characteristic of studies and major outcomes of Ktx were extracted and meta-analyses were performed with RevMan 4.2 software. The odds ratio (OR) with a 95% confidence intervals (CI) was the principle measurement of effect.
  
  
  RESULTS
  Five RCTs were included. The chi square test showed no significant between-study heterogeneity, thus fixed effect model was employed. Sub-group analysis with studies including alemtuzumab induction followed by a tacrolimus-based immunosuppressive regimen showed that the acute rejection rate (ARR) was lower relative to the control (OR = 0.59, 95% CI 0.34 - 1.01, P = 0.05). However, meta-analysis with all included studies revealed that neither ARR nor patient/graft survival rates differ significantly between the test and the control group, but the cytomegalovirus (CMV) infection rate was higher in the test group (OR 2.50, 95% CI 1.22 - 5.12, P = 0.01). A great number of the test group recipients safely remained on a regimen that was steroid-free and with a reduced dose of conventional immunosuppressive drugs.
  
  
  CONCLUSIONS
  Alemtuzumab induction therapy for KTx was an effective and safe protocol in the tested follow-up period. Steroid avoidance and a dose reduction of conventional immunosuppressive drugs after alemtuzumab induction therapy may have clinical importance. However, high quality RCTs with larger population and longer follow-up are needed for a more accurate and objective appraisal of this novel protocol.
authors.affiliation: Kidney Diseases Center, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. zfshou@zju.edu.cn
authors.forename: Zhang-fei
authors.initials: ZF
authors.lastname: Shou
authors.forename: Qin
authors.initials: Q
authors.lastname: Zhou
authors.forename: Jie-ru
authors.initials: JR
authors.lastname: Cai
authors.forename: Jun
authors.initials: J
authors.lastname: Cheng
authors.forename: Qiang
authors.initials: Q
authors.lastname: He
authors.forename: Jian-yong
authors.initials: JY
authors.lastname: Wu
authors.forename: Jiang-hua
authors.initials: JH
authors.lastname: Chen
mesh_terms: D000074323:Alemtuzumab; D000911:Antibodies, Monoclonal / Q000494:pharmacology / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm / Q000494:pharmacology / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D006084:Graft Rejection / Q000517:prevention & control; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000191:economics / Q000276:immunology / Q000379:methods*; D016032:Randomized Controlled Trials as Topic; D015996:Survival Rate
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm; D007166:Immunosuppressive Agents; D000074323:Alemtuzumab