OBJECTIVETo systematically evaluate the safety and efficacy of natalizumab in treating multiple sclerosis (MS) and Crohn's disease(CD).

METHODSLiteratures from 1998 to 2009 were searched in databases including MEDLINE,EMBASE,The Cochrane Library, and CBM for randomized controlled trials (RCTs) and quasi-randomization controlled trials. Quality assessment and data extraction were conducted using the Cochrane Collaboration's RevMan 5.0 software and then a Meta analysis was performed. The main indicators included the rate of adverse reactions, the rate of serious adverse reactions,response rate,and remission rate.

RESULTSThirteen trials entered the final analysis. The main findings in the MS trials included: the rate of serious and general adverse effects were no significantly different among different groups (P>0.05). The new lesions rate was not significantly different within 3 months after treatment [RR=0.99, 95%CI (0.82, 1.18), P=0.87], but was significantly lower in 6 months in the treatment group [RR=0.45, 95%CI (0.33, 0.60), P<0.00001], and such advantage was maintained till 2 years later [RR=0.49, 95%CI (0.45, 0.53), P<0.00001]. The 2-year relapse rate was also significantly lower in the treatment group [RR=0.51, 95%CI (0.38, 0.69), P<0.0001]. The main findings in CD trials were as follows: The incidences between serious reactions and general adverse reactions were not significantly different (P>0.05). The remission rate was not significantly different between treatment group and control group in the 2nd week [RR=4.67, 95%CI (0.65, 33.26), P=0.12], but became significantly higher in the treatment group after 12 weeks [RR=1.46, 95%CI (1.26, 1.70), P<0.00001]. The response rate was significantly higher in the treatment group [RR=1.53, 95%CI (1.15, 2.03), P=0.004].

CONCLUSIONSThe rates of serious and general adverse reactions are not remarkably increased after natalizumab treatment for both MS and CD. The new lesions rate and 2-year relapse rate of MS as well as the response rate and remission rate of CD are all improved after natalizumab treatment,especially after long-term administration. Although severe adverse effect such as progressive multifocal leukoencephalopathy may occur,its clinical application can be further promoted after cautiously balancing the benefits and risks.