500mg Of Rituximab For The Treatment Of ITP:a Prospective,One-arm,Single-center Clinical Study

ObjectiveTo investigate the clinical efficacy and safety of 500mg of rituximab administrated in patients with immune thrombocytopenia.Materials and MethodsCase selection:We collected cases of ITP patients who were given rituximab in Qilu hospital during January 2010 to August 2016.Then we finally selected out 71 patients according to the inclusion criteria.MethodsPatients with ITP were administrated with 500mg of rituximab,then followed by intravenous immunoglobulin of 5 to 10 grams per month for 6 to 8 months.Necessary information about the ITP patients before and during 6 months after the therapy was recorded in detail.Observe and evaluate the efficacy and safety of this treatment,moreover,analyze the correlation between efficacy and various suspicious factors,respectively,such as age,gender,BSA,staging of ITP.Assessing outcomes complete response(CR),response(R),no response(NR),loss of CR or R,time to response(TTR),adverse reaction and response duration.Statistical methods The analysis was performed using SPSS software version 23.Measurement data according with normal distribution were expressed as mean±standard deviation(x ± s),analyzed by t test,or expressed as median,analyzed by nonparametric test.While the categorical data were analyzed by ?2 test,P values below 0.05 were considered statistically significant.Response duration and relapse-free survival fraction were described using the Kaplan-Meier approach.Comparisons between survival distributions were performed using log-rank test.Predictor variables for R and CR were analyzed using logistic regression.ResultsEfficacy The CR rate of 71 ITP patients was 38.03%(27/71),and overall response rate was 67.61%(48/71).The median time of observation was 17.1 months(range 6.8-91.7 months).At the end of observation,10 patients relapsed.Therefore,CR was achieved in 53.52%(38/71),and response patients free-relapsed survival rate was 79.17%(38/48).In patients having achieved CR or R,the median TTR was 27.5 days(16-80 days).Differences were observed in terms of response duration between duration of the disease before rituximab administration<12 months vs.?12 months.Safety Adverse events were observed in 15 patients,among which there were 4 patients with infusion reaction,4 patients with gastrointestinal discomfort,2 patients with arthralgia,2 patients with fatigue and 1 patient with angioedema.Neither severe adverse reaction was observed,nor alteration or termination of treatment occurred due to adverse reaction of RTX.Conclusion1.500mg of rituximab administrated in patients with ITP was safe and effective.2.There was no correlation between efficacy and various suspicious factors,such as age,gender,BSA,weight,previous therapies,blood pressure.However,only staging of ITP did affect the efficacy of this regimen,in other wards,the earlier the patients accept this treatment,the better efficacy they may achieve from it.Besides,it also affected the response duration and CR.3.Different BSA value didn't affect the efficacy of this therapy.Therefore,fixed low-dose RTX can be administrated to various patients without consideration of individual differences.4.There was no difference between single-dose and multi-dose therapies,furthermore,the economy and practical appliance of single-dose were prominent.