A Randomized Controlled Trial Of Two Different Dosing Regiments Of Azathioprine In The Treatment Of Active Cohn’s Disease

ObjectiveTo compare the efficacy and safty of different dosing of azathioprine(AZA) in long term treatment of patients with active Crohn’s disease(CD) in China through a randomised controlled trial.MethodsFrom2012to2014, fifty patients with active CD who need to be treated with systemic steroids were recruited. The patients were randomised divided into two arms:1mg/kg/d AZA vs.2mg/k:g/d AZA (n=25per arm). All patients initially received AZA combined with steroids therapy and AZA was maintained for treatment after withdrawal of steroids. Clinical efficacy and adverse events were assessed at the end of the12th,24th,48th weeks.ResultsAnalysis was done by ’Intention To Treat’(ITT) and ’Per-Protocol’(PP).The complete remission (CR) rates and the response rates (RR complete remission rates plus partial remission rates) at week12in1mg/kg/d arm and2mg/kg/d arm were proved to be with no significant difference,(CR n=4vs.5,ITT: P=0.941,PP:P=1.000; RR n=18vs.20ITT:P=0.242,PP:P=0.920). At week24the the complete remission rates was different(CR n=6vs.14,ITT:P=0.011, PP:P=0.027;RR n=llvs.17,ITT:P=0.042,PP:P=0.112).The Clinical efficacy became statistically significant at week48(CR n=3vs.11,ITT:P=0.007,PP:P=0.010; RR n=4vs.13,ITT:P=0.004,PP:P=0.005).In lmg/kg/d arm four Patients(16%) had adverse events,one of whom had pancreatitis,one had arthritis,two had leukopenia. While in2mg/kg/d arm five Patients(20%) had adverse events,four of whom had leukopenia,one had arthritis. There were no differences in the rate of adverse events between the treatment groups (P>0.05)ConcisionAZA at the dose of2mg/kg/day is more effective compared to lmg dosing in active Crohn’s disease in long-run, without impaired safety.