Treatment of active lupus nephritis with the novel immunosuppressant 15-deoxyspergualin an open-label dose escalation study 英文参考文献.docVIP

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Treatment of active lupus nephritis with the novel immunosuppressant 15-deoxyspergualin an open-label dose escalation study 英文参考文献.doc

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Treatment of active lupus nephritis with the novel immunosuppressant 15-deoxyspergualin an open-label dose escalation study 英文参考文献

Lorenzetal.ArthritisResearchTherapy2011,13:R36 /content/13/2/R36 RESEARCH ARTICLE OpenAccess Treatmentofactivelupusnephritiswiththe novelimmunosuppressant15-deoxyspergualin: anopen-labeldoseescalationstudy Hanns-MartinLorenz1*,WilhelmHSchmitt2,VladimirTesar3,UlfMüller-Ladner4,IngoTarner4,IngeborgAHauser5, FalkHiepe6,TobiasAlexander6,HeikeWoehling7,KyuichiNemoto8andPeterAHeinzel8 Abstract Introduction:Astheimmunosuppressivepotencyof15-deoxyspergualin(DSG)hasbeenshowninthetherapyof renaltransplantrejectionandWegener’sgranulomatosis,theintentionofthisstudywastoevaluatethesafetyof DSGinthetherapyoflupusnephritis(LN). Methods:PatientswithhistologicallyprovenactiveLNafterpriortreatmentwithatleastoneimmunosuppressant weretreatedwith0.5mg/kgnormalbodyweight/dayDSG,injectedsubcutaneouslyfor14days,followedbya breakofoneweek.Thesecycleswererepeatedtoamaximumofninetimes.Dosesoforalcorticosteroidswere graduallyreducedto7.5mg/dayorlowerbycycle4.Responsewasmeasuredaccordingtoapredefineddecision pattern.ThedoseofDSGwasadjusteddependingontheefficacyandsideeffects. Results:Atotalof21patientswereincludedinthisphase-I/IIstudy.AfterthefirstDSGinjection,onepatientwas excludedfromthestudyduetorenalfailure.Fivepatientsdroppedoutduetoadverseeventsorseriousadverse eventsincludingfever,leukopenia,oralcandidiasis,herpeszosterorpneumonia.Elevenoutof20patientsachieved partial(4)orcompleteresponses(7),8werejudgedastreatmentfailuresand1patientwasnotassessable.Twelve patientscompletedallninecycles;inthosepatients,proteinuriadecreasedfrom5.88g/dayto3.37g/day(P= 0.028),Selena-SLEDAI(SafetyofEstrogensinLupusErythematosus-NationalAssessment-systemiclupus erythematosusdiseaseactivityindex)decreasedfrom17.6to11.7.In13outof20patients,proteinuriadecreased byatleast50%;in7patientstolessthan1g/day. Conclusions:Althoughthenumberofpatientswassmall,wecoulddemonstratethatDSGprovidesatolerably safetreatmentforLN.Theimprovementinproteinuriaencourageslargercontrolledtrials. Trialregistration:ClinicalT:NCT0070972