2019
Safety, pharmacokinetics, and pharmacodynamic activity of obinutuzumab, a type 2 anti-CD20 monoclonal antibody for the desensitization of candidates for renal transplant
Redfield RR, Jordan SC, Busque S, Vincenti F, Woodle ES, Desai N, Reed EF, Tremblay S, Zachary AA, Vo AA, Formica R, Schindler T, Tran H, Looney C, Jamois C, Green C, Morimoto A, Rajwanshi R, Schroeder A, Cascino MD, Brunetta P, Borie D. Safety, pharmacokinetics, and pharmacodynamic activity of obinutuzumab, a type 2 anti-CD20 monoclonal antibody for the desensitization of candidates for renal transplant. American Journal Of Transplantation 2019, 19: 3035-3045. PMID: 31257724, PMCID: PMC6899639, DOI: 10.1111/ajt.15514.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAntibodies, Monoclonal, HumanizedAntigens, CD20Antineoplastic Agents, ImmunologicalCohort StudiesDesensitization, ImmunologicFemaleFollow-Up StudiesGraft SurvivalHLA AntigensHumansKidney Failure, ChronicKidney TransplantationMaleMaximum Tolerated DoseMiddle AgedPatient SelectionPrognosisRisk FactorsTissue DistributionYoung AdultConceptsB-cell depletionSerious adverse eventsIntravenous immunoglobulinCell depletionAdverse eventsOpen-label phase 1b studyType 2Doses of IVIGIncomplete B cell depletionPanel reactive antibody scorePeripheral B-cell depletionEnd-stage renal diseasePhase 1b studyAnti-HLA antibodiesRetroperitoneal lymph nodesSingle antigen beadsTime of transplantCD20 monoclonal antibodyMedian followRenal transplantKidney transplantMost patientsWeek 24Lymph nodesRenal disease
2016
Belatacept and Eculizumab for Treatment of Calcineurin Inhibitor-induced Thrombotic Microangiopathy After Kidney Transplantation: Case Report
Merola J, Yoo PS, Schaub J, Smith JD, Rodriguez-Davalos MI, Tichy E, Mulligan DC, Asch W, Formica R, Kashgarian M, Kulkarni S. Belatacept and Eculizumab for Treatment of Calcineurin Inhibitor-induced Thrombotic Microangiopathy After Kidney Transplantation: Case Report. Transplantation Proceedings 2016, 48: 3106-3108. PMID: 27932157, DOI: 10.1016/j.transproceed.2016.04.005.Peer-Reviewed Original ResearchConceptsCalcineurin inhibitorsHemolytic uremic syndromeThrombotic microangiopathyKidney transplantationUremic syndromeMinimization of CNIsAtypical hemolytic uremic syndromeWithdrawal of tacrolimusEarly graft lossFavorable clinical courseGraft dysfunctionGraft lossImmunosuppression strategiesUsual therapyClinical courseCase reportCTLA-4Endothelial reactionFrequent causeChallenging causeUncontrolled activationMonoclonal antibodiesCellular destructionMicroangiopathyComponent C5Eculizumab Therapy for Chronic Antibody‐Mediated Injury in Kidney Transplant Recipients: A Pilot Randomized Controlled Trial
Kulkarni S, Kirkiles‐Smith N, Deng YH, Formica RN, Moeckel G, Broecker V, Bow L, Tomlin R, Pober JS. Eculizumab Therapy for Chronic Antibody‐Mediated Injury in Kidney Transplant Recipients: A Pilot Randomized Controlled Trial. American Journal Of Transplantation 2016, 17: 682-691. PMID: 27501352, DOI: 10.1111/ajt.14001.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAntibodies, Monoclonal, HumanizedChronic DiseaseComplement C5Complement Inactivating AgentsEarly Intervention, EducationalFemaleFollow-Up StudiesGlomerular Filtration RateGraft RejectionGraft SurvivalHumansIsoantibodiesKidney Failure, ChronicKidney Function TestsKidney TransplantationLiving DonorsMaleMiddle AgedPilot ProjectsPrognosisRisk FactorsTissue DonorsTransplant RecipientsYoung AdultConceptsDe novo donor-specific antibodiesComplement inhibitionTreatment groupsNovo donor-specific antibodiesAntibody-Mediated InjuryC1q-positive patientsDonor-specific antibodiesKidney transplant recipientsPrimary end pointEndothelial cell injuryMo of observationEculizumab therapyEculizumab treatmentHumoral injuryTransplant recipientsKidney transplantRenal functionKidney functionChronic settingEGFR trajectoriesTreatment periodCell injuryPatientsEnd pointPercentage change