2023
Cost-Effectiveness of Sutimlimab Versus Standard-of-Care in Transfusion Dependent Patients with Primary Cold Agglutinin Disease in the United States
Ito S, Wang D, Purcell A, Chetlapalli K, Lee A, Cuker A, Goshua G. Cost-Effectiveness of Sutimlimab Versus Standard-of-Care in Transfusion Dependent Patients with Primary Cold Agglutinin Disease in the United States. Blood 2023, 142: 2316. DOI: 10.1182/blood-2023-187270.Peer-Reviewed Original ResearchPrimary cold agglutinin diseaseCold agglutinin diseaseIncremental cost-effectiveness ratioTransfusion-dependent patientsIncremental net monetary benefitProbabilistic sensitivity analysesDistributional cost-effectiveness analysisAnemia severityBody weightPhase 3 clinical studiesHealth resource utilizationRed blood cell destructionDisease-specific mortalityHistory of transfusionAutoimmune hemolytic anemiaMarkov state transition modelCare of patientsHumanized monoclonal antibodyLower body weightBlood cell destructionCost-effectiveness ratioFDA package insertsCold-reactive antibodiesBase-case analysisCost-effectiveness analysis
2020
Trends in FDA cancer registration trial design over time, 1969-2020.
Warner J, Sethi T, Rivera D, Venepalli N, Osterman T, Khaki A, Rubinstein S. Trends in FDA cancer registration trial design over time, 1969-2020. Journal Of Clinical Oncology 2020, 38: 2060-2060. DOI: 10.1200/jco.2020.38.15_suppl.2060.Peer-Reviewed Original ResearchTrial designFDA approvalImmunotherapy trialsRegistration trialsCommon trial designOverall survival endpointOncology drug approvalsClass switchFDA package insertsCancer drug indicationsStudy drugCytotoxic therapyControl armTherapeutic approachesPackage insertsRCTsRCT designIndication approvalsOncology drugsLog-linear regressionSurvival endpointsTherapyTrialsDrug approvalNew drugs
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