Table 2: THEME 3 (Outcomes) Summary of Investigator-Initiated Studies/Case Series for Filgrastim NHMRC NHMRC NHMRC Evidence Evidence Evidence Number of Assessment 3 Reference Indication(s) Comments on Outcomes Assessment Assessment Patients Level of 30 Evidence Applicability Filgrastim 39 Allogeneic Hematopoietic 48 total Similar yields of CD34+ stem III-3 B B (Tevagrastim) Stem Cell Mobilisation cells were mobilised in the (historic and Transplantation in Tevagrastim (10.2x106 ,range: controls) 24 Tevagrastim Patients with Acute 2.52 to 35.4) group and the 24 Neupogen Myelogenous filgrastim (9.35x106, range: 3.7 to 30.6) historical control group Syndromes Similar engraftment kinetics, hematopoietic reconstitution, and transplantation outcome were noted Donor side effects were mild, transient and not different groups Filgrastim 40 Post Autologous 110 total Biosimilar filgrastim following IV B B (Zarzio) Hematopoietic Stem Cell AHSCT is effective and transplant to facilitate generally well tolerated in the 70 post AHSCT engraftment engraftment setting Kinetics of PBSC mobilisation and yield of CD34+ cells were 40 PBSC Mobilisation of Peripheral comparable to the originator mobilisation trial blood stem cell (PBSC) in to AHSCT patients undergoing autologous stem cell transplantation (AHSCT)
Table 2: THEME 3 (Outcomes) Summary of Investigator-Initiated Studies/Case Series for Filgrastim Reference Indication(s) Number of Patients Comments on Outcomes NHMRC Evidence Assessment Level of Evidence NHMRC Evidence Assessment NHMRC Evidence Assessment 30 Applicability Filgrastim (Tevagrastim) 39 Allogeneic Hematopoietic Stem Cell Mobilisation and Transplantation in Patients with Acute Myelogenous Syndromes 48 total 24 Tevagrastim 24 Neupogen Similar yields of CD34+ stem cells were mobilised in the Tevagrastim (10.2x106 ,range: 2.52 to 35.4) group and the filgrastim (9.35x106, range: 3.7 to 30.6) historical control group Similar engraftment kinetics, hematopoietic reconstitution, and transplantation outcome were noted Donor side effects were mild, transient and not different groups III-3 (historic controls) B B Filgrastim (Zarzio) 40 Post Autologous Hematopoietic Stem Cell transplant to facilitate engraftment Mobilisation of Peripheral blood stem cell (PBSC) in patients undergoing autologous stem cell transplantation (AHSCT) 110 total 70 post AHSCT 40 PBSC mobilisation to AHSCT Biosimilar filgrastim following AHSCT is effective and generally well tolerated in the engraftment setting Kinetics of PBSC mobilisation and yield of CD34+ cells were comparable to the originator IV B B 3 trial
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