Comparison of biosimilar filgrastim with originator filgrastim for peripheral blood stem cell mobilization and engraftment in patients with multiple myeloma undergoing autologous stem cell transplantation

Tina Pham, Sushrut Patil, Shaun Alan Fleming, Sharon Avery, Patricia A Walker, Andrew Wei, David John Curtis, Georgia Stuart, Daniela Klarica, Maureen O'Brien, Karen Morris, Tongted Phumoonna Das, Geraldine M Bollard, Jennifer Muirhead, John Coutsouvelis, Andrew Spencer

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Nivestim is a biosimilar approved for the same indications as Neupogen including the mobilization of autologous peripheral blood stem cells (PBSCs). The clinical efficacy and safety of Nivestim for this use have not been formally assessed in clinical trials. STUDY DESIGN AND METHODS In our retrospective single-center study we compared variables of PBSC mobilization and engraftment of 60 patients mobilized with Nivestim to that of 38 patients mobilized with Neupogen. RESULTS We found no difference between Nivestim and Neupogen in peripheral blood CD34+ at first leukapheresis (47 ? 106 cells/L vs. 60 ? 106 cells/L, p = 0.48) nor the total CD34+ collected (5.37 ? 106/kg vs. 4.59 ? 106/kg, p = 0.22). However, a difference in the median number of leukapheresis procedures (one vs. Two, p = 0.0007) was observed. Eighty-one patients (51 Nivestim and 30 Neupogen mobilized) went on to transplantation. Median time to neutrophil engraftment (15 days vs. 13.5 days, p = 0.09) and platelet (PLT) engraftment (20 days vs. 18 days, p = 0.01) was longer in the Nivestim group. The significant delay in PLT engraftment did not, however, translate to increased PLT transfusions (two vs. Three, p = 0.2) or impact significantly on hospitalization time for admissions within 30 days posttransplant (20 days vs. 18 days, p = 0.17). CONCLUSION Nivestim is as effective as Neupogen for PBSC mobilization; however, its use was associated with a delay in PLT recovery. A prospective study should be conducted to confirm our findings.
Original languageEnglish
Pages (from-to)2709 - 2713
Number of pages5
JournalTransfusion
Volume55
Issue number11
DOIs
Publication statusPublished - 2015

Cite this

Pham, Tina ; Patil, Sushrut ; Fleming, Shaun Alan ; Avery, Sharon ; Walker, Patricia A ; Wei, Andrew ; Curtis, David John ; Stuart, Georgia ; Klarica, Daniela ; O'Brien, Maureen ; Morris, Karen ; Das, Tongted Phumoonna ; Bollard, Geraldine M ; Muirhead, Jennifer ; Coutsouvelis, John ; Spencer, Andrew. / Comparison of biosimilar filgrastim with originator filgrastim for peripheral blood stem cell mobilization and engraftment in patients with multiple myeloma undergoing autologous stem cell transplantation. In: Transfusion. 2015 ; Vol. 55, No. 11. pp. 2709 - 2713.
@article{a22863260c6543edaeeb6438be84a209,
title = "Comparison of biosimilar filgrastim with originator filgrastim for peripheral blood stem cell mobilization and engraftment in patients with multiple myeloma undergoing autologous stem cell transplantation",
abstract = "Nivestim is a biosimilar approved for the same indications as Neupogen including the mobilization of autologous peripheral blood stem cells (PBSCs). The clinical efficacy and safety of Nivestim for this use have not been formally assessed in clinical trials. STUDY DESIGN AND METHODS In our retrospective single-center study we compared variables of PBSC mobilization and engraftment of 60 patients mobilized with Nivestim to that of 38 patients mobilized with Neupogen. RESULTS We found no difference between Nivestim and Neupogen in peripheral blood CD34+ at first leukapheresis (47 ? 106 cells/L vs. 60 ? 106 cells/L, p = 0.48) nor the total CD34+ collected (5.37 ? 106/kg vs. 4.59 ? 106/kg, p = 0.22). However, a difference in the median number of leukapheresis procedures (one vs. Two, p = 0.0007) was observed. Eighty-one patients (51 Nivestim and 30 Neupogen mobilized) went on to transplantation. Median time to neutrophil engraftment (15 days vs. 13.5 days, p = 0.09) and platelet (PLT) engraftment (20 days vs. 18 days, p = 0.01) was longer in the Nivestim group. The significant delay in PLT engraftment did not, however, translate to increased PLT transfusions (two vs. Three, p = 0.2) or impact significantly on hospitalization time for admissions within 30 days posttransplant (20 days vs. 18 days, p = 0.17). CONCLUSION Nivestim is as effective as Neupogen for PBSC mobilization; however, its use was associated with a delay in PLT recovery. A prospective study should be conducted to confirm our findings.",
author = "Tina Pham and Sushrut Patil and Fleming, {Shaun Alan} and Sharon Avery and Walker, {Patricia A} and Andrew Wei and Curtis, {David John} and Georgia Stuart and Daniela Klarica and Maureen O'Brien and Karen Morris and Das, {Tongted Phumoonna} and Bollard, {Geraldine M} and Jennifer Muirhead and John Coutsouvelis and Andrew Spencer",
year = "2015",
doi = "10.1111/trf.13233",
language = "English",
volume = "55",
pages = "2709 -- 2713",
journal = "Transfusion",
issn = "0041-1132",
publisher = "Wiley-Blackwell",
number = "11",

}

Comparison of biosimilar filgrastim with originator filgrastim for peripheral blood stem cell mobilization and engraftment in patients with multiple myeloma undergoing autologous stem cell transplantation. / Pham, Tina; Patil, Sushrut; Fleming, Shaun Alan; Avery, Sharon; Walker, Patricia A; Wei, Andrew; Curtis, David John; Stuart, Georgia; Klarica, Daniela; O'Brien, Maureen; Morris, Karen; Das, Tongted Phumoonna; Bollard, Geraldine M; Muirhead, Jennifer; Coutsouvelis, John; Spencer, Andrew.

In: Transfusion, Vol. 55, No. 11, 2015, p. 2709 - 2713.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Comparison of biosimilar filgrastim with originator filgrastim for peripheral blood stem cell mobilization and engraftment in patients with multiple myeloma undergoing autologous stem cell transplantation

AU - Pham, Tina

AU - Patil, Sushrut

AU - Fleming, Shaun Alan

AU - Avery, Sharon

AU - Walker, Patricia A

AU - Wei, Andrew

AU - Curtis, David John

AU - Stuart, Georgia

AU - Klarica, Daniela

AU - O'Brien, Maureen

AU - Morris, Karen

AU - Das, Tongted Phumoonna

AU - Bollard, Geraldine M

AU - Muirhead, Jennifer

AU - Coutsouvelis, John

AU - Spencer, Andrew

PY - 2015

Y1 - 2015

N2 - Nivestim is a biosimilar approved for the same indications as Neupogen including the mobilization of autologous peripheral blood stem cells (PBSCs). The clinical efficacy and safety of Nivestim for this use have not been formally assessed in clinical trials. STUDY DESIGN AND METHODS In our retrospective single-center study we compared variables of PBSC mobilization and engraftment of 60 patients mobilized with Nivestim to that of 38 patients mobilized with Neupogen. RESULTS We found no difference between Nivestim and Neupogen in peripheral blood CD34+ at first leukapheresis (47 ? 106 cells/L vs. 60 ? 106 cells/L, p = 0.48) nor the total CD34+ collected (5.37 ? 106/kg vs. 4.59 ? 106/kg, p = 0.22). However, a difference in the median number of leukapheresis procedures (one vs. Two, p = 0.0007) was observed. Eighty-one patients (51 Nivestim and 30 Neupogen mobilized) went on to transplantation. Median time to neutrophil engraftment (15 days vs. 13.5 days, p = 0.09) and platelet (PLT) engraftment (20 days vs. 18 days, p = 0.01) was longer in the Nivestim group. The significant delay in PLT engraftment did not, however, translate to increased PLT transfusions (two vs. Three, p = 0.2) or impact significantly on hospitalization time for admissions within 30 days posttransplant (20 days vs. 18 days, p = 0.17). CONCLUSION Nivestim is as effective as Neupogen for PBSC mobilization; however, its use was associated with a delay in PLT recovery. A prospective study should be conducted to confirm our findings.

AB - Nivestim is a biosimilar approved for the same indications as Neupogen including the mobilization of autologous peripheral blood stem cells (PBSCs). The clinical efficacy and safety of Nivestim for this use have not been formally assessed in clinical trials. STUDY DESIGN AND METHODS In our retrospective single-center study we compared variables of PBSC mobilization and engraftment of 60 patients mobilized with Nivestim to that of 38 patients mobilized with Neupogen. RESULTS We found no difference between Nivestim and Neupogen in peripheral blood CD34+ at first leukapheresis (47 ? 106 cells/L vs. 60 ? 106 cells/L, p = 0.48) nor the total CD34+ collected (5.37 ? 106/kg vs. 4.59 ? 106/kg, p = 0.22). However, a difference in the median number of leukapheresis procedures (one vs. Two, p = 0.0007) was observed. Eighty-one patients (51 Nivestim and 30 Neupogen mobilized) went on to transplantation. Median time to neutrophil engraftment (15 days vs. 13.5 days, p = 0.09) and platelet (PLT) engraftment (20 days vs. 18 days, p = 0.01) was longer in the Nivestim group. The significant delay in PLT engraftment did not, however, translate to increased PLT transfusions (two vs. Three, p = 0.2) or impact significantly on hospitalization time for admissions within 30 days posttransplant (20 days vs. 18 days, p = 0.17). CONCLUSION Nivestim is as effective as Neupogen for PBSC mobilization; however, its use was associated with a delay in PLT recovery. A prospective study should be conducted to confirm our findings.

UR - http://onlinelibrary.wiley.com/doi/10.1111/trf.13233/epdf

U2 - 10.1111/trf.13233

DO - 10.1111/trf.13233

M3 - Article

VL - 55

SP - 2709

EP - 2713

JO - Transfusion

JF - Transfusion

SN - 0041-1132

IS - 11

ER -