Efficacy and Safety of Biosimilar Peg-filgrastim After Autologous Stem Cell Transplant in Myeloma and Lymphoma Patients: a Comparative Study with Biosimilar Filgrastim, Lenograstim, and Originator Peg-filgrastim

Overview

Journal Ann Hematol

Specialty Hematology

Date 2024 Jan 8

PMID 38189833

Authors

Francesco Marchesi

Irene Terrenato

Elena Papa

Martina Tomassi

Paolo Falcucci

Svitlana Gumenyuk

Francesca Palombi

Francesco Pisani

Daniela Renzi

Atelda Romano

Antonio Spadea

Giulia Regazzo

Maria Giulia Rizzo

Mafalda De Rienzo

Claudio Ripellino

Simona Sgromo

Caterina Viggiani

Eleonora Ponte

Ramy Kayal

Iole Cordone

Maria Laura Foddai

Andrea Mengarelli

Affiliations

Soon will be listed here.

Abstract

Data about biosimilar Peg-filgrastim (bioPEG) in autologous stem cell transplant (ASCT) are still scarce. The aim of this study has been to assess efficacy and safety of bioPEG among lymphoma and myeloma patients undergoing ASCT, comparing these data with historical controls receiving other G-CSFs. Furthermore, an economic evaluation has been included to estimate the savings by using bioPEG. This is a prospective cohort study comparing lymphoma and myeloma patients undergoing ASCT and receiving bioPEG (n = 73) with three historical consecutive cohorts collected retrospectively who received other G-CSFs (Lenograstim - Leno - n = 101, biosimilar Filgrastim - bioFIL n = 392, and originator Peg-filgrastim - oriPEG n = 60). We observed a significantly shorter time to neutrophils and platelet engraftment (p < 0.001) in patients treated with bioPEG and oriPEG. Moreover, patients who received bioPEG showed a shorter hospitalization time (p < 0.001) and a lower transfusion need (p < 0.001). We did not observe any significant difference in terms of transplant-related mortality, mucositis, and diarrhea among the four groups. No serious adverse events were associated with bioPEG. Similar data were obtained after running a stratified analysis for lymphomas and myeloma separately conducted by using a propensity score matching. The average total cost per patient of bioPEG was € 18218.9 compared to € 23707.8, € 20677.3 and € 19754.9 of Leno, oriPEG, and bioFIL, respectively. In conclusion, bioPEG seems to be as effective as the originator and more effective than short-acting G-CSFs in terms of post-transplant engraftment in myeloma and lymphoma patients undergoing ASCT. Moreover, bioPEG was cost-effective when compared with the other G-CSFs.

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