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.
Autologous stem cell transplant
Biosimilars
Granulocyte colony-stimulating factors
Lymphoma
Myeloma
Peg-filgrastim
Journal
Annals of hematology
ISSN: 1432-0584
Titre abrégé: Ann Hematol
Pays: Germany
ID NLM: 9107334
Informations de publication
Date de publication:
08 Jan 2024
08 Jan 2024
Historique:
received:
17
11
2023
accepted:
21
12
2023
medline:
8
1
2024
pubmed:
8
1
2024
entrez:
8
1
2024
Statut:
aheadofprint
Résumé
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.
Identifiants
pubmed: 38189833
doi: 10.1007/s00277-023-05604-9
pii: 10.1007/s00277-023-05604-9
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024. The Author(s).
Références
Auletta JJ, Kou J, Chen M, Shaw BE (2021) Current use and outcome of hematopoietic stem cell transplantation: CIBMTR US summary slides. https://www.cibmtr.org/ReferenceCenter/SlidesReports/SummarySlides/pages/index.aspx . Assessed Aug 31 2023
Snowden JA, Sánchez-Ortega I, Corbacioglu S et al (2022) Indications for haematopoietic cell transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe, 2022. Bone Marrow Transplant 57:1217–1239
doi: 10.1038/s41409-022-01691-w
pubmed: 35589997
pmcid: 9119216
Bhatt VR, Loberiza FR Jr, Jing H et al (2015) Mortality patterns among recipients of autologous hematopoietic stem cell transplantation for lymphoma and myeloma in the past three decades. Clin Lymphoma Myeloma Leuk 15:409-415.e1
doi: 10.1016/j.clml.2015.02.024
pubmed: 25816932
Lalami Y, Klastersky J (2017) Impact of chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN) on cancer treatment outcomes: an overview about well-established and recently emerging clinical data. Crit Rev Oncol Hematol 120:163–179
doi: 10.1016/j.critrevonc.2017.11.005
pubmed: 29198330
Marchesi F, Mengarelli A (2016) Biosimilar filgrastim in autologous peripheral blood hematopoietic stem cell mobilization and post-transplant hematologic recovery. Curr Med Chem 23:2217–2229
doi: 10.2174/0929867323666160517115907
pubmed: 27183986
Weise M, Bielsky MC, De Smet K et al (2012) Biosimilars: what clinicians should know. Blood 120:5111–5117
doi: 10.1182/blood-2012-04-425744
pubmed: 23093622
McCamish M, Woollett G (2012) The state of art in the development of biosimilars. Clin Pharmacol Ther 91:405–417
doi: 10.1038/clpt.2011.343
U.S. Food and Drug Administration (2017) Biosimilar and interchangeable products. https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products
Heredia E, Ribeiro A (2018) Discount offered by first and subsequent biosimilars in the US, EU and LATAM: impact trends of originator starting price, market dynamics and regulations. Value Health 21(Suppl. 1):S103–S104
doi: 10.1016/j.jval.2018.04.700
Dutta B, Huys I, Vulto AG et al (2020) Identifying key benefits in European off-patent biologics and biosimilar markets: it is not only about price! BioDrugs 34:159–170
doi: 10.1007/s40259-019-00395-w
pubmed: 31792843
Martino M, Gori M, Porto G et al (2023) Effectiveness of biosimilar pegfilgrastim in patients with multiple myeloma after high-dose melphalan and autologous stem cell transplantation. Ann Hematol 102:1915–1925
doi: 10.1007/s00277-023-05228-z
pubmed: 37079070
pmcid: 10281896
Averbuch D, Orasch C, Cordonnier C et al (2013) ECIL4, a joint venture of EBMT, EORTC, ICHS, ESGICH/ESCMID and ELN. European guidelines for empirical antibacterial therapy for febrile neutropenic patients in the era of growing resistance: summary of the 2011 4th European conference on infections in leukemia. Haematologica 98:1826–1835
doi: 10.3324/haematol.2013.091025
pubmed: 24323983
pmcid: 3856957
Baden LR, Swaminathan S, Angarone M et al (2016) Prevention and treatment of cancer-related infections, version 2.2016, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw 14:882–913
doi: 10.6004/jnccn.2016.0093
pubmed: 27407129
Austin PC (2011) Comparing paired vs non-paired statistical methods of analyses when making inference about absolute risk reduction in propensity score matched samples. Stat Med 30:1292–1301
doi: 10.1002/sim.4200
pubmed: 21337595
pmcid: 3110307
Accordo interregionale per la compensazione della mobilità sanitaria (2020) Emocomponenti ad uso trasfusionale (1 unità), Italy, cod. 99758, 99766
Italia Ministero dell’Economia e delle Finanze; Commissione Tecnica per la Finanza Pubblica. Libro Verde Sulla Spesa Pubblica. Spendere Meglio: Alcune Prime Indicazioni; Ministero dell’Economia e delle Finanze (2007) Roma, Italy, pp 36–57.
Wannesson L, Luthi F, Zucca E et al (2011) Pegfilgrastim to accelerate neutrophil engraftment following peripheral blood stem cell transplant and reduce the duration of neutropenia, hospitalization, and use of intravenous antibiotics: a phase II study in multiple myeloma and lymphoma and comparison with filgrastim-treated matched controls. Leuk Lymphoma 52:436–443
doi: 10.3109/10428194.2010.545462
pubmed: 21323524
Marchesi F, Cerchiara E, Dessanti ML et al (2015) Comparison between biosimilar vs other granulocyte-colony stimulating factor formulations (originator filgrastim, peg-filgrastim and lenograstim) after autologous stem cell transplantation: a retrospective survey from the Rome Transplant Network. Br J Haematol 169:293–296
doi: 10.1111/bjh.13199
pubmed: 25371286
Vanstraelen G, Frere P, Ngirabacu MC et al (2006) Pegfilgrastim compared with filgrastim after autologous hematopoietic peripheral blood stem cell transplantation. Exp Hematol 34:382–388
doi: 10.1016/j.exphem.2005.11.013
pubmed: 16543072
Bellon A, Wang J, Skerjanec A et al (2020) A large multicenter, randomized, double-blind, cross-over study in healthy volunteers to compare pharmacokinetics, pharmacodynamics and safety of a pegfilgrastim biosimilar with its US- and EU-reference biologics. Br J Clin Pharmacol 86:1139–1149
doi: 10.1111/bcp.14226
pubmed: 32022282
pmcid: 7256126
Wang X, Ren J, Liang X, He P (2021) Efficacy and cost of G-CSF derivatives for prophylaxis of febrile neutropenia in lymphoma and multiple myeloma patients underwent autologous hematopoietic stem cell transplantation. Hematology 26:950–955
doi: 10.1080/16078454.2021.2003071
pubmed: 34904529
Allen RC (2002) Ex vivo half-life of neutrophils from healthy human subjects pre and post treatment with daily filgrastim or single-dose pegfilgrastim. Blood 100:A918
Molineux G (2004) The design and development of pegfilgrastim (PEG-rmetHuG-CSF, Neulasta). Curr Pharm Des 10:1235–1244
doi: 10.2174/1381612043452613
pubmed: 15078138
Yang BB, Kido A (2011) Pharmacokinetics and pharmacodynamics of pegfilgrastim. Clin Pharmacokinet 50:295–306
doi: 10.2165/11586040-000000000-00000
pubmed: 21456630
Hassan MN, Fauzi HM, Husin A et al (2019) Autologous peripheral blood stem cell transplantation among lymphoproliferative disease patients: factors influencing engraftment. Oman Med J 34:34–43
doi: 10.5001/omj.2019.06
pubmed: 30671182
pmcid: 6330180
Cooper KL, Madan J, Whyte S et al (2011) Granulocyte colony-stimulating factors for febrile neutropenia prophylaxis following chemotherapy: systematic review and meta-analysis. BMC Cancer 11:404
doi: 10.1186/1471-2407-11-404
pubmed: 21943360
pmcid: 3203098
Pfeil AM, Allcott K, Pettengell R et al (2015) Efficacy, effectiveness and safety of long-acting granulocyte colony-stimulating factors for prophylaxis of chemotherapy-induced neutropenia in patients with cancer: a systematic review. Sup Care Cancer 23:525–545
doi: 10.1007/s00520-014-2457-z
Castagna L, Bramanti S, Levis A et al (2010) Pegfilgrastim versus filgrastim after high-dose chemotherapy and autologous peripheral blood stem cell support. Ann Oncol 21:1482–1485
doi: 10.1093/annonc/mdp576
pubmed: 20007996
Marchesi F, Tendas A, Giannarelli D et al (2017) Cryotherapy reduces oral mucositis and febrile episodes in myeloma patients treated with high-dose melphalan and autologous stem cell transplant: a prospective, randomized study. Bone Marrow Transplant 52:154–156
doi: 10.1038/bmt.2016.207
pubmed: 27526285
Kvien TK, Patel K, Strand V (2022) The cost savings of biosimilars can help increase patient access and lift the financial burden of health care systems. Semin Arthritis Rheum 52:151939
doi: 10.1016/j.semarthrit.2021.11.009
pubmed: 35027243
Singh SC, Bagnato KM (2015) The economic implications of biosimilars. Am J Manag Care 21(16 Suppl):s331-340
pubmed: 26788809
Moorkens E, Broux H, Huys I et al (2020) Economic evaluation of biosimilars for reimbursement purposes - what, when, how? J Mark Access Health Policy 8:1739509
doi: 10.1080/20016689.2020.1739509
pubmed: 32284827
pmcid: 7144192
Gascón P, Tesch H, Verpoort K et al (2013) Clinical experience with Zarzio® in Europe: what have we learned? Support Care Cancer 21:2925–2932
doi: 10.1007/s00520-013-1911-7
pubmed: 23903799
pmcid: 3765845
Schwartzberg LS, Lal LS, Balu S et al (2018) Clinical outcomes of treatment with filgrastim versus a filgrastim biosimilar and febrile neutropenia-associated costs among patients with nonmyeloid cancer undergoing chemotherapy. J Manag Care Spec Pharm 24:976–984
pubmed: 29687743
Cornes P, Gascon P, Vulto AG et al (2020) Biosimilar pegfilgrastim: improving access and optimising practice to supportive care that enables cure. BioDrugs 34:255–263
doi: 10.1007/s40259-020-00411-4
pubmed: 32232676
pmcid: 7211191
Tilleul PR, Rodgers-Gray BS, Edwards JO (2021) Introduction of biosimilar pegfilgrastim in France: economic analysis of switching from originator. J Oncol Pharm Pract 27:1604–1615
doi: 10.1177/1078155220962208
pubmed: 33019875
Hübel K, Kron F, Lux MP (2020) Biosimilars in oncology: effects on economy and therapeutic innovations. Eur J Cancer 139:10–19
doi: 10.1016/j.ejca.2020.07.037
pubmed: 32950935
Cornes P, Kelton J, Liu R et al (2022) Real-world cost-effectiveness of primary prophylaxis with G-CSF biosimilars in patients at intermediate/high risk of febrile neutropenia. Future Oncol. https://doi.org/10.2217/fon-2022-0095
Blackwell K, Gascon P, Jones CM et al (2017) Pooled analysis of two randomized, double blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer. Ann Oncol 28:2272–2277
doi: 10.1093/annonc/mdx303
pubmed: 28637287
pmcid: 5834021