Статті в журналах: "Extended half-life"

1

Kontermann, Roland E. "Half-life extended biotherapeutics." Expert Opinion on Biological Therapy 16, no. 7 (April 18, 2016): 903–15. http://dx.doi.org/10.1517/14712598.2016.1165661.

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2

FUJII, Teruhisa. "Extended half life coagulation products for hemophilia." Japanese Journal of Thrombosis and Hemostasis 28, no. 4 (2017): 472–79. http://dx.doi.org/10.2491/jjsth.28.472.

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3

Padhi, Desmond, Liyun Ni, Blaire Cooke, Rafael Marino, and Graham Jang. "An Extended Terminal Half-Life for Darbepoetin Alfa." Clinical Pharmacokinetics 45, no. 5 (2006): 503–10. http://dx.doi.org/10.2165/00003088-200645050-00005.

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4

Morfini, Massimo. "A new, promising, extended half-life rFIX concentrate." Lancet Haematology 4, no. 2 (February 2017): e59-e60. http://dx.doi.org/10.1016/s2352-3026(17)30003-0.

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5

Nesspor, Thomas C., and Bernard Scallon. "Chimeric antibodies with extended half‐life in ferrets." Influenza and Other Respiratory Viruses 8, no. 5 (July 30, 2014): 596–604. http://dx.doi.org/10.1111/irv.12273.

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6

Croteau, S. E., and E. J. Neufeld. "Transition considerations for extended half-life factor products." Haemophilia 21, no. 3 (April 9, 2015): 285–88. http://dx.doi.org/10.1111/hae.12683.

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7

Graf, Lukas. "Extended Half-Life Factor VIII and Factor IX Preparations." Transfusion Medicine and Hemotherapy 45, no. 2 (2018): 86–91. http://dx.doi.org/10.1159/000488060.

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8

Kontermann, Roland E. "Strategies for extended serum half-life of protein therapeutics." Current Opinion in Biotechnology 22, no. 6 (December 2011): 868–76. http://dx.doi.org/10.1016/j.copbio.2011.06.012.

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9

Tortella, Bartholomew J., José Alvir, Margaret McDonald, Dean Spurden, Patrick F. Fogarty, Amit Chhabra, and Andreas M. Pleil. "Real-World Analysis of Dispensed IUs of Coagulation Factor IX and Resultant Expenditures in Hemophilia B Patients Receiving Standard Half-Life Versus Extended Half-Life Products and Those Switching from Standard Half-Life to Extended Half-Life Products." Journal of Managed Care & Specialty Pharmacy 24, no. 7 (July 2018): 643–53. http://dx.doi.org/10.18553/jmcp.2018.17212.

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10

GEHRING, R., R. E. BAYNES, A. L. CRAIGMILL, and J. E. RIVIERE. "Feasibility of Using Half-Life Multipliers To Estimate Extended Withdrawal Intervals following the Extralabel Use of Drugs in Food-Producing Animals." Journal of Food Protection 67, no. 3 (March 1, 2004): 555–60. http://dx.doi.org/10.4315/0362-028x-67.3.555.

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Under the Animal Medicinal Drug Use Clarification Act of 1994, veterinarians are legally allowed to use drugs in food-producing animals in an extralabel manner. This could potentially lead to violative residues in food of animal origin. It is therefore essential that an appropriately extended withdrawal interval be established. Ideally, these extended withdrawal intervals should be calculated on the basis of the tissue half-life of the drug in the target animal. However, these data are not readily available for all drugs of extralabel use in food-producing animals. For this reason, the use of a half-life multiplier has been proposed as a simple alternative method to estimate the effective tissue half-life of a drug. Extended withdrawal intervals, estimated using various half-life multipliers, were compared with the withdrawal intervals calculated using actual tissue half-lives. For the group of drugs investigated, a half-life multiplier of 5 resulted in estimates of extended withdrawal intervals that were potentially inadequate to prevent violative tissue residues for drugs that had relatively long tissue half-lives, high tolerances, or both. This is possibly because fewer half-lives are required for these drugs to reach the target tissue concentrations following administration at label doses. Use of a smaller half-life multiplier (in this case 3) is therefore suggested to ensure that extended withdrawal intervals are adequate to prevent violative tissue residues.

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11

Abraham, Jonathan. "Monoclonal Antibodies with Extended Half-Life to Prevent Covid-19." New England Journal of Medicine 386, no. 23 (June 9, 2022): 2236–38. http://dx.doi.org/10.1056/nejme2205563.

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12

Farchione, Louis A. "Comment: Extended Half-Life, Second-Generation Cephalosporins in Surgical Prophylaxis." Drug Intelligence & Clinical Pharmacy 19, no. 11 (November 1985): 842–43. http://dx.doi.org/10.1177/106002808501901115.

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13

Scalley, Robert D., and Clifford C. Stuart. "Is There Cost Reduction Potential for Extended Half-Life Cephalosporins?" Drug Intelligence & Clinical Pharmacy 20, no. 12 (December 1986): 975–80. http://dx.doi.org/10.1177/106002808602001213.

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Two new second-generation cephalosporin derivatives with extended half-lives, ceforanide and cefonicid, have recently entered the U.S. marketplace. Because longer dosing intervals require fewer daily doses, potential exists for overall cost reduction if pharmacy and nursing time can be effectively saved. Reduction in personnel costs, however, must be sufficient for these more expensive products to be truly cost effective. We studied the impact of substituting these newer agents for older, less expensive products with formulary status at our 200-bed community hospital. Results show that no nursing expenses could be recovered, and there is little chance of consistently reducing pharmacy compounding expenses. Within the constraints of these studies, particularly physician prescribing habits, the GRASP (Grace Reynolds Application and Study of PETO) system of determining nurse staffing, and our drug acquisition costs, we find that the newer extended half-life products have very limited usefulness and may only increase the cost of antibiotic utilization.

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14

Croteau, S. E., and E. J. Neufeld. "Author's response: ‘Transition considerations for extended half-life factor products’." Haemophilia 21, no. 5 (May 4, 2015): e454-e455. http://dx.doi.org/10.1111/hae.12718.

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15

Keepanasseril, A., J. Stoffman, V. Bouskill, M. Carcao, A. Iorio, and S. Jackson. "Switching to extended half-life products in Canada - preliminary data." Haemophilia 23, no. 4 (May 26, 2017): e365-e367. http://dx.doi.org/10.1111/hae.13245.

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16

Anchordoguy, T. J., G. E. Hofmann, and S. C. Hand. "Extension of enzyme half-life during quiescence in Artemia embryos." American Journal of Physiology-Regulatory, Integrative and Comparative Physiology 264, no. 1 (January 1, 1993): R85—R89. http://dx.doi.org/10.1152/ajpregu.1993.264.1.r85.

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Encysted gastrulae of Artemia franciscana are known to enter a reversible state of quiescence in which biosynthetic and catabolic pathways are markedly suppressed. Given that these embryos can survive months of anoxia, we investigated their ability to extend the half-life of cytochrome-c oxidase (COX), a key metabolic enzyme, during anoxia. We calculate that the half-life of COX is extended to 101 days under anoxia, an estimated 77-fold increase compared with aerobic values. During conditions of aerobic acidosis, the half-life of COX was extended sevenfold to a value of 9.7 days. We propose that the extended lifetimes of COX in both cases may be due to suppressed mitochondrial proteolysis under depressed pH. The shorter enzyme half-life observed under the latter condition may be due to the availability of ATP for degradative processes during aerobic acidosis. We also suggest that the presence of oxygen in aerobic acidosis may lead to increased rates of protein damage due to autooxidation.

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17

Versloot, Olav, Emma Iserman, Pierre Chelle, Federico Germini, Andrea N. Edginton, Roger E. G. Schutgens, Alfonso Iorio, and Kathelijn Fischer. "Predicting Individual Changes in Terminal Half-Life After Switching to Extended Half-Life Concentrates in Patients With Severe Hemophilia." HemaSphere 6, no. 4 (March 21, 2022): e694. http://dx.doi.org/10.1097/hs9.0000000000000694.

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18

Megías-Vericat, J. E., S. Bonanad Boix, R. Berrueco Moreno, M. E. Mingot-Castellano, M. Rodríguez López, M. Canaro Hirnyk, J. Mateo Arranz, et al. "Pharmacokinetic and clinical improvements after PK-guided switch from standard half-life to extended half-life factor VIII products." Thrombosis Research 216 (August 2022): 35–42. http://dx.doi.org/10.1016/j.thromres.2022.06.001.

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19

Megias, Juan Eduardo, Santiago Bonanad Boix, María Fernanda Martínez García, Rubén Berrueco, Maria Eva Mingot-Castellano, Manuel Rodríguez López, Mariana Canaro, et al. "Cross-Sectional Comparative Study of PK-Guided Switch between Standard Half-Life and Extended Half-Life Factor VIII Products." Blood 134, Supplement_1 (November 13, 2019): 2405. http://dx.doi.org/10.1182/blood-2019-127946.

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Background The high inter-individual variability in pharmacokinetics (PK) of factor VIII (FVIII) justifies the use of PK-guided prophylaxis, especially in switching between different products. A proposed definition of extended half-life (EHL) FVIII requires improvements of at least 1.3 times in half-life (t1/2) and 1.25 times the area under the curve (AUC) compared to standard half-life (SHL) products (Mahlangu et al. Haemophilia. 2018;24(3):348-358). The objective of this multicenter study was to analyze the results of a PK-guided switch from SHL to EHL in patients with hemophilia A (HA). Methods Multicenter comparative, cross-sectional, prospective study in HA severe/moderate patients in prophylaxis analyzing PK differences after switch from SHL to EHL (efmoroctocog alfa [rFVIII-Fc] and rurioctocog alfa pegol [PEG-rFVIII]). WAPPS-Hemo® was used to analyze PK parameters with 2-3 samples: t1/2; AUC, peak level (PL); trough level at 24, 48 and 72 h (TL24, TL48, TL72); and time to reach FVIII levels of 1, 2, 5% (T1%, T2%, T5%). We have also compared the ratio of t1/2 and AUC, the number of weekly doses and the dose/kg/week before and after the switch. Wilcoxon and Kruskal-Wallis tests (SPSS®) were used to compare the PK parameters. Results are expressed with the median and interquartile range (IQR) or range, and mean and standard deviation (SD). Results Eighty-one patients from 8 Spanish hospitals were analyzed (61 rFVIII-Fc; 20 PEG-rFVIII), 78 had severe HA and 3 moderate HA. Mean age was 30 years (range=3-64) and no differences in weight were observed between both periods [70 (range=12-116) vs 70 (13.7-116) kg; p=0,141]. Dose/kg/week and weekly infusion frequency were reduced after the switch to EHL, and significant improvements were observed in all PK parameters after the change from SHL to EHL (Table 1). These results were similar in adult and pediatric patients switching to rFVIII-Fc. The median ratios of t1/2 and AUC were 1.3 (IQR:1.2-1.6) and 1.5 (IQR:1.3-2.3) in the entire cohort. These results were reproduced in the subset of patients with ≥12 years treated with rFVIII-Fc and PEG-rFVIII (ratio t1/2: 1.4 [IQR:1.3-1.6]; ratio AUC: 1.6 [IQR:1.3-2.3]), and were slightly in the cohort of 15 patients <12 years treated with rFVIII-Fc (ratio t1/2: 1.3 [IQR:0.9-1.3]; ratio AUC: 1.3 [IQR:1.1-1.9]), the only EHL approved in Europe for children. After the switch to EHL, weekly dose frequency (median 23.3%, IQR:0-33.3%) and dose/kg/week (median 16%, IQR:5.3-30%) were reduced. In a small subset of 17 patients the dose/kg/week increased a median of 31.4%, and this subset was younger than the patients with dose/kg/week reduction or no changes (median age 18 [IQR:8-22] vs. 33 [IQR:16.5-42.5]). No differences were observed in any of the PK parameters and median ratios of t1/2 and AUC in patients aged ≥12 years treated with rFVIII-Fc vs. PEG-rFVIII (46 rFVIII-Fc; 20 PEG-rFVIII; Table 2). Conclusions EHL FVIII have shown significant PK improvements in clinical real practice, allowing to reduce weekly infusion number and dose/kg/week, especially in adult patients. Outside the clinical trial setting, we have observed an increase in t1/2 and AUC ratios accordingly to EHL definition. Comparisons regarding clinical outcomes (bleeding rate after switch) will be performed after a follow-up of 1 year with EHL for the full cohort. WAPPS-Hemo PK-guided switch easily facilitates individualization of prophylaxis with a potential reduction in the cost of treatment and patient perceived outcomes. Disclosures Megias: Baxalta US INC.: Research Funding; Grifols: Research Funding. Bonanad Boix:Baxalta US INC.: Research Funding. Berrueco:NovoNordisk: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; SOBI: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Bayer: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; CSL-Bering: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Mingot-Castellano:Sobi: Consultancy; Bayer: Consultancy; Amgen: Consultancy; Roche: Consultancy; Novartis: Consultancy; Novonordisk: Consultancy; Takeda: Consultancy; CSL Behring: Consultancy. Cid:Shire, a Takeda company: Honoraria; Novo Nordisk: Honoraria. Sanz:AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Membership on an entity's Board of Directors or advisory committees, Research Funding; Boehringer-Ingelheim: Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Helsinn Healthcare: Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen - Cilag: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Onconova: Membership on an entity's Board of Directors or advisory committees, Research Funding; Hoffman - La Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding.

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20

Sudirman, Agriawan, Suharjono Suharjono, Ahmad Nasir, and Rudi Safarudin. "Review: Perbandingan antara Standard Half-Life (SHL) dan Extended Half-Life (EHL) Replacement Therapy berbasis Real-World Evidence (RWE)." Jurnal Sains Farmasi & Klinis 9, no. 3 (January 27, 2023): 221. http://dx.doi.org/10.25077/jsfk.9.3.221-226.2022.

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Hemophilia is a common hereditary coagulation blood disorder due to the deficiency activity of clotting factors. Hemophilia is divided into two, namely hemophilia A and hemophilia B. Among all treatments, standard half-life (SHL) and extended half-life (EHL) factor replacement products are the most commonly used. This study aimed to review real-world evidence on the comparison of SHL and EHL. A literature search was conducted in PubMed and google scholar published from 2017 to 2021. There were 10 articles that met the criteria. Based on the synthesis results, the total proportion of patients using EHL factor concentrates for both on‐demand and prophylactic factor replacement therapy increased. Recent evidence reveals that EHL may reduce the number of infusions, increase factor trough levels, and substantially decrease the annual bleeding rate. Efficacy-wise, EHLs unquestionably have better performances than SHLs; however, the EHL products seem to be too expensive to be utilized as the primary standard of care for hemophilia. However, the economic aspect of the replacement factor switching still required more in-depth studies.

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21

Tiede, A. "Half-life extended factor VIII for the treatment of hemophilia A." Journal of Thrombosis and Haemostasis 13 (June 2015): S176—S179. http://dx.doi.org/10.1111/jth.12929.

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22

Sparkes, Amanda, Patrick De Baetselier, Lea Brys, Inês Cabrito, Yann G. J. Sterckx, Steve Schoonooghe, Serge Muyldermans, et al. "Novel half‐life extended anti‐MIF nanobodies protect against endotoxic shock." FASEB Journal 32, no. 6 (January 25, 2018): 3411–22. http://dx.doi.org/10.1096/fj.201701189r.

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23

Young, G., and J. N. Mahlangu. "Extended half-life clotting factor concentrates: results from published clinical trials." Haemophilia 22 (July 2016): 25–30. http://dx.doi.org/10.1111/hae.13028.

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24

Malec, L. M., J. Journeycake, and M. V. Ragni. "Extended half-life factor VIII for immune tolerance induction in haemophilia." Haemophilia 22, no. 6 (September 19, 2016): e552-e554. http://dx.doi.org/10.1111/hae.13064.

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25

Mahlangu, J., G. Young, C. Hermans, V. Blanchette, E. Berntorp, and E. Santagostino. "Defining extended half-life rFVIII-A critical review of the evidence." Haemophilia 24, no. 3 (April 6, 2018): 348–58. http://dx.doi.org/10.1111/hae.13438.

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26

Nederlof, Angelique, Ron A. A. Mathôt, Frank W. G. Leebeek, Karin Fijnvandraat, Kathelijn Fischer, and Marjon H. Cnossen. "Positioning extended half-life concentrates for future use: a practical proposal." Haemophilia 24, no. 5 (August 24, 2018): e369-e372. http://dx.doi.org/10.1111/hae.13588.

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27

Weimer, Thomas, Wilfried Wormsbächer, Ulrich Kronthaler, Wiegand Lang, Uwe Liebing, and Stefan Schulte. "Prolonged in-vivo half-life of factor VIIa by fusion to albumin." Thrombosis and Haemostasis 99, no. 04 (2008): 659–67. http://dx.doi.org/10.1160/th07-08-0525.

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SummaryFor the treatment of haemophilia patients with inhibitors, recombinant factor VIIa (rFVIIa) is available as a therapeutic option to control bleeding episodes with a good balance of safety and efficacy. However, the short in-vivo half-life of approximately 2.5 hours makes multiple injections necessary, which is inconvenient for both physicians and patients. Here we describe the generation of a recombinant FVIIa molecule with an extended half-life based on genetic fusion to human albumin. The recombinant FVII albumin fusion protein (rVII-FP) was expressed in mammalian cells and upon activation displayed a FVII activity close to that of wild type FVIIa. Pharmacokinetic studies in rats demonstrated that the half-life of the activated recombinant FVII albumin fusion protein (rVIIa-FP) was extended six- to sevenfold compared with wild type rFVIIa. The in-vitro and in-vivo efficacy was evaluated and was found to be comparable to a commercially available rFVIIa (NovoSeven®). The results of this study demonstrate that it is feasible to develop a half-life extended FVIIa molecule with haemostatic properties very similar to the wild-type factor.

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28

Peyvandi, Flora, Isabella Garagiola, Marco Boscarino, Aislin Ryan, Cedric Hermans, and Michael Makris. "Real‐life experience in switching to new extended half‐life products at European haemophilia centres." Haemophilia 25, no. 6 (August 16, 2019): 946–52. http://dx.doi.org/10.1111/hae.13834.

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29

Lambert, Thierry, Gary Benson, Gerry Dolan, Cedric Hermans, Victor Jiménez-Yuste, Rolf Ljung, Massimo Morfini, Silva Zupančić-Šalek, and Elena Santagostino. "Practical aspects of extended half-life products for the treatment of haemophilia." Therapeutic Advances in Hematology 9, no. 9 (September 2018): 295–308. http://dx.doi.org/10.1177/2040620718796429.

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Haemophilia A and haemophilia B are congenital X-linked bleeding disorders caused by deficiency of coagulation factor VIII (FVIII) and IX (FIX), respectively. The preferred treatment option for patients with haemophilia is replacement therapy. For patients with severe disease, prophylactic replacement of coagulation factor is the treatment of choice; this has been shown to reduce arthropathy significantly, reduce the frequency of bleeds and improve patients’ quality of life. Prophylaxis with standard recombinant factor requires regular intravenous infusion at least two (FIX) to three (FVIII) times a week. Recombinant FVIII and FIX products with an extended half-life are in development, or have been recently licensed. With reported mean half-life extensions of 1.5–1.8 times that of standard products for FVIII and 3–5 times that of standard products for FIX, these products have the potential to address many of the unmet needs of patients currently treated with standard factor concentrates. For example, they may encourage patients to switch from on-demand treatment to prophylaxis and improve the quality of life of patients receiving prophylaxis. Indeed, extended half-life products have the potential to reduce the burden of frequent intravenous injections, reducing the need for central venous lines in children, promote adherence, improve outcomes, potentially allow for more active lifestyles and, depending on the dosing regimen, increase factor trough levels. Members of the Zürich Haemophilia Forum convened for their 19th meeting to discuss the practicalities of incorporating new treatments into the management of people with haemophilia. This review of extended half-life products considers their introduction in haemophilia treatment, including the appropriate dose and schedule of infusions, laboratory monitoring, patient selection, safety considerations, and the economic aspects of care.

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30

Morfini, Massimo, and Stefano Gherardini. "Pharmacokinetic-based prediction of real-life dosing of extended half-life clotting factor concentrates on hemophilia." Therapeutic Advances in Hematology 9, no. 6 (June 2018): 149–62. http://dx.doi.org/10.1177/2040620718774258.

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The improvement of clotting factor concentrates (CFCs) has undergone an impressive boost during the last six years. Since 2010, several new recombinant factor (rF)VIII/IX concentrates entered phase I/II/III clinical trials. The improvements are related to the culture of human embryonic kidney (HEK) cells, post-translational glycosylation, PEGylation, and co-expression of the fragment crystallizable (Fc) region of immunoglobulin (Ig)G1 or albumin genes in the manufacturing procedures. The extended half-life (EHL) CFCs allow an increase of the interval between bolus administrations during prophylaxis, a very important advantage for patients with difficulties in venous access. Although the inhibitor risk has not been fully established, phase III studies have provided standard prophylaxis protocols, which, compared with on-demand treatment, have achieved very low annualized bleeding rates (ABRs). The key pharmacokinetics (PK) parameter to tailor patient therapy is clearance, which is more reliable than the half-life of CFCs; the clearance considers the decay rate of the drug concentration–time profile, while the half-life considers only the half concentration of the drug at a given time. To tailor the prophylaxis of hemophilia patients in real-life, we propose two formulae (expressed in terms of the clearance, trough and dose interval between prophylaxis), respectively based on the one- and two-compartmental models (CMs), for the prediction of the optimal single dose of EHL CFCs. Once the data from the time decay of the CFCs are fitted by the one- or two-CMs after an individual PK analysis, such formulae provide to the treater the optimal trade-off among trough and time-intervals between boluses. In this way, a sufficiently long time-interval between bolus administration could be guaranteed for a wider class of patients, with a preassigned level of the trough. Finally, a PK approach using repeated dosing is discussed, and some examples with new EHL CFCs are shown.

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31

Mancuso, Maria, and Elena Santagostino. "Outcome of Clinical Trials with New Extended Half-Life FVIII/IX Concentrates." Journal of Clinical Medicine 6, no. 4 (March 28, 2017): 39. http://dx.doi.org/10.3390/jcm6040039.

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32

Lau, David, Gregory Kuzma, Cha-Mer Wei, David J. Livingston, and Nancy Hsiung. "A Modified Human Tissue Plasminogen Activator with Extended Half–Life In Vivo." Nature Biotechnology 5, no. 9 (September 1987): 953–58. http://dx.doi.org/10.1038/nbt0987-953.

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33

Bowyer, Annette E., M. Fiona Shepherd, Steve Kitchen, Rhona M. Maclean, and Mike Makris. "Measurement of extended half‐life recombinant factor IX products in clinical practice." International Journal of Laboratory Hematology 41, no. 2 (December 7, 2018): e46-e49. http://dx.doi.org/10.1111/ijlh.12953.

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34

Khurana, Harshit, and Shailendra Prasad Verma. "Perioperative management in haemophilia with extended half-life factors: a case series." F1000Research 13 (January 17, 2024): 73. http://dx.doi.org/10.12688/f1000research.142117.1.

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Hemophilia B is a hereditary bleeding disorder characterized by deficient or defective coagulation factor IX, leading to a propensity for recurrent bleeding episodes, particularly in the joints. Management of Hemophilia B in surgical settings poses unique challenges due to the risk of excessive bleeding. This paper presents a series of two cases that demonstrate the effective use of perioperative extended half-life (EHL) factor IX products, specifically N9-GP (Refixia), in the surgical management of Hemophilia B. The cases include total knee replacement and total hip replacement. In each case, early initiation of EHL was observed to maintain adequate factor IX levels and control perioperative bleeding effectively, leading to successful surgical outcomes. These findings support the growing body of evidence suggesting the advantages of EHL perioperative treatment in patients with Hemophilia B, particularly in preparation for surgery. The implementation of EHL factor IX products as part of perioperative management plans may contribute to improved surgical outcomes and overall quality of life in Hemophilia B patients.

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35

Chhabra, Amit, Dean Spurden, Patrick F. Fogarty, Bartholomew J. Tortella, Emily Rubinstein, Simon Harris, Andreas M. Pleil, Jennifer Mellor, Jonathan de Courcy, and José Alvir. "Real-world outcomes associated with standard half-life and extended half-life factor replacement products for treatment of haemophilia A and B." Blood Coagulation & Fibrinolysis 31, no. 3 (April 2020): 186–92. http://dx.doi.org/10.1097/mbc.0000000000000885.

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36

Schulte, Stefan, Thomas Weimer, Wilfried Wormsbaecher, Ulrich Kronthaler, Albrecht Groener, Wiegand Lang, and Uwe Liebing. "Prolonged In-Vivo Half-Life of FVIIa by Fusion to Albumin." Blood 110, no. 11 (November 16, 2007): 3142. http://dx.doi.org/10.1182/blood.v110.11.3142.3142.

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Abstract For the treatment of hemophilia patients with inhibitors, recombinant Factor VIIa (rFVIIa) is available as a therapeutic option to control bleeding episodes with a good balance of safety and efficacy. The short in-vivo half-life of approximately 2.5 h requires multiple injections, which is inconvenient for treaters and patients. Here we describe the generation of a half-life extended recombinant FVIIa molecule based on genetic fusion of FVIIa to human albumin. In this fusion protein the design of the linker sequence is important to optimize the effect of the albumin moiety on FVII activity. The recombinant FVII-albumin fusion protein (rVII-FP) was expressed in mammalian cells and upon activation displayed a FVII activity comparable to wild type rFVIIa. Pharmacokinetic studies in rats and rabbits demonstrated that the half-life of the activated recombinant FVII albumin fusion protein (rVIIa-FP) was 6 to 9 fold extended compared to wild type rFVIIa. The in-vitro and in-vivo efficacy was evaluated and found comparable to commercially available rFVIIa (NovoSeven®). The results of this study demonstrate that it is feasible to improve the attributes of a rVIIa molecule by extending its half life, while retaining a molecule with very similar hemostatic properties to the wild type factor.

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37

Dunn, Amy, Manuel Carcao, and Riten Kumar. "Changing Paradigm of Hemophilia Management: Extended Half-Life Factor Concentrates and Gene Therapy." Seminars in Thrombosis and Hemostasis 42, no. 01 (January 15, 2016): 018–29. http://dx.doi.org/10.1055/s-0035-1568877.

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38

Rapp, Robert P., and Donna Blue. "The Role of the Extended Half-Life Second-Generation Cephalosporins in Surgical Prophylaxis." Drug Intelligence & Clinical Pharmacy 19, no. 3 (March 1985): 214–16. http://dx.doi.org/10.1177/106002808501900316.

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39

Stork, Roland, Emmanuelle Campigna, Bruno Robert, Dafne Müller, and Roland E. Kontermann. "Biodistribution of a Bispecific Single-chain Diabody and Its Half-life Extended Derivatives." Journal of Biological Chemistry 284, no. 38 (July 23, 2009): 25612–19. http://dx.doi.org/10.1074/jbc.m109.027078.

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40

Yu, Shengze, Amira Alkharusi, Gunnar Norstedt, and Torbjörn Gräslund. "An in vivo half-life extended prolactin receptor antagonist can prevent STAT5 phosphorylation." PLOS ONE 14, no. 5 (May 7, 2019): e0215831. http://dx.doi.org/10.1371/journal.pone.0215831.

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41

Aledort, Louis M., Nisha Jain, Nanxin Li, Sangeeta Krishnan, Benjamin Hagberg, and Jun Su. "Changing the Paradigm in Hemophilia Care: Extended Half-Life Products (rFVIIIFc and rFIXFc)." Blood 132, Supplement 1 (November 29, 2018): 3514. http://dx.doi.org/10.1182/blood-2018-99-114905.

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Abstract Background: Prophylactic treatment with factor products has demonstrated superior outcomes and care compared to on-demand treatment in hemophilia patients, including patients with pre-existing joint diseases. However, 40% to 50% of severe or moderate hemophilia A and B patients are still treated on-demand in the US. Recombinant factor VIII and IX Fc fusion proteins (rFVIIIFc and rFIXFc) were the first extended half-life (EHL) products approved in the US (in 2014) with the promise of optimizing prophylactic regimens by achieving low bleeding rates and improving joint health with fewer injections overall. Objective: This is the first real-world study to assess the impact of EHL rFVIIIFc and rFIXFc on overall prophylaxis rates, particularly to understand how patients have transitioned from on-demand treatment. Methods: A retrospective analysis was conducted on aggregate, de-identified United States Specialty Pharmacy Provider (SPP) records from Jan 2014 to June 2018 (data pull on June 14th, 2018). Adult hemophilia patients (age 18 and above) were included for an analysis of treatment regimens prior to and after switching to EHL rFVIIIFc and rFIXFc (on-demand or prophylaxis). The results were descriptively compared to those who switch to the other EHL PEGylated rFVIII and rFIX albumin Fusion Protein (rFIX-FP) and conventional factors. Results: A total of 304 hemophilia A patients who switched to rFVIIIFc and 133 hemophilia B patients who switched to rFIXFc were included in this study. For the hemophilia A and B patients, the median age was 31 and 32 years and median weight was 82 and 79 kg. The proportion of patients who switched from on-demand treatment with conventional factors to prophylaxis treatment with EHL rFVIIIFc and rFIXFc among all patients who switched to these products increased over time since the FDA approval (3 time points: 2014-2015, 2016-2017, and 2018: rFVIIIFc: 13%, 20%, and 21%; rFIXFc: 25%, 29%, and 57%). Such proportions were higher compared to those who switched from on-demand with conventional factors to prophylaxis with the other EHLs (2016-2017, 2018: PEGylated rFVIII: 16%, 18%; rFIX-FP: 18%, 13%, see comparison in the Figure) and with conventional factors (2014-2015, 2016-2017, and 2018: conventional rFVIII: 10%, 7%, and 9%; conventional rFIX: sample size was too small and not suitable for analysis). Discussion: rFVIIIFc and rFIXFc have transformed the paradigm of hemophilia care by shifting on demand patients to prophylaxis significantly faster than conventional factors and any other EHLs to date. This shift is significant as it is helping more hemophilia patients achieve optimal protection through low bleeding rates and improved joint health over the long-term. Figure. Figure. Disclosures Jain: Bioverativ: Employment. Li:Bioverativ: Employment. Krishnan:Bioverativ: Employment. Hagberg:Bioverativ: Employment. Su:Bioverativ: Employment.

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42

Chowdary, Pratima. "Extended half-life recombinant products in haemophilia clinical practice – Expectations, opportunities and challenges." Thrombosis Research 196 (December 2020): 609–17. http://dx.doi.org/10.1016/j.thromres.2019.12.012.

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43

Finelli, Lyn, Yoonyoung Choi, and Edward Goldstein. "Number needed to immunize to prevent RSV with extended half-life monoclonal antibody." Vaccine 38, no. 34 (July 2020): 5474–79. http://dx.doi.org/10.1016/j.vaccine.2020.06.034.

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44

Borrok, M. Jack, Neil Mody, Xiaojun Lu, Megan L. Kuhn, Herren Wu, William F. Dall'Acqua, and Ping Tsui. "An “Fc-Silenced” IgG1 Format With Extended Half-Life Designed for Improved Stability." Journal of Pharmaceutical Sciences 106, no. 4 (April 2017): 1008–17. http://dx.doi.org/10.1016/j.xphs.2016.12.023.

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45

Oganesyan, Vaheh, Melissa M. Damschroder, Robert M. Woods, Kimberly E. Cook, Herren Wu, and William F. Dall’Acqua. "Structural characterization of a human Fc fragment engineered for extended serum half-life." Molecular Immunology 46, no. 8-9 (May 2009): 1750–55. http://dx.doi.org/10.1016/j.molimm.2009.01.026.

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46

Morath, Volker, Florian Bolze, Martin Schlapschy, Sarah Schneider, Ferdinand Sedlmayer, Katrin Seyfarth, Martin Klingenspor, and Arne Skerra. "PASylation of Murine Leptin Leads to Extended Plasma Half-Life and Enhancedin VivoEfficacy." Molecular Pharmaceutics 12, no. 5 (April 10, 2015): 1431–42. http://dx.doi.org/10.1021/mp5007147.

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47

Beam, Thomas R. "Ceftriaxone: A Beta-lactamase-stable, Broad-spectrum Cephalosporin with an Extended Half-life." Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy 5, no. 5 (September 10, 1985): 237–53. http://dx.doi.org/10.1002/j.1875-9114.1985.tb03423.x.

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48

Cho, Jinhwan, Junyong Park, Giyoong Tae, Mi Sun Jin, and Inchan Kwon. "The Minimal Effect of Linker Length for Fatty Acid Conjugation to a Small Protein on the Serum Half-Life Extension." Biomedicines 8, no. 5 (April 26, 2020): 96. http://dx.doi.org/10.3390/biomedicines8050096.

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Conjugation of serum albumin or one of its ligands (such as fatty acid) has been an effective strategy to prolong the serum half-lives of drugs via neonatal Fc receptor (FcRn)–mediated recycling of albumin. So far, fatty acid (FA) has been effective in prolonging the serum half-lives for therapeutic peptides and small proteins, but not for large therapeutic proteins. Very recently, it was reported a large protein conjugated to FA competes with the binding of FcRn with serum albumin, leading to limited serum half-life extension, because primary FA binding sites in serum albumin partially overlap with FcRn binding sites. In order to prevent such competition, longer linkers between FA and the large proteins were required. Herein, we hypothesized that small proteins do not cause substantial competition for FcRn binding to albumin, resulting in the extended serum half-life. Using a small protein (28 kDa), we investigated whether the intramolecular distance in FA-protein conjugate affects the FcRn binding with albumin and serum half-life using linkers with varying lengths. Unlike with the FA-conjugated large protein, all FA-conjugated small proteins with different linkers exhibited comparable the FcRn binding to albumin and extended serum half-life.

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49

Chhabra, A., D. Spurden, BJ Tortella, PF Fogarty, A. Pleil, E. Rubinstein, and J. Alvir. "Real World Factor Dispensation and Expenditures in us Patients with Hemophilia B: Standard Half-Life vs. Extended Half-Life Factor IX Replacement Products." Value in Health 21 (September 2018): S111. http://dx.doi.org/10.1016/j.jval.2018.07.849.

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Owens, Carley, Zachariah Tritz, Katayoun Ayasoufi, Delaney Wolf, Ian Parney, Michael Hanson, Jin Fang та ін. "EXTH-77. EXTENDED HALF-LIFE IL-2 SYNERGIZES WITH Α-PD-1 FOR TREATMENT OF PRECLINICAL MURINE GLIOBLASTOMA MODELS". Neuro-Oncology 25, Supplement_5 (1 листопада 2023): v242. http://dx.doi.org/10.1093/neuonc/noad179.0930.

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Abstract α-PD-1 checkpoint blockade is a promising immunotherapeutic approach for many solid tumors; however, this strategy is minimally effective for GBM patients as a monotherapy. One potential reason why α-PD-1 checkpoint blockade is ineffective is the tumor microenvironment and systemic derangements of the immune system which are prevalent in GBM patients. We have successfully modeled peripheral immune derangements in experimental murine GBM models. These include low peripheral blood CD4 T cell counts, reduced MHC class II expression on monocytes, and atrophy of primary immune organs in animals harboring gliomas. We therefore hypothesized that extended half-life IL-2, a potent cytokine which promotes the proliferation, differentiation, and killing activity of T cells, could overcome immune derangements and could potentially synergize with α-PD-1 checkpoint blockade therapy. In cohorts of C57Bl/6 mice, we supplemented α-PD-1 checkpoint blockade with multiple bio-engineered extended half-life IL-2 molecules to treat GL261 and CT2A orthotopic glioma models which are normally resistant to monotherapy. We observe a statistically significant increase in survival in GL261-bearing animals receiving the combination of extended half-life IL-2 reagents and αPD-1 therapy relative to control-treated mice. Some animals receiving this combination therapy had a reduction in tumor burden to levels below detection. These long-term survivors underwent a rechallenge experiment with a second inoculation of GL261-Luc and effectively cleared tumor without further therapeutic intervention. This intervention causes a significant shift in the immune profile, including the formation of mature T cell responses, as well as restoring the diminished peripheral immune cell counts in GL261-bearing animals. Finally, combining extended half-life IL-2 with α-PD-1 checkpoint blockade is effective independently of the CD8 T cell response. Together, these data suggest that combination immunotherapies employing extended half-life IL-2 fusion proteins are translational to the clinic and do not require the identification of tumor specific antigens for efficacy

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