Pharmacokinetic properties of BAY 81-8973, a full-length recombinant factor VIII

Introduction BAY 81‐8973 is a full‐length recombinant factor VIII (FVIII) with the same primary amino acid sequence as sucrose‐formulated recombinant FVIII (rFVIII‐FS) but is produced with advanced manufacturing technologies. Aim To analyse the pharmacokinetics (PK) of BAY 81‐8973 after single and m...

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Published in:Haemophilia : the official journal of the World Federation of Hemophilia 2015-11, Vol.21 (6), p.766-771
Main Authors: Shah, A., Delesen, H., Garger, S., Lalezari, S.
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aging - metabolism
Child
Child, Preschool
clinical trial
Ethnic Groups
Factor VIII - pharmacokinetics
Female
haemophilia A
half-life
Humans
Male
Middle Aged
pharmacokinetics
prophylaxis
recombinant FVIII
Recombinant Proteins - pharmacokinetics
Young Adult
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container_issue 6
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container_title Haemophilia : the official journal of the World Federation of Hemophilia
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creator Shah, A.
Delesen, H.
Garger, S.
Lalezari, S.
description Introduction BAY 81‐8973 is a full‐length recombinant factor VIII (FVIII) with the same primary amino acid sequence as sucrose‐formulated recombinant FVIII (rFVIII‐FS) but is produced with advanced manufacturing technologies. Aim To analyse the pharmacokinetics (PK) of BAY 81‐8973 after single and multiple dosing across different age and ethnic groups in the LEOPOLD clinical trial programme. Methods The LEOPOLD trials enrolled patients with severe haemophilia A aged 12–65 years (LEOPOLD I and II) or ≤12 years (LEOPOLD Kids) with ≥150 (LEOPOLD I and II) or ≥50 (LEOPOLD Kids) exposure days to any FVIII product and no history of FVIII inhibitors. PK were assessed using chromogenic and one‐stage assays (only chromogenic assay for LEOPOLD Kids) after a single 50‐IU kg−1 dose of BAY 81‐8973 and, in a subset of patients in LEOPOLD I, after repeated dosing. Pharmacokinetic analyses were also performed based on age (18 to 65, 12 to
doi_str_mv 10.1111/hae.12691
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Aim To analyse the pharmacokinetics (PK) of BAY 81‐8973 after single and multiple dosing across different age and ethnic groups in the LEOPOLD clinical trial programme. Methods The LEOPOLD trials enrolled patients with severe haemophilia A aged 12–65 years (LEOPOLD I and II) or ≤12 years (LEOPOLD Kids) with ≥150 (LEOPOLD I and II) or ≥50 (LEOPOLD Kids) exposure days to any FVIII product and no history of FVIII inhibitors. PK were assessed using chromogenic and one‐stage assays (only chromogenic assay for LEOPOLD Kids) after a single 50‐IU kg−1 dose of BAY 81‐8973 and, in a subset of patients in LEOPOLD I, after repeated dosing. Pharmacokinetic analyses were also performed based on age (18 to 65, 12 to &lt;18, 6 to &lt;12 and &lt;6 years) and ethnicity (Asian and non‐Asian). Results Pharmacokinetic assessments in the LEOPOLD I trial showed non‐inferiority of BAY 81‐8973 vs. rFVIII‐FS. The PK of BAY 81‐8973 were comparable after single and multiple dosing. Age‐based analysis in the three trials showed that plasma concentrations were slightly lower for children, but similar for adolescents compared with adults. Pharmacokinetic results were similar in the different ethnic groups. Conclusions Results of the LEOPOLD trials show that the BAY 81‐8973 pharmacokinetic profile is non‐inferior to rFVIII‐FS. Similar BAY 81‐8973 pharmacokinetic values were observed following single and repeated dosing and across ethnic groups.</description><identifier>ISSN: 1351-8216</identifier><identifier>EISSN: 1365-2516</identifier><identifier>DOI: 10.1111/hae.12691</identifier><identifier>PMID: 25952661</identifier><language>eng</language><publisher>England: Blackwell Publishing Ltd</publisher><subject>Adolescent ; Adult ; Aging - metabolism ; Child ; Child, Preschool ; clinical trial ; Ethnic Groups ; Factor VIII - pharmacokinetics ; Female ; haemophilia A ; half-life ; Humans ; Male ; Middle Aged ; pharmacokinetics ; prophylaxis ; recombinant FVIII ; Recombinant Proteins - pharmacokinetics ; Young Adult</subject><ispartof>Haemophilia : the official journal of the World Federation of Hemophilia, 2015-11, Vol.21 (6), p.766-771</ispartof><rights>2015 John Wiley &amp; Sons Ltd</rights><rights>2015 John Wiley &amp; Sons Ltd.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3631-27dbad594aa75aa661a5c10431982fef53b5731775c73586b06818220411a64a3</citedby><cites>FETCH-LOGICAL-c3631-27dbad594aa75aa661a5c10431982fef53b5731775c73586b06818220411a64a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25952661$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Shah, A.</creatorcontrib><creatorcontrib>Delesen, H.</creatorcontrib><creatorcontrib>Garger, S.</creatorcontrib><creatorcontrib>Lalezari, S.</creatorcontrib><title>Pharmacokinetic properties of BAY 81-8973, a full-length recombinant factor VIII</title><title>Haemophilia : the official journal of the World Federation of Hemophilia</title><addtitle>Haemophilia</addtitle><description>Introduction BAY 81‐8973 is a full‐length recombinant factor VIII (FVIII) with the same primary amino acid sequence as sucrose‐formulated recombinant FVIII (rFVIII‐FS) but is produced with advanced manufacturing technologies. Aim To analyse the pharmacokinetics (PK) of BAY 81‐8973 after single and multiple dosing across different age and ethnic groups in the LEOPOLD clinical trial programme. Methods The LEOPOLD trials enrolled patients with severe haemophilia A aged 12–65 years (LEOPOLD I and II) or ≤12 years (LEOPOLD Kids) with ≥150 (LEOPOLD I and II) or ≥50 (LEOPOLD Kids) exposure days to any FVIII product and no history of FVIII inhibitors. PK were assessed using chromogenic and one‐stage assays (only chromogenic assay for LEOPOLD Kids) after a single 50‐IU kg−1 dose of BAY 81‐8973 and, in a subset of patients in LEOPOLD I, after repeated dosing. Pharmacokinetic analyses were also performed based on age (18 to 65, 12 to &lt;18, 6 to &lt;12 and &lt;6 years) and ethnicity (Asian and non‐Asian). Results Pharmacokinetic assessments in the LEOPOLD I trial showed non‐inferiority of BAY 81‐8973 vs. rFVIII‐FS. The PK of BAY 81‐8973 were comparable after single and multiple dosing. Age‐based analysis in the three trials showed that plasma concentrations were slightly lower for children, but similar for adolescents compared with adults. Pharmacokinetic results were similar in the different ethnic groups. Conclusions Results of the LEOPOLD trials show that the BAY 81‐8973 pharmacokinetic profile is non‐inferior to rFVIII‐FS. Similar BAY 81‐8973 pharmacokinetic values were observed following single and repeated dosing and across ethnic groups.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aging - metabolism</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>clinical trial</subject><subject>Ethnic Groups</subject><subject>Factor VIII - pharmacokinetics</subject><subject>Female</subject><subject>haemophilia A</subject><subject>half-life</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>pharmacokinetics</subject><subject>prophylaxis</subject><subject>recombinant FVIII</subject><subject>Recombinant Proteins - pharmacokinetics</subject><subject>Young Adult</subject><issn>1351-8216</issn><issn>1365-2516</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><recordid>eNp1kMtOwzAQRS0E4r3gB5CXIJHWY8d2siwI2krlIcRzZU1chwbyKHYq4O8JFNgxm5nFuUejS8gesB5005-h6wFXKayQTRBKRlyCWv26JUQJB7VBtkJ4ZgwEZ2qdbHCZSq4UbJKrqxn6Cm3zUtSuLSyd-2bufFu4QJucHg8eadI5Ui2OKNJ8UZZR6eqndka9s02VFTXWLc3Rto2nd-PxeIes5VgGt_uzt8nt2enNySiaXA7HJ4NJZIUSEHE9zXAq0xhRS8TuF5QWWCwgTXjucikyqQVoLa0WMlEZUwkknLMYAFWMYpscLL3dw68LF1pTFcG6ssTaNYtgQHMdi5TxtEMPl6j1TQje5Wbuiwr9hwFmvgo0XYHmu8CO3f_RLrLKTf_I38Y6oL8E3orSffxvMqPB6a8yWiaK0Lr3vwT6F6O00NLcXwzNtZhMHuLzB3MhPgFa1oV2</recordid><startdate>201511</startdate><enddate>201511</enddate><creator>Shah, A.</creator><creator>Delesen, H.</creator><creator>Garger, S.</creator><creator>Lalezari, S.</creator><general>Blackwell Publishing Ltd</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>201511</creationdate><title>Pharmacokinetic properties of BAY 81-8973, a full-length recombinant factor VIII</title><author>Shah, A. ; Delesen, H. ; Garger, S. ; Lalezari, S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3631-27dbad594aa75aa661a5c10431982fef53b5731775c73586b06818220411a64a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aging - metabolism</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>clinical trial</topic><topic>Ethnic Groups</topic><topic>Factor VIII - pharmacokinetics</topic><topic>Female</topic><topic>haemophilia A</topic><topic>half-life</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>pharmacokinetics</topic><topic>prophylaxis</topic><topic>recombinant FVIII</topic><topic>Recombinant Proteins - pharmacokinetics</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Shah, A.</creatorcontrib><creatorcontrib>Delesen, H.</creatorcontrib><creatorcontrib>Garger, S.</creatorcontrib><creatorcontrib>Lalezari, S.</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Haemophilia : the official journal of the World Federation of Hemophilia</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shah, A.</au><au>Delesen, H.</au><au>Garger, S.</au><au>Lalezari, S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pharmacokinetic properties of BAY 81-8973, a full-length recombinant factor VIII</atitle><jtitle>Haemophilia : the official journal of the World Federation of Hemophilia</jtitle><addtitle>Haemophilia</addtitle><date>2015-11</date><risdate>2015</risdate><volume>21</volume><issue>6</issue><spage>766</spage><epage>771</epage><pages>766-771</pages><issn>1351-8216</issn><eissn>1365-2516</eissn><abstract>Introduction BAY 81‐8973 is a full‐length recombinant factor VIII (FVIII) with the same primary amino acid sequence as sucrose‐formulated recombinant FVIII (rFVIII‐FS) but is produced with advanced manufacturing technologies. Aim To analyse the pharmacokinetics (PK) of BAY 81‐8973 after single and multiple dosing across different age and ethnic groups in the LEOPOLD clinical trial programme. Methods The LEOPOLD trials enrolled patients with severe haemophilia A aged 12–65 years (LEOPOLD I and II) or ≤12 years (LEOPOLD Kids) with ≥150 (LEOPOLD I and II) or ≥50 (LEOPOLD Kids) exposure days to any FVIII product and no history of FVIII inhibitors. PK were assessed using chromogenic and one‐stage assays (only chromogenic assay for LEOPOLD Kids) after a single 50‐IU kg−1 dose of BAY 81‐8973 and, in a subset of patients in LEOPOLD I, after repeated dosing. Pharmacokinetic analyses were also performed based on age (18 to 65, 12 to &lt;18, 6 to &lt;12 and &lt;6 years) and ethnicity (Asian and non‐Asian). Results Pharmacokinetic assessments in the LEOPOLD I trial showed non‐inferiority of BAY 81‐8973 vs. rFVIII‐FS. The PK of BAY 81‐8973 were comparable after single and multiple dosing. Age‐based analysis in the three trials showed that plasma concentrations were slightly lower for children, but similar for adolescents compared with adults. Pharmacokinetic results were similar in the different ethnic groups. Conclusions Results of the LEOPOLD trials show that the BAY 81‐8973 pharmacokinetic profile is non‐inferior to rFVIII‐FS. Similar BAY 81‐8973 pharmacokinetic values were observed following single and repeated dosing and across ethnic groups.</abstract><cop>England</cop><pub>Blackwell Publishing Ltd</pub><pmid>25952661</pmid><doi>10.1111/hae.12691</doi><tpages>6</tpages></addata></record>
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subjects Adolescent
Adult
Aging - metabolism
Child
Child, Preschool
clinical trial
Ethnic Groups
Factor VIII - pharmacokinetics
Female
haemophilia A
half-life
Humans
Male
Middle Aged
pharmacokinetics
prophylaxis
recombinant FVIII
Recombinant Proteins - pharmacokinetics
Young Adult
title Pharmacokinetic properties of BAY 81-8973, a full-length recombinant factor VIII
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