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Safe switching from a pdFIX (Immunine®) to a rFIX (Bax326)
Summary The ability to switch between coagulation factors safely is of common interest to haemophilia patients and treating physicians. This is the first formal prospective comparative evaluation of safety, efficacy and incremental recovery of a plasma‐derived FIX (pdFIX) and a recombinant FIX (rFIX...
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| Published in: | Haemophilia : the official journal of the World Federation of Hemophilia 2014-09, Vol.20 (5), p.674-681 |
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| Main Authors: | , , , , , , , , , , , |
| Format: | Article |
| Language: | English |
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| cited_by | cdi_FETCH-LOGICAL-c6044-1bf74fb84da4c597467b8c918d8c02859fcc39359b08c00fb7397c51228fa2003 |
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| cites | cdi_FETCH-LOGICAL-c6044-1bf74fb84da4c597467b8c918d8c02859fcc39359b08c00fb7397c51228fa2003 |
| container_end_page | 681 |
| container_issue | 5 |
| container_start_page | 674 |
| container_title | Haemophilia : the official journal of the World Federation of Hemophilia |
| container_volume | 20 |
| creator | Solano Trujillo, M. H. Stasyshyn, O. Rusen, L. Serban, M. Lamas, J. L. Perina, F. G. Urasinski, T. Oh, M. Knowlton, W. B. Valenta-Singer, B. Pavlova, B. G. Abbuehl, B. |
| description | Summary
The ability to switch between coagulation factors safely is of common interest to haemophilia patients and treating physicians. This is the first formal prospective comparative evaluation of safety, efficacy and incremental recovery of a plasma‐derived FIX (pdFIX) and a recombinant FIX (rFIX) in the same haemophilia B patients following a switch from pdFIX Immunine® to a recently developed rFIX Bax326 product. Patients (aged |
| doi_str_mv | 10.1111/hae.12444 |
| format | article |
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The ability to switch between coagulation factors safely is of common interest to haemophilia patients and treating physicians. This is the first formal prospective comparative evaluation of safety, efficacy and incremental recovery of a plasma‐derived FIX (pdFIX) and a recombinant FIX (rFIX) in the same haemophilia B patients following a switch from pdFIX Immunine® to a recently developed rFIX Bax326 product. Patients (aged <65 years) who completed a pretreatment study which prospectively documented the exposure to Immunine® and monitored FIX inhibitors while receiving prophylactic treatment were transitioned into pivotal (patients aged 12–65 years) and paediatric (patients aged <12 years) clinical studies investigating prophylaxis and treatment of bleeding episodes with Bax326. None of the 44 patients developed inhibitory or specific binding anti‐FIX antibodies during the course of the studies. A total of 38 unrelated adverse events (AEs) were occurred in 20/44 (45.5%) subjects during the Immunine® study. Following a switch to Bax326, 51 AEs were reported in 25/44 (56.8%) subjects. The incidence of AEs related to Bax326 treatment (two episodes of dysgeusia in one patient) was low (2.3%); there were no serious adverse reactions. The comparison between Immunine® and Bax326 demonstrated analogous haemostatic characteristics and annualized bleeding rates. Overall, there is direct evidence indicating a safe and clinically effective transition from a pdFIX (Immunine®) to a newly developed rFIX (Bax3261) for prophylaxis and treatment of bleeding in previously treated patients of all age cohorts with severe or moderately severe haemophilia B.</description><identifier>ISSN: 1351-8216</identifier><identifier>EISSN: 1365-2516</identifier><identifier>DOI: 10.1111/hae.12444</identifier><identifier>PMID: 24720694</identifier><language>eng</language><publisher>England: Blackwell Publishing Ltd</publisher><subject>Adolescent ; Adult ; Blood Coagulation - drug effects ; Blood Coagulation Factor Inhibitors - blood ; Child ; Coagulants - adverse effects ; Coagulants - pharmacokinetics ; Coagulants - therapeutic use ; Cross-Over Studies ; Drug Substitution - standards ; Factor IX - adverse effects ; Factor IX - therapeutic use ; Female ; haemophilia B ; Hemophilia B - drug therapy ; Hemophilia B - immunology ; Hemorrhage - epidemiology ; Humans ; Incidence ; Male ; Middle Aged ; pdFIX (Immunine®) ; previously treated patients ; Prospective Studies ; Recombinant Proteins - adverse effects ; Recombinant Proteins - pharmacokinetics ; Recombinant Proteins - therapeutic use ; rFIX (Rixubis®) ; safety ; Young Adult</subject><ispartof>Haemophilia : the official journal of the World Federation of Hemophilia, 2014-09, Vol.20 (5), p.674-681</ispartof><rights>2014 John Wiley & Sons Ltd</rights><rights>2014 John Wiley & Sons Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c6044-1bf74fb84da4c597467b8c918d8c02859fcc39359b08c00fb7397c51228fa2003</citedby><cites>FETCH-LOGICAL-c6044-1bf74fb84da4c597467b8c918d8c02859fcc39359b08c00fb7397c51228fa2003</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24720694$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Solano Trujillo, M. H.</creatorcontrib><creatorcontrib>Stasyshyn, O.</creatorcontrib><creatorcontrib>Rusen, L.</creatorcontrib><creatorcontrib>Serban, M.</creatorcontrib><creatorcontrib>Lamas, J. L.</creatorcontrib><creatorcontrib>Perina, F. G.</creatorcontrib><creatorcontrib>Urasinski, T.</creatorcontrib><creatorcontrib>Oh, M.</creatorcontrib><creatorcontrib>Knowlton, W. B.</creatorcontrib><creatorcontrib>Valenta-Singer, B.</creatorcontrib><creatorcontrib>Pavlova, B. G.</creatorcontrib><creatorcontrib>Abbuehl, B.</creatorcontrib><title>Safe switching from a pdFIX (Immunine®) to a rFIX (Bax326)</title><title>Haemophilia : the official journal of the World Federation of Hemophilia</title><addtitle>Haemophilia</addtitle><description>Summary
The ability to switch between coagulation factors safely is of common interest to haemophilia patients and treating physicians. This is the first formal prospective comparative evaluation of safety, efficacy and incremental recovery of a plasma‐derived FIX (pdFIX) and a recombinant FIX (rFIX) in the same haemophilia B patients following a switch from pdFIX Immunine® to a recently developed rFIX Bax326 product. Patients (aged <65 years) who completed a pretreatment study which prospectively documented the exposure to Immunine® and monitored FIX inhibitors while receiving prophylactic treatment were transitioned into pivotal (patients aged 12–65 years) and paediatric (patients aged <12 years) clinical studies investigating prophylaxis and treatment of bleeding episodes with Bax326. None of the 44 patients developed inhibitory or specific binding anti‐FIX antibodies during the course of the studies. A total of 38 unrelated adverse events (AEs) were occurred in 20/44 (45.5%) subjects during the Immunine® study. Following a switch to Bax326, 51 AEs were reported in 25/44 (56.8%) subjects. The incidence of AEs related to Bax326 treatment (two episodes of dysgeusia in one patient) was low (2.3%); there were no serious adverse reactions. The comparison between Immunine® and Bax326 demonstrated analogous haemostatic characteristics and annualized bleeding rates. Overall, there is direct evidence indicating a safe and clinically effective transition from a pdFIX (Immunine®) to a newly developed rFIX (Bax3261) for prophylaxis and treatment of bleeding in previously treated patients of all age cohorts with severe or moderately severe haemophilia B.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Blood Coagulation - drug effects</subject><subject>Blood Coagulation Factor Inhibitors - blood</subject><subject>Child</subject><subject>Coagulants - adverse effects</subject><subject>Coagulants - pharmacokinetics</subject><subject>Coagulants - therapeutic use</subject><subject>Cross-Over Studies</subject><subject>Drug Substitution - standards</subject><subject>Factor IX - adverse effects</subject><subject>Factor IX - therapeutic use</subject><subject>Female</subject><subject>haemophilia B</subject><subject>Hemophilia B - drug therapy</subject><subject>Hemophilia B - immunology</subject><subject>Hemorrhage - epidemiology</subject><subject>Humans</subject><subject>Incidence</subject><subject>Male</subject><subject>Middle Aged</subject><subject>pdFIX (Immunine®)</subject><subject>previously treated patients</subject><subject>Prospective Studies</subject><subject>Recombinant Proteins - adverse effects</subject><subject>Recombinant Proteins - pharmacokinetics</subject><subject>Recombinant Proteins - therapeutic use</subject><subject>rFIX (Rixubis®)</subject><subject>safety</subject><subject>Young Adult</subject><issn>1351-8216</issn><issn>1365-2516</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><recordid>eNp1kMtOwkAYhSdGI4gufAHTJSwKc-1M4wqRmyG4QKO7yXQ6I1VKsQMBXsqH8MksFNj5b_6Tk--cxQHgFsEmKq41VaaJMKX0DFQRCZiPGQrOd5ohX2AUVMCVc58QIoJhcAkqmPJChLQK7ifKGs-tk6WeJvMPz-ZZ6ilvEfeG7159mKareTI3vz8Nb5kVfr63H9SG4KBxDS6smjlzc_g18NrrvnQG_ui5P-y0R74OIKU-iiynNhI0VlSzkNOAR0KHSMRCQyxYaLUmIWFhBAsD2oiTkGuGMBZWYQhJDdTL3kWefa-MW8o0cdrMZmpuspWTiDHBECeYFmijRHWeOZcbKxd5kqp8KxGUu61ksZXcb1Wwd4faVZSa-EQexymAVgmsk5nZ_t8kB-3usdIvE4lbms0pofIvGXDCmXwb9-XT41gM2GAiIfkDzyV90A</recordid><startdate>201409</startdate><enddate>201409</enddate><creator>Solano Trujillo, M. H.</creator><creator>Stasyshyn, O.</creator><creator>Rusen, L.</creator><creator>Serban, M.</creator><creator>Lamas, J. L.</creator><creator>Perina, F. G.</creator><creator>Urasinski, T.</creator><creator>Oh, M.</creator><creator>Knowlton, W. B.</creator><creator>Valenta-Singer, B.</creator><creator>Pavlova, B. G.</creator><creator>Abbuehl, B.</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>201409</creationdate><title>Safe switching from a pdFIX (Immunine®) to a rFIX (Bax326)</title><author>Solano Trujillo, M. H. ; Stasyshyn, O. ; Rusen, L. ; Serban, M. ; Lamas, J. L. ; Perina, F. G. ; Urasinski, T. ; Oh, M. ; Knowlton, W. B. ; Valenta-Singer, B. ; Pavlova, B. G. ; Abbuehl, B.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c6044-1bf74fb84da4c597467b8c918d8c02859fcc39359b08c00fb7397c51228fa2003</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Blood Coagulation - drug effects</topic><topic>Blood Coagulation Factor Inhibitors - blood</topic><topic>Child</topic><topic>Coagulants - adverse effects</topic><topic>Coagulants - pharmacokinetics</topic><topic>Coagulants - therapeutic use</topic><topic>Cross-Over Studies</topic><topic>Drug Substitution - standards</topic><topic>Factor IX - adverse effects</topic><topic>Factor IX - therapeutic use</topic><topic>Female</topic><topic>haemophilia B</topic><topic>Hemophilia B - drug therapy</topic><topic>Hemophilia B - immunology</topic><topic>Hemorrhage - epidemiology</topic><topic>Humans</topic><topic>Incidence</topic><topic>Male</topic><topic>Middle Aged</topic><topic>pdFIX (Immunine®)</topic><topic>previously treated patients</topic><topic>Prospective Studies</topic><topic>Recombinant Proteins - adverse effects</topic><topic>Recombinant Proteins - pharmacokinetics</topic><topic>Recombinant Proteins - therapeutic use</topic><topic>rFIX (Rixubis®)</topic><topic>safety</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Solano Trujillo, M. H.</creatorcontrib><creatorcontrib>Stasyshyn, O.</creatorcontrib><creatorcontrib>Rusen, L.</creatorcontrib><creatorcontrib>Serban, M.</creatorcontrib><creatorcontrib>Lamas, J. L.</creatorcontrib><creatorcontrib>Perina, F. G.</creatorcontrib><creatorcontrib>Urasinski, T.</creatorcontrib><creatorcontrib>Oh, M.</creatorcontrib><creatorcontrib>Knowlton, W. B.</creatorcontrib><creatorcontrib>Valenta-Singer, B.</creatorcontrib><creatorcontrib>Pavlova, B. G.</creatorcontrib><creatorcontrib>Abbuehl, B.</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>Solano Trujillo, M. H.</au><au>Stasyshyn, O.</au><au>Rusen, L.</au><au>Serban, M.</au><au>Lamas, J. L.</au><au>Perina, F. G.</au><au>Urasinski, T.</au><au>Oh, M.</au><au>Knowlton, W. B.</au><au>Valenta-Singer, B.</au><au>Pavlova, B. G.</au><au>Abbuehl, B.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safe switching from a pdFIX (Immunine®) to a rFIX (Bax326)</atitle><jtitle>Haemophilia : the official journal of the World Federation of Hemophilia</jtitle><addtitle>Haemophilia</addtitle><date>2014-09</date><risdate>2014</risdate><volume>20</volume><issue>5</issue><spage>674</spage><epage>681</epage><pages>674-681</pages><issn>1351-8216</issn><eissn>1365-2516</eissn><abstract>Summary
The ability to switch between coagulation factors safely is of common interest to haemophilia patients and treating physicians. This is the first formal prospective comparative evaluation of safety, efficacy and incremental recovery of a plasma‐derived FIX (pdFIX) and a recombinant FIX (rFIX) in the same haemophilia B patients following a switch from pdFIX Immunine® to a recently developed rFIX Bax326 product. Patients (aged <65 years) who completed a pretreatment study which prospectively documented the exposure to Immunine® and monitored FIX inhibitors while receiving prophylactic treatment were transitioned into pivotal (patients aged 12–65 years) and paediatric (patients aged <12 years) clinical studies investigating prophylaxis and treatment of bleeding episodes with Bax326. None of the 44 patients developed inhibitory or specific binding anti‐FIX antibodies during the course of the studies. A total of 38 unrelated adverse events (AEs) were occurred in 20/44 (45.5%) subjects during the Immunine® study. Following a switch to Bax326, 51 AEs were reported in 25/44 (56.8%) subjects. The incidence of AEs related to Bax326 treatment (two episodes of dysgeusia in one patient) was low (2.3%); there were no serious adverse reactions. The comparison between Immunine® and Bax326 demonstrated analogous haemostatic characteristics and annualized bleeding rates. Overall, there is direct evidence indicating a safe and clinically effective transition from a pdFIX (Immunine®) to a newly developed rFIX (Bax3261) for prophylaxis and treatment of bleeding in previously treated patients of all age cohorts with severe or moderately severe haemophilia B.</abstract><cop>England</cop><pub>Blackwell Publishing Ltd</pub><pmid>24720694</pmid><doi>10.1111/hae.12444</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Haemophilia : the official journal of the World Federation of Hemophilia, 2014-09, Vol.20 (5), p.674-681 |
| issn | 1351-8216 1365-2516 |
| language | eng |
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| source | Wiley-Blackwell Read & Publish Collection |
| subjects | Adolescent Adult Blood Coagulation - drug effects Blood Coagulation Factor Inhibitors - blood Child Coagulants - adverse effects Coagulants - pharmacokinetics Coagulants - therapeutic use Cross-Over Studies Drug Substitution - standards Factor IX - adverse effects Factor IX - therapeutic use Female haemophilia B Hemophilia B - drug therapy Hemophilia B - immunology Hemorrhage - epidemiology Humans Incidence Male Middle Aged pdFIX (Immunine®) previously treated patients Prospective Studies Recombinant Proteins - adverse effects Recombinant Proteins - pharmacokinetics Recombinant Proteins - therapeutic use rFIX (Rixubis®) safety Young Adult |
| title | Safe switching from a pdFIX (Immunine®) to a rFIX (Bax326) |
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