{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T00:54:05Z","timestamp":1790729645343,"version":"4.1.0"},"reference-count":29,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2014,9,11]],"date-time":"2014-09-11T00:00:00Z","timestamp":1410393600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/3.0\/"}],"funder":[{"DOI":"10.13039\/100006314","name":"Biogen Idec","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006314","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Br J Haematol"],"published-print":{"date-parts":[[2015,1]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>In the phase 3 B\u2010LONG [Recombinant Factor IX Fc Fusion Protein (<jats:styled-content style=\"fixed-case\">rFIXF<\/jats:styled-content>c) in Subjects with Haemophilia B] study, <jats:styled-content style=\"fixed-case\">rFIXF<\/jats:styled-content>c dosed every 1\u20132\u00a0weeks was safe and efficacious in previously treated subjects with haemophilia B. To date, there are no evaluations of transitioning from conventional to long\u2010acting factor IX (FIX) prophylaxis. This <jats:italic>post\u2010hoc<\/jats:italic> analysis of B\u2010LONG subjects compared prophylaxis with other FIX products and r<jats:styled-content style=\"fixed-case\">FIXF<\/jats:styled-content>c. Pre\u2010 and on\u2010study data were analysed to assess dosing regimen, weekly FIX consumption and annualized bleeding rates (ABRs). Population pharmacokinetics models were used to generate FIX activity profiles with r<jats:styled-content style=\"fixed-case\">FIXF<\/jats:styled-content>c and recombinant FIX prophylaxis. Thirty\u2010nine subjects, previously treated prophylactically, were evaluated. Prior to study, most subjects (69\u00b72%) received twice\u2010weekly FIX infusions; on study, subjects infused r<jats:styled-content style=\"fixed-case\">FIXF<\/jats:styled-content>c once every 1\u20132\u00a0weeks with <jats:italic>c<\/jats:italic>.\u00a030\u201350% reductions in weekly consumption. On\u2010study estimated mean ABRs were lower than pre\u2010study estimated mean ABRs. Models predicted that r<jats:styled-content style=\"fixed-case\">FIXF<\/jats:styled-content>c administered 50\u00a0iu\/kg weekly and 100\u00a0iu\/kg every 10\u00a0d would maintain steady\u2010state FIX trough levels \u22651\u00a0iu\/dl in 95\u00b74% and 89\u00b72% of subjects, respectively. These results indicate that patients receiving r<jats:styled-content style=\"fixed-case\">FIXF<\/jats:styled-content>c prophylaxis can markedly reduce infusion frequency and FIX consumption, have a greater likelihood of maintaining FIX activity &gt;1\u00a0iu\/dl and experience fewer bleeding episodes compared with prior FIX prophylaxis.<\/jats:p>","DOI":"10.1111\/bjh.13109","type":"journal-article","created":{"date-parts":[[2014,9,11]],"date-time":"2014-09-11T07:03:01Z","timestamp":1410418981000},"page":"113-123","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":28,"title":["Switching to recombinant factor <scp>IX<\/scp> Fc fusion protein prophylaxis results in fewer infusions, decreased factor <scp>IX<\/scp> consumption and lower bleeding rates"],"prefix":"10.1111","volume":"168","author":[{"given":"Jerry","family":"Powell","sequence":"first","affiliation":[{"name":"University of California Davis Sacramento CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy","family":"Shapiro","sequence":"additional","affiliation":[{"name":"Department of Hematology Indiana Hemophilia and Thrombosis Center Indianapolis IN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margaret","family":"Ragni","sequence":"additional","affiliation":[{"name":"University of Pittsburgh and the Hemophilia Center of Western Pennsylvania Pittsburgh PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claude","family":"Negrier","sequence":"additional","affiliation":[{"name":"H\u00f4pital Edouard Herriot Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jerzy","family":"Windyga","sequence":"additional","affiliation":[{"name":"Department of Disorders of Haemostasis and Internal Medicine Institute of Haematology and Transfusion Medicine Warsaw 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