{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T11:25:06Z","timestamp":1785410706092,"version":"3.56.0"},"reference-count":33,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2024,10,21]],"date-time":"2024-10-21T00:00:00Z","timestamp":1729468800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100012112","name":"Swedish Orphan Biovitrum","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100012112","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["European J of Haematology"],"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>The 24\u2010month, prospective, non\u2010interventional, European multicenter A\u2010SURE study evaluated the real\u2010world effectiveness of prophylaxis using an extended half\u2010life recombinant factor VIII (FVIII) Fc fusion protein, efmoroctocog alfa (hereinafter rFVIIIFc), compared with prophylaxis using standard half\u2010life (SHL) FVIII products in patients with hemophilia A.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Primary endpoints were annualized bleeding rate (ABR), annualized injection frequency, and annualized factor consumption. A comparative study design unique for an observational hemophilia study was implemented to reduce potential confounding in effectiveness estimates, wherein each patient prescribed rFVIIIFc was matched with one receiving SHL FVIII. Propensity scores were used for adjustment in statistical analyses.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Outcomes for all primary endpoints were significantly better in the rFVIIIFc group (<jats:italic>n<\/jats:italic>\u2009=\u2009184) compared with the SHL FVIII group (<jats:italic>n<\/jats:italic>\u2009=\u2009170): mean ABR 1.5 versus 2.3 (difference of \u22120.8; <jats:italic>p<\/jats:italic>\u2009=\u20090.0147); mean annualized injection frequency 114.4 versus 169.2 (difference of \u221254.8; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.0001); and mean annualized factor consumption 243\u2009024.2 versus 288\u2009718.6 International Units (difference of 45\u2009694.5; <jats:italic>p<\/jats:italic>\u2009=\u20090.0003). rFVIIIFc was well tolerated, with no inhibitor development.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>rFVIIIFc has superior prophylactic effectiveness versus SHL FVIII, providing higher bleed protection with fewer injections and lower factor consumption.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ejh.14309","type":"journal-article","created":{"date-parts":[[2024,10,22]],"date-time":"2024-10-22T05:48:26Z","timestamp":1729576106000},"page":"248-257","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Superior Prophylactic Effectiveness of a Recombinant <scp>FVIIIFc<\/scp> Over Standard Half\u2010Life <scp>FVIII<\/scp> in Hemophilia A: A\u2010<scp>SURE<\/scp> Study"],"prefix":"10.1111","volume":"114","author":[{"given":"Johannes","family":"Oldenburg","sequence":"first","affiliation":[{"name":"Institute of Experimental Hematology and Transfusion Medicine, University Hospital Bonn, Medical Faculty University of Bonn  Bonn Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Hay","sequence":"additional","affiliation":[{"name":"University Department of Haematology Manchester Royal Infirmary  Manchester UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Flora","family":"Peyvandi","sequence":"additional","affiliation":[{"name":"Angelo Bianchi Bonomi Hemophilia and Thrombosis Center and Fondazione Luigi Villa Fondazione IRCCS C\u00e0 Granda Ospedale Maggiore Policlinico  Milan Italy"},{"name":"Department of Pathophysiology and Transplantation University of Milan  Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annarita","family":"Tagliaferri","sequence":"additional","affiliation":[{"name":"Regional Reference Center for Inherited Bleeding Disorders University Hospital of Parma  Parma Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P\u00e5l Andr\u00e8","family":"Holme","sequence":"additional","affiliation":[{"name":"Department of Haematology, Oslo University Hospital, Institute of Clinical Medicine University of Oslo  Oslo Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda Teresa","family":"\u00c1lvarez\u2010Rom\u00e1n","sequence":"additional","affiliation":[{"name":"Department of Haematology La Paz University Hospital\u2010IdiPaz  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Biron\u2010Andr\u00e9ani","sequence":"additional","affiliation":[{"name":"Haemophilia Treatment Centre, Department of Biological Haematology University Hospital Montpellier  Montpellier France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H\u00e5kan","family":"Malmstr\u00f6m","sequence":"additional","affiliation":[{"name":"Observational Research Sobi  Stockholm Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda","family":"Bystrick\u00e1","sequence":"additional","affiliation":[{"name":"Global Medical Affairs and Clinical Development Sobi  Stockholm 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