{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,5]],"date-time":"2026-03-05T23:31:39Z","timestamp":1772753499330,"version":"3.50.1"},"reference-count":21,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2023,8,16]],"date-time":"2023-08-16T00:00:00Z","timestamp":1692144000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Haemophilia"],"published-print":{"date-parts":[[2023,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Recombinant porcine factor VIII (rpFVIII, susoctocog alfa) is indicated for the treatment of bleeding episodes in adults with acquired haemophilia A (AHA).<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To provide long\u2010term real\u2010world safety and effectiveness data for rpFVIII in the management of AHA bleeding episodes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>US PASS (NCT02610127) was a multicentre, uncontrolled, open\u2010label, post\u2010marketing safety surveillance study conducted in adults with AHA. Data were collected retrospectively or prospectively for 180 days after rpFVIII treatment. The primary outcome was the incidence of treatment\u2010related serious adverse events (SAEs). Secondary outcomes included haemostatic effectiveness of rpFVIII and rpFVIII utilization.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Fifty\u2010three patients were enrolled from December 2015 to June 2019 (prospective, <jats:italic>n<\/jats:italic>\u00a0=\u00a030; retrospective, <jats:italic>n<\/jats:italic>\u00a0=\u00a023). Six patients experienced seven treatment\u2010related SAEs (incidence 12.0%). The most common treatment\u2010related SAE was FVIII inhibition (inhibiting antibodies to rpFVIII; incidence 8.0%, 95% CI: 2.2\u201319.2). Five patients reported seven thromboembolic events; one was an SAE and possibly related to rpFVIII. Of bleeding events treated with rpFVIII, 80.3% (57\/71) of bleeds resolved with rpFVIII. The median (range) dose of rpFVIII per infusion was 50 (10\u2013300) units\/kg, with a median (range) of 6.0 (1\u2013140) infusions and a median (range) time from bleed onset to bleed resolution of 14.0 (2.0\u2013132.7)\u00a0days.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>In this real\u2010world study of rpFVIII for AHA, no new safety signals were identified compared with previous clinical trial findings. Eighty percent of bleeds resolved with rpFVIII treatment.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hae.14832","type":"journal-article","created":{"date-parts":[[2023,8,16]],"date-time":"2023-08-16T16:17:18Z","timestamp":1692202638000},"page":"1259-1268","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Real\u2010world safety and effectiveness of recombinant porcine sequence factor VIII in acquired haemophilia A: A non\u2010interventional, post\u2010authorization safety study"],"prefix":"10.1111","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0069-8176","authenticated-orcid":false,"given":"Michael D.","family":"Tarantino","sequence":"first","affiliation":[{"name":"Bleeding and Clotting Disorders Institute Peoria Illinois USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6819-3898","authenticated-orcid":false,"given":"Brandon","family":"Hardesty","sequence":"additional","affiliation":[{"name":"Indiana Hemophilia and Thrombosis Center Indianapolis Indiana USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ara","family":"Metjian","sequence":"additional","affiliation":[{"name":"University of Colorado Anschutz Medical Campus Aurora Colorado USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas L.","family":"Ortel","sequence":"additional","affiliation":[{"name":"Duke University Durham North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jie","family":"Chen","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas Inc. Cambridge Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1336-6346","authenticated-orcid":false,"given":"Kayode","family":"Badejo","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas Inc. Cambridge Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alice","family":"Ma","sequence":"additional","affiliation":[{"name":"University of North Carolina Chapel Hill North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adam","family":"Cuker","sequence":"additional","affiliation":[{"name":"Perelman School of Medicine University of Pennsylvania Philadelphia Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anita","family":"Rajasekhar","sequence":"additional","affiliation":[{"name":"Department of Hematology\/Oncology University of Florida Health Gainesville Florida USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenneth D.","family":"Friedman","sequence":"additional","affiliation":[{"name":"Medical College of Wisconsin and Versiti\/Blood Center of Wisconsin Milwaukee Wisconsin USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maissaa","family":"Janbain","sequence":"additional","affiliation":[{"name":"Tulane School of Medicine New Orleans Louisiana USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,8,16]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.3324\/haematol.2008.001743"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2006-06-029850"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0038-1650169"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2012-02-409185"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1538-7836.2012.04654.x"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/ajh.24777"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-018-1027-y"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2014-07-587089"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2516.2010.02294.x"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1177\/2040620717720861"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/jth.14296"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2020006315"},{"key":"e_1_2_11_14_1","unstructured":"European Medicines Agency.Obizur (susoctocog alfa). 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