{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T01:11:48Z","timestamp":1747185108391,"version":"3.40.5"},"reference-count":19,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2024,2,11]],"date-time":"2024-02-11T00:00:00Z","timestamp":1707609600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100016469","name":"Takeda Pharmaceuticals International","doi-asserted-by":"publisher","award":["IIR\u2010DE\u2010002670"],"award-info":[{"award-number":["IIR\u2010DE\u2010002670"]}],"id":[{"id":"10.13039\/100016469","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Haemophilia"],"published-print":{"date-parts":[[2024,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Recombinant porcine factor VIII (rpFVIII) is a treatment option for break\u2010through bleeds in patients with congenital haemophilia A with inhibitors (CHAwI) on emicizumab. However, there are limited data about the measurement of rpFVIII in the presence of emicizumab.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To analyse whether rpFVIII can be measured with a chromogenic assay with bovine component (bCSA) in plasma from CHAwI on emicizumab treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In the first part of the study, FVIII deficient plasma was spiked with rpFVIII, in the second part, commercial plasma from CHAwI was spiked with emicizumab and rpFVIII, and in the third part, plasma from CHAwI on emicizumab treatment was spiked with rpFVIII. FVIII was then measured with bCSA and a chromogenic assay with human component (hCSA). Thrombin generation (TG) and clot\u2010waveform analysis (CWA) were also carried out.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The recovery of rpFVIII measured with bCSA is approximately 80% and is further influenced by the presence of an anti\u2010porcine inhibitor. rpFVIII assessed with hCSA was influenced by emicizumab. CWA and TG showed a weak correlation with baseline emicizumab concentration, but peak thrombin and CWA correlated well with increasing emicizumab concentrations and rpFVIII activities.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This study indicates that rpFVIII can be measured in the presence of emicizumab with a bCSA. A calibration curve for the measurement of rpFVIII with bCSA should be established.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hae.14955","type":"journal-article","created":{"date-parts":[[2024,2,12]],"date-time":"2024-02-12T06:19:50Z","timestamp":1707718790000},"page":"545-553","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Measurement of recombinant porcine factor VIII in patients with congenital haemophilia A and inhibitors in the presence of emicizumab"],"prefix":"10.1111","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0485-7402","authenticated-orcid":false,"given":"Christian","family":"Pfrepper","sequence":"first","affiliation":[{"name":"Division of Hemostaseology Department of Hematology Cellular Therapy, Hemostaseology and Infectiology University of Leipzig Medical Centre  Leipzig Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4194-8183","authenticated-orcid":false,"given":"Robert","family":"Klamroth","sequence":"additional","affiliation":[{"name":"Department for Internal Medicine Vascular Medicine and Hemostaseology Vivantes Klinikum im Friedrichshain  Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carmen Escuriola","family":"Ettingshausen","sequence":"additional","affiliation":[{"name":"Hemophilia Centre Rhine Main GmbH Hessenring 13a  M\u00f6rfelden\u2010Walldorf Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sirak","family":"Petros","sequence":"additional","affiliation":[{"name":"Division of Hemostaseology Department of Hematology Cellular Therapy, Hemostaseology and Infectiology University of Leipzig Medical Centre  Leipzig Germany"},{"name":"Medical ICU University of Leipzig Medical Centre  Leipzig Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Annelie","family":"Siegemund","sequence":"additional","affiliation":[{"name":"Division of Hemostaseology Department of Hematology Cellular Therapy, Hemostaseology and Infectiology University of Leipzig Medical Centre  Leipzig Germany"},{"name":"MVZ Limbach Magdeburg  Magdeburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Siegemund","sequence":"additional","affiliation":[{"name":"MVZ Limbach Magdeburg  Magdeburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,2,11]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1703068"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.13495"},{"key":"e_1_2_10_4_1","unstructured":"Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation.Recommendation on the Use and Management of Emicizumab\u2010kxwh (Hemlibra\u00ae) for Hemophilia A with and without Inhibitors: MASAC Document 268; April 27 2022."},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.12627"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.13108"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0039-1692427"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.13903"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1055\/a-1665-6232"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14536"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2516.2009.02173.x"},{"issue":"1","key":"e_1_2_10_12_1","first-page":"S48","article-title":"Clot waveform analysis in patients with haemophilia A","volume":"34","author":"Siegemund T","year":"2014","journal-title":"Hamostaseologie"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.13001"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.3390\/diagnostics12081999"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1160\/TH03-01-0027"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1511769"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.3324\/haematol.2017.185330"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14317"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/jth.14022"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14785"}],"container-title":["Haemophilia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hae.14955","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,4,30]],"date-time":"2024-04-30T02:06:42Z","timestamp":1714442802000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/hae.14955"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,2,11]]},"references-count":19,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2024,3]]}},"alternative-id":["10.1111\/hae.14955"],"URL":"https:\/\/doi.org\/10.1111\/hae.14955","archive":["Portico"],"relation":{},"ISSN":["1351-8216","1365-2516"],"issn-type":[{"type":"print","value":"1351-8216"},{"type":"electronic","value":"1365-2516"}],"subject":[],"published":{"date-parts":[[2024,2,11]]},"assertion":[{"value":"2023-06-18","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-01-23","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-02-11","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}