{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,3]],"date-time":"2026-04-03T10:31:41Z","timestamp":1775212301249,"version":"3.50.1"},"reference-count":19,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2024,6,25]],"date-time":"2024-06-25T00:00:00Z","timestamp":1719273600000},"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":[[2024,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Non\u2010factor replacement therapies are emerging as prophylactic treatment options in haemophilia A or B (HA\/HB) with and without inhibitors. Concizumab is an anti\u2010tissue factor pathway inhibitor (TFPI) monoclonal antibody preventing factor (F)Xa inhibition and enhancing thrombin generation. Based on experience with other non\u2010factor therapies and extended half\u2010life products, there is a focus on potential interference with common clinical coagulation assays used to monitor patients treated with concizumab.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To evaluate the impact of concizumab on standard clinical coagulation assays.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Plasma samples (normal, HA\/HB with\/without inhibitors) in the presence\/absence of added concizumab (250\u201316,000\u00a0ng\/mL) were analysed in clinical assays including activated partial thromboplastin time (aPTT), prothrombin time (PT), FVIII and FIX one\u2010stage clot and chromogenic substrate assay, assays for detecting FVIII or FIX inhibitors and other assays for coagulation factors.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Concizumab did not impact PT assays, but resulted in a small shortening of aPTT (up to 5 s in haemophilia plasma and 0.4 s in normal plasma). Concizumab had no, or only a minor impact on FVIII and FIX activity assays or Bethesda inhibitor assays. FXI and FXII activity in normal plasma, as measured by single factor aPTT\u2010based assay, was significantly increased in the presence of concizumab (+11% each). This was also the case for FVII and FX measured by PT\u2010based assays using plasma with 25% of FVII or FX (+64% and +22%, respectively).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The presence of concizumab did not, or only slightly, influence the outcome of standard clinical coagulation assays relevant for HA and HB.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hae.15070","type":"journal-article","created":{"date-parts":[[2024,6,25]],"date-time":"2024-06-25T16:38:51Z","timestamp":1719333531000},"page":"1059-1066","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Minimal interference of concizumab with standard clinical coagulation laboratory assays \u2013 An in vitro study"],"prefix":"10.1111","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5587-3712","authenticated-orcid":false,"given":"Cecilia","family":"Augustsson","sequence":"first","affiliation":[{"name":"Department of Clinical Chemistry and Pharmacology Division of Laboratory Medicine Coagulation Laboratory Malm\u00f6 Regional Laboratories Region Sk\u00e5ne  Malm\u00f6 Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5554-6631","authenticated-orcid":false,"given":"Karin","family":"Strandberg","sequence":"additional","affiliation":[{"name":"Department of Clinical Chemistry and Pharmacology Division of Laboratory Medicine Coagulation Laboratory Malm\u00f6 Regional Laboratories Region Sk\u00e5ne  Malm\u00f6 Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marianne","family":"Kjalke","sequence":"additional","affiliation":[{"name":"Rare Disease Research Global Drug Discovery Novo Nordisk A\/S  M\u00e5l\u00f8v Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,6,25]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1055\/a\u20101665\u20106232"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1055\/s\u20100039\u20101688687"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.Atv.0000193624.28251.83"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/ijlh.12877"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/ejh.13339"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14831"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2020-142132"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.13903"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14884"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtha.2022.12.023"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2019001542"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2216455"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood\u20102012\u201001\u2010401620"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.rpth.2023.100444"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcla.24276"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365\u20102516.2012.02903.x"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood\u20102020\u2010140272"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.13897"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.13671"}],"container-title":["Haemophilia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hae.15070","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,13]],"date-time":"2025-04-13T18:08:18Z","timestamp":1744567698000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/hae.15070"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,6,25]]},"references-count":19,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2024,7]]}},"alternative-id":["10.1111\/hae.15070"],"URL":"https:\/\/doi.org\/10.1111\/hae.15070","archive":["Portico"],"relation":{},"ISSN":["1351-8216","1365-2516"],"issn-type":[{"value":"1351-8216","type":"print"},{"value":"1365-2516","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,6,25]]},"assertion":[{"value":"2024-03-27","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-06-04","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-06-25","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}