{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T01:11:44Z","timestamp":1747185104548,"version":"3.40.5"},"reference-count":21,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2023,12,27]],"date-time":"2023-12-27T00:00:00Z","timestamp":1703635200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"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>Background<\/jats:title><jats:p>Efmoroctocog alfa (rFVIIIFc) is an extended half\u2010life FVIII used notably in surgery for patients with haemophilia A. More information is needed of its usage in real\u2010life.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Adult patients with HA followed at the Lyon Comprehensive Hemophilia Care Center who underwent a surgery with rFVIIIFc were included in this retrospective analysis. The pharmacokinetics of rFVIIIFc was assessed by plasma factor VIII clotting activity (FVIII:C) using both one\u2010stage (OSA) and chromogenic substrate (CSA) assays.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 39 major and 31 minor surgeries were performed in 49 patients treated with rFVIIIFc. The median dose of rFVIIIFc infused before major and minor surgeries respectively was 67.5 ((interquartile range [IQR] 52.6\u201076.9) and 48.0 (38.5\u201051.8) IU\/kg. For major surgeries, during the first postoperative week, the median residual FVIII:C was 78 (64.5\u2010101.5) IU\/dL with OSA and 99 (71\u2010118) IU\/dL with CSA (<jats:italic>p<\/jats:italic>\u00a0&lt;\u00a0.0001).<\/jats:p><jats:p>After surgery, rFVIIIFc doses were adjusted according to CSA results. This led to a significant decrease of rFVIIIFc consumption compared to what would have been proposed according to the OSA assay, without unusual bleeding or appearance of inhibitor. Considering the high price of the molecule, this was also associated with a significant cost reduction.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Dose adjustment of rFVIIIFc according to FVIII: C measured by CSA is effective, safe and well tolerated in patients with haemophilia A undergoing invasive surgery.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hae.14929","type":"journal-article","created":{"date-parts":[[2023,12,27]],"date-time":"2023-12-27T11:25:54Z","timestamp":1703676354000},"page":"538-544","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Comparison of one\u2010stage and chromogenic factor VIII assays to tailor the dose of recombinant factor VIII\u2010Fc fusion protein (rFVIIIFc, efmoroctocog alfa) in adult patients with haemophilia A: Single\u2010centre, real\u2010world experience of surgery"],"prefix":"10.1111","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0455-0248","authenticated-orcid":false,"given":"St\u00e9phanie","family":"D\u00e9sage","sequence":"first","affiliation":[{"name":"Unit\u00e9 d'H\u00e9mostase Clinique H\u00f4pital Cardiologique Louis Pradel Hospices Civils de Lyon  Lyon France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christophe","family":"Nougier","sequence":"additional","affiliation":[{"name":"Laboratoire d'H\u00e9mostase Centre de Biologie et de Pathologie Est Hospices Civils de Lyon  Lyon France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6785-4332","authenticated-orcid":false,"given":"Sandrine","family":"Meunier","sequence":"additional","affiliation":[{"name":"Unit\u00e9 d'H\u00e9mostase Clinique H\u00f4pital Cardiologique Louis Pradel Hospices Civils de Lyon  Lyon France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Val\u00e9rie","family":"Chamouard","sequence":"additional","affiliation":[{"name":"Unit\u00e9 d'H\u00e9mostase Clinique H\u00f4pital Cardiologique Louis Pradel Hospices Civils de Lyon  Lyon France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emilie","family":"Jousselme","sequence":"additional","affiliation":[{"name":"Laboratoire d'H\u00e9mostase Centre de Biologie et de Pathologie Est Hospices Civils de Lyon  Lyon France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yesim","family":"Dargaud","sequence":"additional","affiliation":[{"name":"Unit\u00e9 d'H\u00e9mostase Clinique H\u00f4pital Cardiologique Louis Pradel Hospices Civils de Lyon  Lyon France"},{"name":"Laboratoire d'H\u00e9mostase Centre de Biologie et de Pathologie Est Hospices Civils de Lyon  Lyon France"},{"name":"UR4609 H\u00e9mostase et Thrombose Facult\u00e9 de m\u00e9decine RTH La\u00ebnnec Universit\u00e9 Claude Bernard Lyon 1  Lyon France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne","family":"Lienhart","sequence":"additional","affiliation":[{"name":"Unit\u00e9 d'H\u00e9mostase Clinique H\u00f4pital Cardiologique Louis Pradel Hospices Civils de Lyon  Lyon France"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,12,27]]},"reference":[{"volume-title":"Elocta\u2014Autorisation de mise sur le march\u00e9 Elocta\u2014avis de la commission de la transparence","year":"2016","author":"HAS","key":"e_1_2_10_2_1"},{"key":"e_1_2_10_3_1","unstructured":"EMA\/CHMP\/BPWP\/144533\/2009 rev. 1.Guideline on the clinical investigation of recombinant and human plasma\u2010derived factor VIII products. EMA\/CHMP\/BPWP\/144533\/2009 Rev 1.2016;22."},{"issue":"1","key":"e_1_2_10_4_1","article-title":"New challenges and best practices for the laboratory monitoring of factor VIII and factor IX replacement","volume":"40","author":"Van den Bossche D","year":"2018","journal-title":"Int J Lab Hematol"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2011-09-382846"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2013-10-529974"},{"key":"e_1_2_10_7_1","unstructured":"Swedish Orphan Biovitrum AB. European Medicines Agency.Efmoroctocog alfa\u2014summary of product characteristics.2015. Disponible sur:https:\/\/ec.europa.eu\/health\/documents\/community\u2010register\/2022\/20220106154484\/anx_154484_fr.pdf"},{"issue":"2","key":"e_1_2_10_8_1","article-title":"Comparative field study evaluating the activity of recombinant factor VIII Fc fusion protein in plasma samples at clinical haemostasis laboratories","volume":"20","author":"Sommer JM","year":"2014","journal-title":"Haemoph Off J World Fed Hemoph"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.2147\/JBM.S80814"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1155\/2020\/8768074"},{"issue":"2","key":"e_1_2_10_11_1","article-title":"Factor VIII and IX assays for post\u2010infusion monitoring in hemophilia patients: guidelines from the French BIMHO group (GFHT)","volume":"105","author":"Jeanpierre E","year":"2020","journal-title":"Eur J Haematol ao\u00fbt"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/jth.12911"},{"issue":"3","key":"e_1_2_10_13_1","article-title":"Recombinant factor VIII Fc fusion protein for the treatment of severe haemophilia A: final results from the ASPIRE extension study","volume":"26","author":"Nolan B","year":"2020","journal-title":"Haemoph Off J World Fed Hemoph"},{"issue":"1","key":"e_1_2_10_14_1","first-page":"1\u20118","article-title":"Long\u2010acting recombinant factor VIII Fc fusion protein (rFVIIIFc) for perioperative haemostatic management in severe haemophilia A","volume":"116","author":"Mahlangu JN","year":"2016","journal-title":"Thromb Haemost"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/rth2.12760"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14585"},{"issue":"4","key":"e_1_2_10_17_1","article-title":"Major and minor classifications for surgery in people with hemophilia: a literature review","volume":"24","author":"Solimeno LP","year":"2018","journal-title":"Clin Appl Thromb Off J Int Acad Clin Appl Thromb"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14046"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.rpth.2023.100070"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/ijlh.12940"},{"issue":"4","key":"e_1_2_10_21_1","article-title":"Continuous infusion of extended half\u2010life factor VIII (efmoroctocog alpha) for surgery in severe haemophilia A","volume":"24","author":"Kremer Hovinga ICL","year":"2018","journal-title":"Haemoph Off J World Fed Hemoph"},{"issue":"6","key":"e_1_2_10_22_1","article-title":"Perioperative management of haemophilia A using recombinant factor VIII Fc fusion protein in a patient undergoing endoscopic nasal pituitary adenomectomy for a growth hormone\u2010producing pituitary adenoma","volume":"23","author":"Okamoto A","year":"2017","journal-title":"Haemoph Off J World Fed Hemoph"}],"container-title":["Haemophilia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hae.14929","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,4,30]],"date-time":"2024-04-30T02:08:21Z","timestamp":1714442901000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/hae.14929"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,12,27]]},"references-count":21,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2024,3]]}},"alternative-id":["10.1111\/hae.14929"],"URL":"https:\/\/doi.org\/10.1111\/hae.14929","archive":["Portico"],"relation":{},"ISSN":["1351-8216","1365-2516"],"issn-type":[{"type":"print","value":"1351-8216"},{"type":"electronic","value":"1365-2516"}],"subject":[],"published":{"date-parts":[[2023,12,27]]},"assertion":[{"value":"2023-08-21","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-12-15","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-12-27","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}