{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T19:08:11Z","timestamp":1792609691695,"version":"4.5.0"},"reference-count":25,"publisher":"Elsevier BV","issue":"3","license":[{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2026,4,17]],"date-time":"2026-04-17T00:00:00Z","timestamp":1776384000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100032735","name":"LFB","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100032735","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Blood Vessels, Thrombosis &amp; Hemostasis"],"published-print":{"date-parts":[[2026,8]]},"DOI":"10.1016\/j.bvth.2026.100169","type":"journal-article","created":{"date-parts":[[2026,4,19]],"date-time":"2026-04-19T00:59:44Z","timestamp":1776560384000},"page":"100169","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":1,"title":["Safety and real-world effectiveness of eptacog beta with emicizumab prophylaxis: an interim analysis of the ATHN 16 study"],"prefix":"10.1016","volume":"3","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4372-723X","authenticated-orcid":false,"given":"Tammuella","family":"Chrisentery-Singleton","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suchitra","family":"Acharya","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanjay","family":"Ahuja","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3357-898X","authenticated-orcid":false,"given":"Lauren E.","family":"Amos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7656-0694","authenticated-orcid":false,"given":"Meera","family":"Chitlur","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-7844-561X","authenticated-orcid":false,"given":"Nabil","family":"Daoud","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashley","family":"Eason","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2944-0240","authenticated-orcid":false,"given":"Miguel","family":"Escobar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carol","family":"Fedor","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shveta","family":"Gupta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip","family":"Kuriakose","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonia","family":"Nasr","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sharon","family":"Pennington","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajiv K.","family":"Pruthi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Recht","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-2272-9942","authenticated-orcid":false,"given":"Andreana","family":"Robertson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Doris V.","family":"Quon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3967-4873","authenticated-orcid":false,"given":"Allison P.","family":"Wheeler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Reding","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"9","key":"10.1016\/j.bvth.2026.100169_bib1","doi-asserted-by":"crossref","first-page":"809","DOI":"10.1056\/NEJMoa1703068","article-title":"Emicizumab prophylaxis in hemophilia A with inhibitors","volume":"377","author":"Oldenburg","year":"2017","journal-title":"N Engl J Med"},{"issue":"4","key":"10.1016\/j.bvth.2026.100169_bib2","doi-asserted-by":"crossref","DOI":"10.1016\/j.rpth.2024.102415","article-title":"Emicizumab is well tolerated and effective in people with congenital hemophilia A regardless of age, severity of disease, or inhibitor status: a scoping review","volume":"8","author":"Young","year":"2024","journal-title":"Res Pract Thromb Haemost"},{"issue":"1","key":"10.1016\/j.bvth.2026.100169_bib3","doi-asserted-by":"crossref","DOI":"10.1016\/j.rpth.2024.102670","article-title":"Recombinant factor VIIa: new insights into the mechanism of action through product innovation","volume":"9","author":"Escobar","year":"2025","journal-title":"Res Pract Thromb Haemost"},{"key":"10.1016\/j.bvth.2026.100169_bib4","series-title":"Package insert","year":"2022"},{"key":"10.1016\/j.bvth.2026.100169_bib5","series-title":"Package insert","year":"2022"},{"issue":"6","key":"10.1016\/j.bvth.2026.100169_bib6","doi-asserted-by":"crossref","first-page":"832","DOI":"10.1111\/hae.13301","article-title":"PERSEPT 1: a phase 3 trial of activated eptacog beta for on-demand treatment of haemophilia inhibitor-related bleeding","volume":"23","author":"Wang","year":"2017","journal-title":"Haemophilia"},{"key":"10.1016\/j.bvth.2026.100169_bib7","series-title":"Package insert","year":"2014"},{"issue":"1","key":"10.1016\/j.bvth.2026.100169_bib8","doi-asserted-by":"crossref","first-page":"7","DOI":"10.3390\/bioengineering5010007","article-title":"Bioengineering of rFVIIa biopharmaceutical and structure characterization for biosimilarity assessment","volume":"5","author":"Montacir","year":"2018","journal-title":"Bioengineering (Basel)"},{"issue":"12","key":"10.1016\/j.bvth.2026.100169_bib9","doi-asserted-by":"crossref","first-page":"1531","DOI":"10.1093\/glycob\/cwt085","article-title":"N-\/O-glycosylation analysis of human FVIIa produced in the milk of transgenic rabbits","volume":"23","author":"Chevreux","year":"2013","journal-title":"Glycobiology"},{"issue":"4","key":"10.1016\/j.bvth.2026.100169_bib10","doi-asserted-by":"crossref","first-page":"373","DOI":"10.1055\/s-2001-16890","article-title":"Recombinant activated factor VII (rFVIIa): characterization, manufacturing, and clinical development","volume":"27","author":"Jurlander","year":"2001","journal-title":"Sem Thromb Haem"},{"issue":"1-2","key":"10.1016\/j.bvth.2026.100169_bib11","doi-asserted-by":"crossref","first-page":"147","DOI":"10.1016\/S0022-1759(99)00151-9","article-title":"Transgenic milk as a method for the production of recombinant antibodies","volume":"231","author":"Pollock","year":"1999","journal-title":"J Immunol Methods"},{"issue":"2","key":"10.1016\/j.bvth.2026.100169_bib12","doi-asserted-by":"crossref","first-page":"300","DOI":"10.1111\/hae.13110","article-title":"Kinetic analysis and binding studies of a new recombinant human factor VIIa for treatment of haemophilia","volume":"23","author":"Grandoni","year":"2017","journal-title":"Haemophilia"},{"issue":"10","key":"10.1016\/j.bvth.2026.100169_bib14","doi-asserted-by":"crossref","first-page":"335","DOI":"10.2147\/JBM.S219573","article-title":"Thrombotic events with recombinant activated factor VII (rFVIIa) in approved indications are rare and associated with older age, cardiovascular disease, and concomitant use of activated prothrombin complex concentrates (aPCC)","volume":"10","author":"Rajpurkar","year":"2019","journal-title":"J Blood Med"},{"issue":"9","key":"10.1016\/j.bvth.2026.100169_bib15","doi-asserted-by":"crossref","first-page":"1470","DOI":"10.1111\/jth.14491","article-title":"Safety analysis of rFVIIa with emicizumab dosing in congenital hemophilia A with inhibitors: experience from the HAVEN clinical program","volume":"17","author":"Levy","year":"2019","journal-title":"J Thromb Haemost"},{"issue":"6","key":"10.1016\/j.bvth.2026.100169_bib16","doi-asserted-by":"crossref","first-page":"921","DOI":"10.1111\/hae.14419","article-title":"The safety of activated eptacog beta in the management of bleeding episodes and perioperative haemostasis in adult and paediatric haemophilia patients with inhibitors","volume":"27","author":"Escobar","year":"2021","journal-title":"Haemophilia"},{"issue":"6","key":"10.1016\/j.bvth.2026.100169_bib17","doi-asserted-by":"crossref","first-page":"1321","DOI":"10.1111\/hae.15094","article-title":"Real-world effectiveness of eptacog beta in patients with haemophilia and inhibitors: a multi-institutional case series","volume":"30","author":"Youkhana","year":"2024","journal-title":"Haemophilia"},{"issue":"6","key":"10.1016\/j.bvth.2026.100169_bib18","doi-asserted-by":"crossref","first-page":"911","DOI":"10.1111\/hae.14418","article-title":"PERSEPT 3: a phase 3 clinical trial to evaluate the haemostatic efficacy of eptacog beta (recombinant human FVIIa) in perioperative care in subjects with haemophilia A or B with inhibitors","volume":"27","author":"Escobar","year":"2021","journal-title":"Haemophilia"},{"issue":"4","key":"10.1016\/j.bvth.2026.100169_bib19","doi-asserted-by":"crossref","first-page":"548","DOI":"10.1111\/hae.14563","article-title":"Eptacog beta efficacy and safety in the treatment and control of bleeding in paediatric subjects (<12 years) with haemophilia A or B with inhibitors","volume":"28","author":"Pipe","year":"2022","journal-title":"Haemophilia"},{"issue":"2","key":"10.1016\/j.bvth.2026.100169_bib21","doi-asserted-by":"crossref","first-page":"321","DOI":"10.1111\/hae.14253","article-title":"Exploratory in vitro evaluation of thrombin generation of eptacog beta (recombinant human fviia) and emicizumab in congenital haemophilia A plasma","volume":"27","author":"Grandoni","year":"2021","journal-title":"Haemophilia"},{"issue":"6","key":"10.1016\/j.bvth.2026.100169_bib22","doi-asserted-by":"crossref","first-page":"1321","DOI":"10.1111\/hae.15094","article-title":"Real-world effectiveness of eptacog beta in patients with haemophilia and inhibitors: a multi-institutional case series","volume":"30","author":"Youkhana","year":"2024","journal-title":"Haemophilia"},{"issue":"suppl 2","key":"10.1016\/j.bvth.2026.100169_bib24","doi-asserted-by":"crossref","first-page":"S22","DOI":"10.1016\/S0049-3848(10)70150-X","article-title":"EUHASS: the European haemophilia safety surveillance system","volume":"127","author":"Makris","year":"2011","journal-title":"Thromb Res"},{"issue":"5","key":"10.1016\/j.bvth.2026.100169_bib25","doi-asserted-by":"crossref","first-page":"1116","DOI":"10.1007\/s43441-020-00130-6","article-title":"WHODrug: a global, validated and updated dictionary for medicinal information","volume":"54","author":"Lagerlund","year":"2020","journal-title":"Ther Innov Regul Sci"},{"issue":"1","key":"10.1016\/j.bvth.2026.100169_bib26","doi-asserted-by":"crossref","first-page":"78","DOI":"10.1111\/hae.15109","article-title":"Bleed treatment with eptacog beta (rFVIIa) results in a low incidence of rebleeding in adult and adolescent patients with haemophilia A or B with inhibitors","volume":"31","author":"Dunn","year":"2025","journal-title":"Haemophilia"},{"issue":"4","key":"10.1016\/j.bvth.2026.100169_bib27","doi-asserted-by":"crossref","first-page":"549","DOI":"10.1177\/1076029617715117","article-title":"Major and minor classifications for surgery in people with hemophilia: a literature review","volume":"24","author":"Solimeno","year":"2018","journal-title":"Clin Appl Thromb Hemost"},{"issue":"suppl 1","key":"10.1016\/j.bvth.2026.100169_bib28","article-title":"Surgery in patients with inherited bleeding disorders","volume":"70","author":"Mensah","year":"2015","journal-title":"Anaesthesia"}],"container-title":["Blood Vessels, Thrombosis &amp; Hemostasis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2950327226000343?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2950327226000343?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T15:25:24Z","timestamp":1787757924000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S2950327226000343"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8]]},"references-count":25,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,8]]}},"alternative-id":["S2950327226000343"],"URL":"https:\/\/doi.org\/10.1016\/j.bvth.2026.100169","relation":{},"ISSN":["2950-3272"],"issn-type":[{"value":"2950-3272","type":"print"}],"subject":[],"published":{"date-parts":[[2026,8]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Safety and real-world effectiveness of eptacog beta with emicizumab prophylaxis: an interim analysis of the ATHN 16 study","name":"articletitle","label":"Article Title"},{"value":"Blood Vessels, Thrombosis & Hemostasis","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.bvth.2026.100169","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 American Society of Hematology. Published by Elsevier Inc. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.","name":"copyright","label":"Copyright"}],"article-number":"100169"}}