{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T00:54:49Z","timestamp":1790729689373,"version":"4.1.0"},"reference-count":26,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2022,10,11]],"date-time":"2022-10-11T00:00:00Z","timestamp":1665446400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Br J Haematol"],"published-print":{"date-parts":[[2023,1]]},"abstract":"<jats:title>Summary<\/jats:title>\n                  <jats:p>\n                    Marstacimab, an investigational human monoclonal antibody targeting tissue factor pathway inhibitor, demonstrated safety and efficacy in preventing bleeding episodes in patients with haemophilia. This multicentre, open\u2010label study investigated safety, tolerability, and efficacy of long\u2010term weekly prophylactic marstacimab treatment in participants with severe haemophilia A and B, with or without inhibitors. Adult participants were enrolled from a previous phase Ib\/II study or de novo and assigned to one of two subcutaneous (SC) marstacimab doses: once\u2010weekly 300\u2009mg or a 300\u2010mg loading dose followed by once\u2010weekly 150\u2010mg doses, for up to 365\u2009days. Study end\u2010points included safety assessments and annualised bleeding rates (ABRs). Of 20 enrolled participants, 18 completed the study. Overall, 70% of participants had treatment\u2010emergent adverse events, including injection site reactions, injection site haematoma, and haemarthrosis. No treatment\u2010related serious adverse events or thrombotic events occurred. Across all dose cohorts, mean and median on\u2010study ABRs ranged from 0 to 3.6 and 0 to 2.5\u2009bleeding episodes\/participant\/year respectively, demonstrating comparable efficacy to that observed in the short\u2010term parent study. No treatment\u2010induced anti\u2010drug antibodies were detected. Once\u2010weekly SC marstacimab prophylaxis was well tolerated, with an acceptable safety profile, and maintained long\u2010term efficacy up to 365\u2009days. (\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">Clinicaltrials.gov<\/jats:ext-link>\n                    identifier, NCT03363321).\n                  <\/jats:p>","DOI":"10.1111\/bjh.18495","type":"journal-article","created":{"date-parts":[[2022,10,11]],"date-time":"2022-10-11T19:59:53Z","timestamp":1665518393000},"page":"240-248","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":74,"title":["Long\u2010term safety and efficacy of the anti\u2010tissue factor pathway inhibitor marstacimab in participants with severe haemophilia: Phase II study results"],"prefix":"10.1111","volume":"200","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5781-7669","authenticated-orcid":false,"given":"Johnny","family":"Mahlangu","sequence":"first","affiliation":[{"name":"Faculty of Health Sciences University of the Witwatersrand and National Health Laboratory Service, Charlotte Maxeke Johannesburg Academic Hospital  Johannesburg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jose","family":"Luis Lamas","sequence":"additional","affiliation":[{"name":"Hospital S\u00f3tero del R\u00edo  Santiago Chile"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan","family":"Cristobal Morales","sequence":"additional","affiliation":[{"name":"Hospital S\u00f3tero del R\u00edo  Santiago Chile"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel R.","family":"Malan","sequence":"additional","affiliation":[{"name":"Phoenix Pharma  Port Elizabeth South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Teeter","sequence":"additional","affiliation":[{"name":"Pfizer Inc  Collegeville Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert J.","family":"Charnigo","sequence":"additional","affiliation":[{"name":"Pfizer Inc  Collegeville Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eunhee","family":"Hwang","sequence":"additional","affiliation":[{"name":"Pfizer Inc  Collegeville Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven","family":"Arkin","sequence":"additional","affiliation":[{"name":"Rare Diseases Research Unit Pfizer Worldwide R&amp;D  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,10,11]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14046"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1177\/2040620717746312"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.12438"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.seminhematol.2006.03.006"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2141.2001.02828.x"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2516.2012.02756.x"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1803550"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.2741\/3926"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2013-11-512764"},{"key":"e_1_2_10_11_1","unstructured":"ApgarJ ParngC BenardS JuoS TamM TuC et al.X\u2010ray crystallography and hemostatic activities of a neutralizing anti\u2010TFPI antibody marstacimab [poster]. 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