{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T09:46:05Z","timestamp":1780479965453,"version":"3.54.1"},"reference-count":20,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2019,7,28]],"date-time":"2019-07-28T00:00:00Z","timestamp":1564272000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Haemophilia"],"published-print":{"date-parts":[[2019,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Rurioctocog alfa pegol (BAX 855, TAK\u2010660) is a PEGylated, full\u2010length, recombinant factor VIII (rFVIII) with extended half\u2010life developed from unmodified rFVIII (antihaemophilic factor [recombinant]).<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To determine the perioperative haemostatic efficacy and safety of rurioctocog alfa pegol in male previously treated patients (PTPs) with severe haemophilia A.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This multicentre, single\u2010arm, phase III study included PTPs who were to undergo major or minor elective or minor emergency surgical, dental or other invasive procedures. Rurioctocog alfa pegol dose and frequency were individualized based on patients\u2019 pharmacokinetic profiles for major surgeries and by rurioctocog alfa pegol incremental recovery for minor surgeries. Haemostatic efficacy was assessed using the Global Haemostatic Efficacy Assessment score.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Twenty\u2010one patients aged 16\u201061\u00a0years underwent 21 major and five minor surgeries. For all 24 evaluable surgeries, overall haemostatic efficacy was rated as excellent and blood loss comparable to that expected in non\u2010haemophilic patients. No blood transfusions were required intraoperatively but were administered postoperatively for four surgeries in three patients. Five injury\u2010related postoperative bleeding episodes occurred in five patients, of which two required additional rurioctocog alfa pegol treatment. Two non\u2010serious adverse events of mild severity (increased ALT level and headache) were considered possibly related to rurioctocog alfa pegol. There were no deaths or treatment\u2010related serious adverse events. No patients developed inhibitory antibodies to FVIII or persistent IgG\u2010 or IgM\u2010binding antibodies to FVIII, PEG\u2010FVIII or PEG.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Rurioctocog alfa pegol was well tolerated and effective for perioperative use in patients with haemophilia A and showed no signs of immunogenicity.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hae.13807","type":"journal-article","created":{"date-parts":[[2019,7,29]],"date-time":"2019-07-29T03:28:46Z","timestamp":1564370926000},"page":"773-781","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["Perioperative haemostasis with full\u2010length, PEGylated, recombinant factor VIII with extended half\u2010life (rurioctocog alfa pegol) in patients with haemophilia A: Final results of a multicentre, single\u2010arm phase III trial"],"prefix":"10.1111","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2095-180X","authenticated-orcid":false,"given":"Ralph","family":"Gruppo","sequence":"first","affiliation":[{"name":"Cincinnati Children\u2019s Hospital Medical Center Cincinnati Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria\u2010Fernanda","family":"L\u00f3pez\u2010Fern\u00e1ndez","sequence":"additional","affiliation":[{"name":"Complejo Hospitalario Universitario A Coru\u00f1a Coru\u00f1a Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tung T.","family":"Wynn","sequence":"additional","affiliation":[{"name":"College of Medicine University of Florida Gainesville Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Werner","family":"Engl","sequence":"additional","affiliation":[{"name":"Baxalta Innovations GmbH, a Takeda company Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marlies","family":"Sharkhawy","sequence":"additional","affiliation":[{"name":"Baxalta Innovations GmbH, a Takeda company Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9721-4993","authenticated-orcid":false,"given":"Srilatha","family":"Tangada","sequence":"additional","affiliation":[{"name":"Baxalta US Inc., a Takeda company Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,7,28]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(11)61139-2"},{"key":"e_1_2_9_3_1","unstructured":"KonkleBA HustonH Nakaya FletcherS. 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Accessed May 22 2018."},{"key":"e_1_2_9_18_1","unstructured":"Committee for Medicinal Products for Human Use. Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products.http:\/\/www.ema.europa.eu\/ema\/doc_index.jsp?curl=pages\/includes\/document\/document_detail.jsp?webContentId=WC500237865&murl=menus\/document_library\/document_library.jsp&mxml:id=0b01ac058009a3dc. Accessed May 11 2018."},{"key":"e_1_2_9_19_1","unstructured":"European Medicines Agency. Guideline on the clinical investigation of recombinant and human plasma\u2010derived factor VIII products.www.ema.europa.eu\/docs\/en_GB\/document_library\/...\/2017\/...\/WC500237866.pdf. 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