{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T07:38:33Z","timestamp":1792654713349,"version":"4.5.0"},"reference-count":19,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2025,3,18]],"date-time":"2025-03-18T00:00:00Z","timestamp":1742256000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,3,18]],"date-time":"2025-03-18T00:00:00Z","timestamp":1742256000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Haemophilia"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>The Phase 3 studies, XTEND\u20101 (NCT04161495) and XTEND\u2010Kids (NCT04759131), showed once\u2010weekly efanesoctocog alfa provided high\u2010sustained factor VIII (FVIII) activity levels that translated into highly effective bleed prevention in patients with severe haemophilia A.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>This analysis evaluated the efficacy and safety of efanesoctocog alfa for perioperative management during XTEND\u20101 and XTEND\u2010Kids.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients undergoing major or minor surgery were to receive a single preoperative 50\u00a0IU\/kg dose, with additional 30 or 50\u00a0IU\/kg doses every 2\u20133 days as needed following major surgery. Outcomes assessed included FVIII activity levels, number and dose of efanesoctocog alfa injections, surgeon's\/investigator's assessment of haemostatic response, total factor consumption, estimated blood loss, number and type of blood transfusions, and safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In XTEND\u20101, 11 adults\/adolescents underwent 12 evaluable major surgeries (6 orthopaedic). Eleven surgeries had one preoperative dose (median [range]: 49.9 [13\u201352] IU\/kg); one had no preoperative dose. Median (range) total consumption from Day \u22121 to 14 was 163.3 (45\u2013361) IU\/kg. In XTEND\u2010Kids, two children underwent major surgery with a single preoperative loading dose (60.4 and 61.9\u00a0IU\/kg). Across trials, 15 adults\/adolescents underwent 18 minor surgeries and 8 children underwent 9 minor surgeries, with a single preoperative dose or no preoperative dose (5 surgeries in adults\/adolescents). Haemostatic response was rated excellent for all surgeries. No surgeries required blood transfusion. No safety concerns or inhibitor development was reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Efanesoctocog alfa provided highly effective perioperative protection in patients with severe haemophilia A.<\/jats:p>\n                    <jats:p>\n                      <jats:bold>Trial Registration<\/jats:bold>\n                      : XTEND\u20101: NCT04161495\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT04161495\">https:\/\/clinicaltrials.gov\/study\/NCT04161495<\/jats:ext-link>\n                      ; XTEND\u2010Kids: NCT04759131\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT04759131\">https:\/\/clinicaltrials.gov\/study\/NCT04759131<\/jats:ext-link>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/hae.70017","type":"journal-article","created":{"date-parts":[[2025,3,18]],"date-time":"2025-03-18T05:28:21Z","timestamp":1742275701000},"page":"391-400","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Perioperative Management With Efanesoctocog Alfa in Patients With Haemophilia A in the Phase 3 XTEND\u20101 and XTEND\u2010Kids Studies"],"prefix":"10.1111","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4194-8183","authenticated-orcid":false,"given":"Robert","family":"Klamroth","sequence":"first","affiliation":[{"name":"Vivantes Klinikum, Friedrichshain Berlin, and Institute of Experimental Hematology and Transfusion Medicine University Hospital Bonn Medical Faculty University of Bonn  Bonn Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annette","family":"von Drygalski","sequence":"additional","affiliation":[{"name":"Department of Medicine Division of Hematology\/Oncology University of California San Diego  San Diego California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5429-8437","authenticated-orcid":false,"given":"Cedric","family":"Hermans","sequence":"additional","affiliation":[{"name":"Haemostasis and Thrombosis Unit Division of Haematology Cliniques Universitaires Saint\u2010Luc Universit\u00e9 Catholique de Louvain  Brussels Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6643-4245","authenticated-orcid":false,"given":"Young\u2010Shil","family":"Park","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Division of Hematology\/Oncology Kyung Hee University Hospital at Gangdong  Seoul South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1551-3995","authenticated-orcid":false,"given":"Anthony K. C.","family":"Chan","sequence":"additional","affiliation":[{"name":"McMaster Children's Hospital McMaster University  Hamilton Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8827-5567","authenticated-orcid":false,"given":"Alphan","family":"Kupesiz","sequence":"additional","affiliation":[{"name":"Akdeniz University  Antalya Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3296-4288","authenticated-orcid":false,"given":"Mar\u00eda Teresa","family":"Alvarez\u2010Rom\u00e1n","sequence":"additional","affiliation":[{"name":"Hematology Department Hospital La Paz  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9173-7179","authenticated-orcid":false,"given":"Lynn","family":"Malec","sequence":"additional","affiliation":[{"name":"Versiti Blood Research Institute  Milwaukee Wisconsin USA"},{"name":"Departments of Medicine and Pediatrics Division of Hematology and Oncology Medical College of Wisconsin  Milwaukee Wisconsin USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Santagostino","sequence":"additional","affiliation":[{"name":"Sobi  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Graham","family":"Neill","sequence":"additional","affiliation":[{"name":"Sanofi  Reading UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9787-7866","authenticated-orcid":false,"given":"Linda","family":"Bystrick\u00e1","sequence":"additional","affiliation":[{"name":"Sobi  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer","family":"Dumont","sequence":"additional","affiliation":[{"name":"Sanofi  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lydia","family":"Abad\u2010Franch","sequence":"additional","affiliation":[{"name":"Sobi  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lila\u2010Sabrina","family":"Fetita","sequence":"additional","affiliation":[{"name":"Sanofi  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liane","family":"Khoo","sequence":"additional","affiliation":[{"name":"Institute of Haematology Royal Prince Alfred Hospital  Sydney NSW Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,3,18]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14046"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1080\/17474086.2023.2223925"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2019001292"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1182\/bloodadvances.2021006119"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.rpth.2023.100176"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2209226"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2312611"},{"key":"e_1_2_11_9_1","unstructured":"Bioverativ Therapeutics Inc. 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