{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T16:13:20Z","timestamp":1777479200742,"version":"3.51.4"},"reference-count":27,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2025,3,21]],"date-time":"2025-03-21T00:00:00Z","timestamp":1742515200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,3,21]],"date-time":"2025-03-21T00:00:00Z","timestamp":1742515200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Clin Appl Thromb Hemost"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Hemophilia A (HA) occurs due to the deficiency of factor VIII (FVIII). Individuals with HA generally present with elevated activated partial thromboplastin time (aPTT) and normal prothrombin time (PT). The only possible treatment for this bleeding condition is factor concentrate.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>The aim of this study is to compare the effect of recombinant factor VIII (rFVIII) and recombinant factor VII (rFVII) on prothrombin time (PT), activated partial thromboplastin time (aPTT), FVIII and FVII in severe HA.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methodology<\/jats:title>\n                    <jats:p>A mixing study was conducted on 30 samples of severe HA patients to assess the correction of PT, aPTT, FVIII, and FVII values using biosimilars of rFVIII (NovoEight and Kogenate FS) and rFVII (NovoSeven and AryoSeven) using a fully automated coagulation analyser \u2018Ceveron alpha\u2019.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      All the four drugs demonstrated a significant alteration for both PT (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      \u2009&lt;\u2009.0001) and aPTT (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      \u2009&lt;\u2009.0001) values. A significant, notable increase of FVIII levels were observed for FVIII biosimilars. Further investigation into the effect of rFVII biosimilars on inhibitor-positive patients revealed a significant alteration in PT (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      \u2009&lt;\u2009.0001) and aPTT (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      \u2009&lt;\u2009.001) values.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>To the best of our knowledge, this is the first study to compare the effect of all four drugs on PT, aPTT, FVIII, and FVII. Two different groups of biosimilars were found to have a high potential to alter the PT and aPTT values. The FVIII biosimilars are efficient in increasing the FVIII levels.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10760296251329329","type":"journal-article","created":{"date-parts":[[2025,3,21]],"date-time":"2025-03-21T16:54:04Z","timestamp":1742576044000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Comparative Efficacy of Recombinant FVIII and Recombinant FVII Biosimilars in Severe Hemophilia A"],"prefix":"10.1177","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6107-4228","authenticated-orcid":false,"given":"Meganathan","family":"Kannan","sequence":"first","affiliation":[{"name":"Central University of Tamil Nadu"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chitrali Laha","family":"Roy","sequence":"additional","affiliation":[{"name":"Central University of Tamil Nadu"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2901-0339","authenticated-orcid":false,"given":"Prakasha","family":"Kempaiah","sequence":"additional","affiliation":[{"name":"Loyola University Chicago"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ravi","family":"Ranjan","sequence":"additional","affiliation":[{"name":"All India Institute of Medical Sciences"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manoranjan","family":"Mahapatra","sequence":"additional","affiliation":[{"name":"All India Institute of Medical Sciences"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Renu","family":"Saxena","sequence":"additional","affiliation":[{"name":"All India Institute of Medical Sciences"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3465-2499","authenticated-orcid":false,"given":"Jawed","family":"Fareed","sequence":"additional","affiliation":[{"name":"Loyola University Chicago"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2025,3,21]]},"reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1055\/s-0037-1615621"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1111\/jth.12672"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1111\/jth.14784"},{"issue":"6","key":"e_1_3_4_5_2","doi-asserted-by":"crossref","first-page":"344","DOI":"10.1097\/MPH.0000000000002692","article-title":"Hemophilia joint health score, functional independence score in hemophilia, and pettersson score in pediatric patients with severe hemophilia A","volume":"45","author":"Mabrouk AG","year":"2023","unstructured":"Mabrouk AG, Abbas MAE, Ezzat DA, Sayed MT, Ali FM. Hemophilia joint health score, functional independence score in hemophilia, and pettersson score in pediatric patients with severe hemophilia A. J Pediatr Hematol Oncol. 2023;45(6):344-348.","journal-title":"J Pediatr Hematol Oncol"},{"issue":"9","key":"e_1_3_4_6_2","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2023-082204","article-title":"Assessment of joint health in patients receiving prophylaxis for haemophilia A: A cross-sectional survey in five European countries","volume":"14","author":"De la Corte-Rodr\u00edguez H","year":"2024","unstructured":"De la Corte-Rodr\u00edguez H, Bystrick\u00e1 L, Ball N, et al. Assessment of joint health in patients receiving prophylaxis for haemophilia A: A cross-sectional survey in five European countries. BMJ Open. 2024;14(9):e082204.","journal-title":"BMJ Open"},{"key":"e_1_3_4_7_2","article-title":"Low-dose emicizumab versus low-\/intermediate-dose factor VIII secondary prophylaxis for noninhibitor haemophilia A patients with severe bleeding phenotype","author":"Kessakorn N","unstructured":"Kessakorn N, Gosriwatana I, Sasipong N, Srichumpuang C, Moonla C, Sosothikul D. Low-dose emicizumab versus low-\/intermediate-dose factor VIII secondary prophylaxis for noninhibitor haemophilia A patients with severe bleeding phenotype. Haemophilia. Published online December 31, 2024. doi:https:\/\/doi.org\/10.1111\/hae.15146","journal-title":"Haemophilia"},{"issue":"1","key":"e_1_3_4_8_2","article-title":"Half-life extended factor VIII for the treatment of hemophilia A","volume":"13","author":"Tiede A.","year":"2015","unstructured":"Tiede A. Half-life extended factor VIII for the treatment of hemophilia A. J Thromb Haemost. 2015;13(Suppl 1):S176-S179. doi:https:\/\/doi.org\/10.1111\/jth.12929","journal-title":"J Thromb Haemost"},{"issue":"1","key":"e_1_3_4_9_2","doi-asserted-by":"crossref","first-page":"36","DOI":"10.1016\/j.htct.2022.11.008","article-title":"Extended half-life recombinant factor VIII treatment of hemophilia A in Brazil: An expert consensus statement","volume":"46","author":"Ozelo MC","year":"2024","unstructured":"Ozelo MC, Antunes SV, Villaca PR, et al. Extended half-life recombinant factor VIII treatment of hemophilia A in Brazil: An expert consensus statement. Hematol Transfus Cell Ther. 2024;46(1):36-41.","journal-title":"Hematol Transfus Cell Ther"},{"issue":"3","key":"e_1_3_4_10_2","doi-asserted-by":"crossref","first-page":"348","DOI":"10.1111\/hae.13438","article-title":"Defining extended half-life rFVIII-A critical review of the evidence","volume":"24","author":"Mahlangu J","year":"2018","unstructured":"Mahlangu J, Young G, Hermans C, Blanchette V, Berntorp E, Santagostino E. Defining extended half-life rFVIII-A critical review of the evidence. Haemophilia. 2018;24(3):348-358.","journal-title":"Haemophilia"},{"key":"e_1_3_4_11_2","doi-asserted-by":"crossref","first-page":"261","DOI":"10.3389\/fmed.2019.00261","article-title":"Status of recombinant factor VIII concentrate treatment for hemophilia a in Italy: Characteristics and clinical benefits","volume":"6","author":"Schiavoni M","year":"2019","unstructured":"Schiavoni M, Napolitano M, Giuffrida G, et al. Status of recombinant factor VIII concentrate treatment for hemophilia a in Italy: Characteristics and clinical benefits. Front Med (Lausanne). 2019;6:261. doi:https:\/\/doi.org\/10.3389\/fmed.2019.00261","journal-title":"Front Med (Lausanne)"},{"issue":"11","key":"e_1_3_4_12_2","doi-asserted-by":"crossref","first-page":"3033","DOI":"10.1016\/j.jtha.2023.05.011","article-title":"A review of the rationale for gene therapy for hemophilia A with inhibitors: One-shot tolerance and treatment?","volume":"21","author":"Valentino LA","year":"2023","unstructured":"Valentino LA, Ozelo MC, Herzog RW, et al. A review of the rationale for gene therapy for hemophilia A with inhibitors: One-shot tolerance and treatment? J Thromb Haemost. 2023;21(11):3033-3044.","journal-title":"J Thromb Haemost"},{"issue":"5","key":"e_1_3_4_13_2","doi-asserted-by":"crossref","DOI":"10.1002\/rth2.12561","article-title":"The effect of emicizumab and bypassing agents in patients with hemophilia \u2013 an in vitro study","volume":"5","author":"Schultz NH","year":"2021","unstructured":"Schultz NH, Glosli H, Bj\u00f8rnsen S, Holme PA. The effect of emicizumab and bypassing agents in patients with hemophilia \u2013 an in vitro study. Res Pract Thromb Haemost. 2021;5(5):e12561.","journal-title":"Res Pract Thromb Haemost"},{"key":"e_1_3_4_14_2","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2014-05-577643"},{"issue":"2","key":"e_1_3_4_15_2","doi-asserted-by":"crossref","first-page":"184","DOI":"10.1177\/1076029614555902","article-title":"A comparison of efficacy between recombinant activated factor VII (aryoseven) and novoseven in patients with hereditary FVIII deficiency with inhibitor","volume":"22","author":"Faranoush M","year":"2016","unstructured":"Faranoush M, Abolghasemi H, Mahboudi F, et al. A comparison of efficacy between recombinant activated factor VII (aryoseven) and novoseven in patients with hereditary FVIII deficiency with inhibitor. Clin Appl Thromb Hemost. 2016;22(2):184-190.","journal-title":"Clin Appl Thromb Hemost"},{"issue":"4","key":"e_1_3_4_16_2","first-page":"557","article-title":"Factor VIIa and its potential therapeutic use in bleeding-associated pathologies","volume":"100","author":"Hedner U","year":"2008","unstructured":"Hedner U. Factor VIIa and its potential therapeutic use in bleeding-associated pathologies. Thromb Haemost. 2008;100(4):557-562.","journal-title":"Thromb Haemost"},{"issue":"1","key":"e_1_3_4_17_2","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 O","year":"2018","unstructured":"Montacir O, Montacir H, Eravci M, et al. Bioengineering of rFVIIa biopharmaceutical and structure characterization for biosimilarity assessment. Bioengineering (Basel). 2018;5(1):7.","journal-title":"Bioengineering (Basel)"},{"key":"e_1_3_4_18_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00277-023-05287-2"},{"issue":"2","key":"e_1_3_4_19_2","doi-asserted-by":"crossref","first-page":"327","DOI":"10.1042\/bj2650327","article-title":"The contributions of Ca2+, phospholipids and tissue-factor apoprotein to the activation of human blood-coagulation factor X by activated factor VII","volume":"265","author":"Bom VJ","year":"1990","unstructured":"Bom VJ, Bertina RM. The contributions of Ca2+, phospholipids and tissue-factor apoprotein to the activation of human blood-coagulation factor X by activated factor VII. Biochem J. 1990;265(2):327-336.","journal-title":"Biochem J"},{"key":"e_1_3_4_20_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2141.1997.4463256.x"},{"key":"e_1_3_4_21_2","doi-asserted-by":"publisher","DOI":"10.1177\/2040620717737701"},{"key":"e_1_3_4_22_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cll.2014.06.005"},{"key":"e_1_3_4_23_2","doi-asserted-by":"publisher","DOI":"10.1111\/ijlh.13349"},{"issue":"4","key":"e_1_3_4_24_2","doi-asserted-by":"crossref","first-page":"407","DOI":"10.1055\/s-2007-994943","article-title":"New insights into how blood clots: Implications for the use of APTT and PT as coagulation screening tests and in monitoring of anticoagulant therapy","volume":"25","author":"Bajaj SP","year":"1999","unstructured":"Bajaj SP, Joist JH. New insights into how blood clots: Implications for the use of APTT and PT as coagulation screening tests and in monitoring of anticoagulant therapy. Semin Thromb Hemost. 1999;25(4):407-418.","journal-title":"Semin Thromb Hemost"},{"key":"e_1_3_4_25_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.blre.2019.03.002"},{"issue":"5","key":"e_1_3_4_26_2","doi-asserted-by":"crossref","first-page":"1447","DOI":"10.1213\/ane.0b013e31819bceb1","article-title":"The role of tissue factor and factor VIIa in hemostasis","volume":"108","author":"Mackman N","year":"2009","unstructured":"Mackman N. The role of tissue factor and factor VIIa in hemostasis. Anesth Analg. 2009;108(5):1447-1452.","journal-title":"Anesth Analg"},{"issue":"1","key":"e_1_3_4_27_2","doi-asserted-by":"crossref","first-page":"34","DOI":"10.1111\/hae.12518","article-title":"Safety and efficacy of turoctocog alfa (NovoEight\u00ae) during surgery in patients with haemophilia A: Results from the multinational guardian\u2122 clinical trials","volume":"21","author":"Santagostino E","year":"2015","unstructured":"Santagostino E, Lentz SR, Misgav M, et al. Safety and efficacy of turoctocog alfa (NovoEight\u00ae) during surgery in patients with haemophilia A: Results from the multinational guardian\u2122 clinical trials. Haemophilia. 2015;21(1):34-40.","journal-title":"Haemophilia"},{"issue":"1","key":"e_1_3_4_28_2","doi-asserted-by":"crossref","first-page":"52","DOI":"10.1160\/TH07-06-0409","article-title":"Safety and efficacy of sucrose-formulated full-length recombinant factor VIII: Experience in the standard clinical setting","volume":"99","author":"Musso R","year":"2008","unstructured":"Musso R, Santagostino E, Faradji A, et al. Safety and efficacy of sucrose-formulated full-length recombinant factor VIII: Experience in the standard clinical setting. Thromb Haemost. 2008;99(1):52-58.","journal-title":"Thromb Haemost"}],"container-title":["Clinical and Applied Thrombosis\/Hemostasis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10760296251329329","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/10760296251329329","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10760296251329329","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T14:05:08Z","timestamp":1777385108000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/10760296251329329"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,3,21]]},"references-count":27,"alternative-id":["10.1177\/10760296251329329"],"URL":"https:\/\/doi.org\/10.1177\/10760296251329329","relation":{},"ISSN":["1076-0296","1938-2723"],"issn-type":[{"value":"1076-0296","type":"print"},{"value":"1938-2723","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,3,21]]},"article-number":"10760296251329329"}}