{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,19]],"date-time":"2026-02-19T22:18:30Z","timestamp":1771539510504,"version":"3.50.1"},"reference-count":17,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2021,5,9]],"date-time":"2021-05-09T00:00:00Z","timestamp":1620518400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100016300","name":"Octapharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100016300","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Haemophilia"],"published-print":{"date-parts":[[2021,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>The use of pharmacokinetic assessment for optimal prophylactic dosing of factor concentrates in haemophilia has gained increasing enthusiasm over the last decade. However, blood sampling on several occasions is burdensome and limited sampling using population\u2010based PK is appealing.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To compare the pharmacokinetics and dosing recommendations for prophylaxis using six\u2010point single subject versus population\u2010based method (WAPPS\u2010Hemo) for simoctocog alfa (Nuwiq<jats:sup>\u00ae<\/jats:sup>).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Twelve adult patients with severe haemophilia A received a factor VIII (FVIII) dose of \u224850\u00a0IU\/kg, and the activity was measured pre\u2010infusion and at 30\u00a0min, 6, 9, 24 and 48\u00a0h post\u2010infusion. Half\u2010life (t<jats:sup>1<\/jats:sup>\/<jats:sub>2<\/jats:sub>), weight\u2010normalized AUC and time to troughs of 5%, 3% and 1% were calculated. The correlation between the PK algorithms was assessed using intraclass correlations (ICC) and dosing estimations were provided.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>WAPPS\u2010Hemo yielded a slightly longer mean t<jats:sup>1<\/jats:sup>\/<jats:sub>2<\/jats:sub>, but the overall correlation between the methods was good (ICC \u22650.79) The time to troughs of 5%, 3% and 1% showed ICCs \u22650.86. For all variables, the most converging limited time point was 6+48\u00a0h. Additional time points did not improve the correlation. Despite similar pharmacokinetics, the mean estimated dose for a specific trough level varied from 60% less to 20% more using the population\u2010based approach. The time to 1% and the corresponding dose was sensitive to the baseline assumption.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Our data support the use of population\u2010based PK for patients on simoctocog alfa prophylaxis but also indicates differences, stressing the importance of the sampling scheme and monitoring actual FVIII levels achieved.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hae.14329","type":"journal-article","created":{"date-parts":[[2021,5,9]],"date-time":"2021-05-09T08:49:11Z","timestamp":1620550151000},"page":"626-633","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Comparison of single subject and population\u2010based pharmacokinetics for optimizing prophylaxis with simoctocog alfa in patients with haemophilia A"],"prefix":"10.1111","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8500-2483","authenticated-orcid":false,"given":"Jan","family":"Astermark","sequence":"first","affiliation":[{"name":"Department of Translational Medicine Lund University Malm\u00f6 Sweden"},{"name":"Department of Hematology, Oncology and Radiation Physics Sk\u00e5ne University Hospital Malm\u00f6 Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna","family":"Olsson","sequence":"additional","affiliation":[{"name":"Department of Medicine Region V\u00e4stra G\u00f6taland Sahlgrenska University Hospital Gothenburg Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pierre","family":"Chelle","sequence":"additional","affiliation":[{"name":"School of Pharmacy University of Waterloo Waterloo Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kinga","family":"T\u00e4ckstr\u00f6m","sequence":"additional","affiliation":[{"name":"Octapharma Nordic AB Stockholm Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria","family":"Walger","sequence":"additional","affiliation":[{"name":"Octapharma Nordic AB Stockholm Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria","family":"Magnusson","sequence":"additional","affiliation":[{"name":"Karolinska Institutet Coagulation Unit Department of Hematology Department of Pediatrics, CLINTEC Clinical Chemistry &amp; Coagulation, MMK Karolinska University Hospital Stockholm Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alfonso","family":"Iorio","sequence":"additional","affiliation":[{"name":"Department of Health Research Methods, Evidence, and Impact McMaster University Hamilton ON Canada"},{"name":"Department of Medicine McMaster University Hamilton ON Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,5,9]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2516.2011.02723.x"},{"issue":"9","key":"e_1_2_9_3_1","first-page":"CDOO3429","article-title":"Clotting factor concentrates given to prevent bleeding and bleeding\u2010related complications in people with haemophilia A or B","author":"Iorio A","year":"2011","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_9_4_1","first-page":"165","article-title":"Prophylaxis in haemophilia should be life\u2010long","volume":"10","author":"Makris M","year":"2012","journal-title":"Blood Transfus"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1538-7836.2009.03703.x"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.12216"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.12188"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2516.9.s1.8.x"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2516.2010.02370.x"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0038-1646423"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/jth.13867"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/jth.12055"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.13251"},{"key":"e_1_2_9_14_1","unstructured":"Certara L.P. 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