{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,16]],"date-time":"2026-05-16T11:52:07Z","timestamp":1778932327668,"version":"3.51.4"},"reference-count":31,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2016,3,31]],"date-time":"2016-03-31T00:00:00Z","timestamp":1459382400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Haemophilia"],"published-print":{"date-parts":[[2016,9]]},"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Collecting clinical data under routine conditions remains important to monitor continuously efficacy and tolerability of an established product.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>This prospective observational study aimed at evaluating efficacy and tolerability of full\u2010length sucrose\u2010formulated recombinant <jats:styled-content style=\"fixed-case\">FVIII<\/jats:styled-content> (<jats:styled-content style=\"fixed-case\">rFVIII<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">FS<\/jats:styled-content>;<jats:styled-content style=\"fixed-case\"> KOGENATE<\/jats:styled-content><jats:sup>\u00ae<\/jats:sup> Bayer\/<jats:styled-content style=\"fixed-case\">KOGENATE<\/jats:styled-content><jats:sup>\u00ae<\/jats:sup> <jats:styled-content style=\"fixed-case\">FS<\/jats:styled-content>) in routine use and analysing concomitant diseases and medication.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Haemophilia A patients treated with <jats:styled-content style=\"fixed-case\">rFVIII<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">FS<\/jats:styled-content> were followed up for 24 or 36 months. Efficacy, tolerability, concomitant medication and diseases were assessed at yearly intervals.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Two hundred and twenty\u2010one documented patients were mainly pretreated, predominantly with prophylaxis (74%). On study, 54 (31%) patients in the efficacy set (<jats:italic>n<\/jats:italic> = 174) documented regular prophylaxis, 91 patients (52.3%) failed to document their prescribed prophylactic infusions, 25 (14.4%) received on\u2010demand treatment and four patients (2%) inhibitor adapted therapy. Patients on regular prophylaxis reported 8.4% of infusions for bleeding treatment and on\u2010demand patients reported 55.3%. Young patients experienced mainly trauma\u2010related bleedings and older patients reported spontaneous bleedings. Joint status was good overall. Median annual spontaneous joint bleeding rate in all groups was zero. A total of 79.0% of all bleedings were successfully treated with one or two infusions. Degenerative arthropathy and arterial hypertension were the most prominent concomitant diseases. Eighty\u2010seven patients (40.5%) took at least one concomitant drug on study, mostly drugs for pain treatment related to haemophilic arthropathy. Two patients presented with positive inhibitor titres on study, one of them was a previously untreated patient and the other had a positive inhibitor history.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This study corroborates the tolerability and efficacy profile of <jats:styled-content style=\"fixed-case\">rFVIII<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">FS<\/jats:styled-content>.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hae.12941","type":"journal-article","created":{"date-parts":[[2016,3,31]],"date-time":"2016-03-31T23:06:00Z","timestamp":1459465560000},"page":"684-691","source":"Crossref","is-referenced-by-count":3,"title":["Prospective evaluation of treatment regimens, efficacy and safety of a recombinant factor <scp>VIII<\/scp> concentrate in haemophilia A: the German EffeKt study"],"prefix":"10.1111","volume":"22","author":[{"given":"R.","family":"Klamroth","sequence":"first","affiliation":[{"name":"Abteilung f\u00fcr 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