Safe switching from a pdFIX (Immunine®) to a rFIX (Bax326)

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Safe switching from a pdFIX (Immunine®) to a rFIX (Bax326)†M. H. Solano Trujillo1, O. Stasyshyn2, L. Rusen3, M. Serban4, J. L. Lamas5, F. G. Perina6, T. Urasinski7, M. Oh8, W. B. Knowlton9, B. Valenta-Singer9, B. G. Pavlova9 andB. Abbuehl9,*Article first published online: 10 APR 2014

DOI: 10.1111/hae.12444

© 2014 John Wiley & Sons Ltd

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HaemophiliaEarly View (Online Version of Record published before inclusion in an issue)

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How to CiteSolano Trujillo, M. H., Stasyshyn, O., Rusen, L., Serban, M., Lamas, J. L., Perina, F. G., Urasinski, T., Oh, M., Knowlton, W. B., Valenta-Singer, B., Pavlova, B. G. and Abbuehl, B. (2014), Safe switching from a pdFIX (Immunine®) to a rFIX (Bax326). Haemophilia. doi: 10.1111/hae.12444

Author Information1

Hospital de San Jose FUCS, Bogotá, Colombia

2

Institute of Blood Pathology and Transfusion Medicine of Academy of Medical Sciences of Ukraine, Lviv, Ukraine

3

S.C. Sanador SRL, Bucharest, Romania

4

Louis Turcanu Emergency Clinical Children's Hospital, Timisoara, Romania

5

Dr. Sotero del Rio Hospital, Santiago, Chile

6

Regional Clinical Hospital Ekaterinburg, Ekaterinburg, Russia

7

Department of Paediatrics, Paediatric Hematology and Oncology, Pomeranian Medical University, Szczecin, Poland

8

Baxter Healthcare Corporation, Westlake Village, CA, USA

9

Baxter Innovations GmbH, Vienna, Austria

*Correspondence: Dr. Brigitt E. Abbuehl, Donau-City-Strasse 7, A-1220 Vienna, Austria. Tel.: +43 (0) 1 20 100 2473421; fax: +43 (0) 1 20 100 247 717; e-mail: brigitt_abbuehl@baxter.com

†

Licensed in the USA in 2013 (Rixubis®; Baxter Healthcare Corp., USA).

Publication HistoryArticle first published online: 10 APR 2014Manuscript Accepted: 19 MAR 2014Manuscript Received: 24 JAN 2014Funded byBaxter SEARCH Search Scope All contentPublication titlesIn this journalIn this issue Search String Advanced >Saved Searches > SEARCH BY CITATION Volume: Issue: Page: ARTICLE TOOLSGet PDF (177K)Save to My ProfileE-mail Link to this ArticleExport Citation for this ArticleGet Citation AlertsRequest Permissions AbstractArticleReferencesCited By View Full Article (HTML) Enhanced Article (HTML) Get PDF (177K) Keywords:haemophilia B;pdFIX (Immunine®);previously treated patients;rFIX (Rixubis®);safetySummary

The ability to switch between coagulation factors safely is of common interest to haemophilia patients and treating physicians. This is the first formal prospective comparative evaluation of safety, efficacy and incremental recovery of a plasma-derived FIX (pdFIX) and a recombinant FIX (rFIX) in the same haemophilia B patients following a switch from pdFIX Immunine® to a recently developed rFIX Bax326 product. Patients (aged <65 years) who completed a pretreatment study which prospectively documented the exposure to Immunine® and monitored FIX inhibitors while receiving prophylactic treatment were transitioned into pivotal (patients aged 12–65 years) and paediatric (patients aged <12 years) clinical studies investigating prophylaxis and treatment of bleeding episodes with Bax326. None of the 44 patients developed inhibitory or specific binding anti-FIX antibodies during the course of the studies. A total of 38 unrelated adverse events (AEs) were occurred in 20/44 (45.5%) subjects during the Immunine® study. Following a switch to Bax326, 51 AEs were reported in 25/44 (56.8%) subjects. The incidence of AEs related to Bax326 treatment (two episodes of dysgeusia in one patient) was low (2.3%); there were no serious adverse reactions. The comparison between Immunine® and Bax326 demonstrated analogous haemostatic characteristics and annualized bleeding rates. Overall, there is direct evidence indicating a safe and clinically effective transition from a pdFIX (Immunine®) to a newly developed rFIX (Bax3261) for prophylaxis and treatment of bleeding in previously treated patients of all age cohorts with severe or moderately severe haemophilia B.

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