Managing surgery in hemophilia with recombinant factor VIII Fc and factor IX Fc: Data on safety and effectiveness from phase 3 pivotal studies
Background Surgical procedures impose hemostatic risk to people with hemophilia, which may be minimized by optimal factor (F) replacement therapy. Methods This analysis evaluates the efficacy and safety of extended half‐life factor replacement recombinant FVIII and FIX Fc fusion proteins (rFVIIIFc a...
Saved in:
Published in | Research and practice in thrombosis and haemostasis Vol. 6; no. 5; pp. e12760 - n/a |
---|---|
Main Authors | , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
United States
Elsevier Limited
01.07.2022
John Wiley and Sons Inc Elsevier |
Subjects | |
Online Access | Get full text |
Cover
Loading…
Summary: | Background
Surgical procedures impose hemostatic risk to people with hemophilia, which may be minimized by optimal factor (F) replacement therapy.
Methods
This analysis evaluates the efficacy and safety of extended half‐life factor replacement recombinant FVIII and FIX Fc fusion proteins (rFVIIIFc and rFIXFc) during surgery in phase 3 pivotal (A‐LONG/Kids A‐LONG and B‐LONG/Kids B‐LONG) and extension (ASPIRE and B‐YOND) studies. Dosing regimens were determined by investigators. Injection frequency, dosing, blood loss, transfusions, and hemostatic response were assessed.
Results
Forty‐five major (n = 31 subjects) and 90 minor (n = 70 subjects) procedures were performed in hemophilia A; 35 major (n = 22) and 62 minor (n = 37) procedures were performed in hemophilia B. Unilateral knee arthroplasty was the most common major orthopedic procedure (hemophilia A: n = 15/34; hemophilia B: n = 8/24). On the day of surgery, median total dose in adults/adolescents was 81 IU/kg for rFVIIIFc and 144 IU/kg for rFIXFc; most major procedures required ≤2 injections (including loading dose). Through days 1–14, most major procedures had ≤1 injection/day. Hemostasis was rated excellent (rFVIIIFc: n = 39/42; rFIXFc: n = 29/33) or good (n = 3/42; n = 4/33) in evaluable major surgeries, with blood loss comparable with subjects without hemophilia. Most minor procedures in adults/adolescents required one injection on the day of surgery, including median loading dose of 51 IU/kg (rFVIIIFc) and 80 IU/kg (rFIXFc). No major treatment‐related safety concerns were identified. No subjects developed inhibitors or serious vascular thromboembolic events.
Conclusions
rFVIIIFc and rFIXFc were efficacious and well tolerated for the management of perioperative hemostasis across a wide spectrum of major and minor surgeries in hemophilia. |
---|---|
Bibliography: | Funding information This study was sponsored by Sanofi and Sobi. This article was based on data from the A‐LONG, Kids A‐LONG, ASPIRE, B‐LONG, Kids B‐LONG, B‐YOND studies ClinicalTrials.gov Chris Barnowski: Employee at time of study. Currently affiliated with Alexion, AstraZeneca Rare Disease http://www.ismpp.org/gpp3 identifiers: NCT01181128, NCT01458106, NCT01454739, NCT01027364, NCT01440946, NCT01425723), sponsored by Sobi and Sanofi. Support for third‐party writing assistance for this article, provided Abbie Rogers, BSc, and Jessica Patel, PhD, Costello Medical, UK, was funded by Sobi and Sanofi in accordance with Good Publication Practice (GPP3) guidelines Handling Editor: Dr Michelle Sholzberg . ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 This study was sponsored by Sanofi and Sobi. This article was based on data from the A‐LONG, Kids A‐LONG, ASPIRE, B‐LONG, Kids B‐LONG, B‐YOND studies (ClinicalTrials.gov identifiers: NCT01181128, NCT01458106, NCT01454739, NCT01027364, NCT01440946, NCT01425723), sponsored by Sobi and Sanofi. Support for third‐party writing assistance for this article, provided Abbie Rogers, BSc, and Jessica Patel, PhD, Costello Medical, UK, was funded by Sobi and Sanofi in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3). |
ISSN: | 2475-0379 2475-0379 |
DOI: | 10.1002/rth2.12760 |