التفاصيل البيبلوغرافية
| العنوان: |
Real‐world safety and effectiveness of recombinant porcine sequence factor VIII in acquired haemophilia A: A non‐interventional, post‐authorization safety study |
| المؤلفون: |
Tarantino, Michael D., Hardesty, Brandon, Metjian, Ara, Ortel, Thomas L., Chen, Jie, Badejo, Kayode, Ma, Alice, Cuker, Adam, Rajasekhar, Anita, Friedman, Kenneth D., Janbain, Maissaa |
| المصدر: |
Haemophilia ; volume 29, issue 5, page 1259-1268 ; ISSN 1351-8216 1365-2516 |
| بيانات النشر: |
Wiley |
| سنة النشر: |
2023 |
| المجموعة: |
Wiley Online Library (Open Access Articles via Crossref) |
| الوصف: |
Introduction Recombinant porcine factor VIII (rpFVIII, susoctocog alfa) is indicated for the treatment of bleeding episodes in adults with acquired haemophilia A (AHA). Aim To provide long‐term real‐world safety and effectiveness data for rpFVIII in the management of AHA bleeding episodes. Methods US PASS (NCT02610127) was a multicentre, uncontrolled, open‐label, post‐marketing safety surveillance study conducted in adults with AHA. Data were collected retrospectively or prospectively for 180 days after rpFVIII treatment. The primary outcome was the incidence of treatment‐related serious adverse events (SAEs). Secondary outcomes included haemostatic effectiveness of rpFVIII and rpFVIII utilization. Results Fifty‐three patients were enrolled from December 2015 to June 2019 (prospective, n = 30; retrospective, n = 23). Six patients experienced seven treatment‐related SAEs (incidence 12.0%). The most common treatment‐related SAE was FVIII inhibition (inhibiting antibodies to rpFVIII; incidence 8.0%, 95% CI: 2.2–19.2). Five patients reported seven thromboembolic events; one was an SAE and possibly related to rpFVIII. Of bleeding events treated with rpFVIII, 80.3% (57/71) of bleeds resolved with rpFVIII. The median (range) dose of rpFVIII per infusion was 50 (10–300) units/kg, with a median (range) of 6.0 (1–140) infusions and a median (range) time from bleed onset to bleed resolution of 14.0 (2.0–132.7) days. Conclusion In this real‐world study of rpFVIII for AHA, no new safety signals were identified compared with previous clinical trial findings. Eighty percent of bleeds resolved with rpFVIII treatment. |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
English |
| DOI: |
10.1111/hae.14832 |
| الإتاحة: |
https://doi.org/10.1111/hae.14832Test |
| حقوق: |
http://creativecommons.org/licenses/by-nc/4.0Test/ |
| رقم الانضمام: |
edsbas.5688A4AB |
| قاعدة البيانات: |
BASE |
