Experience with Continuous Infusion of Recombinant Porcine FVIII in Patients with Acquired Hemophilia a
Notice bibliographique
Résumé
Background: Acquired hemophilia A (AHA) is a rare disorder with high morbidity and mortality that results from the development of autoantibodies against factor VIII (FVIII). To manage acute bleeding, recombinant porcine FVIII (rpFVIII) can be administered intravenously as a bolus dose of 50IU/kg to 200IU/kg depending on bleeding severity and the level of baseline cross-reacting anti-porcine FVIII inhibitors(Kruse-Jarres et al., 2017). Here we describe the efficacy of rpFVIII used as a continuous infusion (CI) and compare total product utilization to bolus infusions (BI). Methods: Retrospective chart review was conducted on patients with AHA who met the International Society on Thrombosis and Hemostasis criteria for major bleeding and who received rpFVIII at our institution from 2015 to 2020(Kaatz, Ahmad, Spyropoulos, & Schulman, 2015). Efficacy was defined as clinical bleeding control and achievement of adequate FVIII levels. Data were collected through electronic patient records and analyzed using simple descriptive (mean ± standard deviation (SD)) and inferential statistics (T-Test, alpha=0.05). Institutional Research Ethics Board approval was obtained. Results: During the study period, 13 patients received rpFVIII (CI n=3, BI n=10). The mean age of patients receiving CI and BI was 75.3 years (SD 2.5) and 72.0 years (SD 14.5) respectively. All patients who received rpFVIII as a CI received a bolus dose ranging between 102.6IU/kg-200.8IU/kg prior to initiation of the CI. CI rates between 3.4IU/kg/hr-11.5IU/kg/hr were administered. Two of the patients receiving rpFVIII as a CI had their infusion rates adjusted according to their clinical symptoms and FVIII levels. One patient had the rpFVIII CI stopped due to an increase in anti-rpFVIII antibodies which interfered with hemostatic efficacy. Thirty-three percent of CI patients and 60% of BI patients required a red blood cell (RBC) transfusion after starting rpFVIII. Sixty-six percent of CI patients and 20% of BI patients had worsening of bleeding after initiation of rpFVIII. Lastly, rpFVIII usage in the CI group (170.4 ± 25.9 IU/kg/day) was not significantly different compared to the BI group (120.9 ± 64.4 IU/kg/day) when accounting for the duration of admission and weight of the patients (P>0.05). No thromboembolic events occurred in either group while receiving rpFVIII. Conclusions: Our study shows that the total amount of rpFVIII administered to patients as a CI is not significantly different to those receiving BI. The CI group required less RBC transfusions but reported more exacerbation of bleeding. Thus, the efficacy of rpFVIII given as a CI requires further evaluation in future prospective studies. Disclosures Sholzberg: NovoNordisk: Honoraria, Other: Scientific Advisory Board; Novartis: Honoraria, Other: Scientific Advisory Board; Takeda: Honoraria, Other: Scientific Advisory Board, Research Funding; Octapharma: Honoraria, Other: Scientific Advisory Board, Research Funding; Amgen: Honoraria, Other: Scientific Advisory Board, Research Funding. OffLabel Disclosure: Antihemophilic Factor (Recombinant), Porcine Sequence (OBIZUR) is a purified protein produced by recombinant DNA that is a B-domain deleted recombinant factor VIII, porcine sequence, manufactured in tissue culture in baby hamster kidney (BHK) cells. OBIZUR is indicated for the treatment of bleeding episodes in patients with Acquired Hemophilia A (AHA). OBIZUR is administered as a bolus infusion.
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Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,004 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,001 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».