Successful Use of rFVIII, Turoctocog Alfa, during Orthopedic and Nonorthopedic Surgery in Patients with Severe Hemophilia A

Introduction

Recombinant factor VIII can be used to provide hemostatic coverage during surgery in patients with hemophilia A (Santagostino E, et al. Haemophilia 2015;21(1):34–40). Turoctocog alfa is a third-generation, human recombinant B-domain truncated FVIII molecule that has previously been found to be safe and effective in a limited number of patients with hemophilia A undergoing surgery (Santagostino, et al. Haemophilia 2015;21(1):34–40). We report new, previously unreported data that support and extend the findings of this publication.

Objectives

The primary objective was to assess the clinical safety and hemostatic effect of turoctocog alfa in patients with severe hemophilia A (FVIII ≤1%) undergoing surgery in the ongoing guardian™2 clinical trial (interim cut-off date, 31 December 2013). Hemostatic outcomes were assessed according to a predefined 4-point scale: excellent, good, moderate, none. Secondary objectives included consumption of turoctocog alfa; comparison of actual and anticipated blood loss; hemoglobin level prior to, during, and after surgery; and use of blood-product transfusions.

Methods

A total of 57 procedures were performed in 40 patients aged 2–57 years with severe hemophilia A and no history of inhibitors (patients <12 years and ≥12 years had ≥50 and ≥150 exposure days prior to surgery, respectively). Before, during, and after surgery, turoctocog alfa dosing was at the investigators’ discretion. Only 1 patient received continuous infusion during surgery. In 12 major (9 orthopedic) and 3 minor surgeries on 15 patients (aged 6–56 years) data on hemostatic outcomes were collected during and after surgery (5 of the major surgeries have been presented previously [Santagostino E, et al. Haemophilia 2015;21(1):34–40]). In 42 other surgical procedures (those requiring <7 days of surgery-related treatment with turoctocog alfa) on 31 patients (aged 2–57 years), data were collected during the procedure only.

Results

Turoctocog alfa provided successful (defined as ‘excellent’ or ‘good’ hemostatic outcome) coverage in 15/15 (100%) major or minor surgeries where data were collected during and after surgery. Successful outcomes were reported in 41/42 (98%) other surgical procedures; 1 endoscopy procedure was not provided with a rating. None of the patients developed FVIII inhibitors during the surgery period, and no safety concerns were observed when reviewing adverse events, consumption of turoctocog alfa, blood loss, hemoglobin levels, or use of blood-product transfusions.

Conclusions

The success rate for hemostatic response during both major and minor surgeries was 100%. No inhibitors or other safety concerns were identified. Turoctocog alfa has a favorable efficacy and safety profile that makes it suitable for use in patients with severe hemophilia A undergoing surgery.