Immune Tolerance Induction With a Recombinant Factor VIII Fc in Haemophilia A: Data From a Chart Review Study.

ABSTRACT:

Objective

To report data from an ITI chart review study (NCT03951103) for first-time and rescue ITI with recombinant factor VIII Fc fusion protein (rFVIIIFc) in persons with haemophilia A.

Methods

Retrospective and prospective real-world data are reported from a non-interventional, multicentre study of patients who had been or were currently being treated with rFVIIIFc ITI. ITI treatment outcome (defined by investigators) and regimens are reported.

Results

Forty-one patients from 16 sites were included. First-time ITI was used in 24 patients; 16 had an ITI outcome at study end. Thirteen patients (81.3%) had ITI success, and three had failure. Median (range) rFVIIIFc consumption was 300 (61-2800) IU/kg/week, and most (70.8%) used ≤ 300 IU/kg/week. The vast majority of

SUBMITTER: Klamroth R 

PROVIDER: S-EPMC12224564 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature