OBJECTIVES:

The most recent interim analysis of the HEM-POWR study (NCT03932201) demonstrated the effectiveness and safety of damoctocog alfa pegol in previously treated patients (PTPs) with haemophilia A in a real-word setting. This post-hoc subgroup analysis aims to establish damoctocog alfa pegol utilisation during routine clinical practice.

METHODS:

HEM-POWR is an ongoing prospective, Phase 4, non-interventional, open-label cohort study in PTPs aged ≥12 years with mild, moderate or severe haemophilia A. Primary endpoints included annualised bleeding rate; data on treatment utilisation and FVIII consumption were collected by patients in e-diaries.

RESULTS:

At the second interim data cut-off (31 August 2021), 31 patients from the full-analysis set had nearly complete prophylaxis documentation of diary, defined as ≥90 days in study observation period with ≤10 days between entries, and were included in this analysis. All patients (n=21, 10 missing) received FVIII replacement therapy prior to study initiation, either with damoctocog alfa pegol or another FVIII product. Most patients were from Japan (n=15; 48.4%) and Canada (n=10; 32.3%) and were aged ≥18 years (n=28; 90.3%).

Prior to the initiation of damoctocog alfa pegol prophylaxis, the mean (SD) dose/week/kg for the patients’ previous FVIII product was 82.7 (39.9) IU/kg with a median (Q1, Q3) dose of 76.9 (51.7, 111.1) IU/kg. During the study observation period, when the same 21 patients received damoctocog alfa pegol prophylaxis, the mean (SD) dose/week/kg was 71.2 (27.4) IU/kg with a median (Q1, Q3) of 68.7 (60.9, 88.1) IU/kg, resulting in an approximate 14% reduction in mean FVIII utilisation with damoctocog alfa pegol compared with other FVIII products.

CONCLUSIONS:

Patients receiving prophylactic treatment with damoctocog alfa pegol demonstrate reduced resource utilisation with lower mean weekly dose per kg compared with other FVIII products, supporting the use of damoctocog alfa pegol in a real-world clinical setting.