PB1142 - Canadian Patient Experience on Switching from Octocog Alfa to Extended Half-Life FVIII Damoctocog Alfa Pegol in Patients with Severe Hemophilia A

Tuesday, July 12, 2022

6:30 PM – 7:30 PM

Location: Exhibition

Presentation Format: In-Person

Presenting Author(s)

Davide Matino, MD

Assistant Professor
Department of Medicine, Division of Hematology, McMaster University, Hamilton, ON
Hamilton, Ontario, Canada

Co-Author(s)

KD

Kay Decker

RN
Hamilton Health Scienes
Hamilton, Ontario, Canada
EI

Emma Iserman

Statistical Analyst
Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON
Hamilton, Ontario, Canada
AK

Arun Keepanasseril

Assistant Professor
Department of Health Research Methods, Evidence, and Impact (HEI), McMaster University, Hamilton, Canada
Hamilton, Ontario, Canada
FG

Federico Germini

Assistant Professor
Department of Medicine, McMaster University, Hamilton, ON
Hamilton, Ontario, Canada
Anthony K. Chan, MBBS, FRCP (C), MBBS

Pediatric Hematologist
Department of Pediatrics, McMaster Children's Hospital
Hamilton, Ontario, Canada
LW

Leo Walsh

Research and Data Management: Bleeding Disorders
McMaster University Medical Centre
Hamilton, Ontario, Canada
AI

Alfonso Iorio

Professor
Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON
Hamilton, Ontario, Canada

Background: In Canada, as yet, there are no reports on real-world safety, effectiveness and patient satisfaction outcomes when switching from a previous factor (F)VIII product to the extended half-life recombinant FVIII, damoctocog alfa pegol (BAY 94-9027/Jivi^®).

Aims: To report on changes in effectiveness, utilization, and patient satisfaction when switching to damoctocog alfa pegol prophylaxis from previous standard half-life octocog alfa (BAY 81-8973/Kovaltry^®) treatment in patients with severe hemophilia A aged ≥12 years in a Canadian real-world setting.

Methods: This observational, retrospective, intra-patient comparison study uses real-world data collected at the Hamilton-Niagara Regional Hemophilia Treatment Centre. Patients with severe hemophilia A (FVIII:C < 0.01 IU/mL) aged ≥12 years receiving octocog alfa prophylaxis for ≥9 months and willing to switch to damoctocog alfa pegol were included and were observed for 9 months pre- and post-switch. Clinical outcomes included annualized bleeding rate and quality-of-life (QoL) evaluations (Patient Reported Outcomes, Burdens and Experiences [PROBE]).

Results: Clinical outcomes data were available for 18 patients. Median annualized bleeding rates following the switch to damoctocog alfa pegol are shown in Table 1. For damoctocog alfa pegol vs octocog alfa, the median (Q1;Q3) number of infusions per week was 2.20 (2.01;2.98) vs 2.67 (2.09;2.93), respectively and the median annualized recorded FVIII utilization was 3819.6 (2980.9;4564.8) vs 4348.7 (3769.0;5156.5) IU/kg/year, respectively. QoL was maintained following the switch: median (Q1;Q3) improvement in PROBE score was 0.02 (−0.08;0.07, n=12).

Conclusion(s): These data provide real-world evidence supporting the use of damoctocog alfa pegol as an effective alternative therapy for patients with severe hemophilia A currently receiving octocog alfa. Improved clinical outcomes were observed following this switch even when patients’ QoL and bleeding control were well-maintained with octocog alfa. Long-term observation of patients on damoctocog alfa pegol prophylaxis may reveal progressive improvement in clinical outcomes and/or QoL. Study sponsored by Hemalytic, Inc.