OBJECTIVES:

Damoctocog alfa pegol (Jivi^® Bayer) is an extended half-life recombinant factor VIII (rFVIII) approved for the treatment and prophylaxis of bleeding in previously treated hemophilia A patients aged ≥12 years. The clinical efficacy and safety of damoctocog alfa pegol were demonstrated in the PROTECT VIII Phase II/III international multicenter trial. An experience monitoring survey was performed to evaluate physicians’ experience with damoctocog alfa pegol.

METHODS:

A CAWI (Computer Assisted Web Interviewing) survey was performed to assess Italian hematologists’ satisfaction and concern about the drug in clinical practice. It involved 15 centers with patients on prophylaxis with damoctocog alfa pegol for at least 3 months.

RESULTS:

Ninety-one of 1947 patients with hemophilia A without reported inhibitors were treated with damoctocog alfa pegol. The main reasons for switching were reduced injections and the perception of better bleeding control.

Reduced weekly infusions were reported in 89% of patients. Respectively, 80% and 86% of patients reported zero total bleeds and zero joint bleeds, a significant increase compared to previous treatment, where patients with zero total bleeds and joints bleeds were respectively 46% and 55% (p=0.05). According to 71% of respondents, joint function of patients who switched to damoctocog alfa pegol improved. All the clinicians were satisfied with the drug. The reported perception of patient satisfaction was good.

CONCLUSIONS:

This experience monitoring survey confirms the clinical study outcomes: prophylactic use of damoctocog alfa pegol was able to reduce bleeding rate and joint bleeding rate in most patients, improving joint health and patients’ quality of life, and reducing the number of weekly infusions. As a result, the annual drug consumption and overall prophylaxis costs for damoctocog alfa pegol could be reduced in compliance with the dosages indicated in the product characteristics summary.