Efficacy and safety of damoctocog alfa pegol prophylaxis in patients ⩾40 years with severe haemophilia A and comorbidities: analysis from the PROTECT VIII study
| Title: | Efficacy and safety of damoctocog alfa pegol prophylaxis in patients ⩾40 years with severe haemophilia A and comorbidities: analysis from the PROTECT VIII study |
|---|---|
| Authors: | Mark T. Reding, Ingrid Pabinger, Pål Andrè Holme, Monika Maas Enriquez, Maria Elisa Mancuso, Shadan Lalezari, Wolfgang Miesbach, Giovanni Di Minno, Robert Klamroth, Cedric Hermans |
| Source: | Therapeutic Advances in Hematology, Vol 14 (2023) |
| Publisher Information: | SAGE Publishing, 2023. |
| Publication Year: | 2023 |
| Collection: | LCC:Diseases of the blood and blood-forming organs |
| Subject Terms: | Diseases of the blood and blood-forming organs, RC633-647.5 |
| More Details: | Background: Advances in treatment have enabled patients with haemophilia A to live longer and therefore may be subjected to comorbidities associated with ageing, in addition to disease-associated morbidities. There have been few reports to date on efficacy and safety of treatment specifically in patients with severe haemophilia A and comorbidities. Objective: To explore the efficacy and safety of damoctocog alfa pegol prophylaxis in patients with severe haemophilia A aged ⩾40 years with comorbidities of interest. Design: A post hoc analysis of data from the phase 2/3 PROTECT VIII study and its extension. Methods: Bleeding and safety outcomes were analysed in a subgroup of patients aged ⩾40 years with ⩾1 comorbidity receiving damoctocog alfa pegol (BAY 94-9027; Jivi ® ) prophylaxis. Results: Thirty-four patients with severe haemophilia A were included in this analysis, with a mean age of 49.4 years at time of enrolment. The most prevalent comorbidities were hepatitis C ( n = 33; chronic, n = 23), hepatitis B ( n = 8) and hypertension ( n = 11). Four patients had human immunodeficiency virus. All received damoctocog alfa pegol prophylaxis for the entire study [median (range) time in study = 3.9 (1.0–6.9) years]. During the main study and extension, median total annualised bleeding rates (ABRs) (Q1; Q3) were 2.1 (0.0; 5.8) and 2.2 (0.6; 6.0), respectively; median joint ABRs were 1.9 (0.0; 4.4) and 1.6 (0.0; 4.0), respectively. Mean adherence with prophylaxis schedule was greater than 95% throughout the study. No deaths or thrombotic events were reported. Conclusion: Efficacy, safety and adherence of damoctocog alfa pegol were confirmed in patients aged ⩾40 years with haemophilia A and one or more comorbidities, with data for up to 7 years supporting its use as a long-term treatment option in this group. |
| Document Type: | article |
| File Description: | electronic resource |
| Language: | English |
| ISSN: | 2040-6215 20406207 |
| Relation: | https://doaj.org/toc/2040-6215 |
| DOI: | 10.1177/20406207231166779 |
| Access URL: | https://doaj.org/article/3106ae96a0814ef99d906c776d898f7c |
| Accession Number: | edsdoj.3106ae96a0814ef99d906c776d898f7c |
| Database: | Directory of Open Access Journals |
| ISSN: | 20406215 20406207 |
|---|---|
| DOI: | 10.1177/20406207231166779 |
| Published in: | Therapeutic Advances in Hematology |
| Language: | English |