H Platokouki1, K Fischer2, S C Gouw3, A Rafowicz4, M Carcao5, G Kenet6, R Liesner7, K Kurnik8, G E Rivard9, H M van den Berg10. 1. Haemophilia-Haemostasis Unit, St. Sophia Children's Hospital, Athens, Greece. 2. Van Creveldkliniek, University Medical Centre Utrecht, Utrecht, The Netherlands. 3. Department of Paediatric Haematology, Academic Medical Centre Amsterdam, Emma Children's Hospital, Amsterdam, The Netherlands. 4. Centre de Référence pour le Traitement des Maladies Hémorragiques (CRTH), Hôpital Bicêtre, Paris, France. 5. Division of Haematology/Oncology, Department of Paediatrics and Child Health Evaluative Sciences, Research Institute, Hospital for Sick Children, Toronto, ON, Canada. 6. National Haemophilia Centre, Ministry of Health, Sheba Medical Center, Tel Hashomer, Israel. 7. Department of Haematology, Haemophilia Centre, Great Ormond Street Hospital for Children, London, UK. 8. Dr. v. Haunersches Kinderspital, University of Munich, Munich, Germany. 9. Division of Haematology/Oncology, Hôpital St. Justine, Montréal, QC, Canada. 10. PedNet Haemophilia Research Foundation, Mollerusstraat1, 3743BW, Baarn, The Netherlands.
Abstract
BACKGROUND: Inhibitor development in previously untreated patients (PUPs) with severe haemophilia A is a multifactorial event. It is unknown whether paediatric vaccinations given in close proximity to factor VIII (FVIII) are associated with inhibitor development. OBJECTIVE: To assess whether paediatric vaccinations in close proximity to FVIII within the first 75 exposure days (EDs) are associated with inhibitor development in PUPs with severe haemophilia A. METHODS: We included 375 PUPs with severe haemophilia A (<0.01 IU/mL) from the PedNet Registry who had received vaccinations between the first and 75th ED or inhibitor development. Inhibitor risk was compared between patients who did and who did not receive vaccinations within 24, 72 or 120 hours of FVIII infusion. Unadjusted and adjusted hazard ratios were calculated for any or repeated vaccinations in close proximity to FVIII, using Cox regression. RESULTS: Inhibitor development occurred in 77 of 375 patients (20.5%). Overall inhibitor development appeared similar or lower in patients receiving vaccinations in close proximity to FVIII as compared to patients receiving vaccinations without FVIII: for 24 hours, this was 19.2% and 21.4% (P = .186), for 72 hours, 16.4% and 27.3% (P = .023) and for 120 hours, 18.3% and 25.0% (P = .085), respectively. CONCLUSION: We found no association between vaccinations given in close proximity to FVIII exposure within the first 75 EDs and inhibitor development. Our data do not support avoiding administration of FVIII at time of routine vaccinations.
BACKGROUND: Inhibitor development in previously untreated patients (PUPs) with severe haemophilia A is a multifactorial event. It is unknown whether paediatric vaccinations given in close proximity to factor VIII (FVIII) are associated with inhibitor development. OBJECTIVE: To assess whether paediatric vaccinations in close proximity to FVIII within the first 75 exposure days (EDs) are associated with inhibitor development in PUPs with severe haemophilia A. METHODS: We included 375 PUPs with severe haemophilia A (<0.01 IU/mL) from the PedNet Registry who had received vaccinations between the first and 75th ED or inhibitor development. Inhibitor risk was compared between patients who did and who did not receive vaccinations within 24, 72 or 120 hours of FVIII infusion. Unadjusted and adjusted hazard ratios were calculated for any or repeated vaccinations in close proximity to FVIII, using Cox regression. RESULTS: Inhibitor development occurred in 77 of 375 patients (20.5%). Overall inhibitor development appeared similar or lower in patients receiving vaccinations in close proximity to FVIII as compared to patients receiving vaccinations without FVIII: for 24 hours, this was 19.2% and 21.4% (P = .186), for 72 hours, 16.4% and 27.3% (P = .023) and for 120 hours, 18.3% and 25.0% (P = .085), respectively. CONCLUSION: We found no association between vaccinations given in close proximity to FVIII exposure within the first 75 EDs and inhibitor development. Our data do not support avoiding administration of FVIII at time of routine vaccinations.
Authors: Davide Matino; Sajjad Afraz; George Zhao; Paul Tieu; Marco Gargaro; Francesca Fallarino; Alfonso Iorio Journal: Front Immunol Date: 2020-04-15 Impact factor: 7.561
Authors: Radoslaw Kaczmarek; Magdy El Ekiaby; Daniel P Hart; Cedric Hermans; Mike Makris; Declan Noone; Brian O'Mahony; David Page; Flora Peyvandi; Steven W Pipe; Thomas Sannié; Uwe Schlenkrich; Mark W Skinner; Alok Srivastava; Amanda Bok; Glenn F Pierce Journal: Haemophilia Date: 2021-03-02 Impact factor: 4.263