Inhibitor development upon switching from plasma-derived to recombinant factor VIII in previously untreated patients with severe hemophilia A: the PUP-SWITCH study
Research and Practice in Thrombosis and Haemostasis, vol. 8, pp. 102595
Abstract
Background: The SIPPET randomized clinical trial showed that in previously untreated patients (PUPs) with severe hemophilia A, treatment with plasma-derived factor (F)VIII (pdFVIII) within the first 50 exposure days (EDs) was associated with a lower cumulative incidence of inhibitors than with recombinant FVIII (rFVIII). Switching to rFVIII beyond 50 EDs with pdFVIII is a treatment often implemented by many centers. The question is whether or not this switch may induce a risk of inhibitor development. Objectives: We investigated if in PUPs with severe hemophilia A switched after 50 EDs from pdFVIII to rFVIII, a novel inhibitor peak appears. Methods: The PUP-SWITCH observational retrospective study was designed to investigate the cumulative incidence of novel inhibitors after switching PUPs to rFVIII after 50 and before 150 EDs. Hemophilia centers that routinely switched PUPs from pdFVIII to rFVIII within this exposure time frame were invited to participate. Patients were followed up for at least 50 EDs after the switch. Results: Ninety-seven patients were evaluated, and 87 were included according to eligibility criteria between 2020 and 2022. Only one of them developed an inhibitor 20 EDs after switching, so the cumulative incidence was 1.15% (95% CI, 0.03%-6.24%). Conclusion: PUP-SWITCH, a study focusing on PUPs undergoing a product class switch from pdFVIII to rFVIII after 50 EDs, showed that switching appears to be safe pertaining to the risk of development of new inhibitors.
Authors 25
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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Affiliation as printed
Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy
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Leiden University Medical Center
Affiliation as printed
Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands
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Affiliation as printed
Ege Hemophilia Center, Pediatric Congenital Hematologic Disorders Research Center, Izmir, Türkiye
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Shahid Beheshti University of Medical Sciences
Affiliation as printed
Pediatric Congenital Hematologic Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
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Shahid Beheshti University of Medical Sciences
Affiliation as printed
Pediatric Congenital Hematologic Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Affiliation as printed
Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy
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Shahid Beheshti University of Medical Sciences
Affiliation as printed
Pediatric Congenital Hematologic Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
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Affiliation as printed
Department of Pediatric Hematology/Oncology, Ain Shams University, Cairo, Egypt
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Affiliation as printed
Coagulation and Thrombosis Centre, Gerinnungszentrum Rhein Ruhr, Duisburg, Germany
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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Affiliation as printed
Department of Healthcare Professions, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy
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Affiliation as printed
Department of Pediatric Hematology/Oncology and Pediatric Bone Marrow Transplantation Unit, Ankara Bilkent City Hospital, Ankara, Türkiye
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Affiliation as printed
Department of Pediatric Hematology/Oncology and Pediatric Bone Marrow Transplantation Unit, Ankara Bilkent City Hospital, Ankara, Türkiye
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Istanbul University-Cerrahpaşa · Istanbul University
Affiliation as printed
Department of Pediatric Hematology and Oncology, Cerrahpaşa Faculty of Medicine, İstanbul University, Istanbul, Türkiye
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Affiliation as printed
Esfahan Hemophilia Treatment Centre, Seyed Shohada Hospital, Esfahan, Iran
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Dubai Health Authority · Shiraz University · Shiraz University of Medical Sciences
Affiliation as printed
Hematology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
Pediatric Hematology-Oncology Department, American Hospital Dubai, Dubai, United Arab Emirates
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Shiraz University · Shiraz University of Medical Sciences
Affiliation as printed
Hematology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
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Affiliation as printed
Department of Pediatric Health and Diseases, Marmara University, Istanbul, Türkiye
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Affiliation as printed
Department of Pediatric Hematology and Oncology BMT Unit, Ondokuz Mayıs University Faculty of Medicine, Samsun, Türkiye
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Izmir Tepecik Eğitim ve Araştırma Hastanesi
Affiliation as printed
İzmir Tepecik Training and Research Hospital, Clinic of Pediatric Hematology, İzmir, Türkiye
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Affiliation as printed
Department of Pediatric Hematology, Gazi University Faculty of Medicine, Ankara, Türkiye
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Affiliation as printed
Department of Pediatric Hematology, Pamukkale University Faculty of Medicine, Denizli, Türkiye
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Affiliation as printed
Department of Pediatric Hematology and Oncology BMT Unit, Gaziantep University Faculty of Medicine, Gaziantep, Türkiye
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Affiliation as printed
Department of Pediatric Hematology, Kocaeli University School of Medicine, Kocaeli, Türkiye
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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Affiliation as printed
Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy
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Flora Peyvandi corresponding
University of Milan · Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Affiliation as printed
Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy
Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy
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