Evidence map›Paper›PMID 39649130›Full record

ArticleResearch and practice in thrombosis and haemostasis2024

Inhibitor development upon switching from plasma-derived to recombinant factor VIII in previously untreated patients with severe hemophilia A: the PUP-SWITCH study.

Syna Miri, Frits R Rosendaal, Kaan Kavakli, Peyman Eshghi, Soha Mohammadi Moghaddam, Sara Scardo, Behnaz Habibpanah, Mohsen Elalfy, Susan Halimeh, Gabriella Nicolò and 16 more

Abstract read
In one paragraph

Article in Research and practice in thrombosis and haemostasis, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Shaping hemophilia care: lessons and legacy of the SIPPET trial after 10 years.Research and practice in thrombosis and haemostasis · 2026
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors.

Syna MiriAngelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy.
Frits R RosendaalDepartment of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands.
Kaan KavakliEge Hemophilia Center, Pediatric Congenital Hematologic Disorders Research Center, Izmir, Türkiye.
Peyman EshghiPediatric Congenital Hematologic Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Soha Mohammadi MoghaddamPediatric Congenital Hematologic Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Sara ScardoAngelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy.
Behnaz HabibpanahPediatric Congenital Hematologic Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Mohsen ElalfyDepartment of Pediatric Hematology/Oncology, Ain Shams University, Cairo, Egypt.
Susan HalimehCoagulation and Thrombosis Centre, Gerinnungszentrum Rhein Ruhr, Duisburg, Germany.
Gabriella NicolòDepartment of Healthcare Professions, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy.
Dilek GökçebayDepartment of Pediatric Hematology/Oncology and Pediatric Bone Marrow Transplantation Unit, Ankara Bilkent City Hospital, Ankara, Türkiye.
Namık ÖzbekDepartment of Pediatric Hematology/Oncology and Pediatric Bone Marrow Transplantation Unit, Ankara Bilkent City Hospital, Ankara, Türkiye.
Tiraje CelkanDepartment of Pediatric Hematology and Oncology, Cerrahpaşa Faculty of Medicine, İstanbul University, Istanbul, Türkiye.
Ahmad MohammadiEsfahan Hemophilia Treatment Centre, Seyed Shohada Hospital, Esfahan, Iran.
Mehran KarimiPediatric Hematology-Oncology Department, American Hospital Dubai, Dubai, United Arab Emirates.
Amin ShahsavaniHematology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
Bariş YılmazDepartment of Pediatric Health and Diseases, Marmara University, Istanbul, Türkiye.
Canan AlbayrakDepartment of Pediatric Hematology and Oncology BMT Unit, Ondokuz Mayıs University Faculty of Medicine, Samsun, Türkiye.
Burcak Gunesİzmir Tepecik Training and Research Hospital, Clinic of Pediatric Hematology, İzmir, Türkiye.
Zühre KayaDepartment of Pediatric Hematology, Gazi University Faculty of Medicine, Ankara, Türkiye.
Yilmaz AyDepartment of Pediatric Hematology, Pamukkale University Faculty of Medicine, Denizli, Türkiye.
Sinan AkbayramDepartment of Pediatric Hematology and Oncology BMT Unit, Gaziantep University Faculty of Medicine, Gaziantep, Türkiye.
Nazan SarperDepartment of Pediatric Hematology, Kocaeli University School of Medicine, Kocaeli, Türkiye.
Pier Mannuccio MannucciAngelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy.
Flora PeyvandiAngelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy.
PUP-SWITCH Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

factor VIIIfactor VIII/adverse eventsfactor VIII/immunologyfactor VIII/therapeutic usehemophilia A/drug therapy

Identifiers

PMID39649130
PMCPMC11625208

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.