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Article ; Online: Comment on: Interpreting data on inhibitor development from previously untreated patient studies, beware of premature conclusions.

Liesner, Dr R J

Haemophilia : the official journal of the World Federation of Hemophilia

2018 Volume 24, Issue 4, Page(s) e273–e275

Language	English
Publishing date	2018-07-13
Publishing country	England
Document type	Letter ; Comment
ZDB-ID	1229713-6
ISSN	1365-2516 ; 1351-8216 ; 1355-0691
ISSN (online)	1365-2516
ISSN	1351-8216 ; 1355-0691
DOI	10.1111/hae.13545
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Zs.A 4249: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Prophylactic treatment of bleeding episodes in children <12 years with moderate to severe hereditary factor X deficiency (FXD): Efficacy and safety of a high-purity plasma-derived factor X (pdFX) concentrate.

Liesner, R / Akanezi, C / Norton, M / Payne, J

Haemophilia : the official journal of the World Federation of Hemophilia

2018 Volume 24, Issue 6, Page(s) 941–949

Abstract: Background: Hereditary factor X (FX) deficiency (FXD) affects 1:500 000-1:1 000 000 people worldwide. A novel, high-purity plasma-derived FX concentrate (pdFX) is available in the United States and European Union as replacement therapy for FXD, but data ...

Abstract	Background: Hereditary factor X (FX) deficiency (FXD) affects 1:500 000-1:1 000 000 people worldwide. A novel, high-purity plasma-derived FX concentrate (pdFX) is available in the United States and European Union as replacement therapy for FXD, but data are scarce on pdFX use in children <12 years. Aim: This prospective, open-label phase 3 study assessed the safety, efficacy and pharmacokinetics of pdFX in children <12 years with moderate/severe FXD. Methods: Subjects aged <12 years with basal plasma FX activity (FX:C) <5 IU/dL received pdFX as prophylactic and on-demand treatment, with doses adjusted to maintain FX:C > 5 IU/dL. After ≥26 weeks and ≥50 exposure days, investigators rated pdFX efficacy for preventing/decreasing bleeds. Secondary endpoints included number and severity of bleeds, trough FX:C and incremental recovery. Safety parameters were adverse events (AEs), inhibitor development and changes in laboratory parameters. Results: The study enrolled 9 subjects (0-5 years, n = 4; 6-11 years, n = 5) with severe (n = 8) or moderate (n = 1) FXD. At end of study, investigators rated pdFX efficacy excellent for all subjects. Ten bleeds occurred (n = 3 subjects; 6 major, 3 minor, 1 unassessed for severity). Trough FX:C levels remained >5 IU/dL for all subjects after the last dose adjustment study visit. Mean incremental recovery was significantly lower for younger vs older subjects (1.53 vs 1.91 IU/dL per IU/kg; P = .001). All AEs were unrelated to treatment; no inhibitor development or clinically significant changes in laboratory parameters were observed. Conclusions: These results demonstrate the efficacy and safety of pdFX for treating children <12 years with moderate/severe hereditary FXD.
MeSH term(s)	Child ; Child, Preschool ; Dose-Response Relationship, Drug ; Factor X/adverse effects ; Factor X/metabolism ; Factor X/pharmacokinetics ; Factor X/pharmacology ; Factor X Deficiency/complications ; Female ; Hemorrhage/complications ; Hemorrhage/prevention & control ; Humans ; Infant ; Infant, Newborn ; Male ; Plasma/metabolism ; Safety
Chemical Substances	Factor X (9001-29-0)
Language	English
Publishing date	2018-04-30
Publishing country	England
Document type	Clinical Trial, Phase III ; Journal Article
ZDB-ID	1229713-6
ISSN	1365-2516 ; 1351-8216 ; 1355-0691
ISSN (online)	1365-2516
ISSN	1351-8216 ; 1355-0691
DOI	10.1111/hae.13500
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Zs.A 4249: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Genotype analysis and identification of novel mutations in a multicentre cohort of patients with hereditary factor X deficiency.

Mitchell, Michael / Gattens, Michael / Kavakli, Kaan / Liesner, Ri / Payne, Jeanette / Norton, Miranda / Austin, Steven

Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis

2019 Volume 30, Issue 1, Page(s) 34–41

Abstract: The objective was to examine the genotypic and phenotypic characteristics of individuals with hereditary factor X deficiency (FXD), a rare autosomal recessive bleeding disorder caused by mutations in the F10 gene located on chromosome 13q34-ter. To ... ...

Abstract	: The objective was to examine the genotypic and phenotypic characteristics of individuals with hereditary factor X deficiency (FXD), a rare autosomal recessive bleeding disorder caused by mutations in the F10 gene located on chromosome 13q34-ter. To date, 149 F10 mutations have been identified as contributory to FXD. Three open-label phase 3 trials enrolled individuals with mild, moderate, or severe FXD. Individuals received plasma-derived factor X concentrate as routine prophylaxis, to treat bleeds, and/or during or after surgery. F10 genotyping was performed (studies 1 and 2) or genotype data was collected at screening (study 3), and identified F10 mutations were compared against the Human Gene Mutation Database to assess novelty. Genotype data were combined to evaluate the number, type, and novelty of the F10 mutations identified. Genotype data were available for 24 of 27 individuals with mild (n = 2), moderate (n = 2), or severe (n = 20) FXD. Analyses identified 22 separate mutations, including 15 missense mutations, 2 deletions, 4 splice site mutations, and 1 nonsense mutation. Sixteen individuals had homozygous mutations; 8 had compound heterozygous mutations. Eleven unique novel mutations (all compound heterozygous) were identified in seven individuals: six missense mutations, three splice site mutations, one exon deletion, and one nonsense mutation. In silico analyses strongly supported the pathogenicity of all novel mutations. The identification of 11 novel F10 mutations provides a substantial contribution to the mutations known to cause FXD.
MeSH term(s)	Clinical Trials as Topic ; Cohort Studies ; Computer Simulation ; DNA Mutational Analysis ; Factor X/genetics ; Factor X Deficiency/etiology ; Factor X Deficiency/genetics ; Genetic Association Studies ; Genotype ; Humans ; Mutation
Chemical Substances	Factor X (9001-29-0)
Language	English
Publishing date	2019-02-28
Publishing country	England
Document type	Journal Article ; Multicenter Study
ZDB-ID	1033551-1
ISSN	1473-5733 ; 0957-5235
ISSN (online)	1473-5733
ISSN	0957-5235
DOI	10.1097/MBC.0000000000000787
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Zs.A 2920: Show issues

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Article ; Online: Modern management of severe platelet function disorders.

Alamelu, Jayanthi / Liesner, Ri

British journal of haematology

2010 Volume 149, Issue 6, Page(s) 813–823

Abstract: Severe platelet function defects are rare disorders that require expertise in diagnosis and management. Therefore patients with such disorders should be referred to and managed in centres with the full laboratory repertoire of tests and clinical support ... ...

Abstract	Severe platelet function defects are rare disorders that require expertise in diagnosis and management. Therefore patients with such disorders should be referred to and managed in centres with the full laboratory repertoire of tests and clinical support necessary to optimise their quality of care. The aim of this review is to discuss the management of these patients in various clinical situations including surgical intervention.
MeSH term(s)	Bernard-Soulier Syndrome/diagnosis ; Bernard-Soulier Syndrome/therapy ; Blood Platelet Disorders/complications ; Blood Platelet Disorders/diagnosis ; Blood Platelet Disorders/therapy ; Female ; Hemorrhage/etiology ; Hemorrhage/therapy ; Humans ; Perioperative Care/methods ; Pregnancy ; Pregnancy Complications, Hematologic/therapy ; Thrombasthenia/diagnosis ; Thrombasthenia/therapy
Language	English
Publishing date	2010-06
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	80077-6
ISSN	1365-2141 ; 0007-1048
ISSN (online)	1365-2141
ISSN	0007-1048
DOI	10.1111/j.1365-2141.2010.08191.x
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Article ; Online: Long-term tolerability, immunogenicity and efficacy of Nuwiq

Klukowska, A / Szczepański, T / Vdovin, V / Knaub, S / Bichler, J / Jansen, M / Dzhunova, I / Liesner, R J

Haemophilia : the official journal of the World Federation of Hemophilia

2018 Volume 24, Issue 4, Page(s) 595–603

Abstract: Introduction: Nuwiq: Aim/methods: This study (GENA-13) was an extension of the GENA-03 study in which previously treated children aged 2-12 years with severe haemophilia A received Nuwiq: Results: Of 59 patients enrolled in GENA-03, 49 continued ... ...

Abstract	Introduction: Nuwiq Aim/methods: This study (GENA-13) was an extension of the GENA-03 study in which previously treated children aged 2-12 years with severe haemophilia A received Nuwiq Results: Of 59 patients enrolled in GENA-03, 49 continued Nuwiq Conclusion: Long-term treatment with Nuwiq
MeSH term(s)	Child ; Child, Preschool ; Factor VIII/adverse effects ; Factor VIII/immunology ; Factor VIII/therapeutic use ; Female ; Hemophilia A/complications ; Hemophilia A/drug therapy ; Hemophilia A/immunology ; Hemorrhage/complications ; Hemorrhage/prevention & control ; Humans ; Male ; Recombinant Proteins/adverse effects ; Recombinant Proteins/immunology ; Recombinant Proteins/therapeutic use ; Safety ; Severity of Illness Index ; Treatment Outcome
Chemical Substances	Recombinant Proteins ; Factor VIII (9001-27-8)
Language	English
Publishing date	2018-03-26
Publishing country	England
Document type	Clinical Trial, Phase III ; Journal Article
ZDB-ID	1229713-6
ISSN	1365-2516 ; 1351-8216 ; 1355-0691
ISSN (online)	1365-2516
ISSN	1351-8216 ; 1355-0691
DOI	10.1111/hae.13460
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Article: Does thrombophilia cause Perthes' disease in children?

Liesner, R J

The Journal of bone and joint surgery. British volume

1999 Volume 81, Issue 4, Page(s) 565–566

MeSH term(s)	Child ; Humans ; Legg-Calve-Perthes Disease/complications ; Thrombophilia/complications
Language	English
Publishing date	1999-07
Publishing country	England
Document type	Comment ; Editorial
ZDB-ID	220626-2
ISSN	2044-5377 ; 0301-620X ; 0447-9076
ISSN (online)	2044-5377
ISSN	0301-620X ; 0447-9076
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Article ; Online: The B-Natural study-The outcome of immune tolerance induction therapy in patients with severe haemophilia B.

Astermark, Jan / Holstein, Katharina / Abajas, Yasmina L / Kearney, Susan / Croteau, Stacy E / Liesner, Riana / Funding, Eva / Kempton, Christine L / Acharya, Suchitra / Lethagen, Stefan / LeBeau, Petra / Bowen, Joel / Berntorp, Erik / Shapiro, Amy D

Haemophilia : the official journal of the World Federation of Hemophilia

2021 Volume 27, Issue 5, Page(s) 802–813

Abstract: Introduction: Inhibitors develop less frequently in haemophilia B (HB) than haemophilia A (HA). However, when present, the success of tolerization by immune tolerance induction (ITI) therapy is lower and the risk of complications higher.: Aim: To ... ...

Abstract	Introduction: Inhibitors develop less frequently in haemophilia B (HB) than haemophilia A (HA). However, when present, the success of tolerization by immune tolerance induction (ITI) therapy is lower and the risk of complications higher. Aim: To evaluate the use and outcome of ITI in patients with HB and inhibitors. Methods: Subjects include singletons or siblings with a current/history of inhibitors enrolled in B-Natural-an observational study designed to increase understanding of clinical management of patients with HB. Patients were followed for 6 months and information on demographics, medical and social history, and treatment were recorded. Results: Twenty-nine patients with severe HB and inhibitors were enrolled in 24 centres. Twenty-two underwent one or more courses of ITI with or without immune suppression. Eight patients (36.4%) were successfully tolerized after the first course of ITI. One of these successes (12.5%) experienced allergic manifestations, whereas the corresponding number for the 10 treatment failures was five (50%). One of seven (14.2%) patients with large deletions and three of eight (37.5%) with nonsense mutations were tolerized at the first attempt, and all patients experiencing nephrosis either failed or were on-going. At study end, 11 (50%) were considered successfully tolerized after one or more ITI courses, three were unsuccessful, and eight were still undergoing treatment. Conclusion: Our data underscore the possibilities and difficulties of achieving tolerization in patients with HB with inhibitors. The type of mutation and complications appear to correlate with ITI outcome, but more accurate definitions of successful ITI are warranted.
MeSH term(s)	Factor VIII/genetics ; Factor VIII/therapeutic use ; Hemophilia A/drug therapy ; Hemophilia A/genetics ; Hemophilia B/drug therapy ; Hemophilia B/genetics ; Humans ; Immune Tolerance ; Immunosuppression
Chemical Substances	Factor VIII (9001-27-8)
Language	English
Publishing date	2021-06-12
Publishing country	England
Document type	Journal Article ; Observational Study
ZDB-ID	1229713-6
ISSN	1365-2516 ; 1351-8216 ; 1355-0691
ISSN (online)	1365-2516
ISSN	1351-8216 ; 1355-0691
DOI	10.1111/hae.14357
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Article ; Online: The changing face of immune tolerance induction in haemophilia A with the advent of emicizumab.

Carcao, Manuel / Escuriola-Ettingshausen, Carmen / Santagostino, Elena / Oldenburg, Johannes / Liesner, Ri / Nolan, Beatrice / Bátorová, Angelika / Haya, Saturnino / Young, Guy

Haemophilia : the official journal of the World Federation of Hemophilia

2019 Volume 25, Issue 4, Page(s) 676–684

Abstract: Introduction: As a result of the new treatment paradigm that the haemophilia community will face with the availability of novel (non-factor) therapies, an updated consensus on ITI recommendations and inhibitor management strategies is needed.: Aim: ... ...

Abstract	Introduction: As a result of the new treatment paradigm that the haemophilia community will face with the availability of novel (non-factor) therapies, an updated consensus on ITI recommendations and inhibitor management strategies is needed. Aim: The Future of Immunotolerance Treatment (FIT) group was established to contemplate, determine and recommend the best management options for patients with haemophilia A and inhibitors. Discussion and conclusions: Despite the considerable success of emicizumab in the management of inhibitor patients, the FIT group still sees the importance of eradicating inhibitors. However, the availability of emicizumab and other non-factor therapies in the future might impact greatly on how ITI is undertaken. Theoretically, concomitant use of emicizumab and FVIII might allow emicizumab to effectively prevent bleeding with lower dose ITI regimens. This might allow for the greater adoption of low-dose/low-frequency FVIII ITI regimens, which may result in a reduced need for central venous access devices while still maintaining a reasonable likelihood of ITI success. The FIT group proposes a new management algorithm for current ITI (without emicizumab) and a hypothetical new approach with the availability of emicizumab. As there are no published data regarding the concomitant use of emicizumab and FVIII for ITI, the FIT Expert group encourages the undertaking of properly conducted prospective studies to explore these approaches further.
MeSH term(s)	Antibodies, Bispecific/pharmacology ; Antibodies, Monoclonal, Humanized/pharmacology ; Antibodies, Neutralizing/immunology ; Dose-Response Relationship, Drug ; Factor VIII/immunology ; Hemophilia A/drug therapy ; Hemophilia A/immunology ; Humans ; Immune Tolerance/drug effects ; Risk Assessment
Chemical Substances	Antibodies, Bispecific ; Antibodies, Monoclonal, Humanized ; Antibodies, Neutralizing ; emicizumab (7NL2E3F6K3) ; Factor VIII (9001-27-8)
Language	English
Publishing date	2019-04-29
Publishing country	England
Document type	Journal Article
ZDB-ID	1229713-6
ISSN	1365-2516 ; 1351-8216 ; 1355-0691
ISSN (online)	1365-2516
ISSN	1351-8216 ; 1355-0691
DOI	10.1111/hae.13762
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Zs.A 4249: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Final results of the PUPs B-LONG study: evaluating safety and efficacy of rFIXFc in previously untreated patients with hemophilia B.

Nolan, Beatrice / Klukowska, Anna / Shapiro, Amy / Rauch, Antoine / Recht, Michael / Ragni, Margaret / Curtin, Julie / Gunawardena, Sriya / Mukhopadhyay, Sutirtha / Jayawardene, Deepthi / Winding, Bent / Fischer, Kathelijn / Liesner, Raina

Blood advances

2021 Volume 5, Issue 13, Page(s) 2732–2739

Abstract: PUPs B-LONG evaluated the safety and efficacy of recombinant factor IX Fc fusion protein (rFIXFc) in previously untreated patients (PUPs) with hemophilia B. In this open-label, phase 3 study, male PUPs (age <18 years) with hemophilia B (≤2 IU/dL of ... ...

Abstract	PUPs B-LONG evaluated the safety and efficacy of recombinant factor IX Fc fusion protein (rFIXFc) in previously untreated patients (PUPs) with hemophilia B. In this open-label, phase 3 study, male PUPs (age <18 years) with hemophilia B (≤2 IU/dL of endogenous factor IX [FIX]) were to receive treatment with rFIXFc. Primary end point was occurrence of inhibitor development, with a secondary end point of annualized bleed rate (ABR). Of 33 patients who received ≥1 dose of rFIXFc, 26 (79%) were age <1 year at study entry and 6 (18%) had a family history of inhibitors. Twenty-eight patients (85%) received prophylaxis; median dosing interval was 7 days, with an average weekly dose of 58 IU/kg. Twenty-seven patients (82%) completed the study. Twenty-one (64%), 26 (79%), and 28 patients (85%) had ≥50, ≥20, and ≥10 exposure days (EDs) to rFIXFc, respectively. One patient (3.03%; 95% confidence interval, 0.08% to 15.76%) developed a low-titer inhibitor after 11 EDs; no high-titer inhibitors were detected. Twenty-three patients (70%) had 58 treatment-emergent serious adverse events; 2 were assessed as related (FIX inhibition and hypersensitivity in 1 patient, resulting in withdrawal). Median ABR was 1.24 (interquartile range, 0.00-2.49) for patients receiving prophylaxis. Most (>85%) bleeding episodes required only 1 infusion for bleed resolution. In this first study reporting results with rFIXFc in pediatric PUPs with hemophilia B, rFIXFc was well tolerated, with the adverse event profile as expected in a pediatric hemophilia population. rFIXFc was effective, both as prophylaxis and in the treatment of bleeding episodes. This trial was registered at www.clinicaltrials.gov as #NCT02234310.
MeSH term(s)	Adolescent ; Blood Coagulation Tests ; Child ; Hemophilia A ; Hemophilia B/drug therapy ; Hemorrhage ; Humans ; Male
Language	English
Publishing date	2021-07-09
Publishing country	United States
Document type	Clinical Trial, Phase III ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2915908-8
ISSN	2473-9537 ; 2473-9529
ISSN (online)	2473-9537
ISSN	2473-9529
DOI	10.1182/bloodadvances.2020004085
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Article ; Online: Transgenic cotton and sterile insect releases synergize eradication of pink bollworm a century after it invaded the United States.

Tabashnik, Bruce E / Liesner, Leighton R / Ellsworth, Peter C / Unnithan, Gopalan C / Fabrick, Jeffrey A / Naranjo, Steven E / Li, Xianchun / Dennehy, Timothy J / Antilla, Larry / Staten, Robert T / Carrière, Yves

Proceedings of the National Academy of Sciences of the United States of America

2020 Volume 118, Issue 1

Abstract: Invasive organisms pose a global threat and are exceptionally difficult to eradicate after they become abundant in their new habitats. We report a successful multitactic strategy for combating the pink bollworm ( ...

Abstract	Invasive organisms pose a global threat and are exceptionally difficult to eradicate after they become abundant in their new habitats. We report a successful multitactic strategy for combating the pink bollworm (
MeSH term(s)	Animals ; Animals, Genetically Modified ; Arizona ; Bacillus thuringiensis/genetics ; Bacillus thuringiensis Toxins/genetics ; Bacillus thuringiensis Toxins/metabolism ; Computer Simulation ; Disease Eradication/economics ; Disease Eradication/methods ; Gossypium/genetics ; Infertility/genetics ; Insecticides/metabolism ; Mexico ; Moths/genetics ; Moths/growth & development ; Moths/pathogenicity ; Pest Control, Biological/methods ; Plants, Genetically Modified ; Southwestern United States
Chemical Substances	Bacillus thuringiensis Toxins ; Insecticides
Language	English
Publishing date	2020-12-21
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	209104-5
ISSN	1091-6490 ; 0027-8424
ISSN (online)	1091-6490
ISSN	0027-8424
DOI	10.1073/pnas.2019115118
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