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Article ; Online: Combination of CLEC4M rs868875 G-Carriership and ABO O Genotypes May Predict Faster Decay of FVIII Infused in Hemophilia A Patients

Barbara Lunghi / Massimo Morfini / Nicola Martinelli / Silvia Linari / Giancarlo Castaman / Francesco Bernardi

Journal of Clinical Medicine, Vol 11, Iss 733, p

2022 Volume 733

Abstract: ... in twenty-six patients (FVIII:C ≤ 2 IU/dL). F8 , ABO blood-groups, and the CLEC4M rs868875A/G polymorphism ... rs868875A/G and ABO genotypes displayed significant interaction (K 1-0, p = 0.014). Compared ... to other combined genotypes, the G-carriers/O genotypes showed half-reduced K 1-0 HL ( p = 0.008), and faster FVIII ...

Abstract	The C-type lectin CLEC4M binds and internalizes factor VIII (FVIII). Common CLEC4M variants have been associated with FVIII pharmacokinetic (PK) profiles in hemophilia A (HA) patients. The two-compartment PK analysis of plasma-derived (pd-) and full length recombinant FVIII concentrates was conducted in twenty-six patients (FVIII:C ≤ 2 IU/dL). F8 , ABO blood-groups, and the CLEC4M rs868875A/G polymorphism were genotyped. CLEC4M genotype groups differed for the elimination rate constant K 1-0 ( p < 0.001), half-life (K 1-0 HL), and the Beta rate constant. Patients treated with pd-FVIII also differed in the Alpha phase. In linear regression models, the contribution of the CLEC4M genotypes to FVIII PK parameters remained significant after correction for ABO , age, and VWF antigen levels at PK. Combined CLEC4M rs868875A/G and ABO genotypes displayed significant interaction (K 1-0, p = 0.014). Compared to other combined genotypes, the G-carriers/O genotypes showed half-reduced K 1-0 HL ( p = 0.008), and faster FVIII clearance (mean 7.1 ± 2.2 mL/h/kg SE) than in the G-carriers/non-O (mean 2.4 ± 0.3 mL/h/kg SE), ( p = 0.038). Comparison in HA patients recruited in several countries suggests that CLEC4M genotypes coherently influence infused FVIII half-life and clearance. Our analysis supports substantially faster FVIII decay associated with the rs868875 G-carrier/ ABO O genotypes, which has potential implications for genetically tailored substitutive HA treatment.
Keywords	CLEC4M ; CLEC4M SNPs ; factor VIII ; haemophilia A ; pharmacokinetics ; ABO ; Medicine ; R
Subject code	610
Language	English
Publishing date	2022-01-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Awareness of von Willebrand disease among gynecologists: Investigating the referral of women with heavy menstrual bleeding to hematologists.

Schmiedl, Jolana / Castaman, Giancarlo

International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics

2024

Language	English
Publishing date	2024-04-12
Publishing country	United States
Document type	Journal Article
ZDB-ID	80149-5
ISSN	1879-3479 ; 0020-7292
ISSN (online)	1879-3479
ISSN	0020-7292
DOI	10.1002/ijgo.15546
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Article ; Online: How I treat von Willebrand disease.

Castaman, Giancarlo

Thrombosis research

2020 Volume 196, Page(s) 618–625

Abstract: ... required cannot be used for an extended time (e.g., major surgery), von Willebrand factor-containing ...

Abstract	The deficiency or abnormal activity of von Willebrand factor, a multi-adhesive protein which binds platelets to exposed subendothelium and carries factor VIII in circulation, is responsible for von Willebrand disease, the most frequent inherited bleeding disorder. Clinical symptoms are characterized by mucous membrane and soft tissue bleeding, bleeding after surgery and rarely joint and gastrointestinal bleeding. Intriguingly, also factor VIII, the protein deficient in hemophilia A, may be variably reduced because VWF stabilizes it into circulation. Treatment strategies are well designed for patients with levels of VWF activity <30 U/dL, while the diagnosis and the magnitude of risk may be difficult to be assessed accurately for subjects with levels between 30 and 50 U/dL. Three types of the disorder have been identified according to partial (type 1) or severe VWF quantitative deficiency (type 3) while patients who present variable abnormality of VWF structure are categorized as type 2. The aim of treatment is to correct either the abnormal/reduced von Willebrand factor and the associated deficiency of factor VIII, when present. Desmopressin is able to transiently correct the deficiency of FVIII and VWF for up to 8-12 h in a significant proportion of patients with type 1 von Willebrand disease and factor VIII and von Willebrand factor levels ≥10 U/dL. When desmopressin is not usual (mainly in patients with type 2 and 3 VWD) or correction is required cannot be used for an extended time (e.g., major surgery), von Willebrand factor-containing concentrates, with or without FVIII, must be used.
MeSH term(s)	Deamino Arginine Vasopressin/therapeutic use ; Factor VIII ; Hemophilia A ; Hemorrhage ; Humans ; von Willebrand Disease, Type 1 ; von Willebrand Diseases/diagnosis ; von Willebrand Diseases/drug therapy ; von Willebrand Factor
Chemical Substances	von Willebrand Factor ; Factor VIII (9001-27-8) ; Deamino Arginine Vasopressin (ENR1LLB0FP)
Language	English
Publishing date	2020-08-03
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	121852-9
ISSN	1879-2472 ; 0049-3848
ISSN (online)	1879-2472
ISSN	0049-3848
DOI	10.1016/j.thromres.2020.07.051
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Article ; Online: Next-generation strategies to improve safety and efficacy of adeno-associated virus-based gene therapy for hemophilia: lessons from clinical trials in other gene therapies.

Di Minno, Giovanni / Miesbach, Wolfgang / Castaman, Giancarlo / Peyvandi, Flora

Haematologica

2024

Abstract: ... animal models reflecting the heterogeneity of certain clinical settings (e.g., congestive heart failure) are ... efficacy; be functional in a restricted cellular subset; avoid transgene expression in unwanted cells (e.g ... patient numbers (e.g., hemophilia), clearcut outcomes are mandatory as endpoints of unequivocal efficacy ...

Abstract	Three major directions for the global progress of adeno-associated virus (AAV) vectors for gene therapies (GT) are analyzed: a) engineering vectors to increase transgene expression; b) aligning interests of the health system with costs and challenges for pharmaceutical industry; c) refining patient eligibility criteria, and endpoints definition. Currently employed AAV vectors may cause toxicity and adverse events. Furthermore, studies in animals do not fully predict risks and clinical benefits of AAV-based GT, and animal models reflecting the heterogeneity of certain clinical settings (e.g., congestive heart failure) are poorly available for improving AAV-based GT. Finally, antisense and gene editing approaches will soon complement gene augmentation strategies for the stable solution of unsolved issues of AAV-based GT. While minimizing toxicity, next-generation AAV vectors should decrease the viral load needed to achieve therapeutic efficacy; be functional in a restricted cellular subset; avoid transgene expression in unwanted cells (e.g., hepatocytes), and escape immune oversight in AAV-based GT. The role of stress-induced apoptosis in the loss of transgene expression in GT should be also explored. Aligning interests and obligations of pharmaceutical industry with those of the health system is critical for AAV-based GT success. Costs and challenges for pharmaceutical industry include a) removing impurities from AAV; b) validating tests to measure treatment efficacy, c) promoting training programs to standardize vector genomes delivery, d) collecting long-term follow-up data, and e) maintaining sustainability and cost-effectiveness of AAV-based GT. In rare disorders with small patient numbers (e.g., hemophilia), clearcut outcomes are mandatory as endpoints of unequivocal efficacy data.
Language	English
Publishing date	2024-03-07
Publishing country	Italy
Document type	Journal Article
ZDB-ID	2333-4
ISSN	1592-8721 ; 0017-6567 ; 0390-6078
ISSN (online)	1592-8721
ISSN	0017-6567 ; 0390-6078
DOI	10.3324/haematol.2023.284622
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Article: A novel G-to-A mutation in the intron-N of the protein S gene leading to abnormal RNA splicing in a patient with protein S deficiency.

D'Andrea, Giovanna / Di Perna, Pasquale / Brancaccio, Vincenzo / Faioni, Elena M / Castaman, Giancarlo / Cibelli, Giuseppe / Di Minno, Giovanni / Margaglione, Maurizio

Haematologica

2003 Volume 88, Issue 4, Page(s) 459–464

Abstract: ... Sequence analysis of the PS gene showed a heterozygous G-to-A mutation at the first nucleotide of intron N ... and 28%, respectively) was a heterozygote. The G-to-A change predicts the disappearance of a donor ...

Abstract	Background and objectives: Hereditary protein S (PS) deficiency is a rare autosomal disorder of the coagulation pathway associated with familial thrombophilia. Design and methods: We investigated a young propositus with recurrent deep vein thrombosis, a positive family history for thrombotic episodes, and low plasma concentrations of free, but not total PS antigen (12% and 70%, respectively). Results: Sequence analysis of the PS gene showed a heterozygous G-to-A mutation at the first nucleotide of intron N. The patient's father, who had suffered from deep vein thrombosis and had reduced total and free PS antigen (59% and 28%, respectively) was a heterozygote. The G-to-A change predicts the disappearance of a donor splice site. After transfection with a construct, containing either the wild-type or the mutated sequence, cells with the mutant construct showed an aberrant mRNA, consistent with exclusion of exon 14, but not the expected mRNA. Sequencing of the abnormal mRNA showed the complete absence of exon 14. Exclusion of exon 14 predicts the deletion of the amino acid sequence from residue 508 to residue 582, and the shift of the reading frame of the following 8 amino acids with a premature stop codon within exon 15 at position 591. Thus, the truncated PS gene product would not contain the terminal portion of the sex hormone binding globulin-like domain. Interpretation and conclusions: We have identified a mutation in a highly conserved intronic region of PS gene. The mutation affects in vitro mRNA processing and efficiency of normal splicing.
MeSH term(s)	Adult ; DNA Mutational Analysis ; Heterozygote ; Humans ; Introns ; Male ; Point Mutation ; Protein S/chemistry ; Protein S/genetics ; Protein S Deficiency/genetics ; RNA Splicing/genetics
Chemical Substances	Protein S
Language	English
Publishing date	2003-04
Publishing country	Italy
Document type	Case Reports ; Journal Article
ZDB-ID	2333-4
ISSN	1592-8721 ; 0390-6078 ; 0017-6567
ISSN (online)	1592-8721
ISSN	0390-6078 ; 0017-6567
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Article ; Online: Outcomes and outcome measures.

Castaman, Giancarlo / Jimenez-Yuste, Victor / Gouw, Samanta / D'Oiron, Roseline

Haemophilia : the official journal of the World Federation of Hemophilia

2024 Volume 30 Suppl 3, Page(s) 112–119

Abstract: ... not only from the clinical point of view by using new methodologies (e.g. joint health assessment ... but also from the patient's perspective (e.g. pain, quality of life, treatment satisfaction).: Methods ...

Abstract	Introduction: Advances in haemophilia treatment have resulted in a near-normal life expectancy, lower burden of bleeding and treatment, and improved quality of life in high-income countries. Bleeding rate is approaching zero and novel parameters should be evaluated to assess the efficacy of treatment not only from the clinical point of view by using new methodologies (e.g. joint health assessment), but also from the patient's perspective (e.g. pain, quality of life, treatment satisfaction). Methods and results: This approach should be aimed at combining objective clinical methodologies and patient-reported outcomes (PROs). However, some instruments used for assessing PROs are still suboptimal and not properly validated. Recent evidence suggests that these tools can take advantage from a more personalized designed approach and could be effectively improved and serve to facilitate the patient's self-evaluation. For other congenital bleeding disorders (BDs), a set of patient-relevant outcomes has been also defined that overlap substantially those of haemophilia, including bleeding, side effects and complications, and PROs, such as pain, physical functioning, impact on daily life including school and work and mental health. There is a growing focus on addressing women-specific outcomes in BDs, reflecting an increased awareness of the unique challenges faced by women in this context. However, the development of tailored tools is imperative to further advance the progress in managing women with BDs, ensuring more accurate monitoring and personalized care. Conclusions: How incorporating these outcome measures in the process of approval of novel treatments for these disorders by regulatory authorities remains to be established.
MeSH term(s)	Humans ; Female ; Quality of Life ; Hemophilia A/therapy ; Outcome Assessment, Health Care ; Treatment Outcome ; Pain
Language	English
Publishing date	2024-03-19
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.14990
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Article ; Online: The benefits of prophylaxis in patients with hemophilia B.

Castaman, Giancarlo

Expert review of hematology

2018 Volume 11, Issue 8, Page(s) 673–683

Abstract: Introduction: The health benefits of prophylactic dosing regimens for clotting factor therapy in patients with hemophilia include reduced joint damage and improved quality of life; as such, prophylaxis is recommended in treatment guidelines. However, ... ...

Abstract	Introduction: The health benefits of prophylactic dosing regimens for clotting factor therapy in patients with hemophilia include reduced joint damage and improved quality of life; as such, prophylaxis is recommended in treatment guidelines. However, many patients with hemophilia B are treated on demand, and prophylaxis has been utilized less frequently than in hemophilia A. Areas covered: This review discusses the opportunities and evidence for prophylaxis in hemophilia B, in the context of treatment guidelines and with regard to factor IX (FIX) replacement therapies, including long-acting recombinant FIX (rFIX). Expert commentary: Long-acting rFIX concentrates may increase uptake of and adherence to prophylaxis regimens through attainment of higher trough levels with longer dosing intervals. In this new era of hemophilia B treatment, physicians may be able to achieve better clinical outcomes for their patients and reconsider treatment goals. Maintaining higher FIX trough levels will undoubtedly have long-term benefits for patients, such as preserving joint function. The long-acting rFIX concentrates support robust prophylaxis regimens and offer physician's flexibility in treating patients to best suit their needs, whether to enable an active lifestyle, to achieve higher trough levels for better bleed protection, or simply to decrease the burden of treatment by reducing injection frequency.
MeSH term(s)	Clinical Trials as Topic ; Coagulants/administration & dosage ; Coagulants/therapeutic use ; Factor IX/administration & dosage ; Factor IX/therapeutic use ; Hemophilia B/drug therapy ; Hemophilia B/prevention & control ; Humans ; Practice Guidelines as Topic ; Premedication ; Recombinant Proteins/therapeutic use
Chemical Substances	Coagulants ; Recombinant Proteins ; Factor IX (9001-28-9)
Language	English
Publishing date	2018-07-18
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2516804-6
ISSN	1747-4094 ; 1747-4086
ISSN (online)	1747-4094
ISSN	1747-4086
DOI	10.1080/17474086.2018.1489719
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Article ; Online: Hemophilia A: different phenotypes may be explained by multiple and variable effects of the causative mutation in the

Castaman, Giancarlo

Haematologica

2018 Volume 103, Issue 2, Page(s) 195–196

MeSH term(s)	Factor VIII/genetics ; Hemophilia A ; Humans ; Mutation ; Phenotype
Chemical Substances	Factor VIII (9001-27-8)
Language	English
Publishing date	2018-01-31
Publishing country	Italy
Document type	Editorial ; Comment
ZDB-ID	2333-4
ISSN	1592-8721 ; 0017-6567 ; 0390-6078
ISSN (online)	1592-8721
ISSN	0017-6567 ; 0390-6078
DOI	10.3324/haematol.2017.186353
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Article: Hemostatic Abnormalities in Gaucher Disease: Mechanisms and Clinical Implications.

Linari, Silvia / Castaman, Giancarlo

Journal of clinical medicine

2022 Volume 11, Issue 23

Abstract: Gaucher disease (GD) is a rare inherited lysosomal metabolism disorder, characterized by an accumulation into lysosomes of reticuloendothelial cells, especially in the bone marrow, spleen, and liver of β-glucosylceramide and glucosyl sphingosine, which ... ...

Abstract	Gaucher disease (GD) is a rare inherited lysosomal metabolism disorder, characterized by an accumulation into lysosomes of reticuloendothelial cells, especially in the bone marrow, spleen, and liver of β-glucosylceramide and glucosyl sphingosine, which is its deacylated product. Impaired storage is responsible for a chronic inflammatory state at the sites of accumulation and together represents the pathophysiological cause of GD. GD is a progressive, multi-organ chronic disorder. Type 1 GD is the most prevalent form, with heterogeneous multisystem involvement and different severity of symptoms at any age. Hematological involvement is consistent, and a bleeding tendency is frequent, particularly at diagnosis. Several coagulation and primary hemostasis abnormalities are observed in GD. Bleeding manifestations are rarely severe and usually mucocutaneous. Post-operative, delivery, and post-partum hemorrhages are also common. Thrombocytopenia, platelet function defects, and clotting abnormalities, alone or variably associated, contribute to increase the risk of bleeding in GD. Enzyme replacement therapy (ERT) or substrate reduction therapy (SRT) are the two specific available treatments effective in improving typical hematological symptoms and abnormalities, including those of hemostasis. However, the use of medication to potentiate hemostasis may be also useful in defined clinical situations: recent starting of ERT/SRT, surgery, delivery, and life-threatening bleeding.
Language	English
Publishing date	2022-11-24
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2662592-1
ISSN	2077-0383
ISSN	2077-0383
DOI	10.3390/jcm11236920
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Article ; Online: Etranacogene dezaparvovec for the treatment of adult patients with severe and moderately severe hemophilia B.

Castaman, Giancarlo / Coppens, Michiel / Pipe, Steven W

Expert review of hematology

2023 Volume 16, Issue 12, Page(s) 919–932

Abstract: Introduction: Etranacogene dezaparvovec is the first gene therapy approved for treatment of adults with severe and moderately severe hemophilia B.: Areas covered: This review describes the results of the clinical trial program of AMT-060 and ... ...

Abstract	Introduction: Etranacogene dezaparvovec is the first gene therapy approved for treatment of adults with severe and moderately severe hemophilia B. Areas covered: This review describes the results of the clinical trial program of AMT-060 and etranacogene dezaparvovec, outlining the pharmacokinetic, clinical efficacy and safety data. With the entry of etranacogene dezaparvovec into the market, this review summarizes the treatment landscape in hemophilia B and discusses the current unknowns in the field. Expert opinion: Gene therapy appears to be a feasible option for adults with severe and moderately severe hemophilia B. Etranacogene dezaparvovec enables most patients to reach stable factor IX (FIX) levels after a single intravenous infusion, eliminating the need for regular prophylaxis; thus, drastically reducing treatment burden and avoiding variable bleeding risk owing to fluctuating FIX activity levels. Efficacy of etranacogene dezaparvovec has been demonstrated even in the presence of preexisting neutralizing antibodies (up to a titer of 1:678), with a relative low risk of transaminitis and its associated potential loss of transgene expression. However, long-term data are required to ascertain the durability of FIX levels achieved and safety. The cost-effectiveness and adoption of innovative payment models for reimbursement are key in choosing gene therapy over existing treatments.
MeSH term(s)	Adult ; Humans ; Hemophilia B/drug therapy ; Hemophilia B/genetics ; Factor IX/genetics ; Factor IX/therapeutic use ; Genetic Therapy/methods ; Antibodies, Neutralizing/therapeutic use
Chemical Substances	Factor IX (9001-28-9) ; Antibodies, Neutralizing
Language	English
Publishing date	2023-12-18
Publishing country	England
Document type	Journal Article ; Review ; Research Support, Non-U.S. Gov't
ZDB-ID	2516804-6
ISSN	1747-4094 ; 1747-4086
ISSN (online)	1747-4094
ISSN	1747-4086
DOI	10.1080/17474086.2023.2276206
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