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2. Inhibitor development according to concentrate after 50 exposure days in severe hemophilia: data from the European HAemophilia Safety Surveillance (EUHASS)

Author

Ay, Cihan, Male, Christoph, Hermans, Cedric, Verhamme, Peter, Lissitchkov, Toshko, Antoniades, Marios, Penka, Miroslav, Blatny, Jan, Komrska, Vladimir, Poulsen, Lone Hvitfeldt, Kampmann, Peter, Lehtinen, Anna-Elina, Susen, Sophie, Dargaud, Yesim, Biron, Christine, D'Oiron, Roseline, Harroche, Annie, Klamroth, Robert, Oldenburg, Johannes, Buehrlen, Martina, Miesbach, Wolfgang, Langer, Florian, Spannag, Patrick, Oliveri, Martin, Platokouki, Helen, Nomikou, Efrosyni, Katsarou, Olga, Garypidou, Vasileia, Economou, Marina, Nemes, Laszlo, Nolan, Beatrice, O'Connell, Niamh, Paolo, Radossi, Castaman, Giancarlo, Peyvandi, Flora, Rocino, Angiola, Zanon, Ezio, Tagliaferri, Annarita, Agnelli, Giancarlo, De Crisotofaro, Raimondo, Schinco, Piercarla, Tosetto, Alberto, Lejniece, Sandra, Gailiute, Neringa, Gatt, Alexander, Mäkelburg, Anja, Laros-van Gorkom, Britta, Brons, Paul, Leebeek, Frank W.G., Schutgens, Roger, Windyga, Jerzy, Catarino, Cristina, Aires, Anabela, Fraga, Cristina, Morais, Sara, Araújo, Fernando, Serban, Margit, Davydkin, Igor, Batorova, Angelika, Anzej Doma, Sasa, Martinez, Laura Segura, Palomo Bravo, Angeles, Ortega, Immaculada Soto, Bonanad, Santiago, Baghaei, Fariba, Astermark, Jan, Holmström, Margareta, Fontana, Pierre, Schmugge, Markus, Zulfikar, Bulent, Kavakli, Kaan, Khan, Mohammed, Benson, Gary, Lester, Will, Andrew, Page, Catherine, Bagot, Pinto, Fernando, Salta, Styliani, Farrelly, Cathy, Matthias, Mary, Laffan, Mike, Thynn Thynn, Yee, Mcdonald, Vickie, Austin, Steve, Bella, Madan, Hay, Charles, Grainger, John, Talks, Kate, Shapiro, Susie, Maclean, Rhona, Payne, Jeanette, Fischer, Kathelijn, Lassila, Riitta, Gouw, Samantha C., Hollingsworth, Rob, Lambert, Thierry, Kaczmarek, Radek, Carbonero, Diana, and Makris, Mike

Published
2024
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3. Little discrepancy between one-stage and chromogenic factor VIII (FVIII)/IX assays in a large international cohort of persons with nonsevere hemophilia A and B

Author

Zwagemaker, Anne-Fleur, Kloosterman, Fabienne R., Gouw, Samantha C., Boyce, Sara, Brons, Paul, Cnossen, Marjon H., Collins, Peter W., Eikenboom, Jeroen, Hay, Charles, Hengeveld, Rutger C.C., Jackson, Shannon, Klopper-Tol, Caroline A.M., Kruip, Marieke J.H. A., Gorkom, Britta Laros-van, Male, Christoph, Nieuwenhuizen, Laurens, Shapiro, Susan, Fijnvandraat, Karin, and Coppens, Michiel

Published
2023
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6. The bleeding phenotype in people with nonsevere hemophilia

Author

Kloosterman, Fabienne R., Zwagemaker, Anne-Fleur, Bagot, Catherine N., Beckers, Erik A.M., Castaman, Giancarlo, Cnossen, Marjon H., Collins, Peter W., Hay, Charles, Hof, Michel, Laros-van Gorkom, Britta, Leebeek, Frank W.G., Male, Christoph, Meijer, Karina, Pabinger, Ingrid, Shapiro, Susan, Coppens, Michiel, Fijnvandraat, Karin, and Gouw, Samantha C.

Published
2022
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7. Management of multiple myeloma in a patient with haemophilia with concurrent emicizumab – case report

Author

Davies Elizabeth, Carter-Brzezinski Luke, Traintafillou Margarita, Brown Rachel, and Hay Charles R M

Subjects
emicizumab, myeloma, thromboprophylaxis, thalidomide, lenalidomide, Diseases of the blood and blood-forming organs, RC633-647.5
Abstract

With the increased life expectancies of people with severe haemophilia A, diagnoses of disorders associated with increased age are likely to become more common. Multiple myeloma is a commonly diagnosed plasma cell dyscrasia, with incidence strongly related to age. Both the disease itself and specific myeloma therapies are associated with a significant increase in rates of venous thromboembolism (VTE). Management of VTE prophylaxis can be challenging, especially in patients with a bleeding disorder. In this case report, we describe the management of a patient with concurrent diagnosis of multiple myeloma and severe haemophilia A, undergoing first line myeloma chemotherapy. The patient was successfully managed on standard of care myeloma treatment, with use of emicizumab and venous thromboprophylaxis. This case demonstrates the successful management of a haematological malignancy and a bleeding disorder using integrated and multidisciplinary patient-focused care.

Published
2021
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11. Superior Prophylactic Effectiveness of a Recombinant FVIIIFc Over Standard Half‐Life FVIII in Hemophilia A: A‐SURE Study.

Author

Oldenburg, Johannes, Hay, Charles, Peyvandi, Flora, Tagliaferri, Annarita, Holme, Pål Andrè, Álvarez‐Román, María Teresa, Biron‐Andréani, Christine, Malmström, Håkan, Bystrická, Linda, and Lethagen, Stefan

Subjects
*BLOOD coagulation factor VIII, *HEMOPHILIACS, *CHIMERIC proteins, *HEMOPHILIA, *INJECTIONS
Abstract

ABSTRACT Objectives Methods Results Conclusions The 24‐month, prospective, non‐interventional, European multicenter A‐SURE study evaluated the real‐world effectiveness of prophylaxis using an extended half‐life recombinant factor VIII (FVIII) Fc fusion protein, efmoroctocog alfa (hereinafter rFVIIIFc), compared with prophylaxis using standard half‐life (SHL) FVIII products in patients with hemophilia A.Primary endpoints were annualized bleeding rate (ABR), annualized injection frequency, and annualized factor consumption. A comparative study design unique for an observational hemophilia study was implemented to reduce potential confounding in effectiveness estimates, wherein each patient prescribed rFVIIIFc was matched with one receiving SHL FVIII. Propensity scores were used for adjustment in statistical analyses.Outcomes for all primary endpoints were significantly better in the rFVIIIFc group (n = 184) compared with the SHL FVIII group (n = 170): mean ABR 1.5 versus 2.3 (difference of −0.8; p = 0.0147); mean annualized injection frequency 114.4 versus 169.2 (difference of −54.8; p < 0.0001); and mean annualized factor consumption 243 024.2 versus 288 718.6 International Units (difference of 45 694.5; p = 0.0003). rFVIIIFc was well tolerated, with no inhibitor development.rFVIIIFc has superior prophylactic effectiveness versus SHL FVIII, providing higher bleed protection with fewer injections and lower factor consumption. [ABSTRACT FROM AUTHOR]

Published
2024
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12. The factor VIII treatment history of non‐severe hemophilia A

Author

Abdi, Amal, Kloosterman, Fabienne R., Eckhardt, Corien L., Male, Christoph, Castaman, Giancarlo, Fischer, Kathelijn, Beckers, Erik A.M., Kruip, Marieke J.H.A., Peerlinck, Kathelijne, Mancuso, Maria Elisa, Santoro, Cristina, Hay, Charles R., Platokouki, Helen, van der Bom, Johanna G., Gouw, Samantha C., Fijnvandraat, Karin, and Hart, Dan P.

Published
2020
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13. Bleeding symptoms in patients diagnosed as type 3 von Willebrand disease: Results from 3WINTERS‐IPS, an international and collaborative cross‐sectional study

Author

Tosetto, Alberto, Badiee, Zahra, Baghaipour, Mohammad‐Reza, Baronciani, Luciano, Battle, Javier, Berntorp, Erik, Bodó, Imre, Budde, Ulrich, Castaman, Giancarlo, Eikenboom, Jeroen C.J., Eshghi, Peyman, Ettorre, Cosimo, Goodeve, Anne, Goudemand, Jenny, Hay, Charles Richard Morris, Hoorfar, Hamid, Karimi, Mehran, Keikhaei, Bijan, Lassila, Riitta, Leebeek, Frank W.G., Lopez Fernandez, Maria Fernanda, Mannucci, Pier Mannuccio, Mazzucconi, Maria Gabriella, Morfini, Massimo, Oldenburg, Johannes, Peake, Ian, Parra Lòpez, Rafael, Peyvandi, Flora, Schneppenheim, Reinhard, Tiede, Andreas, Toogeh, Gholamreza, Trossaert, Marc, Zekavat, Omidreza, Zetterberg, Eva M.K., and Federici, Augusto B.

Published
2020
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16. Reply

Author

Hay, Charles A., Mallen, Christian D., Belcher, John, Roddy, Edward, and Prior, James A.

Published
2022
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22. Association of patient, treatment and disease characteristics with patient‐reported outcomes: Results of the ECHO Registry.

Author

Hay, Charles R. M., Makris, Michael, Shima, Midori, Nagao, Azusa, Jiménez‐Yuste, Víctor, Skinner, Mark, Kessler, Craig M., and von Mackensen, Sylvia

Subjects
*PATIENT reported outcome measures, *THERAPEUTICS, *PATIENT satisfaction, *JOINTS (Anatomy), *PHYSICAL mobility
Abstract

Introduction: Patient‐reported outcomes (PROs) in people living with haemophilia A (PLWHA) are often under‐reported. Investigating PROs from a single study with a diverse population of PLWHA is valuable, irrespective of FVIII product or regimen. Aim: To report available data from the Expanding Communications on Haemophilia A Outcomes (ECHO) registry investigating the associations of patient, treatment and disease characteristics with PROs and clinical outcomes in PLWHA. Methods: ECHO (NCT02396862), a prospective, multinational, observational registry, enrolled participants aged ≥16 years with moderate or severe haemophilia A using any product or treatment regimen. Data collection, including a variety of PRO questionnaires, was planned at baseline and annually for ≥2 years. Associations between PRO scores and patient, treatment and disease characteristics were determined by statistical analyses. Results: ECHO was terminated early owing to logistical constraints. Baseline data were available from 269 PLWHA from Europe, the United States and Japan. Most participants received prophylactic treatment (76.2%), with those using extended‐half‐life products (10.0%) reporting higher treatment satisfaction. Older age and body weight >30 kg/m2 (>BMI) were associated with poorer joint health. Older age was associated with poorer physical functioning and work productivity. Health‐related quality of life and pain interference also deteriorated with age and >BMI; >BMI also increased pain severity scores. Conclusion: ECHO captured a variety of disease characteristics, treatment patterns, PROs and clinical outcomes obtained in real‐world practice with ≤1 year's follow‐up. Older age, poorer joint health and >BMI adversely affected multiple aspects of participant well‐being. [ABSTRACT FROM AUTHOR]

Published
2024
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24. Little discrepancy between one-stage and chromogenic factor VIII (FVIII)/IX assays in a large international cohort of persons with nonsevere hemophilia A and B

Author

Zwagemaker, Anne Fleur, Kloosterman, Fabienne R., Gouw, Samantha C., Boyce, Sara, Brons, Paul, Cnossen, Marjon H., Collins, Peter W., Eikenboom, Jeroen, Hay, Charles, Hengeveld, Rutger C.C., Jackson, Shannon, Klopper-Tol, Caroline A.M., Kruip, Marieke J.H.A., Gorkom, Britta Laros van, Male, Christoph, Nieuwenhuizen, Laurens, Shapiro, Susan, Fijnvandraat, Karin, Coppens, Michiel, Pediatrics, and Hematology

Subjects
All institutes and research themes of the Radboud University Medical Center, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], Hematology, Rare cancers Radboud Institute for Molecular Life Sciences [Radboudumc 9]
Abstract

Item does not contain fulltext BACKGROUND: Accurate measurements of coagulation factor activity form an essential part of hemophilia management and are performed by the one-stage or chromogenic assay. Current literature suggests that approximately one-third of persons with nonsevere hemophilia A exhibit assay discrepancy, albeit with a high variability between studies. Such data are scarce in nonsevere hemophilia B. OBJECTIVES: To investigate the extent of factor VIII/IX one-stage and chromogenic assay discrepancy in moderate and mild hemophilia A and B. METHODS: Persons with previously diagnosed nonsevere hemophilia A and B with a factor level of 2 to 35 IU/dL were included from the international DYNAMO cohort study. Central measurements of the factor VIII and IX activity levels were performed by the one-stage and chromogenic assay. Relative and absolute discrepancy definitions were used, with the International Society on Thrombosis and Haemostasis-Scientific and Standardization Committee proposed ratio of >2.0 or 10 IU/dL between the assay results. In addition, with more lenient definitions, over 90% of participants (n = 197) had no discrepant results. Only 1 out of 13 persons with a mutation previously associated with discrepancy had significant assay discrepancy. CONCLUSION: Little assay discrepancy was observed despite the presence of mutations previously associated with discrepancy, suggesting that the presence and magnitude of assay discrepancy are largely determined by laboratory variables. 01 april 2023

Published
2023

26. Little discrepancy between one-stage and chromogenic FVIII/IX assays in a large international cohort of persons with non-severe hemophilia A and B

Author

Zwagemaker, Anne-Fleur, primary, Kloosterman, Fabienne R., additional, Gouw, Samantha C., additional, Boyce, Sara, additional, Brons, Paul, additional, Cnossen, Marjon H., additional, Collins, Peter W., additional, Eikenboom, Jeroen, additional, Hay, Charles, additional, Hengeveld, Rutger C.C., additional, Jackson, Shannon, additional, Klopper-Tol, Caroline A.M., additional, Kruip, Marieke J.H.A., additional, Laros-van Gorkom, Britta, additional, Male, Christoph, additional, Nieuwenhuizen, Laurens, additional, Shapiro, Susan, additional, Fijnvandraat, Karin, additional, and Coppens, M., additional

Published
2022
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27. Factor VIII gene (F8) mutation and risk of inhibitor development in nonsevere hemophilia A

Author

Eckhardt, Corien L., van Velzen, Alice S., Peters, Marjolein, Astermark, Jan, Brons, Paul P., Castaman, Giancarlo, Cnossen, Marjon H., Dors, Natasja, Escuriola-Ettingshausen, Carmen, Hamulyak, Karly, Hart, Daniel P., Hay, Charles R.M., Haya, Saturnino, van Heerde, Waander L., Hermans, Cedric, Holmström, Margareta, Jimenez-Yuste, Victor, Keenan, Russell D., Klamroth, Robert, Laros-van Gorkom, Britta A.P., Leebeek, Frank W.G., Liesner, Ri, Mäkipernaa, Anne, Male, Christoph, Mauser-Bunschoten, Evelien, Mazzucconi, Maria G., McRae, Simon, Meijer, Karina, Mitchell, Michael, Morfini, Massimo, Nijziel, Marten, Oldenburg, Johannes, Peerlinck, Kathelijne, Petrini, Pia, Platokouki, Helena, Reitter-Pfoertner, Sylvia E., Santagostino, Elena, Schinco, Piercarla, Smiers, Frans J., Siegmund, Berthold, Tagliaferri, Annarita, Yee, Thynn T., Kamphuisen, Pieter Willem, van der Bom, Johanna G., and Fijnvandraat, Karin

Published
2013
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31. Emicizumab prophylaxis in haemophilia A with inhibitors: Three years follow‐up from the UK Haemophilia Centre Doctors' Organisation (UKHCDO).

Author

Wall, Caroline, Xiang, Hua, Palmer, Ben, Chalmers, Elizabeth, Chowdary, Pratima, Collins, Peter W., Fletcher, Simon, Hall, Georgina W., Hart, Daniel P., Mathias, Mary, Sartain, Paul, Shapiro, Susan, Stephensen, David, Talks, Kate, and Hay, Charles R.M.

Subjects
HEALTH facilities, EMICIZUMAB, PHYSICIANS, HEMOPHILIA, HEMOPHILIACS
Abstract

Introduction: The UK National Haemophilia Database (NHD) collects data from all UK persons with haemophilia A with inhibitors (PwHA‐I). It is well‐placed to investigate patient selection, clinical outcomes, drug safety and other issues not addressed in clinical trials of emicizumab. Aims: To determine safety, bleeding outcomes and early effects on joint health of emicizumab prophylaxis in a large, unselected cohort using national registry and patient reported Haemtrack (HT) data between 01 January 2018 and 30 September 2021. Methods: Prospectively collected bleeding outcomes were analysed in people with ≥6 months emicizumab HT data and compared with previous treatment if available. Change in paired Haemophilia Joint Health Scores (HJHS) were analysed in a subgroup. Adverse events (AEs) reports were collected and adjudicated centrally. Results: This analysis includes 117 PwHA‐I. Mean annualised bleeding rate (ABR) was.32 (95% CI,.18;.39) over a median 42 months treatment with emicizumab. Within‐person comparison (n = 74) demonstrated an 89% reduction in ABR after switching to emicizumab and an increase in zero treated bleed rate from 45 to 88% (p <.01). In a subgroup of 37 people, total HJHS improved in 36%, remained stable in 46% and deteriorated in 18%, with a median (IQR) within‐person change of −2.0 (−9, 1.5) (p =.04). Three arterial thrombotic events were reported, two possibly drug related. Other AEs were generally non‐severe and usually limited to early treatment, included cutaneous reactions (3.6%), headaches (1.4%), nausea (2.8%) and arthralgia (1.4%). Conclusions: Emicizumab prophylaxis is associated with sustained low bleeding rates and was generally well‐tolerated in people with haemophilia A and inhibitors. [ABSTRACT FROM AUTHOR]

Published
2023
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32. Book Notes

Author

Hay, Charles C., Anderson, Linda, Bolin, James Duane, Biegert, Melissa Langley, and Hay, Melba Porter

Published
2001

33. FVIII inhibitor development according to concentrate: data from the EUHASS registry excluding overlap with other studies

Author

Fischer, K., Iorio, A., Hollingsworth, R., Makris, M., Watson, Henry, Rae, Joan, Platokouki, Helen, Pergantou, Helen, Katsarou, Olga, Theodossiades, George, Nomikou, Efrosyni, Parra, Rafael, Alonso, Sofia, Klamroth, Robert, Kubicek, Cornelia, Wilde, Jonathan, Dunkley, Tracey, Oldenburg, Johannes, Schmickler, Daniela, Ackroyd, Sam, Mirza, Lubena, Batorova, Angelika, Jankovicova, Denisa, Auerswald, Günter, Buehrlen, Martina, Penka, Miroslav, Smejkal, Petr, Blatny, Jan, Zapletal, Ondrej, Hermans, Cedric, Lambert, Catherine, Tagariello, Giuseppe, Radossi, Paolo, Nolan, Beatrice, Brady, Bridin, O'Donnell, James, Singleton, Evelyn, Shea, Irma, Morfini, Massimo, Linari, Silvia, de Moerloose, Philippe, Boehlen, Francoise, Campbell Tait, R., Brodie, Nancy, Chalmers, Elizabeth, Gibson, Aileen, Meijer, Karina, Tamminga, Rienk, Lassila, Riitta, Armstrong, Elina, Zulfikar, Bulent, Ozdemir, Nihal, Kavakli, Kaan, Balkan, Can, Jurgutis, Romualdas, Gailiute, Neringa, Peerlinck, Kathelijne, Van Geet, Chris, Goudemand, Jenny, Wibaut, Bénédicte, Joao Diniz, Maria, Antunes, Margarida, Liesner, Ri, Khair, Kate, Laffan, Mike, Patel, Sanjay, Thynn Yee, Thynn, Harrington, Christine, Pasi, John, Bowles, Louise, Bevan, David, Madan, Bella, Negrier, Claude, Ringenbach, Stéphanie, Mingot Castellano, Maria Eva, Astermark, Jan, Lindvall, Karin, Gatt, Alexander, Hay, Charles RM, Grey, Paula, Will, Andrew, Hague, Allyson, Peyvandi, Flora, Mancuso, Maria Elisa, Schved, Jean Francois, Rousseau, Florence, Kurnik, Karin, Bidlingmaier, Christoph, Rocino, Angiola, Hanley, John, Talks, Kate, Antoniades, Marios, Zanon, Ezio, De Bon, Emiliano, Lambert, Thierry, Rothschild, Chantal, Matingou, Marcelline, Tagliaferri, Annarita, Rivolta, Gianna Franca, Marchesini, Emanuela, Fraga, Cristina, Cunha-Ribeiro, Luís, Carvalho, Manuela, Komrska, Vladimir, Pindurova, Ester, Lejniece, Sandra, Kluce, Gunta, Leebeek, Frank, Cnossen, Marjon, Lockley, Caryl, Payne, Jeanette, Vidler, Vicky, Lissitchkov, Toshko, Raia, Petrova, Holmström, Margareta, Garipidou, Vassileia, Vakalopoulou, Sofia, Serban, Margit, Mihailov, Maria-Delia, Schinco, Piercarla, Valeri, Federica, Schutgens, Roger, Bonanad, Santiago, Cid, Ana Rosa, Castaman, Giancarlo, Pabinger, Ingrid, Reitter, Sylvia-Elisabeth, Male, Christoph, Thom, Katharina, Windyga, Jerzy, Piorowski, Michal, Schmugge, Markus, and Albisetti, Manuela

Published
2016
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36. Reply

Author

Hay, Charles A., primary, Mallen, Christian D., additional, Belcher, John, additional, Roddy, Edward, additional, and Prior, James A., additional

Published
2021
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41. Book Notes

Author

Hay, Charles C., Parrish, Charles E., Appleton, Thomas H., Eslinger, Ellen, Friend, Craig T., Marszalek, John F., Harris, James Russell, Hay, Melba Porter, Tyler, Bruce M., Coletta, Paolo E., and Carson, James Taylor

Published
1996

44. Immune tolerance induction in severe haemophilia A: A UKHCDO inhibitor and paediatric working party consensus update

Author

Hart, Daniel P., primary, Alamelu, Jayanthi, additional, Bhatnagar, Neha, additional, Biss, Tina, additional, Collins, Peter W., additional, Hall, Georgina, additional, Hay, Charles, additional, Liesner, Ri, additional, Makris, Michael, additional, Mathias, Mary, additional, Motwani, Jayashree, additional, Palmer, Ben, additional, Payne, Jeanette, additional, Percy, Charles, additional, Richards, Michael, additional, Riddell, Anne, additional, Talks, Kate, additional, Tunstall, Oliver, additional, and Chalmers, Elizabeth, additional

Published
2021
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45. Low Rebleed Incidence with Eptacog Beta Treatment through 24 and 48 Hours in Children (

Author

Pipe, Steven, Oldenburg, Johannes, Carcao, Manuel, Chitlur, Meera, Dargaud, Yesim, Davis, Joanna, Escuriola, Carmen, Hay, Charles, Hermans, Cédric, Hwang, Nina, Jiménez-Yuste, Víctor, Kessler, Craig, Mahlangu, Johnny, Mancuso, Maria Elisa, McGuinn, Catherine, Miesbach, Wolfgang, Chrisentery-Singleton, Tammuella, Thornburg, Courtney, Wang, Michael, Bonzo, Daniel, Mitchell, Ian, Wilkinson, Thomas, and Dunn, Amy

Published
2023
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