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6. Intensity of factor VIII treatment and inhibitor development in children with severe hemophilia A: the RODIN study

Author

Gouw, Samantha C., van den Berg, H. Marijke, Fischer, Kathelijn, Auerswald, Günter, Carcao, Manuel, Chalmers, Elizabeth, Chambost, Hervé, Kurnik, Karin, Liesner, Ri, Petrini, Pia, Platokouki, Helen, Altisent, Carmen, Oldenburg, Johannes, Nolan, Beatrice, Garrido, Rosario Pérez, Mancuso, M. Elisa, Rafowicz, Anne, Williams, Mike, Clausen, Niels, Middelburg, Rutger A., Ljung, Rolf, and van der Bom, Johanna G.

Published
2013
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7. Intracranial haemorrhage in children and adolescents with severe haemophilia A or B – the impact of prophylactic treatment

Author

Andersson, Nadine G., Auerswald, Günter, Barnes, Chris, Carcao, Manuel, Dunn, Amy L., Fijnvandraat, Karin, Hoffmann, Marianne, Kavakli, Kaan, Kenet, Gili, Kobelt, Rainer, Kurnik, Karin, Liesner, Ri, Mäkipernaa, Anne, Manco‐Johnson, Marilyn J., Mancuso, Maria E., Molinari, Angelo C., Nolan, Beatrice, Perez Garrido, Rosario, Petrini, Pia, Platokouki, Helen E., Shapiro, Amy D., Wu, Runhui, and Ljung, Rolf

Published
2017
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12. 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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15. Practical considerations for nonfactor-replacement therapies in the treatment of haemophilia with inhibitors.

Author

UCL - SSS/IREC/CARD - Pôle de recherche cardiovasculaire, UCL - (SLuc) Service d'hématologie, Jiménez-Yuste, Victor, Auerswald, Günter, Benson, Gary, Dolan, Gerry, Hermans, Cédric, Lambert, Thierry, Ljung, Rolf, Morfini, Massimo, Santagostino, Elena, Zupančić Šalek, Silva, UCL - SSS/IREC/CARD - Pôle de recherche cardiovasculaire, UCL - (SLuc) Service d'hématologie, Jiménez-Yuste, Victor, Auerswald, Günter, Benson, Gary, Dolan, Gerry, Hermans, Cédric, Lambert, Thierry, Ljung, Rolf, Morfini, Massimo, Santagostino, Elena, and Zupančić Šalek, Silva

Abstract

New therapeutic agents for haemophilia with inhibitors that are in development or already licensed are expected to provide transformative treatment options. Many of these new therapies are not based on simply replacing the missing factor; new strategies include bispecific antibody technology that mimics factor VIII coagulation function (emicizumab), and inhibition of anticoagulant proteins such as tissue factor pathway inhibitor (eg PF-06741086) and antithrombin (eg fitusiran). These agents are administered subcutaneously and should significantly reduce treatment burden and increase the ability to deliver prophylaxis for patients. Limited real-world data and validated practical guidance on these recently licensed/upcoming treatments resulted in the authors convening to discuss recommendations on their use. Emicizumab is currently the only licenced nonfactor therapy; thus, our recommendations focus on this product. Target candidates for emicizumab prophylaxis are difficult-to-treat patients with haemophilia A and inhibitors and/or venous access issues, frequent bleeds and target joints. In case of breakthrough bleeding while receiving emicizumab, patients still require treatment with bypassing agents; the adjunct treatment of choice is recombinant activated factor VII. This treatment is also recommended to prevent bleeds in patients with inhibitors undergoing surgery. Our recommendations on suitable laboratory assays and monitoring new products, as well as the benefit of patient-reported outcomes (such as pain and physical activity levels), are included. We also briefly discuss future treatment options for patients with haemophilia B and inhibitors. Although these nonfactor treatments offer great promise, further data and real-world evidence are needed.

Published
2021

24. Optimizing the management of patients with haemophilia A and inhibitors in the era of emicizumab: Recommendations from a German expert panel.

Author

Escuriola‐Ettingshausen, Carmen, Auerswald, Günter, Königs, Christoph, Kurnik, Karin, Scholz, Ute, Klamroth, Robert, and Oldenburg, Johannes

Subjects
*HEMOPHILIA, *MEDICAL personnel, *BLOOD coagulation factors, *METRORRHAGIA, *THROMBOTIC thrombocytopenic purpura, *NEUTRALIZATION tests
Abstract

Standard treatment of haemophilia A is based on replacing the missing coagulation factor VIII (FVIII) to treat and prevent bleeding episodes. The most challenging complication of FVIII therapy is the development of neutralizing antibodies (inhibitors) that can render treatment ineffective. Eradication of the inhibitor through immune tolerance induction (ITI) remains the most effective strategy for managing these patients. Bypassing agents can be used to help restore haemostasis in inhibitor patients. Several novel agents have recently been developed, such as the FVIII mimetic agent emicizumab, which has been effective in reducing the annualized bleeding rate in haemophilia A patients with inhibitors. When coadministered with repetitive high doses of activated prothrombin complex concentrate (ie >100 U/kg/d for ≥24 hours), emicizumab was associated with thrombotic microangiopathy and thrombosis events. As a consequence the United Kingdom Haemophilia Centres Doctors' Organisation (UKHCDO) issued the first guidance on the treatment of bleeding episodes in patients receiving emicizumab. To build on and extend this work, a panel of German haemophilia specialists met to discuss the UK guidance, review current evidence and provide additional guidance for German healthcare professionals on how to optimize the management of patients with haemophilia A receiving emicizumab. Recommendations are provided on the use of bypassing and other agents to manage breakthrough bleeding, ITI in the emicizumab era, haemostatic support during surgery and issues relating to laboratory monitoring. [ABSTRACT FROM AUTHOR]

Published
2021
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25. Diagnosis and care of patients with mild haemophilia: practical recommendations for clinical management.

Author

UCL - SSS/IREC/CARD - Pôle de recherche cardiovasculaire, UCL - (SLuc) Service d'hématologie, Benson, Gary, Auerswald, Günter, Dolan, Gerry, Duffy, Anne, Hermans, Cédric, Ljung, Rolf, Morfini, Massimo, Šalek, Silva Zupančić, UCL - SSS/IREC/CARD - Pôle de recherche cardiovasculaire, UCL - (SLuc) Service d'hématologie, Benson, Gary, Auerswald, Günter, Dolan, Gerry, Duffy, Anne, Hermans, Cédric, Ljung, Rolf, Morfini, Massimo, and Šalek, Silva Zupančić

Abstract

Mild haemophilia is defined by factor levels between 0.05 and 0.40 IU/mL and is characterised by traumatic bleeds. Major issues associated with mild haemophilia are that it may not present for many years after birth, and that awareness, even within families, may be low. Methodological problems exist in diagnosis, such as inconsistencies in results obtained from different assays used to measure factor levels in mild haemophilia. Advances in genetic testing provide insight into diagnosis as well as the likelihood of inhibitor development, which is not uncommon in patients with mild or moderate haemophilia and can increase morbidity. The management of patients with mild haemophilia is a challenge. This review includes suggestions around formulating treatment plans for these patients, encompassing the full spectrum from clinical care of the newly diagnosed neonate to that of the ageing patient with multiple comorbidities. Management strategies consider not only the vast differences in these patients' needs, but also risks of inhibitor development and approaches to optimally engage patients.

Published
2018

26. Beyond stopping the bleed: short-term episodic prophylaxis with recombinant activated factor FVII in haemophilia patients with inhibitors

Author

Šalek, Silva Zupančić, Auerswald, Günter, Benson, Gary, Dolan, Gerry, Duffy, Anne, Hermans, Cedric, Jiménez-Yuste, Victor, Ljung, Rolf, Morfini, Massimo, Santagostino, Elena, and Lambert, Thierry

Subjects
Treatment Outcome, Hemarthrosis, Humans, Hemorrhage, Factor VIIa, Meeting Report, Hemophilia A, Recombinant Proteins
Abstract

Preventing haemarthroses and arthropathy is a major challenge in patients with haemophilia and inhibitors, as treatment options are limited. One potential strategy is short-term episodic prophylaxis, which extends bypassing agent therapy beyond the resolution of bleeding to include the post-bleed inflammatory phase. At the 13th Zürich Haemophilia Forum, an expert panel reviewed the rationale behind this strategy, explored its current use with recombinant activated factor VII (rFVIIa) and considered treatment monitoring and optimisation. Two protocols are currently used for short-term episodic prophylaxis, both of which stipulate on-demand rFVIIa until resolution of bleeding, followed by daily dosing for ≥3 days to prevent re-bleeds. Short-term episodic prophylaxis should be individualised to optimise outcomes, perhaps through early treatment initiation or by combining rFVIIa with other treatments (e.g. factor VIII, tranexamic acid). Encouraging treatment compliance can also improve outcomes. Additionally, there is a need to develop objective clinical outcome measures, biomarkers and imaging protocols that can monitor treatment outcomes and joint disease in patients with inhibitors. A proactive approach incorporating a systematic package of care is needed. Currently, short-term episodic prophylaxis with rFVIIa may be an alternative treatment option to on-demand treatment for patients with inhibitors.

Published
2017

27. Outcome measures for adult and pediatric hemophilia patients with inhibitors.

Author

UCL - SSS/IREC/CARD - Pôle de recherche cardiovasculaire, UCL - (SLuc) Service d'hématologie, Hermans, Cédric, Auerswald, Günter, Benson, Gary, Dolan, Gerry, Duffy, Anne, Jiménez-Yuste, Victor, Ljung, Rolf, Morfini, Massimo, Lambert, Thierry, Osooli, Mehdi, Zupančić Šalek, Silva, UCL - SSS/IREC/CARD - Pôle de recherche cardiovasculaire, UCL - (SLuc) Service d'hématologie, Hermans, Cédric, Auerswald, Günter, Benson, Gary, Dolan, Gerry, Duffy, Anne, Jiménez-Yuste, Victor, Ljung, Rolf, Morfini, Massimo, Lambert, Thierry, Osooli, Mehdi, and Zupančić Šalek, Silva

Abstract

Recent advancements in almost all aspects of hemophilia treatment have vastly improved patient care and management, and new and emerging treatments hold the promise of further progress. However, there remains a scarcity of data on long-term outcomes in hemophilia, particularly among those patients with inhibitors, for whom no validated outcome assessment tools are currently available. At the 15 Zürich Haemophilia Forum, an expert panel reviewed the most important outcome measures in inhibitor patients and considered the challenges associated with assessing outcomes in this population. A framework for outcome assessment in inhibitor patients incorporates traditional hemophilia outcome measures, such as bleed frequency and mortality, alongside measures of health, functioning, disability, social participation, quality of life, and economic considerations. It is important to remember that inhibitor patients differ in their clinical needs, perspectives, and priorities according to age, inhibitor status, degree of joint disease, and activity levels; as a result, the relative importance of different outcome measures will change throughout an inhibitor patient's life. Challenges inherent in measuring long-term outcomes in inhibitor patients include the small number of known patients, the subjective nature of many outcome assessment tools, and the risk of overburdening patients with repeated requests to complete questionnaires or participate in studies. Therefore, there is an urgent need to reach consensus on the most important and appropriate assessment tools for measuring outcomes in this population. These tools should ideally be standardized, easily applied, and internationally applicable in order to collect and generate quality outcome data.

Published
2017

29. Pain and pain management in haemophilia

Author

Auerswald, Günter, primary, Dolan, Gerry, additional, Duffy, Anne, additional, Hermans, Cedric, additional, Jiménez-Yuste, Victor, additional, Ljung, Rolf, additional, Morfini, Massimo, additional, Lambert, Thierry, additional, and Šalek, Silva Zupančić, additional

Published
2016
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30. Increased inhibitor incidence in severe haemophilia A since 1990 attributable to more low titre inhibitors

Author

van den Berg, H. Marijke, Hashemi, S. Mojtaba, Fischer, Kathelijn, Petrini, Pia, Ljung, Rolf, Rafowicz, Anne, Carcao, Manuel, Auerswald, Günter, Kurnik, Karin, Kenet, Gili, Santagostino, Elena, van den Berg, H. Marijke, Hashemi, S. Mojtaba, Fischer, Kathelijn, Petrini, Pia, Ljung, Rolf, Rafowicz, Anne, Carcao, Manuel, Auerswald, Günter, Kurnik, Karin, Kenet, Gili, and Santagostino, Elena

Published
2016

31. Pain and pain management in haemophilia

Author

UCL - SSS/IREC/CARD - Pôle de recherche cardiovasculaire, UCL - (SLuc) Service d'hématologie, Auerswald, Günter, Dolan, Gerry, Duffy, Anne, Hermans, Cédric, Jiménez-Yuste, Victor, Ljung, Rolf, Morfini, Massimo, Lambert, Thierry, Šalek, Silva Zupančić, UCL - SSS/IREC/CARD - Pôle de recherche cardiovasculaire, UCL - (SLuc) Service d'hématologie, Auerswald, Günter, Dolan, Gerry, Duffy, Anne, Hermans, Cédric, Jiménez-Yuste, Victor, Ljung, Rolf, Morfini, Massimo, Lambert, Thierry, and Šalek, Silva Zupančić

Abstract

Joint pain is common in haemophilia and may be acute or chronic. Effective pain management in haemophilia is essential to reduce the burden that pain imposes on patients. However, the choice of appropriate pain-relieving measures is challenging, as there is a complex interplay of factors affecting pain perception. This can manifest as differences in patients' experiences and response to pain, which require an individualized approach to pain management. Prophylaxis with factor replacement reduces the likelihood of bleeds and bleed-related pain, whereas on-demand therapy ensures rapid bleed resolution and pain relief. Although use of replacement or bypassing therapy is often the first intervention for pain, additional pain relief strategies may be required. There is an array of analgesic options, but consideration should be paid to the adverse effects of each class. Nevertheless, a combination of medications that act at different points in the pain pathway may be beneficial. Nonpharmacological measures may also help patients and include active coping strategies; rest, ice, compression, and elevation; complementary therapies; and physiotherapy. Joint aspiration may also reduce acute joint pain, and joint steroid injections may alleviate chronic pain. In the longer term, increasing use of prophylaxis or performing surgery may be necessary to reduce the burden of pain caused by the degenerative effects of repeated bleeds. Whichever treatment option is chosen, it is important to monitor pain and adjust patient management accordingly. Beyond specific pain management approaches, ongoing collaboration between multidisciplinary teams, which should include physiotherapists and pain specialists, may improve outcomes for patients.

Published
2016

32. Increased inhibitor incidence in severe haemophilia A since 1990 attributable to more low titre inhibitors

Author

Cardiovasculaire Epi Team 1, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Poli Van Creveldkliniek Medisch, Circulatory Health, van den Berg, H. Marijke, Hashemi, S. Mojtaba, Fischer, Kathelijn, Petrini, Pia, Ljung, Rolf, Rafowicz, Anne, Carcao, Manuel, Auerswald, Günter, Kurnik, Karin, Kenet, Gili, Santagostino, Elena, Cardiovasculaire Epi Team 1, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Poli Van Creveldkliniek Medisch, Circulatory Health, van den Berg, H. Marijke, Hashemi, S. Mojtaba, Fischer, Kathelijn, Petrini, Pia, Ljung, Rolf, Rafowicz, Anne, Carcao, Manuel, Auerswald, Günter, Kurnik, Karin, Kenet, Gili, and Santagostino, Elena

Published
2016

34. Rationale for individualizing haemophilia care

Author

Sørensen, Benny, primary, Auerswald, Günter, additional, Benson, Gary, additional, Elezović, Ivo, additional, Felder, Markus, additional, Lambert, Thierry, additional, Morfini, Massimo, additional, Remor, Eduardo, additional, Salaj, Peter, additional, Santagostino, Elena, additional, Šalek, Silva Z., additional, and Ljung, Rolf, additional

Published
2015
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36. Recombinant, activated factor VII for surgery in factor VII deficiency:a prospective evaluation - the surgical STER

Author

Mariani, Guglielmo, Dolce, Alberto, Batorova, Angelika, Auerswald, Günter, Schved, Jean Francois, Siragusa, Sergio, Napolitano, Mariasanta, Knudsen, Jens Bjerre, and Ingerslev, Jørgen

Subjects
Adult, Male, Adolescent, Coagulants, Factor VII Deficiency, Blood Loss, Surgical, Infant, Factor VIIa, Middle Aged, Hemostasis, Surgical, Recombinant Proteins, Treatment Outcome, Child, Preschool, Drug Evaluation, Humans, Female, Prospective Studies, Child, Epidemiologic Methods, Aged
Abstract

Excessive bleeding represents a major complication of surgical interventions and its control is especially relevant in patients with Congenital Bleeding Disorders (CBD). In factor VII (FVII) deficiency, scanty data on surgery is available to guide treatment strategies. The STER (Seven Treatment Evaluation Registry) is a multi-centre, prospective, observational, web-based study protocol providing the frame for a structured and detailed data collection. Inhibitor occurrence was checked in a centralized fashion. Forty-one surgical operations (24 'major' and 17 'minor') were performed in 34 subjects with a carefully characterized FVII deficiency under the coverage of recombinant activated Factor VII (rFVIIa). Bleeding occurred during three major interventions of orthopaedic surgery, but rFVIIa was given at very low dose in each case. An antibody to FVII was observed in one patient who underwent a multiple dental extraction. No thromboses were reported during the 30-d follow up period. Replacement therapy with rFVIIa proved effective when suitable doses were used, which, during the period of maximum bleeding risk (the day of operation), were calculated (Receiver Operated Characteristic analysis) to be of at least 13 μg/kg/body weight per single dose and no less than three administrations. This indication is important especially in the case of major surgery.

Published
2011

38. Risk Factors for the Development of High-Titer Inhibitors in 260 Children with Severe Hemophilia a Born Between 1990 and 2009: The Remain Study

Author

Mancuso, Maria Elisa, Fischer, Kathelijn, Santagostino, Elena, Oldenburg, Johannes, Platokouki, Helen, Königs, Christoph, Escuriola, Carmen, Rivard, Georges-Etienne, Cid, Ana, Carcao, Manuel, Ljung, Rolf, Petrini, Pia, Rafowicz, Anne, Altisent, Carmen, Kenet, Gili, Liesner, Raina, Kurnik, Karin, Van Geet, Christel, Alvarez-Roman, Teresa, Yee, Tin Tin, Auerswald, Guenter, Sr., Perez-Garrido, Rosario, Nolan, Beatrice, Chambost, Hervé, Makipernaa, Anne, Molinari, Angelo Claudio, Thomas, Angela, Chalmers, Elizabeth, Williams, Mike, Kobelt, Rainer, and Van den Berg, Marijke

Published
2016
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39. Addressing current challenges in haemophilia care: Consensus recommendations of a European Interdisciplinary Working Group

Author

Edinburgh, UK - Department of Haematology, Royal Infirmary, Ludlam, Christopher A., Mannucci, Pier M., Powderly, William G., Roca, Carmen Altisent, Astermark, Jan, Auerswald, Günter, Garcia Barrios, Manuel, Chistolini, Antonio, Dolan, Gerard, Gringeri, Alessandro, Hermans, Cédric, Laurian, Yves, Lopez, Rafael Parra, Peerlinck, Kathelijne, Pollmann, Hartmut, Ritchie, Bruce, Rocino, Angiola, Schramm, Wolfgang, Tagliaferri, Annarita, Thomas, Angela E., Villar, Ana, von Depka, Mario, Heinz, Franz X., Kreil, Thomas, Kretzschmar, Hans A., Simmonds, Peter, Soriano, Vicente, Lambden, Paul, Mantovani, Lorenzo A., Schmid, George, Edinburgh, UK - Department of Haematology, Royal Infirmary, Ludlam, Christopher A., Mannucci, Pier M., Powderly, William G., Roca, Carmen Altisent, Astermark, Jan, Auerswald, Günter, Garcia Barrios, Manuel, Chistolini, Antonio, Dolan, Gerard, Gringeri, Alessandro, Hermans, Cédric, Laurian, Yves, Lopez, Rafael Parra, Peerlinck, Kathelijne, Pollmann, Hartmut, Ritchie, Bruce, Rocino, Angiola, Schramm, Wolfgang, Tagliaferri, Annarita, Thomas, Angela E., Villar, Ana, von Depka, Mario, Heinz, Franz X., Kreil, Thomas, Kretzschmar, Hans A., Simmonds, Peter, Soriano, Vicente, Lambden, Paul, Mantovani, Lorenzo A., and Schmid, George

Abstract

Current challenges facing haemophilia care were identified and reviewed by an interdisciplinary group of experts in haemostasis and thrombosis, infectious disease, epidemiology, pharmacoeconomics and public health who met in February 2005 in Brussels. The outcome of this meeting was a series of consensus recommendations proposed to address the following three challenges: (i) developing the next generation of haemophilia specialists; (ii) reducing the risk that emerging pathogens present to safe haemophilia care and (iii) providing haemophilia care in an environment of cost constraint. It is intended that these consensus recommendations will form the basis of a concerted effort by leading haemophilia clinicians to secure future resources for the development and improvement of haemophilia care throughout Europe. © 2005 Blackwell Publishing Ltd.

Published
2005

40. Beyond patient benefit: clinical development in hemophilia

Author

Auerswald, Günter, primary, Šalek, Silva Zupančić, additional, Benson, Gary, additional, Elezović, Ivo, additional, Lambert, Thierry, additional, Morfini, Massimo, additional, Pasi, John, additional, Remor, Eduardo, additional, Santagostino, Elena, additional, Salaj, Peter, additional, and Ljung, Rolf, additional

Published
2012
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42. Hämophilie bei Kindern

Author

Auerswald, Günter, primary, Kurnik, Karin, additional, Girisch, Monika, additional, Oldenburg, Johannes, additional, and Kreuz, Wolfhart, additional

Published
2008
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43. A systematic overview of the first pasteurised VWF/FVIII medicinal product, Haemate®P/ Humate®-P: History and clinical performance

Author

Berntorp, Erik, primary, Archey, William, additional, Auerswald, Günter, additional, Federici, Augusto B., additional, Franchini, Massimo, additional, Knaub, Sigurd, additional, Kreuz, Wolfhart, additional, Lethagen, Stefan, additional, Mannucci, Pier M., additional, Pollmann, Hartmut, additional, Scharrer, Inge, additional, and Hoots, Keith, additional

Published
2008
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47. Prophylaxis with Recombinant Activated Factor VII in Hemophilia Patients with Inhibitors.

Author

Auerswald, Günter and Morfini, Massimo

Subjects
*HEMOPHILIA treatment, *RECOMBINANT blood proteins, *HEMOPHILIACS, *BLOOD coagulation factor VIII antibodies, *DENTAL prophylaxis, *BLOOD coagulation, *RANDOMIZED controlled trials, *PHARMACOKINETICS, *BLOOD coagulation disorders
Abstract

Treatment of bleeding episodes or during surgery in people with hemophilia A (FVIII deficiency) or hemophilia B (FIX deficiency) who have developed antibodies (inhibitors) to FVIII or FIX (especially high titer inhibitors) is difficult as a normal replacement with factor VIII or IX is not effective. rFVIIa is used to treat bleeds in patients with hemophilia who have developed such antibodies to FVIII or FIX (inhibitors, especially high titer inhibitors). Its effects on the coagulation system, however, may last for longer than pharmacokinetic data suggest. Furthermore, data supporting the concept of rFVIIa-mediated prophylaxis in hemophilia patients with inhibitors are now being published. A recently described clinical trial of prophylaxis with rFVIIa in 22 frequently bleeding hemophilia patients with inhibitors was the first to report the results of a prospective randomized study evaluating the potential benefits of a bypassing agent in such a prophylactic setting. Here we review data from this study together with other information currently available relating to the prophylactic use of rFVIIa in patients with hemophilia and inhibitors outside the surgical arena. Overall, data from more than 70 patients described in a range of publications suggest that prophylaxis with rFVIIa can decrease bleeding frequency, increase mobility, reduce pain and have other quality of life benefits in hemophilia patients with inhibitors. There are no reports of any adverse event profiles attributable to the use of rFVIIa in these patients. The prolonged prophylactic effect of rFVIIa may be explained, at least in part, by its diffusion into the extravascular space and the formation of complexes with tissue factor to facilitate thrombin generation on platelets. In addition, rFVIIa could be internalized into platelets, which subsequently increases the duration of its availability. Further research into rFVIIa prophylaxis and its mechanism of action in hemophilia patients with inhibitors is warranted. [ABSTRACT FROM AUTHOR]

Published
2010

48. Management of the Sponataneous Bleeding Episodes in Factor VII Deficiency. A Prospective Evaluation of the STER,

Author

Napolitano, Mariasanta, Dolce, Alberto, Batorova, Angelika, Auerswald, Guenter K.H., Schved, Jean-Francois, Siragusa, Sergio, Knudsen, Jens Bjerre, Ingerslev, Jorgen, Altisent, Carmen, Kavakli, Kaan, Caliskan, Umran, Shamsi, Tahir S, Bertrand, Marie, Aronis, Sophie, Di Minno, Giovanni, Ruiz-Sáez, Arlette, Chuansumrit, Ampaiwan, Garrido, Rosario Perez, Ghosh, Kanjaksha, Mirbehbahani, Narges, Karimi, Mehran, and Mariani, Guglielmo

Published
2011
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49. Replacement Therapy for Minor Surgery and Invasive Procedures in Factor VII Deficiency: The STER Experience

Author

Napolitano, Mariasanta, Dolce, Alberto, Ingerslev, Jorgen, Giansily-Blaizot, Muriel, Di Minno, Matteo ND, Auerswald, Guenter K.H., de Saez, Arlette Ruiz, Tagliaferri, Annarita, Batorova, Angelika, Caimi, Teresa Maria, Chuansumrit, Ampaiwan, Fernandez, Maria Fernanda Lopez, Bertrand, Marie-Anne, Verdy, Elisabeth, Zanon, Ezio, Abecassis, Lien, Aronis, Sophie, Siragusa, Sergio, Orecchioni, Assunta, and Mariani, Guglielmo

Published
2011
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