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10. Castagno

Author

Beccaro, G. L., Gamba, G., and Tessa, G.

Published
2022

22. New data from the italian national register of congenital coagulopathies, 2016 annual survey

Author

Abbonizio F., Hassan H. J., Riccioni R., Santagostino E., Arcieri R., Giampaolo A., Contino L., Accorsi A., Caremani A., Ettorre P. C., Giordano P., Lassandro G., Valdre L., Notarangelo L., Aru A. B., Radossi P., Tagariello G., Cultrera D., Iannaccaro P., Santoro R., Biasoli C., Di Gregorio P., Daniele F., Testa S., Serino M. L., Castaman G., Linari S. S., Morfini M., Molinari A. C., Delios G., Cantori I., Franchini M., Caimi M. T., Mancuso M. E., Peyvandi F., Marietta M., Todisco A., Speciale V., Cerbone A. M., Di Minno G., Schiavulli M., Rocino A., Spiezia M. M., Zanon E., Gagliano F., Mansueto M. F., Siragusa S., Coppola A., Quintavalle G., Rivolta G. F., Tagliaferri A., Ambaglio C., Gamba G., Marchesini E., Oliovecchio E., Dragani A., Arbasi M. C., MacChi S., Vincenzi D., Sottilotta G., Pizzini A. M., Luciani M., De Cristofaro R., Baldacci E., Mazzucconi M. G., Santoro C., Mameli L. A., Coluccia A., Marino P., Borchiellini A., Schinco P. C., Messina M., Pollio B., Ricca I., Agostini P., Cristallo A. F., Barillari G., De Angelis V., Mosanghini M. E., Feola G., Bonetti E., Cesaro S., Gandini G., Giuffrida A., Tosetto A., Abbonizio, F., Hassan, H. J., Riccioni, R., Santagostino, E., Arcieri, R., Giampaolo, A., Contino, L., Accorsi, A., Caremani, A., Ettorre, P. C., Giordano, P., Lassandro, G., Valdre, L., Notarangelo, L., Aru, A. B., Radossi, P., Tagariello, G., Cultrera, D., Iannaccaro, P., Santoro, R., Biasoli, C., Di Gregorio, P., Daniele, F., Testa, S., Serino, M. L., Castaman, G., Linari, S. S., Morfini, M., Molinari, A. C., Delios, G., Cantori, I., Franchini, M., Caimi, M. T., Mancuso, M. E., Peyvandi, F., Marietta, M., Todisco, A., Speciale, V., Cerbone, A. M., Di Minno, G., Schiavulli, M., Rocino, A., Spiezia, M. M., Zanon, E., Gagliano, F., Mansueto, M. F., Siragusa, S., Coppola, A., Quintavalle, G., Rivolta, G. F., Tagliaferri, A., Ambaglio, C., Gamba, G., Marchesini, E., Oliovecchio, E., Dragani, A., Arbasi, M. C., Macchi, S., Vincenzi, D., Sottilotta, G., Pizzini, A. M., Luciani, M., De Cristofaro, R., Baldacci, E., Mazzucconi, M. G., Santoro, C., Mameli, L. A., Coluccia, A., Marino, P., Borchiellini, A., Schinco, P. C., Messina, M., Pollio, B., Ricca, I., Agostini, P., Cristallo, A. F., Barillari, G., De Angelis, V., Mosanghini, M. E., Feola, G., Bonetti, E., Cesaro, S., Gandini, G., Giuffrida, A., and Tosetto, A.

Subjects
Blood coagulation disorder, Haemophilia B, Haemophilia A, Von Willebrand's disease, Register
Abstract

Background - In Italy, the National Register of Congenital Coagulopathies (NRCC) collects epidemiological and therapeutic data from patients affected by haemophilia A (HA), haemophilia B (HB), von Willebrand's disease (vWD) and other rare coagulation disorders. Here we present data from the 2016 annual survey. Materials and methods - Data are provided by the Italian Haemophilia Centres, on a voluntary basis. Information flows from every Centre to a web-based platform of the Italian Association of Haemophilia Centres, shared with the Italian National Institute of Health, in accordance with current privacy laws. Patients are classified by diagnosis, disease severity, age, gender and treatment-related complications. Results - In 2016, the total number of patients with congenital coagulopathies in the NRCC was 10,360: 39.8% of these patients had HA, 31.5% had vWD, 8.5% had HB, and 20.2% had less common factor deficiencies. The overall prevalence of HA and HB was 13.9/100,000 males and 3.0/100,000 males, respectively. The overall prevalence of vWD was 5.4/100,000 inhabitants. During 2016, 126 patients had current alloantibodies to factor VIII (FVIII) or factor IX (FIX) and were under treatment with bypassing agents and/or immune tolerance induction. Overall, 388 patients with a history of alloantibodies were recorded in the NRCC of whom 337 with severe HA and 12 with severe HB. Coagulation factor use, evaluated from treatment plans, was approximately 451,000,000 IU of FVIII for HA patients (7.5 IU/inhabitant), and approximately 53,000,000 IU of FIX for HB patients (0.9 IU/inhabitant). Discussion - The prevalences of HA and HB fall within the ranges reported in more developed countries; the consumption of FVIII and FIX was in line with that of other European countries (France, United Kingdom) and Canada. The NRCC, with its bleeding disorder dataset, is a helpful tool for shaping public health policies, as well as planning clinical and epidemiological research projects.

Published
2020

23. Emergency management in patients with haemophilia A and inhibitors on prophylaxis with emicizumab: AICE practical guidance in collaboration with SIBioC, SIMEU, SIMEUP, SIPMeL and SISET

Author

Castaman, G., Santoro, C., Coppola, A., Mancuso, M. E., Santoro, R. C., Bernardini, S., Pugliese, F. R., Lubrano, R., Golato, M., Tripodi, A., Rocino, A., Santagostino, E., Biasoli, C., Borchiellini, A., Catalano, A., Contino, L., Coluccia, A., Cultrera, D., De Cristofaro, R., Di Minno, G., Fabbri, A., Franchini, M., Gamba, G., Chiara, A., Gresele, P., Giampaolo, A., Hassan, H. J., Luciani, M., Marchesini, E., Marino, R., Mazzucconi, M. G., Molinari, A. C., Morfini, M., Notarangelo, L. D., Peccarisi, L., Peyvandi, F., Pollio, B., Rivolta, G. F., Ruggieri, M. P., Sargentini, V., Schiavoni, M., Sciacovelli, L., Serino, M. L., Siragusa, S., Tagliaferri, A., Testa, S., Tosetto, A., Zampogna, S., Zanon, E., Castaman, Giancarlo, Santoro, Cristina, Coppola, Antonio, Mancuso, Maria E, Santoro, Rita C, Bernardini, Sergio, Pugliese, Francesco R, Lubrano, Riccardo, Golato, Maria, Tripodi, Armando, Rocino, Angiola, Santagostino, Elena, Biasoli, Chiara, Borchiellini, Alessandra, Catalano, Alberto, Contino, Laura, Coluccia, Antonella, Cultrera, Dorina, De Cristofaro, Raimondo, Di Minno, Giovanni, Fabbri, Andrea, Franchini, Massimo, Gamba, Gabriella, Giuffrida, Anna Chiara, Gresele, Paolo, Giampaolo, Adele, Hassan, Hamisa J, Luciani, Matteo, Marchesini, Emanuela, Marino, Renato, Mazzucconi, Maria Gabriella, Molinari, Angelo C, Morfini, Massimo, Notarangelo, Lucia D, Peccarisi, Lucia, Peyvandi, Flora, Pollio, Berardino, Rivolta, Gianna Franca, Ruggieri, Maria Pia, Sargentini, Vittorio, Schiavoni, Mario, Sciacovelli, Laura, Serino, Maria Luisa, Siragusa, Sergio, Tagliaferri, Annarita, Testa, Sophie, Tosetto, Alberto, Zampogna, Stefania, Zanon, Ezio, Castaman, G., Santoro, C., Coppola, A., Mancuso, M. E., Santoro, R. C., Bernardini, S., Pugliese, F. R., Lubrano, R., Golato, M., Tripodi, A., Rocino, A., Santagostino, E., Biasoli, C., Borchiellini, A., Catalano, A., Contino, L., Coluccia, A., Cultrera, D., De Cristofaro, R., Di Minno, G., Fabbri, A., Franchini, M., Gamba, G., Chiara, A., Gresele, P., Giampaolo, A., Hassan, H. J., Luciani, M., Marchesini, E., Marino, R., Mazzucconi, M. G., Molinari, A. C., Morfini, M., Notarangelo, L. D., Peccarisi, L., Peyvandi, F., Pollio, B., Rivolta, G. F., Ruggieri, M. P., Sargentini, V., Schiavoni, M., Sciacovelli, L., Serino, M. L., Siragusa, S., Tagliaferri, A., Testa, S., Tosetto, A., Zampogna, S., and Zanon, E.

Subjects
Factor VIII, FVIII inhibitor, Settore BIO/12, Antibodies, Bispecific, Antibodies, Monoclonal, Humanized, Factor VIII, Hemophilia A, Hemorrhage, Hemostatics, Humans, Italy, Quality of Life, FVIII inhibitors, Hemorrhage, Antibodies, Monoclonal, Humanized, Hemophilia A, Antibodies, Hemostatics, bypassing agents, emergency, emicizumab, haemophilia A, Italy, hemic and lymphatic diseases, Monoclonal, Emergency, Haemophilia A, Antibodies, Bispecific, Quality of Life, Humans, Bispecific, Bypassing agents, Emicizumab, Humanized, Bypassing agent, Haemostasis
Abstract

Emicizumab has been approved in several countries for regular prophylaxis in patients with congenital haemophilia A and FVIII inhibitors because it substantially reduces their bleeding risk and improves quality of life. However, although significantly less frequent, some breakthrough bleeds may still occur while on emicizumab, requiring treatment with bypassing or other haemostatic agents. Thrombotic complications have been reported with the associated use of activated prothrombin complex concentrates. In addition, when surgery/invasive procedures are needed while on emicizumab, their management requires multidisciplinary competences and direct supervision by experts in the use of this agent. Given this, and in order to expand the current knowledge on the use of emicizumab and concomitant haemostatic agents, and reduce the risk of complications in this setting, the Italian Association of Haemophilia Centres (AICE) here provides guidance on the management of breakthrough bleeds and surgery in emergency situations in patients with haemophilia A and inhibitors on emicizumab prophylaxis. This paper has been shared with other National Scientific Societies involved in the field.

Published
2020

24. Physical activity improved by adherence to prophylaxis in an Italian population of children, adolescents and adults with severe haemophilia A: The SHAPE Study

Author

Zanon, E., Tagliaferri, A., Pasca, S., Ettorre, C. P., Notarangelo, L. D., Biasioli, C., Aru, A. B., Milan, M., Linari, S., Rocino, A., Gagliano, F., Di Minno, G., Gamba, G., Santoro, R. C., Schinco, P., Marietta, M., Seuser, A., Von MacKensen, S., Zanon, E., Tagliaferri, A., Pasca, S., Ettorre, C. P., Notarangelo, L. D., Biasioli, C., Aru, A. B., Milan, M., Linari, S., Rocino, A., Gagliano, F., Di Minno, G., Gamba, G., Santoro, R. C., Schinco, P., Marietta, M., Seuser, A., and Von MacKensen, S.

Subjects
Adult, Male, Factor VIII, Severe haemophilia, Adolescent, Adherence to treatment, FVIII replacement therapy, Orthopaedic haemophilia scores, Physical activity, Child, Exercise, Female, Hemophilia A, Humans, Italy, Patient Compliance, Prospective Studies, Young Adult, Orthopaedic haemophilia score, Haemostasis
Abstract

Background - Physical activity in people with haemophilia (PWH) reduces the development of severe arthropathy, but it must be performed after regular, proper prophylaxis. Strict adherence to treatment is crucial to achieving effectiveness and established outcomes. The primary aim of this study was to collect prospective data on adherence to prophylaxis for over 36 months. A secondary aim was to verify whether adherence correlates with physical activity. Materials and methods - Italian patients with severe haemophilia A treated on prophylaxis with octocog alfa were included in the study. Physical findings were assessed by the Haemophilia and Exercise Project (HEP)-Test-Q and the Early Prophylaxis Immunologic Challenge (EPIC)-Norfolk Physical Activity Questionnaire; orthopaedic status was assessed by the Hemophilia Joint Health Score (HJHS). Adherence was measured as percentage of empty vials returned with respect to the prescribed amount. Results - Forty-two PWH were enrolled: 31% children, 21.4% adolescents, and 47.6% adults. Type, frequency and impact of physical activities differed among the three groups. The HEP-Test-Q showed the highest impairments in the domains "endurance" and "strength/co-ordination". Eight percent of patients were classified as adherent to prophylaxis. Among them, 50% had at least one bleeding episode in the year before enrolment; this percentage dropped during the three years of the study. While remaining stable in the "non-adherent" group, the HJHS score decreased in the "adherent" patients. The mean number of school/work days lost was lower in adherent patients (from 3.4±6.8 to 0.2±0.9) than in non-adherent ones. Discussion - PWH with better orthopaedic scores reported better physical performance. Adherence to long-term prophylaxis proved to be high and correlated with a reduction in bleeds, target joints, school/work days lost, and with a performance improvement in endurance sports activities over time.

Published
2020

27. La moderna castanicoltura passa dalla potatura

Author

Gamba, G., Tomatis, A., Trovò, P., Mellano, M. G., and Beccaro, G.

Subjects
Castanicoltura Intensiva, Castagno, Potatura, Potatura, Castagno, Ibridi, Castanicoltura Intensiva, Ibridi
Published
2021

37. Management of patients with severe haemophilia a without inhibitors on prophylaxis with emicizumab: AICE recommendations with focus on emergency in collaboration with SIBioC, SIMEU, SIMEUP, SIPMeL and SISET

Author

Coppola, A., Castaman, G., Santoro, R. C., Mancuso, M. E., Franchini, M., Marino, R., Rivolta, G. F., Santoro, C., Zanon, E., Sciacovelli, L., Manca, S., Lubrano, R., Golato, M., Tripodi, A., Rocino, A., Bernardini, S., Biasoli, C., Borchiellini, A., Cultrera, D., De Cristofaro, R., Di Minno, G., Gamba, G., Giampaolo, A., Giuffrida, A. C., Giuffrida, C., Gresele, P., Mazzucconi, M. G., Morfini, M., Hassan, H. J., Molinari, A. C., Pollio, B., Sargentini, V., Tagliaferri, A., Tosetto, A., and Zampogna, S.

Subjects
FVIII, Laboratory monitoring, Haemophilia A, haemophilia A, 030204 cardiovascular system & hematology, Antibodies, Monoclonal, Humanized, Hemophilia A, Haemophilia, surgery, 03 medical and health sciences, 0302 clinical medicine, Antibodies, Bispecific, Health care, medicine, bleeding, emergency, emicizumab, Humans, In patient, Genetics (clinical), Emicizumab, Emergency management, business.industry, Hematology, General Medicine, medicine.disease, Severe haemophilia A, Medical emergency, business, 030215 immunology
Abstract

Introduction The factor VIII (FVIII)-mimetic bispecific monoclonal antibody, emicizumab, previously approved for prophylaxis in haemophilia A with inhibitors, has been recently licensed in several countries also in patients with severe haemophilia A (PWSHA) without inhibitors. The introduction of this innovative agent requires the development of specific pathways at Haemophilia Treatment Centres (HTC), particularly regarding laboratory testing and treatment of breakthrough bleeds and invasive procedures/surgeries, even more critical when patients are managed by non-specialist professionals. Limited literature data and clinical experience in PWSHA without inhibitors on emicizumab are currently available. Aim To promote awareness and overcome these challenges, the Italian Association of Haemophilia Centres (AICE) issued a guidance on the management of PWSHA without inhibitors on emicizumab prophylaxis, focused on emergency and shared with other National Scientific Societies in the field. Methods The document, drafted by an AICE expert panel and approved through online consultation, was further revised by a multidisciplinary working group, including members of 5 haemostasis, laboratory and emergency scientific societies. The final version was approved by the Council of each society. Results General recommendations about use of FVIII concentrates for the treatment of bleeding or haemostatic coverage of invasive procedures/surgeries and laboratory monitoring in PWSHA without inhibitors on emicizumab are provided. Specific issues of the management in the emergency room are focused, highlighting the need for direct involvement or formalized supervision by specialist HTC physicians. Conclusions This guidance provides a reference pathway to be implemented in the different healthcare organizations, especially for the challenging emergency management in this setting.

Published
2020

40. Efficacy and safety during formulation switch of a pasteurized VWF/FVIII concentrate: results from an Italian prospective observational study in patients with von Willebrand disease

Author

Castaman, G., Coppola, A., Zanon, E., Boeri, E., Musso, M., Siragusa, S., Federici, A. B., Mancuso, G., Barillari, G., Biasoli, C., Feola, G., Franchini, M., Moratelli, S., Gamba, G., Schinco, P., Valdrè, L., Dragani, A., Mazzucconi, G., Tagliaferri, A., and Morfini, M.

Published
2013
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