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1. Abstracts from the 10th C1-inhibitor deficiency workshop

Author

Alvin H. Schmaier, Marco Cicardi, Avner Reshef, Dumitru Moldovan, Attila Mócsai, Margarita López-Trascasa, Alberto López Lera, Nancy J. Brown, Anastasios E. Germenis, Rafael Filippelli-Silva, Diego A. Duarte, Renan P. Martin, Camila L. Veronez, Michel Bouvier, Michael Bader, Claudio M. Costa-Neto, João Bosco Pesquero, Xavier Charest-Morin, François Marceau, Georges-É. Rivard, Arnaud Bonnefoy, Éric Wagner, Márta L. Debreczeni, Zsuzsanna Németh, Erika Kajdácsi, Endre Schwaner, László Cervenak, Gábor Oroszlán, András Szilágyi, Ráhel Dani, Péter Závodszky, Péter Gál, József Dobó, Jacques Hébert, Matthieu Vincent, Jean-Nicolas Boursiquot, Hugo Chapdeleine, Marylin Desjardins, Benoit Laramée, Rémi Gagnon, Nancy Payette, Oleksandra Lepeshkina, Delphine Charignon, Arije Ghannam, Denise Ponard, Christian Drouet, Kusumam Joseph, Baby G. Tholanikunnel, Daniel J. Sexton, Allen P. Kaplan, Stefania Loffredo, Maria Bova, Anne Lise Ferrara, Angelica Petraroli, Chiara Suffritti, Nóra Veszeli, Andrea Zanichelli, Henriette Farkas, Gianni Marone, Samuel Luyasu, Bertrand Favier, Ludovic Martin, Kinga Viktória Kőhalmi, György Temesszentandrási, Katalin Várnai, Lilian Varga, Bruce L. Zuraw, Annette Feussner, Michael A. Tortorici, Dipti Pawaskar, Huamin Henry Li, John Anderson, Jonathan A. Bernstein, Ying Zhang, Ingo Pragst, on behalf of COMPACT investigators, Emel Aygören-Pürsün, Kraig Jacobson, Jim Christensen, Arthur Van Leerberghe, Yi Wang, Jennifer Schranz, Inmaculada Martinez-Saguer, Daniel Soteres, Urs Steiner, Vesna Grivcheva Panovska, William Rae, Werner Aberer, Aarnoud Huissoon, Anette Bygum, Markus Magerl, Jochen Graff, Hilary Longhurst, Ramón Lleonart, Lei Fang, Melanie Cornpropst, Desiree Clemons, Amanda Mathis, Phil Collis, Sylvia Dobo, William P. Sheridan, Marcus Maurer, Marc A. Riedl, Timothy Craig, Aleena Banerji, Mustafa Shennak, William Yang, Jovanna Baptista, Paula Busse, Ira Kalfus, Andrew McDonald, Shawn Qian, Anthony Roberts, Con Panousis, Tim Green, Andreas Gille, Maria Zamanakou, Gedeon Loules, Dorottya Csuka, Fotis Psarros, Faidra Parsopoulou, Matthaios Speletas, Davide Firinu, Tiziana Maria Angela De Pasquale, Alessandra Zoli, Anna Radice, Stefano Pizzimenti, Emmanouil Manoussakis, George N. Konstantinou, Valeria Bafunno, Vincenzo Montinaro, Mauro Cancian, Maurizio Margaglione, Konrad Bork, Karin Wulff, Guenther Witzke, Jochen Hardt, Laurence Bouillet, Teresa Caballero, Anete S. Grumach, Christelle Pommie, Irmgard Andresen, Carmen Escuriola Ettingshausen, Zeynep Gutowski, Karin Andritschke, Richard Linde, Noémi Andrási, Tamás Szilágyi, Iris Leibovich-Nassi, Christine Symons, John Dempster, Isabelle Boccon-Gibod, Anne Pagnier, Audrey Lehmann, Kristian B. Kreiberg, Sandra A. Nieto, Raquel Martins, Renata Martins, Alejandra Menendez, Solange O. R. Valle, Margarita Olivares, Maria E. Hernandez-Landeros, Elma Nievas, Natalia Fili, Olga M. Barrera, René Bailleau, Ana Maria Gallardo-Olivos, Masumi Grau, Julian Rodriguez-Galindo, Marlon J. O. Carabantes, Edison Zapata-Venegas, Mario Martinez Alfonso, Maria Rosario-Grauert, Manuel Ratti, Daniel Vaszquez, Dario Josviack, Luis Fernando Landivar-Salinas, Oscar M. E. Calderón-Llosa, Rolando Campilay-Sarmiento, Pablo Raby, Jose Fabiani, William R. Lumry, Henrike Feuersenger, Douglas J. Watson, Thomas Machnig, on behalf of the Investigators of the COMPACT study, Donatella Lamacchia, Adriana Hernanz, Ana Alvez, Mariana Lluncor, Maria Pedrosa, Rosario Cabañas, Nieves Prior, Patrik Nordenfelt, Mats Nilsson, Anders Lindfors, Carl-Fredrik Wahlgren, Janne Björkander, Roman Hakl, Pavel Kuklínek, Irena Krčmová, Jana Hanzlíková, Martina Vachová, Radana Zachová, Marta Sobotková, Jana Strenková, Jiří Litzman, Maria Palasopoulou, Gerasimina Tsinti, Panagiota Gianni, Maria Kompoti, Sofia Garrido, Wojciech Dyga, Anna Bogdali, Aleksander Obtułowicz, Mikolajczyk Tomasz, Ewa Czarnobilska, Krystyna Obtulowicz, Teofila Książek, Anna Koncz, Dominik Gulyás, Maria Staevska, Milos Jesenak, Katarina Hrubiskova, L. Bellizzi, A. Relan, Maddalena A. Wu, Antonio Castelli, Riccardo Colombo, Gianmarco Podda, Marta Del Medico, Emanuele Catena, Francesco Casella, Francesca Perego, Nada Afifi Afifi, Eleonora Tobaldini, Nicola Montano, for the IOS Study Group, Marta Sánchez-Jareño, Marcin Stobiecki, Krystyna Obtułowicz, Irina Guryanova, Ekaterina Polyakova, Viktar Lebedz, Andrej Salivonchik, Svetlana Aleshkevich, Mikhail Belevtsev, Melanie Nordmann-Kleiner, Susanne Trainotti, Janina Hahn, Jens Greve, Liudmyla Zabrodska, Maria L. Oliva Alonso, Rosangela P. Tórtora, Alfeu T. França, Marcia G. Ribeiro, Lisa Fu, Amin Kanani, Gina Lacuesta, Susan Waserman, Stephen Betschel, Melissa I. Espinosa, Francisco A. Contreras, Martin Hrubisko, Ludmila Vavrova, Peter Banovcin, Maryam Ayazi, Mohammad Reza Fazlollahi, Shiva Saghafi, Sajedeh Mohammadian, Susan Nabilou Deshiry, Kiana Bidad, Raheleh Shokouhi Shoormasti, Iraj Mohammadzadeh, Mohammad Hassan Bemanian, Seyed Alireza Mahdaviani, Zahra Pourpak, Anna Valerieva, Mariela Vasileva, Tsvetelina Velikova, Elena Petkova, Vasil Dimitrov, Ruggero Di Maulo, on behalf of participating centers, Raz Somech, Hava Golander, Erika J. Sifuentes, Catherine Mansard, Anne Gompel, Bernard Floccard, Claire Blanchard-Delaunay, David Launay, Olivier Fain, Alain Sobel, Stéphane Gayet, Stéphanie Amarger, Guillaume Armengol, Yann Ollivier, Ariane Zélinsky-Gurung, Pierre-Yves Jeandel, Gisèle Kanny, Brigitte Coppéré, Marie Dubrel, Fabien Pelletier, Aurélie Du Thanh, Sébastien Trouiller, Jérôme Laurent, Claire De Moreuil, Christine Audouin Pajot, Alexandre Belot, Ana Rodríguez, Dasha Roa, Alicia Prieto, Maria Luisa Baeza, Borislava Krusheva, Stephanie K. A. Almeida, Rosemeire N. Constantino-Silva, Nyla Melo, Joanna Araujo Simoes, Sandra Mitie U. Palma, Jane da Silva, Bruna F. de Azevedo, Eli Mansour, Teresa González-Quevedo, Carmen Marcos, Teófilo Lobera, Blanca Sáenz de San Pedro, Ernie Avilla, Jacquie Badiou, Karen Binkley, Rozita Borici-Mazi, Linda Howlett, Paul K. Keith, Anne Rowe, Peter Waite, Aurore Billebeau, Isabelle Boccon-Gibbod, Kristina Lis, Yael Laitman, Eitan Friedman, N. M. Gokmen, O. Gulbahar, H. Onay, Z. P. Koc, and A. Z. Sin

Subjects
Immunologic diseases. Allergy, RC581-607
Published
2017
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2. A randomized trial of human C1 inhibitor prophylaxis in children with hereditary angioedema

Author

Jennifer Schranz, Jim Christensen, Kraig W. Jacobson, Emel Aygören-Pürsün, Inmaculada Martinez-Saguer, Yongqiang Tang, D. Soteres, Arthur Van Leerberghe, Moshe Y. Vardi, Peng Lu, Dumitru Moldovan, and Sandra A. Nieto-Martinez

Subjects
safety, Male, medicine.medical_specialty, Visual analogue scale, phase 3 study, Immunology, efficacy, Phases of clinical research, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Quality of life, law, Internal medicine, Post-hoc analysis, medicine, Immunology and Allergy, Humans, Drug Dosage Calculations, Single-Blind Method, 030212 general & internal medicine, ddc:610, Adverse effect, Child, health‐related quality of life, pediatric patients, Cross-Over Studies, Angioedema, business.industry, Angioedemas, Hereditary, Original Articles, medicine.disease, C1 esterase inhibitor (human), hereditary angioedema, Treatment Outcome, 030228 respiratory system, Others, Pediatrics, Perinatology and Child Health, Hereditary angioedema, Disease Progression, Quality of Life, Original Article, Administration, Intravenous, Female, prophylaxis, medicine.symptom, business, Complement C1 Inhibitor Protein
Abstract

Background Patients with hereditary angioedema with C1 inhibitor deficiency or dysfunction have burdensome recurrent angioedema attacks. The safety, efficacy, and health-related quality of life (HRQoL) outcomes of C1 inhibitor (C1-INH) prophylaxis (intravenously administered) in patients aged 6-11 years were investigated. Methods Eligible patients were enrolled in a randomized, single-blind, crossover, phase 3 trial. After a 12-week baseline observation period (BOP), patients received 500 or 1000 U C1-INH, twice weekly, for 12 weeks before crossing over to the alternate dose for 12 weeks. The primary efficacy end-point was the monthly normalized number of angioedema attacks (NNA). HRQoL was assessed using the EuroQoL 5-dimensional descriptive system youth version and visual analog scale (EQ-VAS). Results Twelve randomized patients had a median (range) age of 10.0 (7-11) years. Mean (SD) percentage reduction in monthly NNA from BOP was 71.1% (27.1%) with 500 U and 84.5% (20.0%) with 1000 U C1-INH. Mean (SD) within-patient difference (-0.4 [0.58]) for monthly NNA with both doses was significant (P = 0.035 [90% CI, -0.706 to -0.102]). Cumulative attack severity, cumulative daily severity, and number of acute attacks treated were reduced. No serious adverse events or discontinuations occurred. Mean EQ-VAS change from BOP to week 9 of treatment (500 U C1-INH, 10.4; 1000 U C1-INH, 21.6) was greater than the minimal important difference, indicating a meaningful HRQoL change. Conclusions C1-INH prophylaxis was effective, safe, and well tolerated in children aged 6-11 years experiencing recurrent angioedema attacks. A post hoc analysis indicated a meaningful improvement in HRQoL with C1-INH. Trial registration ClinicalTrials.gov identifier NCT02052141.

Published
2019

3. Preventing Hereditary Angioedema Attacks in Children Using Cinryze®: Interim Efficacy and Safety Phase 3 Findings

Author

Inmaculada Martinez-Saguer, James Hao, Jim Christensen, D. Soteres, Dumitru Moldovan, Arthur Van Leerberghe, Jennifer Schranz, Emel Aygören-Pürsün, and Kraig W Jacobson

Subjects
Pediatrics, medicine.medical_specialty, Immunology, Phases of clinical research, Disease, Complement C1 Inactivator Proteins, C1-inhibitor, 03 medical and health sciences, 0302 clinical medicine, Interim, medicine, Humans, Immunology and Allergy, Single-Blind Method, ddc:610, 030212 general & internal medicine, Child, Infusions, Intravenous, Adverse effect, Cross-Over Studies, biology, Angioedema, Basic and Clinical Immunology - Short Communication, business.industry, Angioedemas, Hereditary, General Medicine, medicine.disease, Crossover study, Treatment Outcome, 030228 respiratory system, Anesthesia, Hereditary angioedema, biology.protein, Female, medicine.symptom, business, Complement C1 Inhibitor Protein
Abstract

Background: Hereditary angioedema (HAE) is a rare genetic disease causing unpredictable and potentially life-threatening subcutaneous and submucosal edematous attacks. Cinryze® (Shire ViroPharma Inc., Lexington, MA, USA), a nanofiltered C1 inhibitor (C1-INH), is approved in Europe for the treatment, preprocedure prevention, and routine prophylaxis of HAE attacks, and for the routine prophylaxis of attacks in the USA. This phase 3 study assessed the safety and efficacy of 2 C1-INH doses in preventing attacks in children aged 6-11 years. Methods: A randomized single-blind crossover study was initiated in March 2014. Results for the first 6 patients completing the study are reported here. After a 12-week qualifying observation period, patients were randomly assigned to 1 of 2 C1-INH doses, 500 or 1,000 U, every 3-4 days for 12 weeks and crossed over to the alternative dose for a second 12-week period. The primary efficacy endpoint was the number of angioedema attacks per month. Results: Six females with HAE type I and a median age of 10.5 years received 2 doses of C1-INH (500 and 1,000 U). The mean (SD) difference in the number of monthly angioedema attacks between the baseline observation period and the treatment period was -1.89 (1.31) with 500 U and -1.89 (1.11) with 1,000 U. During the treatment periods, cumulative attack severity, cumulative daily severity, and the number of attacks needing acute treatment were lower. No serious adverse events or study drug discontinuations occurred. Conclusions: Interim findings from this study indicate that routine prevention with intravenous administration of C1-INH is efficacious, safe, and well tolerated in children ≥6 years of age.

Published
2017
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4. Abstracts from the 10th C1-inhibitor deficiency workshop

Author

Mikhail Belevtsev, Jens Greve, Pierre-Yves Jeandel, Ana Maria Gallardo-Olivos, William R. Lumry, Yael Laitman, Marc A. Riedl, Jean-Nicolas Boursiquot, Dasha Roa, Péter Závodszky, Kraig Jacobson, Susanne Trainotti, Maria Staevska, Márcia Gonçalves Ribeiro, Zeynep Gutowski, François Marceau, Alejandra Menendez, Eric Wagner, Y. Ollivier, Alvin H. Schmaier, Rolando Campilay-Sarmiento, Amin S. Kanani, Valeria Bafunno, Christine Symons, Svetlana Aleshkevich, Stephanie K. A. Almeida, Kusumam Joseph, Teresa Caballero, Hava Golander, Nancy J. Brown, Xavier Charest-Morin, Peter Banovcin, Arnaud Bonnefoy, Sajedeh Mohammadian, Mustafa Shennak, William P. Sheridan, Ira Kalfus, Claudio M. Costa-Neto, Rafael Filippelli-Silva, Anete Sevciovic Grumach, Solange Oliveira Rodrigues Valle, Oscar M. E. Calderón-Llosa, Panagiota Gianni, Emel Aygören-Pürsün, Rosemeire Navickas Constantino-Silva, Zsuzsanna Németh, Irmgard Andresen, Konrad Bork, Mauro Cancian, Claire de Moreuil, Janne Björkander, Melissa I. Espinosa, Tamás Szilágyi, Maria Rosario-Grauert, Jane da Silva, Michael Bader, Ying Zhang, Jana Hanzlíková, Sylvia Dobo, Carl-Fredrik Wahlgren, Jacquie Badiou, Diego A. Duarte, Marta Del Medico, Stefania Loffredo, Avner Reshef, Maria Palasopoulou, Ludmila Vavrova, Marie Dubrel, Raheleh Shokouhi Shoormasti, Bruce L. Zuraw, Susan Nabilou Deshiry, Shiva Saghafi, Ekaterina Polyakova, Matthieu Vincent, Douglas J. Watson, Mohammad Reza Fazlollahi, Anne Rowe, Shawn Qian, Blanca Sáenz de San Pedro, Christelle Pommie, Sofía Garrido, Sandra Mitie Ueda Palma, András Szilágyi, Luis Fernando Landivar-Salinas, Audrey Lehmann, Maria L. Baeza, Kiana Bidad, Hugo Chapdeleine, Stéphane Gayet, Davide Firinu, Nancy Payette, Christine Pajot, Nyla Melo, Pavel Kuklínek, Pablo Raby, Nóra Veszeli, Ingo Pragst, Desiree Clemons, Anne Pagnier, Attila Mócsai, Carmen Escuriola Ettingshausen, Henrike Feuersenger, Noémi Andrási, Paul K. Keith, Phil Collis, Ernie Avilla, Olivier Fain, Iris Leibovich-Nassi, Dario O. Josviack, Jiří Litzman, Con Panousis, Denise Ponard, Sébastien Trouiller, Ráhel Dani, Francesco Casella, Ana Rodríguez, Isabelle Boccon-Gibod, Nada Afifi Afifi, Olga M. Barrera, Gina Lacuesta, Gian Marco Podda, Anne Lise Ferrara, Samuel Luyasu, Ludovic Martin, Patrik Nordenfelt, Linda Howlett, William H. Yang, Sandra A. Nieto, Anders Lindfors, Zahra Pourpak, Stéphanie Amarger, Adriana Hernanz, Jochen Hardt, Julian Rodriguez-Galindo, Claire Blanchard-Delaunay, Antonio Castelli, Marta Sánchez-Jareño, Renata Martins, Bertrand Favier, Yi Wang, Rosario Cabañas, Anthony Roberts, Renan Paulo Martin, Alexandre Belot, Vincenzo Montinaro, Eitan Friedman, João Bosco Pesquero, Maria Kompoti, Bruna Franca Azevedo, Mikolajczyk Tomasz, Georges-É. Rivard, Katalin Várnai, Gábor Oroszlán, Arije Ghannam, David Launay, Fotis Psarros, Manuel Ratti, Maria Luiza Oliva Alonso, Bernard Floccard, Mariana Lluncor, Karen Binkley, Gianni Marone, Anne Gompel, Dominik Gulyás, John Dempster, Liudmyla Zabrodska, Emanuele Catena, Anna Bogdali, Irina Guryanova, Andrej Salivonchik, Camila Lopes Veronez, L. Fang, Eleonora Tobaldini, Lilian Varga, Chiara Suffritti, Daniel Vaszquez, Peter Waite, Maria Zamanakou, Ana Alvez, Laurence Bouillet, Péter Gál, Susan Waserman, Krystyna Obtułowicz, Marcin Stobiecki, Alain Sobel, Karin Wulff, A. Z. Sin, Margarita Olivares, Dipti Pawaskar, Mats Nilsson, Endre Schwaner, Brigitte Coppere, Anna Valerieva, Remi Gagnon, Marlon J. O. Carabantes, Stefano Pizzimenti, H. Onay, Paula J. Busse, Delphine Charignon, William Rae, Marco Cicardi, Kinga Viktória Kőhalmi, Inmaculada Martinez-Saguer, Daniel J. Sexton, Matthaios Speletas, Aarnoud Huissoon, René Bailleau, Fabien Pelletier, Elena Petkova, Joanna Araujo Simoes, Guillaume Armengol, Amanda Mathis, Rosangela P. Tortora, Raz Somech, Andreas Gille, Anastasios E. Germenis, Martin Hrubisko, Marylin Desjardins, Dorottya Csuka, María Pedrosa, Jose Fabiani, Stephen Betschel, Timothy J. Craig, Vasil Dimitrov, Andrew McDonald, Alberto López Lera, Márta L. Debreczeni, Eli Mansour, Teofila Książek, Teófilo Lobera, Rozita Borici-Mazi, O. Gulbahar, Aleena Banerji, Jochen Graff, Marta Sobotkova, Annette Feussner, Andrea Zanichelli, Ewa Czarnobilska, Anna Koncz, Milos Jesenak, Edison Zapata-Venegas, Aurore Billebeau, Gedeon Loules, Melanie Nordmann-Kleiner, Werner Aberer, Richard Linde, Guenther Witzke, Kristina Lis, Markus Magerl, Jana Strenková, Emmanouil Manoussakis, József Dobó, Viktar Lebedz, Masumi Grau, Raquel Martins, Melanie Cornpropst, Jovanna Baptista, Marcus Maurer, Dumitru Moldovan, György Temesszentandrási, Isabelle Boccon-Gibbod, Thomas Machnig, C Marcos, Erika Kajdácsi, Tim Green, John Anderson, Karin Andritschke, D. Soteres, Riccardo Colombo, Mario Martinez Alfonso, Anna Radice, Huamin Henry Li, Tsvetelina Velikova, Ruggero Di Maulo, Mariela Borisova Vasileva, Angelica Petraroli, Francesca Perego, Francisco A. Contreras, Roman Hakl, Urs C. Steiner, Anurag Relan, N. Prior, Irena Krčmová, Jennifer Schranz, Martina Vachová, Baby G. Tholanikunnel, R. Lleonart, Maria Bova, Allen P. Kaplan, N. M. Gokmen, Nicola Montano, Margarita López-Trascasa, Tiziana Maria Angela De Pasquale, Alicia Prieto, Kristian Buur Kreiberg, Mohammad Hassan Bemanian, Alessandra Zoli, Michael A. Tortorici, Erika J. Sifuentes, László Cervenak, Borislava Krusheva, Maria E. Hernandez-Landeros, Wojciech Dyga, Oleksandra Lepeshkina, Elma Nievas, L. Bellizzi, Christian Drouet, C. Mansard, Michel Bouvier, Aurélie Du Thanh, Donatella Lamacchia, Janina Hahn, Radana Zachova, Iraj Mohammadzadeh, T González-Quevedo, Z. P. Koc, Jacques Hébert, Hilary Longhurst, Maddalena Alessandra Wu, Ariane Zélinsky-Gurung, Jim Christensen, Maurizio Margaglione, Maryam Ayazi, Vesna Grivcheva Panovska, Faidra Parsopoulou, Jonathan A. Bernstein, Anette Bygum, Seyed Alireza Mahdaviani, Henriette Farkas, Aleksander Obtułowicz, Natalia Fili, Gisèle Kanny, Gerasimina Tsinti, Alfeu Tavares França, George N. Konstantinou, Benoit Laramée, Katarina Hrubiskova, Lisa Fu, J. Laurent, and Arthur Van Leerberghe

Subjects
lcsh:Immunologic diseases. Allergy, 0301 basic medicine, 03 medical and health sciences, 030102 biochemistry & molecular biology, C1 inhibitor deficiency, business.industry, Immunology, Medicine, General Medicine, lcsh:RC581-607, business, Meeting Abstracts
Published
2017
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5. Cinryze is Efficacious for Hereditary Angioedema (HAE) Attack Prevention In Pediatric Patients: Final Phase 3 Efficacy And Safety Results

Author

Inmaculada Martinez-Saguer, Tom Tang, Arthur Van Leerberghe, Dumitru Moldovan, D. Soteres, Sandra Nieto–Martinez, Emel Aygören-Pürsün, Peng Lu, Kraig W. Jacobson, and Jim Christensen

Subjects
medicine.medical_specialty, Attack prevention, business.industry, Immunology, Hereditary angioedema, Immunology and Allergy, Medicine, business, medicine.disease, Dermatology
Published
2018
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