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1. Definition, acronyms, nomenclature, and classification of angioedema (DANCE): AAAAI, ACAAI, ACARE, and APAAACI DANCE consensus

Author

Reshef, Avner, Buttgereit, Thomas, Betschel, Stephen D., Caballero, Teresa, Farkas, Henriette, Grumach, Anete S., Hide, Michihiro, Jindal, Ankur K., Longhurst, Hilary, Peter, Jonathan, Riedl, Marc A., Zhi, Yuxiang, Aberer, Werner, Abuzakouk, Mohamed, Al Farsi, Tariq, Al Sukaiti, Nashat, Al-Ahmad, Mona, Altrichter, Sabine, Aygören-Pürsün, Emel, Baeza, Maria Luisa, Bara, Noemi Anna, Bauer, Andrea, Bernstein, Jonathan A., Boccon-Gibod, Isabelle, Bonnekoh, Hanna, Bouillet, Laurence, Brzoza, Zenon, Bygum, Anette, Calderon, Oscar, de Albuquerque Campos, Regis, Campos Romero, Freya Helena, Cancian, Mauro, Chong-Neto, Herberto Jose, Christoff, George, Cimbollek, Stefan, Cohn, Danny M., Craig, Timothy, Danilycheva, Inna, Darlenski, Razvigor, Du-Thanh, Aurélie, Ensina, Luis Felipe, Fomina, Daria, Fonacier, Luz, Fukunaga, Atsushi, Gelincik, Asli, Giavina-Bianchi, Pedro, Godse, Kiran, Gompels, Mark, Goncalo, Margarida, Gotua, Maia, Guidos-Fogelbach, Guillermo, Guilarte, Mar, Kasperska-Zajac, Alicja, Katelaris, Constance H., Kinaciyan, Tamar, Kolkhir, Pavel, Kulthanan, Kanokvalai, Kurowski, Marcin, Latysheva, Elena, Lauerma, Antti, Launay, David, Lleonart, Ramon, Lumry, William, Malbran, Alejandro, Ali, Ramzy Mohammed, Nasr, Iman, Nieto-Martinez, Sandra, Parisi, Claudio, Pawankar, Ruby, Piñero-Saavedra, Macarena, Popov, Todor A., Porebski, Grzegorz, Prieto Garcia, Alicia, Pyatilova, Polina, Rudenko, Michael, Sekerel, Bulent Enis, Serpa, Faradiba Sarquis, Sheikh, Farrukh, Siebenhaar, Frank, Soria, Angèle, Staevska, Maria, Staubach, Petra, Stobiecki, Marcin, Thomsen, Simon Francis, Triggiani, Massimo, Valerieva, Anna, Valle, Solange, Van Dinh, Nguyen, Vera Ayala, Carolina Elisa, Zalewska-Janowska, Anna, Zanichelli, Andrea, Magerl, Markus, and Maurer, Marcus

Published
2024
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2. Garadacimab for hereditary angioedema attack prevention: long-term efficacy, quality of life, and safety data from a phase 2, randomised, open-label extension study

Author

Craig, Timothy J, Levy, Donald S, Reshef, Avner, Lumry, William R, Martinez-Saguer, Inmaculada, Jacobs, Joshua S, Yang, William H, Ritchie, Bruce, Aygören-Pürsün, Emel, Keith, Paul K, Busse, Paula, Feuersenger, Henrike, Alexandru Bica, Mihai, Jacobs, Iris, Pragst, Ingo, and Magerl, Markus

Published
2024
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3. The international WAO/EAACI guideline for the management of hereditary angioedema – The 2021 revision and update

Author

Maurer, Marcus, Magerl, Markus, Betschel, Stephen, Aberer, Werner, Ansotegui, Ignacio J, Aygören-Pürsün, Emel, Banerji, Aleena, Bara, Noémi-Anna, Boccon-Gibod, Isabelle, Bork, Konrad, Bouillet, Laurence, Boysen, Henrik Balle, Brodszki, Nicholas, Busse, Paula J, Bygum, Anette, Caballero, Teresa, Cancian, Mauro, Castaldo, Anthony J, Cohn, Danny M, Csuka, Dorottya, Farkas, Henriette, Gompels, Mark, Gower, Richard, Grumach, Anete S, Guidos-Fogelbach, Guillermo, Hide, Michihiro, Kang, Hye-Ryun, Kaplan, Allen P, Katelaris, Constance H, Kiani-Alikhan, Sorena, Lei, Wei-Te, Lockey, Richard F, Longhurst, Hilary, Lumry, William, MacGinnitie, Andrew, Malbran, Alejandro, Saguer, Inmaculada Martinez, Campos, Juan José Matta, Nast, Alexander, Nguyen, Dinh, Nieto-Martinez, Sandra A, Pawankar, Ruby, Peter, Jonathan, Porebski, Grzegorz, Prior, Nieves, Reshef, Avner, Riedl, Marc, Ritchie, Bruce, Sheikh, Farrukh Rafique, Smith, William B, Spaeth, Peter J, Stobiecki, Marcin, Toubi, Elias, Varga, Lilian Agnes, Weller, Karsten, Zanichelli, Andrea, Zhi, Yuxiang, Zuraw, Bruce, and Craig, Timothy

Subjects
Prevention, Clinical Research, C1-inhibitor, DELPHI, GRADE therapy, Hereditary angioedema, diagnosis, disease control, guideline, management, prophylaxis, quality of life, recommendations, self-administration, Clinical Sciences
Abstract

Hereditary Angioedema (HAE) is a rare and disabling disease for which early diagnosis and effective therapy are critical. This revision and update of the global WAO/EAACI guideline on the diagnosis and management of HAE provides up-to-date guidance for the management of HAE. For this update and revision of the guideline, an international panel of experts reviewed the existing evidence, developed 28 recommendations, and established consensus by an online DELPHI process. The goal of these recommendations and guideline is to help physicians and their patients in making rational decisions in the management of HAE with deficient C1-inhibitor (type 1) and HAE with dysfunctional C1-inhibitor (type 2), by providing guidance on common and important clinical issues, such as: 1) How should HAE be diagnosed? 2) When should HAE patients receive prophylactic on top of on-demand treatment and what treatments should be used? 3) What are the goals of treatment? 4) Should HAE management be different for special HAE patient groups such as children or pregnant/breast feeding women? 5) How should HAE patients monitor their disease activity, impact, and control? It is also the intention of this guideline to help establish global standards for the management of HAE and to encourage and facilitate the use of recommended diagnostics and therapies for all patients.

Published
2022

4. Efficacy and safety of garadacimab, a factor XIIa inhibitor for hereditary angioedema prevention (VANGUARD): a global, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Author

Craig, Timothy J, Reshef, Avner, Li, H Henry, Jacobs, Joshua S, Bernstein, Jonathan A, Farkas, Henriette, Yang, William H, Stroes, Erik S G, Ohsawa, Isao, Tachdjian, Raffi, Manning, Michael E, Lumry, William R, Saguer, Inmaculada Martinez, Aygören-Pürsün, Emel, Ritchie, Bruce, Sussman, Gordon L, Anderson, John, Kawahata, Kimito, Suzuki, Yusuke, Staubach, Petra, Treudler, Regina, Feuersenger, Henrike, Glassman, Fiona, Jacobs, Iris, and Magerl, Markus

Published
2023
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5. Prophylactic use of an anti-activated factor XII monoclonal antibody, garadacimab, for patients with C1-esterase inhibitor-deficient hereditary angioedema: a randomised, double-blind, placebo-controlled, phase 2 trial

Author

Craig, Timothy, Magerl, Markus, Levy, Donald S, Reshef, Avner, Lumry, William R, Martinez-Saguer, Inmaculada, Jacobs, Joshua S, Yang, William H, Ritchie, Bruce, Aygören-Pürsün, Emel, Keith, Paul K, Busse, Paula, Feuersenger, Henrike, Pawaskar, Dipti, Jacobs, Iris, Pragst, Ingo, and Doyle, Mittie K

Published
2022
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8. Long‐term safety and efficacy of garadacimab for preventing hereditary angioedema attacks: Phase 3 open‐label extension study.

Author

Reshef, Avner, Hsu, Connie, Katelaris, Constance H., Li, Philip H., Magerl, Markus, Yamagami, Keiko, Guilarte, Mar, Keith, Paul K., Bernstein, Jonathan A., Lawo, John‐Philip, Shetty, Harsha, Pollen, Maressa, Wieman, Lolis, and Craig, Tim J.

Subjects
*ANGIONEUROTIC edema, *THROMBOEMBOLISM, *PREVENTIVE medicine, *MONOCLONAL antibodies, *TEENAGERS
Abstract

Background Methods Results Conclusion Hereditary angioedema (HAE) is a chronic, unpredictable disease. Long‐term prophylactic treatments that offer durable efficacy, safety, and convenience are required to assist patients in achieving complete disease control, per international guidelines. We report an interim analysis of an ongoing phase 3 (VANGUARD) open‐label extension (OLE) study evaluating the long‐term safety and efficacy of garadacimab for HAE prophylaxis.Adults and adolescents aged ≥12 years with HAE previously participating in phase 2 and pivotal phase 3 (VANGUARD) studies were rolled over to an OLE, alongside newly enrolled patients. Patients received garadacimab 200 mg subcutaneously, once monthly for ≥12 months. The primary endpoint was treatment‐emergent adverse events (TEAEs) in patients with C1 inhibitor deficiency/dysfunction.At data cut‐off (February 13, 2023; N = 161), median (interquartile range) exposure was 13.8 months (11.9–16.3). For the primary endpoint, 133/159 patients experienced ≥1 TEAE (524 events), equivalent to 0.23 events/administration and 2.84 events/patient‐year. Garadacimab‐related TEAEs (13% of patients, 52 events) were most commonly injection‐site reactions (ISRs). No deaths occurred. One patient discontinued treatment due to garadacimab‐related moderate ISR. Most TEAEs were mild/moderate; three events were serious (COVID‐19, two events; abdominal HAE attack, one event) and not garadacimab related. No abnormal bleeding, thromboembolic, severe hypersensitivity, or anaphylactic events were observed. Mean HAE attack rate decreased by 95% from the run‐in period; 60% of patients were attack‐free. Almost all patients (93%) rated their response to garadacimab as “good” or “excellent.”Garadacimab has a favorable safety profile suitable for long‐term use and provides durable protection against HAE attacks. [ABSTRACT FROM AUTHOR]

Published
2024
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9. International Consensus on the Use of Genetics in the Management of Hereditary Angioedema

Author

Andrejevic, Sladjana, Aygören-Pürsün, Emel, Bara, Noemi-Anna, Bernstein, Jonathan, Bork, Konrad, Bouillet, Laurence, Bova, Maria, Boysen, Henrik Halle, Bygum, Anette, Caballero, Teresa, Castaldo, Anthony, Christiansen, Sandra, Cicardi, Marco, Fabiani, Jose, Katelaris, Connie, Dewald, Georg, Gökmen, Nihal M., Gonzalez-Quevedo, Maria Teresa, Gooi, Jimmy, Grivcheva-Panovska, Vesna, Grumach, Anete, Hakl, Roman, Hardy, Gaelle, Jesenak, Milos, Kaplan, Allen, Kirschfink, Michael, Köhalmi, Kinga Viktoria, Leibovich, Iris, Longhurst, Hilary J., Lumry, William, Magerl, Markus, Saguer, Inmaculada Martinez, Nagy, Imola Beatrix, Nieto, Sandra, Nordenfelt, Patrik, Porębski, Grzegorz, Psarros, Fotis, Reshef, Avner, Riedl, Marc A., Sheikh, Farrukh, Peter, Spath, Speletas, Matthaios, Staevska, Maria, Stobiecki, Marcin, Triggiani, Massimo, Veszeli, Nora, Waserman, Susan, Weber, Christina, Wuillemin, Walter, Zuraw, Bruce, Germenis, Anastasios E., Margaglione, Maurizio, Pesquero, João Bosco, Farkas, Henriette, Cichon, Sven, Csuka, Dorottya, Lera, Alberto López, Rijavec, Matija, Jolles, Stephen, Szilagyi, Agnes, Trascasa, Margarita López, Veronez, Camila Lopes, Drouet, Christian, and Zamanakou, Maria

Published
2020
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10. A core outcome set for efficacy of acute treatment of hereditary angioedema

Author

Petersen, Remy S., primary, Fijen, Lauré M., additional, Apfelbacher, Christian, additional, Magerl, Markus, additional, Weller, Karsten, additional, Aberer, Werner, additional, Adatia, Adil, additional, Audhya, Paul, additional, Bara, Noémi-Anna, additional, Betschel, Stephen, additional, Boccon-Gibod, Isabelle, additional, Bouillet, Laurence, additional, Brodszki, Nicholas, additional, Busse, Paula J., additional, Buttgereit, Thomas, additional, Bygum, Anette, additional, Cancian, Mauro, additional, Craig, Timothy, additional, Csuka, Dorottya, additional, Farkas, Henriette, additional, Fomina, Daria, additional, Gil-Serrano, Johana, additional, Gompels, Mark, additional, Fogelbach, Guillermo Guidos, additional, Guilarte, Mar, additional, Hide, Michihiro, additional, Kiani-Alikhan, Sorena, additional, Kinaciyan, Tamar, additional, Lenten, Annet, additional, lleonart, Ramon, additional, Longhurst, Hilary, additional, Lumry, William R., additional, Malbran, Alejandro, additional, Malinauskiene, Laura, additional, Matta Campos, Juan J., additional, Mendivil, Joan, additional, Nieto-Martinez, Sandra A., additional, Peter, Jonathan G., additional, Porebski, Grzegorz, additional, Reshef, Avner, additional, Riedl, Marc, additional, Valerieva, Anna, additional, Waserman, Susan, additional, Maurer, Marcus, additional, and Cohn, Danny M., additional

Published
2024
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11. Garadacimab For Hereditary Angioedema Prophylaxis In Adolescents: Efficacy And Safety From The Phase 3 (VANGUARD) Study And Open-Label Extension (Second Interim Analysis)

Author

Jacobs, Joshua, primary, Magerl, Markus, additional, Martinez-Saguer, Inmaculada, additional, Li, Huamin, additional, Bernstein, Jonathan, additional, Hsu, Connie, additional, Sitz, Karl, additional, Wieman, Lolis, additional, Feuersenger, Henrike, additional, Pollen, Maressa, additional, and Reshef, Avner, additional

Published
2024
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13. Long-Term Outcomes with Subcutaneous C1-Inhibitor Replacement Therapy for Prevention of Hereditary Angioedema Attacks

Author

Craig, Timothy, Zuraw, Bruce, Longhurst, Hilary, Cicardi, Marco, Bork, Konrad, Grattan, Clive, Katelaris, Constance, Sussman, Gordon, Keith, Paul K., Yang, William, Hébert, Jacques, Hanzlikova, Jana, Staubach-Renz, Petra, Martinez-Saguer, Inmaculada, Magerl, Markus, Aygören-Pürsün, Emel, Farkas, Henriette, Reshef, Avner, Kivity, Shmuel, Neri, Sergio, Crisan, Ioana, Caballero, Teresa, Baeza, Maria L., Hernandez, Maria Dolores, Li, Henry, Lumry, William, Bernstein, Jonathan A., Hussain, Iftikar, Anderson, John, Schwartz, Lawrence B., Jacobs, Joshua, Manning, Michael, Levy, Donald, Riedl, Marc, Christiansen, Sandra, Feuersenger, Henrike, Pragst, Ingo, Mycroft, Sarah, Pawaskar, Dipti, and Jacobs, Iris

Published
2019
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14. Garadacimab for the prevention of hereditary angioedema attacks: a plain language summary of the VANGUARD study

Author

Craig, Timothy J, primary, Reshef, Avner, additional, Li, H Henry, additional, Jacobs, Joshua S, additional, Bernstein, Jonathan A, additional, Farkas, Henriette, additional, Yang, William H, additional, G Stroes, Erik S, additional, Ohsawa, Isao, additional, Tachdjian, Raffi, additional, Manning, Michael E, additional, Lumry, William R, additional, Saguer, Inmaculada Martinez, additional, Aygören-Pürsün, Emel, additional, Ritchie, Bruce, additional, Sussman, Gordon L, additional, Anderson, John, additional, Kawahata, Kimito, additional, Suzuki, Yusuke, additional, Staubach, Petra, additional, Treudler, Regina, additional, Feuersenger, Henrike, additional, Wieman, Lolis, additional, Jacobs, Iris, additional, and Magerl, Markus, additional

Published
2023
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16. 2010 International consensus algorithm for the diagnosis, therapy and management of hereditary angioedema

Author

Bowen, Tom, Cicardi, Marco, Farkas, Henriette, Bork, Konrad, Longhurst, Hilary J, Zuraw, Bruce, Aygoeren-Pürsün, Emel, Craig, Timothy, Binkley, Karen, Hebert, Jacques, Ritchie, Bruce, Bouillet, Laurence, Betschel, Stephen, Cogar, Della, Dean, John, Devaraj, Ramachand, Hamed, Azza, Kamra, Palinder, Keith, Paul K, Lacuesta, Gina, Leith, Eric, Lyons, Harriet, Mace, Sean, Mako, Barbara, Neurath, Doris, Poon, Man-Chiu, Rivard, Georges-Etienne, Schellenberg, Robert, Rowan, Dereth, Rowe, Anne, Stark, Donald, Sur, Smeeksha, Tsai, Ellie, Warrington, Richard, Waserman, Susan, Ameratunga, Rohan, Bernstein, Jonathan, Björkander, Janne, Brosz, Kristylea, Brosz, John, Bygum, Anette, Caballero, Teresa, Frank, Mike, Fust, George, Harmat, George, Kanani, Amin, Kreuz, Wolfhart, Levi, Marcel, Li, Henry, Martinez-Saguer, Inmaculada, Moldovan, Dumitru, Nagy, Istvan, Nielsen, Erik W, Nordenfelt, Patrik, Reshef, Avner, Rusicke, Eva, Smith-Foltz, Sarah, Späth, Peter, Varga, Lilian, and Xiang, Zhi

Abstract

Abstract Background We published the Canadian 2003 International Consensus Algorithm for the Diagnosis, Therapy, and Management of Hereditary Angioedema (HAE; C1 inhibitor [C1-INH] deficiency) and updated this as Hereditary angioedema: a current state-of-the-art review: Canadian Hungarian 2007 International Consensus Algorithm for the Diagnosis, Therapy, and Management of Hereditary Angioedema. Objective To update the International Consensus Algorithm for the Diagnosis, Therapy and Management of Hereditary Angioedema (circa 2010). Methods The Canadian Hereditary Angioedema Network (CHAEN)/Réseau Canadien d'angioédème héréditaire (RCAH) http://www.haecanada.com and cosponsors University of Calgary and the Canadian Society of Allergy and Clinical Immunology (with an unrestricted educational grant from CSL Behring) held our third Conference May 15th to 16th, 2010 in Toronto Canada to update our consensus approach. The Consensus document was reviewed at the meeting and then circulated for review. Results This manuscript is the 2010 International Consensus Algorithm for the Diagnosis, Therapy and Management of Hereditary Angioedema that resulted from that conference. Conclusions Consensus approach is only an interim guide to a complex disorder such as HAE and should be replaced as soon as possible with large phase III and IV clinical trials, meta analyses, and using data base registry validation of approaches including quality of life and cost benefit analyses, followed by large head-to-head clinical trials and then evidence-based guidelines and standards for HAE disease management.

Published
2010

17. HAE international home therapy consensus document

Author

Longhurst, Hilary J, Farkas, Henriette, Craig, Timothy, Aygören-Pürsün, Emel, Bethune, Claire, Bjorkander, Janne, Bork, Konrad, Bouillet, Laurence, Boysen, Henrik, Bygum, Anette, Caballero, Teresa, Cicardi, Marco, Dempster, John, Gompels, Mark, Gooi, Jimmy, Grigoriadou, Sofia, Huffer, Ursula, Kreuz, Wolfhart, Levi, Marcel M, Long, Janet, Martinez-Saguer, Inmaculada, Raguet, Michel, Reshef, Avner, Bowen, Tom, and Zuraw, Bruce

Abstract

Abstract Hereditary angioedema (C1 inhibitor deficiency, HAE) is associated with intermittent swellings which are disabling and may be fatal. Effective treatments are available and these are most useful when given early in the course of the swelling. The requirement to attend a medical facility for parenteral treatment results in delays. Home therapy offers the possibility of earlier treatment and better symptom control, enabling patients to live more healthy, productive lives. This paper examines the evidence for patient-controlled home treatment of acute attacks ('self or assisted administration') and suggests a framework for patients and physicians interested in participating in home or self-administration programmes. It represents the opinion of the authors who have a wide range of expert experience in the management of HAE.

Published
2010

22. Psychometric Field Study of Hereditary Angioedema Quality of Life Questionnaire for Adults: HAE-QoL

Author

Prior, Nieves, Remor, Eduardo, Pérez-Fernández, Elia, Caminoa, Magdalena, Gómez-Traseira, Carmen, Gayá, Francisco, Aabom, Anne, Aberer, Werner, Betschel, Stephen, Boccon-Gibod, Isabelle, Bouillet, Laurence, Bygum, Anette, Csuka, Dorottya, Farkas, Henriette, Gomide, Maria, Grumach, Anete, Leibovich, Iris, Malbran, Alejandro, Moldovan, Dumitru, Mihaly, Eniko, Obtulowicz, Krystyna, Perpén, Cecilia, Peveling-Oberhag, Adriane, Porebski, Grzegorz, Chavannes, Celine Rayonne, Reshef, Avner, Staubach, Petra, Wiednig, Michaela, and Caballero, Teresa

Published
2016
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25. Efficacy And Safety Of Bradykinin B2 Receptor Inhibition With Oral PHVS416 In Treating Hereditary Angioedema Attacks: Results Of RAPIDe-1 Phase 2 Trial

Author

Maurer, Marcus, primary, Anderson, John, additional, Aygören-Pürsün, Emel, additional, Bouillet, Laurence, additional, Baeza, María Luisa, additional, Chapdelaine, Hugo, additional, Cohn, Danny, additional, Du-Thanh, Aurélie, additional, Fain, Olivier, additional, Farkas, Henriette, additional, Greve, Jens, additional, Guilarte, Mar, additional, Hagin, David, additional, Hakl, Roman, additional, Jacobs, Joshua, additional, Kessell, Aharon, additional, Kiani-Alikhan, Sorena, additional, Králíčková, Pavlína, additional, Li, Huamin, additional, Bellfill, Ramon Lleonart, additional, Magerl, Markus, additional, Manning, Michael, additional, Reshef, Avner, additional, Ritchie, Bruce, additional, Spadaro, Giuseppe, additional, Staevska, Maria, additional, Staubach, Petra, additional, Stobiecki, Marcin, additional, Sussman, Gordon, additional, Tarzi, Michael, additional, Valerieva, Anna, additional, Yang, William, additional, Jouvin, Marie-Helene, additional, Crabbé, Rafael, additional, van Leeuwen, Simone, additional, Chen, Huaihou, additional, Zhu, Li, additional, Knolle, Jochen, additional, Lesage, Anne, additional, Lu, Peng, additional, and Riedl, Marc, additional

Published
2023
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26. Efficacy and Safety of Subcutaneous Garadacimab for the Prophylaxis of Hereditary Angioedema Attacks in Adults and Adolescent Patients with HAE: Results from a Multicenter, Placebo-Controlled Phase 3 Trial

Author

Craig, Timothy, primary, Magerl, Markus, additional, Reshef, Avner, additional, Li, Huamin, additional, Jacobs, Joshua, additional, Bernstein, Jonathan, additional, Farkas, Henriette, additional, Yang, William, additional, Stroes, Erik, additional, Ohsawa, Isao, additional, Tachdjian, Raffi, additional, Manning, Michael, additional, Lumry, William, additional, Saguer, Inmaculada Martinez, additional, Aygören-Pürsün, Emel, additional, Ritchie, Bruce, additional, Sussman, Gordon, additional, Anderson, John, additional, Kawahata, Kimito, additional, Suzuki, Yusuke, additional, Staubach, Petra, additional, Treudler, Regina, additional, Feuersenger, Henrike, additional, Wieman, Lolis, additional, and Jacobs, Iris, additional

Published
2023
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28. Garadacimab, a Factor XIIa Inhibitor for Hereditary Angioedema Prevention (VANGUARD Study)

Author

Craig, Timothy, primary, Reshef, Avner, additional, Li, Huamin Henry, additional, Jacobs, Joshua S., additional, Bernstein, Jonathan A., additional, Farkas, Henriette, additional, Yang, William H., additional, Stroes, Erik, additional, Ohsawa, Isao, additional, Tachdjian, Raffi, additional, Manning, Michael E., additional, Lumry, William R., additional, Martinez Saguer, Inmaculada, additional, Aygören-Pürsün, Emel, additional, Ritchie, Bruce, additional, Sussman, Gordon L., additional, Anderson, John, additional, Kawahata, Kimito, additional, Suzuki, Yusuke, additional, Staubach, Petra, additional, Treudler, Regina, additional, Feuersenger, Henrike, additional, Glassman, Fiona, additional, Jacobs, Iris, additional, and Magerl, Markus, additional

Published
2023
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33. Prevention of Hereditary Angioedema Attacks with a Subcutaneous C1 Inhibitor

Author

Longhurst, Hilary, Cicardi, Marco, Craig, Timothy, Bork, Konrad, Grattan, Clive, Baker, James, Li, Huamin H., Reshef, Avner, Bonner, James, Bernstein, Jonathan A., Anderson, John, Lumry, William R., Farkas, Henriette, Katelaris, Constance H., Sussman, Gordon L., Jacobs, Joshua, Riedl, Marc, Manning, Michael E., Hebert, Jacques, Keith, Paul K., Kivity, Shmuel, Neri, Sergio, Levy, Donald S., Baeza, Maria L., Nathan, Robert, Schwartz, Lawrence B., Caballero, Teresa, Yang, William, Crisan, Ioana, Hernandez, María D., Hussain, Iftikhar, Tarzi, Michael, Ritchie, Bruce, Králíčková, Pavlina, Guilarte, Mar, Rehman, Syed M., Banerji, Aleena, Gower, Richard G., Bensen-Kennedy, Debra, Edelman, Jonathan, Feuersenger, Henrike, Lawo, John-Philip, Machnig, Thomas, Pawaskar, Dipti, Pragst, Ingo, and Zuraw, Bruce L.

Published
2017
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34. International consensus on the diagnosis and management of pediatric patients with hereditary angioedema with C1 inhibitor deficiency

Author

Farkas, H., Martinez‐Saguer, I., Bork, K., Bowen, T., Craig, T., Frank, M., Germenis, A. E., Grumach, A. S., Luczay, A., Varga, L., Zanichelli, A., Aberer, Werner, Andrejevic, Sladjana, Aygoeren‐Pürsün, Emel, Banerji, Alena, Bara, Noemi‐Anna, Bas, Murat, Bernstein, Jonathan, Betschel, Stephen, Björkander, Janne, Boccon‐Gibod, Isabelle, Bouillet, Laurence, Bova, Maria, Boysen, Henrik Halle, Branco‐Ferreira, Manuel, Bygum, Anette, Caballero, Teresa, Cancian, Mauro, Castaldo, Anthony, Christiansen, Sandra, Cicardi, Marco, Drouet, Christian, Fabiani, Jose, Gompels, Mark, Gonzalez‐Quevedo, Maria Teresa, Gooi, Jimmy, Gower, Richard, Gökmen, Nihal Mete, Grivcheva‐Panovska, Vesna, Guilarte, Mar, Gülbahar, Okan, Hack, Erik, Hakl, Roman, Harmat, György, Jeseňák, Miloš, Jolles, Stephen, Kaplan, Allen, Katelaris, Connie, Kosnik, Mitja, Kőhalmi, Kinga Viktória, Leibovich, Iris, Levi, Marcel, Li, Henry, Longhurst, Hilary J., Lumry, William, Magerl, Markus, Malbran, Alejandro, Martin, Ludovic, Maurer, Marcus, Mihály, Enikő, Moldovan, Dumitru, Murdjeva, Mariana, Nagy, Imola Beatrix, Nielsen, Erik W., Nieto, Sandra, Nordenfelt, Patrik, Obtulowitzc, Kristine, Pedrosa, Maria, Porębski, Grzegorz, Prior, Nieves, Reshef, Avner, Riedl, Marc A., Rosenkranz, Bernd, Schmid‐Grendelmeier, Peter, Péter, Spath, Speletas, Matthaios, Staevska, Maria, Stobiecki, Marcin, Triggiani, Massimo, Veszeli, Nóra, Wuillemin, Walter, Xiang, Zhi Yu, Yamamoto, Beverley, and Zuraw, Bruce

Published
2017
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36. The international WAO/EAACI guideline for the management of hereditary angioedema—The 2021 revision and update

Author

Maurer, Marcus, primary, Magerl, Markus, additional, Betschel, Stephen, additional, Aberer, Werner, additional, Ansotegui, Ignacio J., additional, Aygören‐Pürsün, Emel, additional, Banerji, Aleena, additional, Bara, Noémi‐Anna, additional, Boccon‐Gibod, Isabelle, additional, Bork, Konrad, additional, Bouillet, Laurence, additional, Boysen, Henrik Balle, additional, Brodszki, Nicholas, additional, Busse, Paula J., additional, Bygum, Anette, additional, Caballero, Teresa, additional, Cancian, Mauro, additional, Castaldo, Anthony, additional, Cohn, Danny M., additional, Csuka, Dorottya, additional, Farkas, Henriette, additional, Gompels, Mark, additional, Gower, Richard, additional, Grumach, Anete S., additional, Guidos‐Fogelbach, Guillermo, additional, Hide, Michihiro, additional, Kang, Hye‐Ryun, additional, Kaplan, Allen Phillip, additional, Katelaris, Constance, additional, Kiani‐Alikhan, Sorena, additional, Lei, Wei‐Te, additional, Lockey, Richard, additional, Longhurst, Hilary, additional, Lumry, William R., additional, MacGinnitie, Andrew, additional, Malbran, Alejandro, additional, Martinez Saguer, Inmaculada, additional, Matta, Juan José, additional, Nast, Alexander, additional, Nguyen, Dinh, additional, Nieto‐Martinez, Sandra A., additional, Pawankar, Ruby, additional, Peter, Jonathan, additional, Porebski, Grzegorz, additional, Prior, Nieves, additional, Reshef, Avner, additional, Riedl, Marc, additional, Ritchie, Bruce, additional, Rafique Sheikh, Farrukh, additional, Smith, William B., additional, Spaeth, Peter J., additional, Stobiecki, Marcin, additional, Toubi, Elias, additional, Varga, Lilian Agnes, additional, Weller, Karsten, additional, Zanichelli, Andrea, additional, Zhi, Yuxiang, additional, Zuraw, Bruce, additional, and Craig, Timothy, additional

Published
2022
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42. Long‐term safety and effectiveness of berotralstat for hereditary angioedema: The open‐label APeX‐S study

Author

Farkas, Henriette, primary, Stobiecki, Marcin, additional, Peter, Jonny, additional, Kinaciyan, Tamar, additional, Maurer, Marcus, additional, Aygören‐Pürsün, Emel, additional, Kiani‐Alikhan, Sorena, additional, Wu, Adrian, additional, Reshef, Avner, additional, Bygum, Anette, additional, Fain, Olivier, additional, Hagin, David, additional, Huissoon, Aarnoud, additional, Jeseňák, Miloš, additional, Lindsay, Karen, additional, Panovska, Vesna Grivcheva, additional, Steiner, Urs C., additional, Zubrinich, Celia, additional, Best, Jessica M., additional, Cornpropst, Melanie, additional, Dix, Daniel, additional, Dobo, Sylvia M., additional, Iocca, Heather A., additional, Desai, Bhavisha, additional, Murray, Sharon C., additional, Nagy, Eniko, additional, and Sheridan, William P., additional

Published
2021
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44. Long‐term safety and effectiveness of berotralstat for hereditary angioedema: The open‐label APeX‐S study

Author

Farkas, Henriette, Stobiecki, Marcin; https://orcid.org/0000-0003-0161-4920, Peter, Jonny, Kinaciyan, Tamar, Maurer, Marcus, Aygören‐Pürsün, Emel, Kiani‐Alikhan, Sorena, Wu, Adrian, Reshef, Avner, Bygum, Anette, Fain, Olivier, Hagin, David, Huissoon, Aarnoud, Jeseňák, Miloš, Lindsay, Karen, Panovska, Vesna Grivcheva, Steiner, Urs C, Zubrinich, Celia, Best, Jessica M, Cornpropst, Melanie, Dix, Daniel, Dobo, Sylvia M, Iocca, Heather A, Desai, Bhavisha, Murray, Sharon C, Nagy, Eniko, Sheridan, William P, Farkas, Henriette, Stobiecki, Marcin; https://orcid.org/0000-0003-0161-4920, Peter, Jonny, Kinaciyan, Tamar, Maurer, Marcus, Aygören‐Pürsün, Emel, Kiani‐Alikhan, Sorena, Wu, Adrian, Reshef, Avner, Bygum, Anette, Fain, Olivier, Hagin, David, Huissoon, Aarnoud, Jeseňák, Miloš, Lindsay, Karen, Panovska, Vesna Grivcheva, Steiner, Urs C, Zubrinich, Celia, Best, Jessica M, Cornpropst, Melanie, Dix, Daniel, Dobo, Sylvia M, Iocca, Heather A, Desai, Bhavisha, Murray, Sharon C, Nagy, Eniko, and Sheridan, William P

Abstract

Background: Berotralstat (BCX7353) is an oral, once-daily inhibitor of plasma kallikrein recently approved for prevention of angioedema attacks in adults and adolescents with hereditary angioedema (HAE). The objective of this report is to summarize results from an interim analysis of an ongoing long-term safety study of berotralstat in patients with HAE. Methods: APeX-S is an ongoing, phase 2, open-label study conducted in 22 countries (ClinicalTrials.gov, NCT03472040). Eligible patients with a clinical diagnosis of HAE due to C1 inhibitor deficiency (HAE-C1-INH) were centrally allocated to receive berotralstat 150 or 110 mg once daily. The primary objective was to determine long-term safety and the secondary objective was to evaluate effectiveness. Results: Enrolled patients (N = 227) received berotralstat 150 mg (n = 127) or 110 mg (n = 100) once daily. The median (range) duration of exposure was 342 (11-540) and 307 (14-429) days for the 150-mg and 110-mg groups, respectively. Treatment-emergent adverse events (TEAEs) occurred in 91% (n = 206) of patients. The most common TEAEs across treatment groups were upper respiratory tract infection (n = 91, 40%), abdominal pain (n = 57, 25%), headache (n = 40, 18%), and diarrhea (n = 31, 14%) and were mostly mild to moderate. Fifty percent (n = 113) of patients had at least one drug-related adverse event (AE; 150 mg, n = 57 [45%]; 110 mg, n = 56 [56%]), and discontinuations due to AEs occurred in 19 (8%) patients (150 mg, n = 13 [10%]; 110 mg, n = 6 [6%]). Three (1.3%) patients experienced a drug-related serious TEAE. Among patients who received berotralstat through 48 weeks (150 mg, n = 73; 110 mg, n = 30), median HAE attack rates were low in month 1 (150 mg, 1.0 attacks/month; 110 mg, 0.5 attacks/month) and remained low through 12 months (0 attacks/month in both dose groups). Mean HAE attack rates followed a similar trend, and no evidence for patient tolerance to berotralstat emerged. In both dose groups, angioedema qua

Published
2021

49. Long-Term Efficacy of Subcutaneous C1 Inhibitor in Pediatric Patients with Hereditary Angioedema

Author

Levy, Donald, primary, Caballero, Teresa, additional, Hussain, Iftikhar, additional, Reshef, Avner, additional, Anderson, John, additional, Baker, James, additional, Schwartz, Lawrence B., additional, Cicardi, Marco, additional, Prusty, Subhransu, additional, Feuersenger, Henrike, additional, Pragst, Ingo, additional, and Manning, Michael E., additional

Published
2020
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50. Definition, aims, and implementation of GA 2 LEN/HAEi Angioedema Centers of Reference and Excellence

Author

Maurer, Marcus, primary, Aberer, Werner, additional, Agondi, Rosana, additional, Al‐Ahmad, Mona, additional, Al‐Nesf, Maryam Ali, additional, Ansotegui, Ignacio, additional, Arnaout, Rand, additional, Arruda, Luisa Karla, additional, Asero, Riccardo, additional, Aygören‐Pürsün, Emel, additional, Banerji, Aleena, additional, Bauer, Andrea, additional, Ben‐Shoshan, Moshe, additional, Berardi, Alejandro, additional, Bernstein, Jonathan A., additional, Betschel, Stephen, additional, Bindslev‐Jensen, Carsten, additional, Bizjak, Mojca, additional, Boccon‐Gibod, Isabelle, additional, Bork, Konrad, additional, Bouillet, Laurence, additional, Boysen, Henrik Balle, additional, Brodszki, Nicholas, additional, Broesby‐Olsen, Sigurd, additional, Busse, Paula, additional, Buttgereit, Thomas, additional, Bygum, Anette, additional, Caballero, Teresa, additional, Campos, Régis A., additional, Cancian, Mauro, additional, Cherrez‐Ojeda, Ivan, additional, Cohn, Danny M., additional, Costa, Célia, additional, Craig, Timothy, additional, Criado, Paulo Ricardo, additional, Criado, Roberta F., additional, Csuka, Dorottya, additional, Dissemond, Joachim, additional, Du‐Thanh, Aurélie, additional, Ensina, Luis Felipe, additional, Ertaş, Ragıp, additional, Fabiani, José E., additional, Fantini, Claudio, additional, Farkas, Henriette, additional, Ferrucci, Silvia Mariel, additional, Figueras‐Nart, Ignasi, additional, Fili, Natalia L., additional, Fomina, Daria, additional, Fukunaga, Atsushi, additional, Gelincik, Asli, additional, Giménez‐Arnau, Ana, additional, Godse, Kiran, additional, Gompels, Mark, additional, Gonçalo, Margarida, additional, Gotua, Maia, additional, Gower, Richard, additional, Grumach, Anete S., additional, Guidos‐Fogelbach, Guillermo, additional, Hide, Michihiro, additional, Ilina, Natalia, additional, Inomata, Naoko, additional, Jakob, Thilo, additional, Josviack, Dario O., additional, Kang, Hye‐Ryun, additional, Kaplan, Allen, additional, Kasperska‐Zając, Alicja, additional, Katelaris, Constance, additional, Kessel, Aharon, additional, Kleinheinz, Andreas, additional, Kocatürk, Emek, additional, Košnik, Mitja, additional, Krasowska, Dorota, additional, Kulthanan, Kanokvalai, additional, Kumaran, M. Sendhil, additional, Larco Sousa, José Ignacio, additional, Longhurst, Hilary J., additional, Lumry, William, additional, MacGinnitie, Andrew, additional, Magerl, Markus, additional, Makris, Michael P., additional, Malbrán, Alejandro, additional, Marsland, Alexander, additional, Martinez‐Saguer, Inmaculada, additional, Medina, Iris V., additional, Meshkova, Raisa, additional, Metz, Martin, additional, Nasr, Iman, additional, Nicolay, Jan, additional, Nishigori, Chikako, additional, Ohsawa, Isao, additional, Özyurt, Kemal, additional, Papadopoulos, Nikolaos G., additional, Parisi, Claudio A. S., additional, Peter, Jonathan Grant, additional, Pfützner, Wolfgang, additional, Popov, Todor, additional, Prior, Nieves, additional, Ramon, German D., additional, Reich, Adam, additional, Reshef, Avner, additional, Riedl, Marc A., additional, Ritchie, Bruce, additional, Röckmann‐Helmbach, Heike, additional, Rudenko, Michael, additional, Salman, Andaç, additional, Sanchez‐Borges, Mario, additional, Schmid‐Grendelmeier, Peter, additional, Serpa, Faradiba S., additional, Serra‐Baldrich, Esther, additional, Sheikh, Farrukh R., additional, Smith, William, additional, Soria, Angèle, additional, Staubach, Petra, additional, Steiner, Urs C., additional, Stobiecki, Marcin, additional, Sussman, Gordon, additional, Tagka, Anna, additional, Thomsen, Simon Francis, additional, Treudler, Regina, additional, Valle, Solange, additional, van Doorn, Martijn, additional, Varga, Lilian, additional, Vázquez, Daniel O., additional, Wagner, Nicola, additional, Wang, Liangchun, additional, Weber‐Chrysochoou, Christina, additional, Ye, Young‐Min, additional, Zalewska‐Janowska, Anna, additional, Zanichelli, Andrea, additional, Zhao, Zuotao, additional, Zhi, Yuxiang, additional, Zuberbier, Torsten, additional, Zwiener, Ricardo D., additional, and Castaldo, Anthony, additional

Published
2020
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