Open-label, multicenter study of self-administered icatibant for attacks of hereditary angioedema
- Autores
- Aberer, W.; Maurer, M.; Reshef, A.; Longhurst, H.; Kivity, S.; Bygum, A.; Caballero, T.; Bloom, B.; Nair, N.; Malbrán, Alejandro
- Año de publicación
- 2014
- Idioma
- inglés
- Tipo de recurso
- artículo
- Estado
- versión publicada
- Descripción
- Background: Historically, treatment for hereditary angioedema (HAE) attacks has been administered by healthcare professionals (HCPs). Patient self-administration could reduce delays between symptom onset and treatment, and attack burden. The primary objective was to assess the safety of self-administered icatibant in patients with HAE type I or II. Secondary objectives included patient convenience and clinical efficacy of self-administration. Methods: In this phase IIIb, open-label, multicenter study, adult patients were trained to self-administer a single 30-mg icatibant subcutaneous injection to treat their next attack. Icatibant-naïve patients were treated by an HCP prior to self-administration. Evaluations included adverse event (AE) reporting, a validated questionnaire for convenience, and visual analog scale for efficacy. Results: A total of 151 patients were enrolled; 104 had an attack requiring treatment during the study, and 97 patients (19 naïve) were included in the self-administration cohort. Recurrence or worsening of HAE symptoms (22 of 97) was the most commonly reported AE; rescue medications including icatibant (N = 3) and C1-inhibitor concentrate (N = 6) were used in 13 cases. Overall, 89 of 97 patients used a single injection of icatibant. No serious AEs or hospitalizations were reported. Most patients (91.7%) found self-administration preferable to administration in the clinic. The median time to symptom relief (3.8 h) was comparable with results from controlled trials of icatibant. Conclusions: With appropriate training, patients were successfully able to recognize HAE attacks and decide when to self-administer icatibant. This, coupled with the patient-reported high degree of satisfaction, convenience and ease of use supports the adoption of icatibant self-administration in clinical practice.
Fil: Aberer, W.. Medical University Graz; Austria
Fil: Maurer, M.. Charite – Universitatsmedizin; Alemania
Fil: Reshef, A.. The Sheba Medical Center; Israel
Fil: Longhurst, H.. Bart’s and The London Hospital; Reino Unido
Fil: Kivity, S.. The Tel Aviv Medical Center; Israel
Fil: Bygum, A.. Odense University Hospital; Dinamarca
Fil: Caballero, T.. Biomedical Research Network on Rare Diseases; España
Fil: Bloom, B.. Global Clinical Research; Estados Unidos
Fil: Nair, N.. Global Clinical Research; Estados Unidos
Fil: Malbrán, Alejandro. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Hospital Británico de Buenos Aires; Argentina - Materia
-
BRADYKININ
C1-ESTERASE INHIBITOR DEFICIENCY
HEREDITARY ANGIOEDEMA
ICATIBANT
SELF-ADMINISTRATION - Nivel de accesibilidad
- acceso abierto
- Condiciones de uso
- https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
- Repositorio
- Institución
- Consejo Nacional de Investigaciones Científicas y Técnicas
- OAI Identificador
- oai:ri.conicet.gov.ar:11336/88835
Ver los metadatos del registro completo
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oai:ri.conicet.gov.ar:11336/88835 |
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CONICET Digital (CONICET) |
spelling |
Open-label, multicenter study of self-administered icatibant for attacks of hereditary angioedemaAberer, W.Maurer, M.Reshef, A.Longhurst, H.Kivity, S.Bygum, A.Caballero, T.Bloom, B.Nair, N.Malbrán, AlejandroBRADYKININC1-ESTERASE INHIBITOR DEFICIENCYHEREDITARY ANGIOEDEMAICATIBANTSELF-ADMINISTRATIONhttps://purl.org/becyt/ford/3.2https://purl.org/becyt/ford/3Background: Historically, treatment for hereditary angioedema (HAE) attacks has been administered by healthcare professionals (HCPs). Patient self-administration could reduce delays between symptom onset and treatment, and attack burden. The primary objective was to assess the safety of self-administered icatibant in patients with HAE type I or II. Secondary objectives included patient convenience and clinical efficacy of self-administration. Methods: In this phase IIIb, open-label, multicenter study, adult patients were trained to self-administer a single 30-mg icatibant subcutaneous injection to treat their next attack. Icatibant-naïve patients were treated by an HCP prior to self-administration. Evaluations included adverse event (AE) reporting, a validated questionnaire for convenience, and visual analog scale for efficacy. Results: A total of 151 patients were enrolled; 104 had an attack requiring treatment during the study, and 97 patients (19 naïve) were included in the self-administration cohort. Recurrence or worsening of HAE symptoms (22 of 97) was the most commonly reported AE; rescue medications including icatibant (N = 3) and C1-inhibitor concentrate (N = 6) were used in 13 cases. Overall, 89 of 97 patients used a single injection of icatibant. No serious AEs or hospitalizations were reported. Most patients (91.7%) found self-administration preferable to administration in the clinic. The median time to symptom relief (3.8 h) was comparable with results from controlled trials of icatibant. Conclusions: With appropriate training, patients were successfully able to recognize HAE attacks and decide when to self-administer icatibant. This, coupled with the patient-reported high degree of satisfaction, convenience and ease of use supports the adoption of icatibant self-administration in clinical practice.Fil: Aberer, W.. Medical University Graz; AustriaFil: Maurer, M.. Charite – Universitatsmedizin; AlemaniaFil: Reshef, A.. The Sheba Medical Center; IsraelFil: Longhurst, H.. Bart’s and The London Hospital; Reino UnidoFil: Kivity, S.. The Tel Aviv Medical Center; IsraelFil: Bygum, A.. Odense University Hospital; DinamarcaFil: Caballero, T.. Biomedical Research Network on Rare Diseases; EspañaFil: Bloom, B.. Global Clinical Research; Estados UnidosFil: Nair, N.. Global Clinical Research; Estados UnidosFil: Malbrán, Alejandro. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Hospital Británico de Buenos Aires; ArgentinaWiley Blackwell Publishing, Inc2014-03info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/88835Aberer, W.; Maurer, M.; Reshef, A.; Longhurst, H.; Kivity, S.; et al.; Open-label, multicenter study of self-administered icatibant for attacks of hereditary angioedema; Wiley Blackwell Publishing, Inc; Allergy; 69; 3; 3-2014; 305-3141398-99950105-4538CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.1111/all.12303info:eu-repo/semantics/altIdentifier/url/https://onlinelibrary.wiley.com/doi/abs/10.1111/all.12303info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T10:17:57Zoai:ri.conicet.gov.ar:11336/88835instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-29 10:17:57.285CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse |
dc.title.none.fl_str_mv |
Open-label, multicenter study of self-administered icatibant for attacks of hereditary angioedema |
title |
Open-label, multicenter study of self-administered icatibant for attacks of hereditary angioedema |
spellingShingle |
Open-label, multicenter study of self-administered icatibant for attacks of hereditary angioedema Aberer, W. BRADYKININ C1-ESTERASE INHIBITOR DEFICIENCY HEREDITARY ANGIOEDEMA ICATIBANT SELF-ADMINISTRATION |
title_short |
Open-label, multicenter study of self-administered icatibant for attacks of hereditary angioedema |
title_full |
Open-label, multicenter study of self-administered icatibant for attacks of hereditary angioedema |
title_fullStr |
Open-label, multicenter study of self-administered icatibant for attacks of hereditary angioedema |
title_full_unstemmed |
Open-label, multicenter study of self-administered icatibant for attacks of hereditary angioedema |
title_sort |
Open-label, multicenter study of self-administered icatibant for attacks of hereditary angioedema |
dc.creator.none.fl_str_mv |
Aberer, W. Maurer, M. Reshef, A. Longhurst, H. Kivity, S. Bygum, A. Caballero, T. Bloom, B. Nair, N. Malbrán, Alejandro |
author |
Aberer, W. |
author_facet |
Aberer, W. Maurer, M. Reshef, A. Longhurst, H. Kivity, S. Bygum, A. Caballero, T. Bloom, B. Nair, N. Malbrán, Alejandro |
author_role |
author |
author2 |
Maurer, M. Reshef, A. Longhurst, H. Kivity, S. Bygum, A. Caballero, T. Bloom, B. Nair, N. Malbrán, Alejandro |
author2_role |
author author author author author author author author author |
dc.subject.none.fl_str_mv |
BRADYKININ C1-ESTERASE INHIBITOR DEFICIENCY HEREDITARY ANGIOEDEMA ICATIBANT SELF-ADMINISTRATION |
topic |
BRADYKININ C1-ESTERASE INHIBITOR DEFICIENCY HEREDITARY ANGIOEDEMA ICATIBANT SELF-ADMINISTRATION |
purl_subject.fl_str_mv |
https://purl.org/becyt/ford/3.2 https://purl.org/becyt/ford/3 |
dc.description.none.fl_txt_mv |
Background: Historically, treatment for hereditary angioedema (HAE) attacks has been administered by healthcare professionals (HCPs). Patient self-administration could reduce delays between symptom onset and treatment, and attack burden. The primary objective was to assess the safety of self-administered icatibant in patients with HAE type I or II. Secondary objectives included patient convenience and clinical efficacy of self-administration. Methods: In this phase IIIb, open-label, multicenter study, adult patients were trained to self-administer a single 30-mg icatibant subcutaneous injection to treat their next attack. Icatibant-naïve patients were treated by an HCP prior to self-administration. Evaluations included adverse event (AE) reporting, a validated questionnaire for convenience, and visual analog scale for efficacy. Results: A total of 151 patients were enrolled; 104 had an attack requiring treatment during the study, and 97 patients (19 naïve) were included in the self-administration cohort. Recurrence or worsening of HAE symptoms (22 of 97) was the most commonly reported AE; rescue medications including icatibant (N = 3) and C1-inhibitor concentrate (N = 6) were used in 13 cases. Overall, 89 of 97 patients used a single injection of icatibant. No serious AEs or hospitalizations were reported. Most patients (91.7%) found self-administration preferable to administration in the clinic. The median time to symptom relief (3.8 h) was comparable with results from controlled trials of icatibant. Conclusions: With appropriate training, patients were successfully able to recognize HAE attacks and decide when to self-administer icatibant. This, coupled with the patient-reported high degree of satisfaction, convenience and ease of use supports the adoption of icatibant self-administration in clinical practice. Fil: Aberer, W.. Medical University Graz; Austria Fil: Maurer, M.. Charite – Universitatsmedizin; Alemania Fil: Reshef, A.. The Sheba Medical Center; Israel Fil: Longhurst, H.. Bart’s and The London Hospital; Reino Unido Fil: Kivity, S.. The Tel Aviv Medical Center; Israel Fil: Bygum, A.. Odense University Hospital; Dinamarca Fil: Caballero, T.. Biomedical Research Network on Rare Diseases; España Fil: Bloom, B.. Global Clinical Research; Estados Unidos Fil: Nair, N.. Global Clinical Research; Estados Unidos Fil: Malbrán, Alejandro. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Hospital Británico de Buenos Aires; Argentina |
description |
Background: Historically, treatment for hereditary angioedema (HAE) attacks has been administered by healthcare professionals (HCPs). Patient self-administration could reduce delays between symptom onset and treatment, and attack burden. The primary objective was to assess the safety of self-administered icatibant in patients with HAE type I or II. Secondary objectives included patient convenience and clinical efficacy of self-administration. Methods: In this phase IIIb, open-label, multicenter study, adult patients were trained to self-administer a single 30-mg icatibant subcutaneous injection to treat their next attack. Icatibant-naïve patients were treated by an HCP prior to self-administration. Evaluations included adverse event (AE) reporting, a validated questionnaire for convenience, and visual analog scale for efficacy. Results: A total of 151 patients were enrolled; 104 had an attack requiring treatment during the study, and 97 patients (19 naïve) were included in the self-administration cohort. Recurrence or worsening of HAE symptoms (22 of 97) was the most commonly reported AE; rescue medications including icatibant (N = 3) and C1-inhibitor concentrate (N = 6) were used in 13 cases. Overall, 89 of 97 patients used a single injection of icatibant. No serious AEs or hospitalizations were reported. Most patients (91.7%) found self-administration preferable to administration in the clinic. The median time to symptom relief (3.8 h) was comparable with results from controlled trials of icatibant. Conclusions: With appropriate training, patients were successfully able to recognize HAE attacks and decide when to self-administer icatibant. This, coupled with the patient-reported high degree of satisfaction, convenience and ease of use supports the adoption of icatibant self-administration in clinical practice. |
publishDate |
2014 |
dc.date.none.fl_str_mv |
2014-03 |
dc.type.none.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion http://purl.org/coar/resource_type/c_6501 info:ar-repo/semantics/articulo |
format |
article |
status_str |
publishedVersion |
dc.identifier.none.fl_str_mv |
http://hdl.handle.net/11336/88835 Aberer, W.; Maurer, M.; Reshef, A.; Longhurst, H.; Kivity, S.; et al.; Open-label, multicenter study of self-administered icatibant for attacks of hereditary angioedema; Wiley Blackwell Publishing, Inc; Allergy; 69; 3; 3-2014; 305-314 1398-9995 0105-4538 CONICET Digital CONICET |
url |
http://hdl.handle.net/11336/88835 |
identifier_str_mv |
Aberer, W.; Maurer, M.; Reshef, A.; Longhurst, H.; Kivity, S.; et al.; Open-label, multicenter study of self-administered icatibant for attacks of hereditary angioedema; Wiley Blackwell Publishing, Inc; Allergy; 69; 3; 3-2014; 305-314 1398-9995 0105-4538 CONICET Digital CONICET |
dc.language.none.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
info:eu-repo/semantics/altIdentifier/doi/10.1111/all.12303 info:eu-repo/semantics/altIdentifier/url/https://onlinelibrary.wiley.com/doi/abs/10.1111/all.12303 |
dc.rights.none.fl_str_mv |
info:eu-repo/semantics/openAccess https://creativecommons.org/licenses/by-nc-sa/2.5/ar/ |
eu_rights_str_mv |
openAccess |
rights_invalid_str_mv |
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/ |
dc.format.none.fl_str_mv |
application/pdf application/pdf |
dc.publisher.none.fl_str_mv |
Wiley Blackwell Publishing, Inc |
publisher.none.fl_str_mv |
Wiley Blackwell Publishing, Inc |
dc.source.none.fl_str_mv |
reponame:CONICET Digital (CONICET) instname:Consejo Nacional de Investigaciones Científicas y Técnicas |
reponame_str |
CONICET Digital (CONICET) |
collection |
CONICET Digital (CONICET) |
instname_str |
Consejo Nacional de Investigaciones Científicas y Técnicas |
repository.name.fl_str_mv |
CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas |
repository.mail.fl_str_mv |
dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar |
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1844614136378425344 |
score |
13.070432 |