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
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/88835
Acceder
id CONICETDig_0d73b3597c3411eeaa63fff82fc5dbec
oai_identifier_str oai:ri.conicet.gov.ar:11336/88835
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str 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 Técnicas2025-10-15T15:15:09Zoai: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:34982025-10-15 15:15:09.67CONICET 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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score 13.22299

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