A step-down protocol for omalizumab treatment in oral corticosteroid-dependent allergic asthma patients

AimsThere are no specific criteria for a step-down or withdrawal dose of omalizumab (OMA). Our purpose was to evaluate the viability of a protocol for OMAlizumab DOse REduction (the OMADORE study) in severe allergic asthma (SAA). MethodsThe study population included 35 SAA patients treated during a...

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Autores: Domingo, C, Pomares, X, Navarro, A, Amengual, MJ, Monton, C, Sogo, A, Mirapeix, RM
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2018
País:España
Institución:Institut d'Investigació i Innovació Parc Taulí (I3PT)
Repositorio:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
OAI Identifier:oai:i3pt.fundanetsuite.com:p4067
Acceso en línea:https://i3pt.portalinvestigacion.com/publicaciones/4067
Access Level:acceso abierto
Palabra clave:omalizumab
omalizumab withdrawal
severe allergic asthma
treatment step-down
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spelling A step-down protocol for omalizumab treatment in oral corticosteroid-dependent allergic asthma patientsDomingo, CPomares, XNavarro, AAmengual, MJMonton, CSogo, AMirapeix, RMomalizumabomalizumab withdrawalsevere allergic asthmatreatment step-downAimsThere are no specific criteria for a step-down or withdrawal dose of omalizumab (OMA). Our purpose was to evaluate the viability of a protocol for OMAlizumab DOse REduction (the OMADORE study) in severe allergic asthma (SAA). MethodsThe study population included 35 SAA patients treated during a minimum period of 1 year with oral corticosteroids (OC) equivalent to a mean daily dose of 4mg of methyl-prednisolone. To qualify for the protocol, the patients had to have received treatment with OMA for at least one and a half years, OC dose had to have reached the lowest tolerated dose and spirometry had to be greater than or equal to that at entry. The interventions were (a) OMA dose was reduced by half; (b) if patients were clinically stable after 6 months, the dose was halved again; (c) if repeated OC boosters were needed and/or spirometry worsened by more than 10%, OMA dose was raised to the previous figure until stabilization. ResultsMean age was 52.5 (17) years, median monthly OC dose was 120 (IQR: 225) mg. Pulmonary function: FVC: 79.7 (20.2)%; FEV1: 64.8 (21.7)%; FEV1/ FVC: 61.7(13.8)%. OMA could be withdrawn in 34.3% of the patients; 22.9% tolerated a reduction, and in 42.9% the dose could not be modified. Follow-up time after reduction or withdrawal ranged from 12 to 30 months. There were no severe exacerbations requiring emergency assistance or admission. ConclusionsThe OMADORE study found that in more than 50% of SAA patients on OC, OMA dose can be safely reduced or withdrawn based on a progressive dose reduction protocol.WILEY2018info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://i3pt.portalinvestigacion.com/publicaciones/4067BRITISH JOURNAL OF CLINICAL PHARMACOLOGYISSN: 03065251ISSNe: 13652125reponame:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulíinstname:Institut d'Investigació i Innovació Parc Taulí (I3PT)Inglésinfo:eu-repo/semantics/openAccessoai:i3pt.fundanetsuite.com:p40672026-06-21T15:30:37Z
dc.title.none.fl_str_mv A step-down protocol for omalizumab treatment in oral corticosteroid-dependent allergic asthma patients
title A step-down protocol for omalizumab treatment in oral corticosteroid-dependent allergic asthma patients
spellingShingle A step-down protocol for omalizumab treatment in oral corticosteroid-dependent allergic asthma patients
Domingo, C
omalizumab
omalizumab withdrawal
severe allergic asthma
treatment step-down
title_short A step-down protocol for omalizumab treatment in oral corticosteroid-dependent allergic asthma patients
title_full A step-down protocol for omalizumab treatment in oral corticosteroid-dependent allergic asthma patients
title_fullStr A step-down protocol for omalizumab treatment in oral corticosteroid-dependent allergic asthma patients
title_full_unstemmed A step-down protocol for omalizumab treatment in oral corticosteroid-dependent allergic asthma patients
title_sort A step-down protocol for omalizumab treatment in oral corticosteroid-dependent allergic asthma patients
dc.creator.none.fl_str_mv Domingo, C
Pomares, X
Navarro, A
Amengual, MJ
Monton, C
Sogo, A
Mirapeix, RM
author Domingo, C
author_facet Domingo, C
Pomares, X
Navarro, A
Amengual, MJ
Monton, C
Sogo, A
Mirapeix, RM
author_role author
author2 Pomares, X
Navarro, A
Amengual, MJ
Monton, C
Sogo, A
Mirapeix, RM
author2_role author
author
author
author
author
author
dc.subject.none.fl_str_mv omalizumab
omalizumab withdrawal
severe allergic asthma
treatment step-down
topic omalizumab
omalizumab withdrawal
severe allergic asthma
treatment step-down
description AimsThere are no specific criteria for a step-down or withdrawal dose of omalizumab (OMA). Our purpose was to evaluate the viability of a protocol for OMAlizumab DOse REduction (the OMADORE study) in severe allergic asthma (SAA). MethodsThe study population included 35 SAA patients treated during a minimum period of 1 year with oral corticosteroids (OC) equivalent to a mean daily dose of 4mg of methyl-prednisolone. To qualify for the protocol, the patients had to have received treatment with OMA for at least one and a half years, OC dose had to have reached the lowest tolerated dose and spirometry had to be greater than or equal to that at entry. The interventions were (a) OMA dose was reduced by half; (b) if patients were clinically stable after 6 months, the dose was halved again; (c) if repeated OC boosters were needed and/or spirometry worsened by more than 10%, OMA dose was raised to the previous figure until stabilization. ResultsMean age was 52.5 (17) years, median monthly OC dose was 120 (IQR: 225) mg. Pulmonary function: FVC: 79.7 (20.2)%; FEV1: 64.8 (21.7)%; FEV1/ FVC: 61.7(13.8)%. OMA could be withdrawn in 34.3% of the patients; 22.9% tolerated a reduction, and in 42.9% the dose could not be modified. Follow-up time after reduction or withdrawal ranged from 12 to 30 months. There were no severe exacerbations requiring emergency assistance or admission. ConclusionsThe OMADORE study found that in more than 50% of SAA patients on OC, OMA dose can be safely reduced or withdrawn based on a progressive dose reduction protocol.
publishDate 2018
dc.date.none.fl_str_mv 2018
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://i3pt.portalinvestigacion.com/publicaciones/4067
url https://i3pt.portalinvestigacion.com/publicaciones/4067
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv WILEY
publisher.none.fl_str_mv WILEY
dc.source.none.fl_str_mv BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
ISSN: 03065251
ISSNe: 13652125
reponame:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
instname:Institut d'Investigació i Innovació Parc Taulí (I3PT)
instname_str Institut d'Investigació i Innovació Parc Taulí (I3PT)
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collection r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
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