Adalimumab vs Azathioprine in the Prevention of Postoperative Crohn's Disease Recurrence. A GETECCU Randomised Trial

Background and Aims: Postoperative recurrence of Crohn's disease [POR-CD] is almost certain if no prophylaxis is administered. Evidence for optimal treatment is lacking. Our aim was to compare the efficacy of adalimumab [ADA] and azathioprine [AZA] in this setting. Methods: We performed a phase...

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Autores: López-Sanromán, A, Vera-Mendoza, I, Domènech, E, Taxonera, C, Ruiz, VV, Marín-Jiménez, I, Guardiola, J, Castro, L, Esteve, M, Iglesias, E, Ceballos, D, Martínez-Montiel, P, Gisbert, JP, Mínguez, M, Echarri, A, Calvet, X, Barrio, J, Hinojosa, J, Martín-Arranz, MD, Márquez-Mosquera, L, Bermejo, F, Rimola, J, Pons, V, Nos, P
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2017
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:p6127
Acceso en línea:https://i3pt.portalinvestigacion.com/publicaciones/6127
Access Level:acceso abierto
Palabra clave:Crohn's disease
azathioprine
adalimumab
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spelling Adalimumab vs Azathioprine in the Prevention of Postoperative Crohn's Disease Recurrence. A GETECCU Randomised TrialLópez-Sanromán, AVera-Mendoza, IDomènech, ETaxonera, CRuiz, VVMarín-Jiménez, IGuardiola, JCastro, LEsteve, MIglesias, ECeballos, DMartínez-Montiel, PGisbert, JPMínguez, MEcharri, ACalvet, XBarrio, JHinojosa, JMartín-Arranz, MDMárquez-Mosquera, LBermejo, FRimola, JPons, VNos, PCrohn's diseaseazathioprineadalimumabBackground and Aims: Postoperative recurrence of Crohn's disease [POR-CD] is almost certain if no prophylaxis is administered. Evidence for optimal treatment is lacking. Our aim was to compare the efficacy of adalimumab [ADA] and azathioprine [AZA] in this setting. Methods: We performed a phase 3, 52-week, multicentre, randomised, superiority study [APPRECIA], in which patients with ileocolonic resection were randomised either to ADA 160-80-40 mg subcutaneously [SC] or AZA 2.5 mg/kg/day, both associated with metronidazole. The primary endpoint was endoscopic recurrence at 1 year [Rutgeerts i2b, i3, i4], as evaluated by a blinded central reader. Results: We recruited 91 patients [median age 35.0 years, disease duration 6.0 years, 23.8% smokers, 7.1% previous resections]. The study drugs were administered to 84 patients. Treatment was discontinued owing to adverse events in 11 patients [13.1%]. Discontinuation was significantly less frequent in the ADA [4.4%] than in the AZA group [23.2%] (dif.: 18.6% [95% CI 4.1-33.2], p = 0.011). According to the intention-to-treat analysis, therapy failed in 23/39 patients in the AZA group [59%] and 19/45 patients in the ADA group [42.2%] [p = 0.12]. In the per-protocol analysis [61 patients with centrally evaluable images], recurrence was recorded in 8/24 [33.3%] patients in the AZA and 11/37 [29.7%] in the ADA group [p = 0.76]. No statistically significant differences between the groups were found for recurrence in magnetic resonance images, biological markers of activity, surgical procedures, or hospital admissions. Conclusions: ADA has not demonstrated a better efficacy than AZA [both associated with metronidazole] for prophylaxis of POR-CD in an unselected population, although tolerance to ADA is significantly better.OXFORD UNIV PRESS2017info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://i3pt.portalinvestigacion.com/publicaciones/6127Journal of Crohns & ColitisISSN: 18739946ISSNe: 18764479reponame: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:p61272026-06-21T15:30:37Z
dc.title.none.fl_str_mv Adalimumab vs Azathioprine in the Prevention of Postoperative Crohn's Disease Recurrence. A GETECCU Randomised Trial
title Adalimumab vs Azathioprine in the Prevention of Postoperative Crohn's Disease Recurrence. A GETECCU Randomised Trial
spellingShingle Adalimumab vs Azathioprine in the Prevention of Postoperative Crohn's Disease Recurrence. A GETECCU Randomised Trial
López-Sanromán, A
Crohn's disease
azathioprine
adalimumab
title_short Adalimumab vs Azathioprine in the Prevention of Postoperative Crohn's Disease Recurrence. A GETECCU Randomised Trial
title_full Adalimumab vs Azathioprine in the Prevention of Postoperative Crohn's Disease Recurrence. A GETECCU Randomised Trial
title_fullStr Adalimumab vs Azathioprine in the Prevention of Postoperative Crohn's Disease Recurrence. A GETECCU Randomised Trial
title_full_unstemmed Adalimumab vs Azathioprine in the Prevention of Postoperative Crohn's Disease Recurrence. A GETECCU Randomised Trial
title_sort Adalimumab vs Azathioprine in the Prevention of Postoperative Crohn's Disease Recurrence. A GETECCU Randomised Trial
dc.creator.none.fl_str_mv López-Sanromán, A
Vera-Mendoza, I
Domènech, E
Taxonera, C
Ruiz, VV
Marín-Jiménez, I
Guardiola, J
Castro, L
Esteve, M
Iglesias, E
Ceballos, D
Martínez-Montiel, P
Gisbert, JP
Mínguez, M
Echarri, A
Calvet, X
Barrio, J
Hinojosa, J
Martín-Arranz, MD
Márquez-Mosquera, L
Bermejo, F
Rimola, J
Pons, V
Nos, P
author López-Sanromán, A
author_facet López-Sanromán, A
Vera-Mendoza, I
Domènech, E
Taxonera, C
Ruiz, VV
Marín-Jiménez, I
Guardiola, J
Castro, L
Esteve, M
Iglesias, E
Ceballos, D
Martínez-Montiel, P
Gisbert, JP
Mínguez, M
Echarri, A
Calvet, X
Barrio, J
Hinojosa, J
Martín-Arranz, MD
Márquez-Mosquera, L
Bermejo, F
Rimola, J
Pons, V
Nos, P
author_role author
author2 Vera-Mendoza, I
Domènech, E
Taxonera, C
Ruiz, VV
Marín-Jiménez, I
Guardiola, J
Castro, L
Esteve, M
Iglesias, E
Ceballos, D
Martínez-Montiel, P
Gisbert, JP
Mínguez, M
Echarri, A
Calvet, X
Barrio, J
Hinojosa, J
Martín-Arranz, MD
Márquez-Mosquera, L
Bermejo, F
Rimola, J
Pons, V
Nos, P
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Crohn's disease
azathioprine
adalimumab
topic Crohn's disease
azathioprine
adalimumab
description Background and Aims: Postoperative recurrence of Crohn's disease [POR-CD] is almost certain if no prophylaxis is administered. Evidence for optimal treatment is lacking. Our aim was to compare the efficacy of adalimumab [ADA] and azathioprine [AZA] in this setting. Methods: We performed a phase 3, 52-week, multicentre, randomised, superiority study [APPRECIA], in which patients with ileocolonic resection were randomised either to ADA 160-80-40 mg subcutaneously [SC] or AZA 2.5 mg/kg/day, both associated with metronidazole. The primary endpoint was endoscopic recurrence at 1 year [Rutgeerts i2b, i3, i4], as evaluated by a blinded central reader. Results: We recruited 91 patients [median age 35.0 years, disease duration 6.0 years, 23.8% smokers, 7.1% previous resections]. The study drugs were administered to 84 patients. Treatment was discontinued owing to adverse events in 11 patients [13.1%]. Discontinuation was significantly less frequent in the ADA [4.4%] than in the AZA group [23.2%] (dif.: 18.6% [95% CI 4.1-33.2], p = 0.011). According to the intention-to-treat analysis, therapy failed in 23/39 patients in the AZA group [59%] and 19/45 patients in the ADA group [42.2%] [p = 0.12]. In the per-protocol analysis [61 patients with centrally evaluable images], recurrence was recorded in 8/24 [33.3%] patients in the AZA and 11/37 [29.7%] in the ADA group [p = 0.76]. No statistically significant differences between the groups were found for recurrence in magnetic resonance images, biological markers of activity, surgical procedures, or hospital admissions. Conclusions: ADA has not demonstrated a better efficacy than AZA [both associated with metronidazole] for prophylaxis of POR-CD in an unselected population, although tolerance to ADA is significantly better.
publishDate 2017
dc.date.none.fl_str_mv 2017
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/6127
url https://i3pt.portalinvestigacion.com/publicaciones/6127
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 OXFORD UNIV PRESS
publisher.none.fl_str_mv OXFORD UNIV PRESS
dc.source.none.fl_str_mv Journal of Crohns & Colitis
ISSN: 18739946
ISSNe: 18764479
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)
reponame_str r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
collection r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,81155

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