Clinical response to linaclotide at week 4 predicts sustained response in irritable bowel syndrome with constipation and improvements in digestive and extra-digestive symptoms

Background: Linaclotide is approved for the treatment of moderate-to-severe irritable bowel syndrome (IBS) with constipation (IBS-C) in adults. This study aimed to assess factors predictive of a clinical response and improvements in non-IBS symptoms with linaclotide treatment in a Spanish patient po...

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Autores: Serrano-Falcón, Blanca, Delgado Aros, Silvia, Mearin, Fermín, Ciriza, Constanza, Serra, Jordi, Mínguez, Miguel, Montoro Huguet, Miguel, Perelló, Antonia, Santander, Cecilio, Pérez Aisa, Ángeles, Bañón-Rodríguez, Inmaculada, Rey, Enrique
Formato: artículo
Estado:Versión aceptada para publicación
Fecha de publicación:2019
País:España
Recursos:Universitat Pompeu Fabra
Repositorio:Repositorio Digital de la UPF
OAI Identifier:oai:repositori.upf.edu:10230/44365
Acesso em linha:http://hdl.handle.net/10230/44365
http://dx.doi.org/10.1177/1756284819857358
Access Level:acceso abierto
Palavra-chave:Abdominal pain
Constipation
Functional gastrointestinal diseases
Irritable bowel syndrome
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spelling Clinical response to linaclotide at week 4 predicts sustained response in irritable bowel syndrome with constipation and improvements in digestive and extra-digestive symptomsSerrano-Falcón, BlancaDelgado Aros, SilviaMearin, FermínCiriza, ConstanzaSerra, JordiMínguez, MiguelMontoro Huguet, MiguelPerelló, AntoniaSantander, CecilioPérez Aisa, ÁngelesBañón-Rodríguez, InmaculadaRey, EnriqueAbdominal painConstipationFunctional gastrointestinal diseasesIrritable bowel syndromeBackground: Linaclotide is approved for the treatment of moderate-to-severe irritable bowel syndrome (IBS) with constipation (IBS-C) in adults. This study aimed to assess factors predictive of a clinical response and improvements in non-IBS symptoms with linaclotide treatment in a Spanish patient population. Methods: In this open-label phase IIIb study, patients with moderate-to-severe IBS-C received linaclotide 290 μg once daily for 12 weeks. The primary endpoint was clinical response at week 12, defined as >30% reduction in IBS symptom severity score (IBS-SSS) or IBS-SSS <75 plus self-reported response of feeling 'better' or 'much better' versus the baseline. Digestive nonintestinal and extra-digestive symptom scores were assessed. Baseline characteristics and week 4 clinical response were assessed as predictors of week 12 clinical response. Results: A total of 96 patients were eligible; 91 were female and the mean age was 47.4 years. Mean (SD) baseline IBS-SSS was 371 (72.5). In the intention-to-treat and per-protocol populations, 22.9% and 31.7% were clinical responders at week 4, respectively, and 25.0% and 36.7% were clinical responders at week 12. Digestive nonintestinal and extra-digestive symptom scores were significantly improved at weeks 4 and 12. Baseline characteristic was not associated with week 12 clinical response; however, clinical response at week 4 was predictive of response at week 12 (OR: 6.5; 95%IC: 2.1-19.8). The most common adverse event was diarrhea inclusive of loose or watery stools (35.4%). Conclusions: Linaclotide improves IBS-C symptoms, including digestive nonintestinal and extra-digestive symptoms. A clinical response at week 4 may predict response at week 12.SAGE Publications202020202019info:eu-repo/semantics/articleinfo:eu-repo/semantics/acceptedVersionapplication/pdfapplication/pdfhttp://hdl.handle.net/10230/44365http://dx.doi.org/10.1177/1756284819857358reponame:Repositorio Digital de la UPFinstname:Universitat Pompeu FabraInglésCopyright © The Author(s), 2019. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).http://www.creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:repositori.upf.edu:10230/443652026-06-12T07:21:37Z
dc.title.none.fl_str_mv Clinical response to linaclotide at week 4 predicts sustained response in irritable bowel syndrome with constipation and improvements in digestive and extra-digestive symptoms
title Clinical response to linaclotide at week 4 predicts sustained response in irritable bowel syndrome with constipation and improvements in digestive and extra-digestive symptoms
spellingShingle Clinical response to linaclotide at week 4 predicts sustained response in irritable bowel syndrome with constipation and improvements in digestive and extra-digestive symptoms
Serrano-Falcón, Blanca
Abdominal pain
Constipation
Functional gastrointestinal diseases
Irritable bowel syndrome
title_short Clinical response to linaclotide at week 4 predicts sustained response in irritable bowel syndrome with constipation and improvements in digestive and extra-digestive symptoms
title_full Clinical response to linaclotide at week 4 predicts sustained response in irritable bowel syndrome with constipation and improvements in digestive and extra-digestive symptoms
title_fullStr Clinical response to linaclotide at week 4 predicts sustained response in irritable bowel syndrome with constipation and improvements in digestive and extra-digestive symptoms
title_full_unstemmed Clinical response to linaclotide at week 4 predicts sustained response in irritable bowel syndrome with constipation and improvements in digestive and extra-digestive symptoms
title_sort Clinical response to linaclotide at week 4 predicts sustained response in irritable bowel syndrome with constipation and improvements in digestive and extra-digestive symptoms
dc.creator.none.fl_str_mv Serrano-Falcón, Blanca
Delgado Aros, Silvia
Mearin, Fermín
Ciriza, Constanza
Serra, Jordi
Mínguez, Miguel
Montoro Huguet, Miguel
Perelló, Antonia
Santander, Cecilio
Pérez Aisa, Ángeles
Bañón-Rodríguez, Inmaculada
Rey, Enrique
author Serrano-Falcón, Blanca
author_facet Serrano-Falcón, Blanca
Delgado Aros, Silvia
Mearin, Fermín
Ciriza, Constanza
Serra, Jordi
Mínguez, Miguel
Montoro Huguet, Miguel
Perelló, Antonia
Santander, Cecilio
Pérez Aisa, Ángeles
Bañón-Rodríguez, Inmaculada
Rey, Enrique
author_role author
author2 Delgado Aros, Silvia
Mearin, Fermín
Ciriza, Constanza
Serra, Jordi
Mínguez, Miguel
Montoro Huguet, Miguel
Perelló, Antonia
Santander, Cecilio
Pérez Aisa, Ángeles
Bañón-Rodríguez, Inmaculada
Rey, Enrique
author2_role author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Abdominal pain
Constipation
Functional gastrointestinal diseases
Irritable bowel syndrome
topic Abdominal pain
Constipation
Functional gastrointestinal diseases
Irritable bowel syndrome
description Background: Linaclotide is approved for the treatment of moderate-to-severe irritable bowel syndrome (IBS) with constipation (IBS-C) in adults. This study aimed to assess factors predictive of a clinical response and improvements in non-IBS symptoms with linaclotide treatment in a Spanish patient population. Methods: In this open-label phase IIIb study, patients with moderate-to-severe IBS-C received linaclotide 290 μg once daily for 12 weeks. The primary endpoint was clinical response at week 12, defined as >30% reduction in IBS symptom severity score (IBS-SSS) or IBS-SSS <75 plus self-reported response of feeling 'better' or 'much better' versus the baseline. Digestive nonintestinal and extra-digestive symptom scores were assessed. Baseline characteristics and week 4 clinical response were assessed as predictors of week 12 clinical response. Results: A total of 96 patients were eligible; 91 were female and the mean age was 47.4 years. Mean (SD) baseline IBS-SSS was 371 (72.5). In the intention-to-treat and per-protocol populations, 22.9% and 31.7% were clinical responders at week 4, respectively, and 25.0% and 36.7% were clinical responders at week 12. Digestive nonintestinal and extra-digestive symptom scores were significantly improved at weeks 4 and 12. Baseline characteristic was not associated with week 12 clinical response; however, clinical response at week 4 was predictive of response at week 12 (OR: 6.5; 95%IC: 2.1-19.8). The most common adverse event was diarrhea inclusive of loose or watery stools (35.4%). Conclusions: Linaclotide improves IBS-C symptoms, including digestive nonintestinal and extra-digestive symptoms. A clinical response at week 4 may predict response at week 12.
publishDate 2019
dc.date.none.fl_str_mv 2019
2020
2020
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/acceptedVersion
format article
status_str acceptedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10230/44365
http://dx.doi.org/10.1177/1756284819857358
url http://hdl.handle.net/10230/44365
http://dx.doi.org/10.1177/1756284819857358
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv http://www.creativecommons.org/licenses/by-nc/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv http://www.creativecommons.org/licenses/by-nc/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv SAGE Publications
publisher.none.fl_str_mv SAGE Publications
dc.source.none.fl_str_mv reponame:Repositorio Digital de la UPF
instname:Universitat Pompeu Fabra
instname_str Universitat Pompeu Fabra
reponame_str Repositorio Digital de la UPF
collection Repositorio Digital de la UPF
repository.name.fl_str_mv
repository.mail.fl_str_mv
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