Serrano-Falcón, BlancaDelgado Aros, SilviaMearin, FermínCiriza, ConstanzaSerra, JordiMínguez, MiguelMontoro Huguet, MiguelPerelló, AntoniaSantander, CecilioPérez Aisa, ÁngelesBañón-Rodríguez, InmaculadaRey, Enrique2020-04-292020-04-292019Serrano-Falcón B, Delgado-Aros S, Mearin F, Ciriza de Los Ríos C, Serra J, Mínguez M, et al. Clinical response to linaclotide at week 4 predicts sustained response in irritable bowel syndrome with constipation and improvements in digestive and extra-digestive symptoms. Therap Adv Gastroenterol. 2019 Aug 5; 12: 1-14. DOI: 10.1177/17562848198573581756-283Xhttp://hdl.handle.net/10230/44365Background: 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.application/pdfengCopyright © 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).info:eu-repo/semantics/articlehttp://dx.doi.org/10.1177/1756284819857358Abdominal painConstipationFunctional gastrointestinal diseasesIrritable bowel syndromeinfo:eu-repo/semantics/openAccess