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1. OP26 Impact of telemonitoring on the management of Inflammatory Bowel Disease in Spain: a multicenter TECCU clinical trial

Author

M Aguas Peris, J Del Hoyo, R Vicente, M Barreiro-de Acosta, L Melcarne, A Hernández-Camba, E Alfambra, L Madero, B Sicilia, M Chaparro, M D Martín-Arranz, R Pajares, F Mesonero, M Mañosa, P Martínez, S Chacón, J Tosca, S Marín, L Sanromán, M Calvo, D Monfort, E Saiz, Y Zabana, I Guerra, P Varela, R Faubel, P Corsino, S Porto-Silva, E Brunet, A Gutiérrez, and P Nos

Subjects
Gastroenterology, General Medicine
Abstract

Background Telemedicine is not consistently superior to standard care in the management of inflammatory bowel disease (IBD). Non-inferiority is an acceptable outcome if telemedicine improves the efficacy and efficiency of care. Owing to the positive results of the TECCU app (Telemonitoring of Crohn’s Disease [CD] and Ulcerative Colitis [Au]) in a pilot trial1, we aimed to evaluate the time in remission and quality of life (QoL) of IBD patients controlled by telemonitoring (G_TECCU), compared to standard care (G_Control) after 12 weeks. 1Del Hoyo J et al. J Med Internet Res. 2018;20(11):e11602. Methods A 2-arm randomized multicenter study with a non-inferiority design was performed in 29 IBD centers in Spain. Adult IBD patients who initiated therapy with immunosuppressant or biological agents for disease activity were included. Exclusion criteria were: patients with ileorectal/ileo-pouch anal anastomosis, stoma, active perianal disease, no Internet access. Time in remission was evaluated with Harvey-Bradshaw/Walmsley indexes (according to CD]/UC, respectively), fecal calprotectin (FC) and reactive C protein (RCP). QoL was assessed with IBDQ-9, medication adherence with Morisky-Green index and patient satisfaction with a questionnaire derived from CSQ-8. Results We included 157 patients, and 126 were analyzed after 12 weeks of follow-up. The demographic and clinical variables are listed in Table 1. The time in remission was not inferior in patients who used the TECCU app (mean 4.2 weeks [SD 3.8]) compared with patients who received standard care (mean 4.2 weeks [SD 3.2]; difference 0.03 [95%CI -1.21 to 1.27]; p=0.017) (Figure 1). In patients with UC, disease activity improved significantly in both TECCU (mean SCCAI improvement -3.60 [SD 3.25]; p= 0.001) and standard care groups (-3.89 [SD 4.56]; p=0.001;). In patients with CD, clinical activity also improved significantly in both groups (mean Harvey-Bradshaw improvement -1.65 [SD 2.51]; p=0.001 in TECCU; -2.24 [SD 4.15]; p=0.001 in standard care group). Similarly, FC and CRP values improved significantly in both groups (Figure 2). Considering QoL, the IBDQ-9 score improved significantly in TECCU (mean 11.29 [SD15.8]; p Conclusion In IBD patients who initiate biological agents or immunomodulators, TECCU app is not inferior to standard care to maintain remission in the short-term. Telemonitoring with TECCU app associated a higher improvement in medication adherence and an increase in QoL. Long-term results are needed to confirm it.

Published
2023
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2. P905 Predictive pharmacogenetic risk of pancreatitis in Inflammatory Bowel Disease patients treated with thiopurines: a case-control study from the ENEIDA registry

Author

I Guerra Marina, F Barros, M Chaparro, J M Benítez, M D Martín Arranz, R de Francisco, M Piqueras, L de Castro, A Y Carbajo, F Bermejo, M Mínguez, A Gutiérrez, F Mesonero, F Cañete, C González-Muñoza, M Calvo, B Sicilia, E Alfambra, C A Tardillo, M Rivero, A J Lucendo, L Bujanda, M Van Domselaar, P Almela, L Ramos, M Fernández Sánchez, E Hinojosa, C Verdejo, A Gimenez, I Rodríguez-Lago, N Manceñido, J L Pérez Calle, M D P Moreno, P G Delgado-Guillena, B Antolín, P Ramírez de la Piscina, M J Casanova, Á Carracedo, E Domènech, and J P Gisbert

Subjects
Gastroenterology, General Medicine
Abstract

Background Treatment with thiopurines may be associated with different adverse effects, including acute pancreatitis. Risk factors for developing pancreatitis due to thiopurines in patients with Inflammatory Bowel Disease (IBD) are not clearly identified, with underlying genetic predisposition being a possible cause. Our aim was to evaluate predictive pharmacogenetic risk of pancreatitis in IBD patients treated with thiopurines. Methods IBD patients treated with thiopurines were identified from the prospectively maintained ENEIDA registry of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU). We included as cases those patients who met the Atlanta diagnostic criteria for pancreatitis and had an imaging test that ruled out biliary origin. We included as controls those patients without pancreatitis after at least two years of treatment with thiopurines. Blood samples were collected, and DNA was extracted from leukocytes for all participants and, subsequently, pooled samples were sequenced. Sequencing of a panel of genes (CASR, CEL, CDLN2, CFTR, CPA1, CTRC, PRSS1, and SPINK1) was carried out in the NextSeq500 platform. Variants detected were classified as pathogenic, variants of unknown significance, and benign according to the American College of Medical Genetics and Genomics (ACMGG) guidelines. Results Ninety-five cases and 105 controls were enrolled, 57% were women. Pancreatitis was diagnosed at a median age of 39±13 years old. No patient had previous history of chronic or acute pancreatitis. There were no differences between thiopurine-treated patients with and without pancreatitis in age, sex, and age at IBD onset. We identified 81 benign variants (50 in cases and 67 in controls) and a total of 35 distinct rare pathogenic and unknown significance variants (10 in CEL, 21 in CFTR, 1 in CDLN2, and 3 in CPA1). Of these 35 variants (12 in cases and 18 in controls), 6 were classified as pathogenic (1 in cases and 5 in controls), belonging to the CEL and CFTR genes, and 30 as variants of uncertain significance (21 in cases and 22 in controls). There were no significant differences between the groups of cases and controls, both in totals and by genes. None of the cases or controls carried pancreatitis-predisposing variants within the CASR, CPA1, PRSS1, and SPINK1 genes. None of the analysed samples with pancreatitis carried a pathogenic CFTR mutation. Four different variants of unknown significance were detected in the CDLN and CPA1 genes. One of them was in the CDLN gene in a single patient with pancreatitis, and 3 variants in the CPA1 gene in 5 control individuals. Conclusion In patients with IBD, there is no predisposition to thiopurine-induced pancreatitis associated with genes known to cause pancreatitis.

Published
2023
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3. DOP52 Safety of Inflammatory Bowel Disease drugs during pregnancy and breastfeeding: Mothers and babies’ outcomes (DUMBO registry)

Author

Javier P. Gisbert, E. Leo Carnerero, I Rodríguez Lago, M T Diz-Lois Palomares, Saioa Rubio, María José Casanova, B Zúñiga de Mora-Figueroa, L Arias García, José María Huguet, M Figueira, Agnès Fernández-Clotet, N. Manceñido Marcos, I Pérez Martínez, R Vicente Lidón, R Rodríguez Insa, Iván Guerra, D. Hervías Cruz, P Martínez Montiel, P Ramírez de la Piscina Urraca, C Calviño Suárez, M Aguas, M Á de Jorge Turrión, L Ramos, A Ruiz Cerulla, A Gutiérrez Casbas, P Lopez Serrano, R Armesto, P Sendra Rumbeu, S Marín Pedrosa, G Molina Arriero, R. Camargo Camero, J M Vázquez Morón, C.A. Tardillo Marín, M. Rivero, C Suarez Ferrer, E Alfambra Cabrejas, Alfredo J. Lucendo, M. Chaparro, Luis Bujanda, and M García Donday

Subjects
medicine.medical_specialty, Pregnancy, Obstetrics, business.industry, Gastroenterology, medicine, Breastfeeding, General Medicine, medicine.disease, business, Inflammatory bowel disease
Abstract

Background Prospective registries are necessary to evaluate the safety of inflammatory bowel disease (IBD) treatment during pregnancy and in children in the long term. Aims The overall aim of DUMBO registry is to know the risk of serious adverse events (SAEs) during pregnancy and in children up to 4 years of age exposed during pregnancy to drugs for IBD (mainly focused on biologics), compared to unexposed children. In this analysis we aim to evaluate the risk of SAEs during pregnancy and the predictive factors of it (mainly focused on IBD drugs). Methods Prospective, observational and multicentre registry, which enrols pregnant women with IBD (Crohn’s disease, ulcerative colitis, IBD-unclassified) over 5 years in 70 centres in Spain. The registry was kicked off in September 2019. SAE was defined based on “Clinical Safety Data Management: Definitions and Standards for Expedited Reporting by European Medicines Agency”. Study protocol is summarized in figure 1. Results 433 women have been included so far; 241 got pregnant at least 9 months before this interim analysis (table 1). Mean age was 34 years, and 17% of women had active disease at any time during pregnancy. 23% of pregnancies were exposed to immumodulators (thiopurines), 25% to biologics and 10% to combo therapy (biologics and immunomodulators). 85 pregnancies (35%) were exposed to biologics (60 anti-TNF, 17 ustekinumab, and 8 vedolizumab) either in combo or in monotherapy. There were 237 newborns (227 singleton and 5 pair of twins), 9 miscarriages and 1 abortion. 72% of patients had vaginal delivery and 28% C-sections (18% due to perianal CD or active disease). A total of 59 pregnancies (24.5%) reported at least one SAE: 32% in exposed to biologics and 20.5% in non-exposed group (p>0.05) (figure 2). Four out of 17 pregnancies exposed to ustekinumab and 3 out of 8 exposed to vedolizumab had SAEs (non-related with the drug). In the multivariate analysis, adjusted by disease activity, in comparison with no immunosuppressive treatment, neither immunosuppressants [Odds ratio (OR)=1.1, 95% confidence interval (CI)=0.3–4.3] nor biologics in monotherapy or in combo (OR=0.8; 95%CI=0.2–3) were associated with higher risk of SAEs. 40 patients (17%) were hospitalised due to complications during pregnancy or delivery (figure 3). Two patients underwent surgery during pregnancy due to IBD complications Conclusion IBD treatment (either immunomodulators or biologics) does not increase the risk of SAEs during pregnancy. Nevertheless, one-quarter of IBD women suffer SAEs during pregnancy and about 20% need hospitalisation, which should be taken into account when managing IBD during pregnancy.

Published
2021
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4. P541 Diagnosis, management, and evolution of acute pancreatitis secondary to thiopurines in patients with Inflammatory Bowel Disease: an ENEIDA registry study

Author

I Guerra Marina, F Barros, F Mesonero, R de Francisco, F Cañete, J M Benítez, B Sicilia, M D Martín Arranz, L de Castro, A Y Carbajo, A Gutiérrez, M Calvo, M J Casanova, C González-Muñoza, M Miguel, E Alfambra, M Rivero, A J Lucendo, C A Tardillo, P Almela, L Bujanda, M Van Domselaar, L Ramos, M Fernández Sánchez, E Hinojosa, C Verdejo, A Gimenez, M Piqueras, I Rodríguez-Lago, N Manceñido, J L Pérez Calle, M D P Moreno, P G Delgado, B Antolín, P Ramírez de la Piscina, F Bermejo, Á Carracedo, E Domènech, and J P Gisbert

Subjects
Gastroenterology, General Medicine
Abstract

Background Treatment with thiopurines in patients with Inflammatory Bowel Disease (IBD) may be associated with different adverse effects, including acute pancreatitis. Our aims were to evaluate the clinical presentation, severity and management of acute pancreatitis related to thiopurines in patients with IBD. Methods IBD patients with acute pancreatitis secondary to treatment with thiopurines for IBD were identified from the prospectively maintained ENEIDA registry of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU). We included those patients who met the Atlanta diagnostic criteria and had an imaging test that ruled out biliary origin of pancreatitis. Investigators at each participating centre provided additional information on pancreatitis clinical evolution and management. Results We included 290 patients with pancreatitis in 34 centres; 54% were women, 84% had Crohn’s disease and 56% were smokers. Five (1.7%) had had pancreatitis before, but no patient met criteria for chronic pancreatitis. The median age at pancreatitis was 36 years (IQR 27-50). In 94% of cases, pancreatitis occurred after the first thiopurine drug. Azathioprine was the thiopurine used in 97% of cases (median dose 2.3 mg/kg/day (IQR 2-2.5)), and 6% were treated with mercaptopurine (1.5 mg/kg/day (IQR 1-1.5)). Pancreatitis was diagnosed after a median of 23 days (IQR 14-35) since the start of the treatment with thiopurines. 81% required hospitalization for pancreatitis for a median of 5 days (IQR 4-7). Four (1.4%) were severe pancreatitis, 16 (5.5%) moderate, and the rest mild, according to the Atlanta classification. No epidemiological or treatment factors were associated with the severity of pancreatitis. Thiopurine was withdrawn in all patients upon diagnosis of pancreatitis. After 2 months (IQR 1-28) of pancreatitis, 16 patients (5.5%) received thiopurines again (5 the same, 11 a different thiopurine), suffering a new episode of pancreatitis in 12 (75%) after a median of 12 days (IQR 5-34). Pancreatitis occurred in all smokers that were treated again with thiopurines (n=7), compared to 5 of the 9 (56%) non-smokers or former smokers (p=0.04, RR 1.8; 95% CI 1.1-3.2). Conclusion Acute pancreatitis secondary to treatment with thiopurines is mild in most patients, usually appearing during the first month of treatment. The reintroduction of thiopurines, although feasible in some cases, is not recommended due to the high risk of developing a new pancreatitis, especially in smokers.

Published
2023
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5. P259 Metabolic associated Liver Disease and sex as key factors of cardiovascular risk in Inflammatory Bowel Disease

Author

S García Mateo, S J Martínez-Domínguez, S Ballesta Martínez, J Espinosa Rueda, C Tejero Justes, M C Aso Gonzalvo, B Gallego Llera, E Alfambra Cabreja, P M Baptista, M M L Nocito Colón, C J Gargallo-Puyuelo, and F Gomollón

Subjects
Gastroenterology, General Medicine
Abstract

Background Atherosclerosis is the main factor for the development of cardiovascular (CV) events. Patients with systemic inflammatory conditions such as inflammatory bowel disease (IBD) are supposed to be at risk of early atherosclerosis. However, data are still contentious. IBD patients are also at risk of other comorbidities such as metabolic associated fatty liver disease (MAFLD), a well-recognised entity associated with increased CV risk. The aim of this study is to demonstrate the impact of MAFLD on CV risk for IBD patients. Methods Prospective cohort study of consecutive IBD outpatients (Leonnard-Jones criteria, > 1 year) was performed from October 2020 to April 2021. Of 947 patients, 50 with IBD who met criteria for MAFLD and 50 with IBD and without MAFLD were matched by sex, age and IBD location. Patients with a previous diagnosis of CV disease, type II diabetes mellitus and under treatment for dyslipidaemia were excluded. Fatty liver disease (FLD) was diagnosed by ultrasonography, controlled attenuation parameter (CAP TM), fatty liver index (FLI), hepatic steatosis index (HSI) and lipid accumulation product (LAP). To assess early atherosclerosis, alterations in carotid artery intima-media thickness (CIMT) and SCORE as non-invasive CV risk test were performed in both groups. Statistical analysis was performed using SPSS, a binomial generalized linear model with logistic regression was performed, with CIMT alteration as dependent variable. For all tests a two-sided p value Results Of 100 IBD patients included 51 (51%) were women with median age of 51.0 (41–59). There were 49 (49%) patients diagnosed of ulcerative colitis (UC) and 51 (51%) of Crohn’s disease (CD). Comorbidities and disease patient’s characteristics are shown in table 1. Most of the patients had an abnormal CIMT (58 (58%)). Of all the variables obtained, only female sex (OR (CI 95%) 3.322 (1.03–10); p=0.033) and MAFLD (OR (CI 95%) 5.05 (1.71–14.92); p=0.003)) were significatively associated with CIMT alterations. SCORE test did not associate with a significatively CIMT alteration. Among the different options to assess FLD, only ultrasonography and CAP were statisticaly associated with CIMT alterations (specificity 66%, sensibility 62%, p=0.005). Conclusion Female sex and MAFLD are associated with early atherosclerosis defined by CIMT alterations in IBD patients. Ultrasonography and CAP are better than biochemical test not only to predict FLD but also to assess CV risk.

Published
2022
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6. DOP32 Long-term outcomes of enterocutaneous fistula complicating Crohn’s Disease: The ECUFIT study from GETECCU

Author

C García Pérez, E Alfambra, R. Pajares, B Luis, Pedro Almela, C Reygosa Castro, M. Chaparro, I Rodríguez-Lago, Ángel Ponferrada, David Busquets, Mario Calvo, Libardo Jiménez, Noelia Alcaide, E Fernández-Salgado, C González-Muñoza, L de Castro, Beatriz Sicilia, F Argüelles, Marievelisse Soto, A. Rodríguez, E Sánchez Rodríguez, F J Garcia-Alonso, C Rodríguez, X. Calvet, R Pérez Fernández, M. Barreiro-de Acosta, M Calafat, Eduardo Doménech, José Luis Cabriada, Miguel Rivero, M Vela, Óscar Roncero, V J Morales-Alvarado, A Utrilla Fornals, S Tamarit-Sebastián, B Caballol, R Ferreiro-Iglesias, Á Iglesias Gómez, Ignacio Marín-Jiménez, and F. Muñoz

Subjects
Enterocutaneous fistula, Crohn's disease, medicine.medical_specialty, Third lumbar vertebra, Tumor necrosis factors, business.industry, General surgery, Disease progression, Gastroenterology, General Medicine, medicine.disease, Vedolizumab, Long term outcomes, medicine, Abscess, business, medicine.drug
Abstract

Background Crohn’s disease (CD) can develop fistulizing complications at any time during the disease course. Enterocutaneous fistulas (ECF) are disabling lesions with a significant impact on quality of life. The aim of this study was to describe the characteristics and natural history of ECF complicating CD, and to analyze its medical and/or surgical management. Methods A retrospective analysis of all adult patients with fistulizing CD with at least one episode of ECF from the ENEIDA registry (over 68,000 patients) was performed. ECF were defined as a communication between the gastrointestinal tract and the skin producing leakage of luminal contents. Additional data describing the ECF and its medical or surgical management were gathered. The main endpoint was any ECF-related surgical intervention. Fistula closure was defined as the absence of drainage, with no new abscess or surgery for at least 6 months. A comparison of the characteristics and outcomes after the availability of biologic agents (Jan/2000) was also performed. The baseline characteristics were analyzed by means of descriptive statistics and were compared by non-parametric tests. Factors associated with surgery were further evaluated in a binary multivariable regression and survival analysis. Results A total of 301 ECF in 286 patients from 46 hospitals diagnosed between Jan/1970-Sept/2020 were included (median age 34 years (IQR, 27–46); 59% male; 67% L3). ECF had a median of 1 external opening (range 1–10), 59% with concomitant internal fistulas, and usually involved the ileum (67%) or colon (23%). After 146 months (IQR, 69–233) of follow-up, 37% received thiopurines, 40% anti-TNF, 6% ustekinumab and 2% vedolizumab. Surgery was performed in 208 patients (69%) after a median of 4 months (IQR, 1.4–12). Fistula closure was achieved in 253 patients (84%) after 30 months (IQR, 4–84), mostly after surgery (54%) and in one third after medical therapy. Fistula recurrence was uncommon (11%) after closure. Patient and fistula characteristics were significantly different after the availability of biologics. In fact, anti-TNF biologics and thiopurines reduced surgery risk (HR 0.5; 0.38–0.67; HR 0.64; 0.47–0.86, respectively). The surgery rate in the biologic era tends to be lower than before (OR 0.63;0.33–1.09) while timing is similar. Closure rates are also comparable, but it was obtained more frequently after medical therapy once biologicals were available (OR 2.21; 1.13–4.29). Conclusion ECF complicating CD entail a high burden of medical and surgical resources. Closure rates are high, usually after surgery, and fistula recurrence is uncommon. A number of patients can benefit from medical therapy and achieve fistula closure.

Published
2021
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7. P213 Risk factors associated with NAFLD and liver fibrosis in patients with Inflammatory Bowel Disease: a prospective cohort study

Author

S J Martínez-Domínguez, S García Mateo, B Gallego Llera, C J Gargallo-Puyuelo, E Refaie, M T Arroyo Villarino, V Laredo de la Torre, E Alfambra Cabrejas, and F Gomollón García

Subjects
Gastroenterology, General Medicine
Abstract

Background Non Alcoholic Fatty Liver Disease (NAFLD) prevalence is increasing quickly all over the world. A higher prevalence has been reported in Inflammatory Bowel Disease (IBD) patients. NAFLD is associated with increased mortality from liver and cardiovascular causes, so defining risk factors is clinically very relevant. Methods Consecutive IBD patients ≥ 18 years were evaluated at a reference center from October 2020 to April 2021, after giving their informed consent. They were investigated the presence of NAFLD by hepatic ultrasonography and Controlled Attenuation Parameter (CAP) performed by two trained gastroenterologists, considering steatosis in case of any degree of ultrasound steatosis or CAP > 245 dB/m. Risk of advanced liver fibrosis was considered if transient elastography was ≥ 8 kPa. Patients with risk alcohol consumption, secondary causes of steatosis or any chronic hepatic disease were excluded. In addition, a blood sample was obtained for biochemical parameters, clinical variables were recovered prospectively and medical records were reviewed. A descriptive analysis was carried out and factors potentially associated with NAFLD and liver fibrosis were analysed through logistic regression multivariate analyses. For all tests a two-sided p value Results 700 patients (50% women) with a median age of 50 (IQR (40–60)) years were included. In 377 (53.9%) the diagnosis was Ulcerative Colitis and in 323 (46.1%) Crohn′s Disease, the median age at diagnosis was 33 (IQR (22–42)) years. 131 (18.7%) had obesity and 238 (34%) had overweight. The prevalence of NAFLD was 42.57% and the prevalence of liver fibrosis was 7.31%. In multivariate analysis, NAFLD was significantly associated with older age (OR (CI 95%) 1.04 (1.02–1.06), p Conclusion NAFLD is very prevalent in IBD and seems to be associated with the same risk factors than in the general population. Screening for NAFLD seems warranted in all IBD patients.

Published
2022
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8. Análisis de los sistemas de comunicación con la unidad de enfermedad inflamatoria intestinal: perspectiva del paciente y relación con variables clínicas

Author

A. Lué, J. Nerin, L. Rebolledo, F. Gomollón, E. Alfambra, I. Bruna-Barranco, and M.T. Arroyo

Subjects
0301 basic medicine, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Treatment adherence, business.industry, Automotive Engineering, Medicine, 030211 gastroenterology & hepatology, business, Humanities
Abstract

Resumen Introduccion La enfermedad inflamatoria intestinal (EII) tiene un curso cronico y recidivante, con gran impacto medico, social y economico que precisa una atencion continuada y multidisciplinar. Para coordinar los recursos disponibles surgen las unidades de EII, donde la telemedicina aparece como instrumento esencial para la comunicacion medico-paciente. Nuestro objetivo es analizar como los pacientes utilizan y valoran los sistemas actuales de comunicacion con nuestra unidad y las relaciones con variables clinicas. Metodos Se ha realizado un estudio transversal incluyendo pacientes con EII que acudieron a nuestra unidad entre febrero y marzo de 2015. Se analizaron datos demograficos y de la enfermedad, actividad clinica, uso y valoracion de los sistemas de comunicacion, adherencia al tratamiento y calidad de vida. Resultados Fueron incluidos 128 pacientes en el estudio. De estos, 126 (98,4%) conocian y 94 (73,4%) utilizaban los sistemas de comunicacion. Concretamente, 38 (40,4%) usaban el telefono (valoracion media 4,45/5); 50 (53,2%) el email (valoracion media 4,75/5) y 6 (6,4%) ambos; 24 pacientes (25,5%) se comunicaban mensualmente, 19 (20,2%) semestralmente y 51 (54,3%) anualmente. En la comparacion por frecuencia de comunicacion, los pacientes que se comunican mensualmente tienen una edad significativamente menor (38,13 vs. 40,16 vs. 48,49 anos; p = 0,005), peor calidad de vida (41,58 vs. 53,79 vs. 51,57; p = 0,002) y emplean mas el email (87,5%, p Conclusiones La mayoria de los pacientes utilizan los sistemas de comunicacion, y los valoran positivamente. Los pacientes jovenes, con peor calidad de vida, utilizan los sistemas con mas frecuencia, empleando predominantemente el email.

Published
2016
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9. P443 Clinical features, therapeutic requirements, and evolution of patients with Crohn's disease and upper digestive tract involvement (CROHNEX study)

Author

Isabel Vera, R. Pajares, M. Van Domselaar, R Ferreiro-Iglesias, M Esteve, Beatriz Sicilia, Eva Iglesias, María José Casanova, E Sáinz Arnau, Jesús Legido, Pilar Martínez, P Ramírez de la Piscina, B. Beltrán, R. Vicente, Alicia Algaba, María del Mar Ruiz Domínguez, Luis Bujanda, L Nuñez, M.D. Martín, Fernando Muñoz, B Camps, E Alfambra, Ana Yaiza Carbajo, Victor J. Morales, David Busquets, Carlos Taxonera, I Miguel, M Piqueras, M C Muñoz, Pablo Navarro, Pedro Almela, José María Huguet, Fiorella Cañete, Ismael Rodríguez, M D Picó, Isabel Pérez-Martínez, María Josefa Bernalte García, X. Calvet, Olga Merino, M Calafat, Beatriz Antolín, Agueda Abad, A Fernandez Clotet, Alfredo J. Lucendo, Y Zabana, Cristina Rodríguez, C González-Muñoza, M Vela, Alexandra Gutierrez, and Rufo Lorente

Subjects
medicine.medical_specialty, Crohn's disease, business.industry, Internal medicine, Gastroenterology, Medicine, General Medicine, business, medicine.disease, Upper digestive tract
Published
2019
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10. P524 Active smoking and personal concerns about treatment can impair adherence to adalimumab in inflammatory bowel diseases: A prospective evaluation

Author

M Gimeno, Fernando Gomollón, P Alarcon, A. Lué, I. Bruna-Barranco, E. Alfambra, and C Gargallo

Subjects
0301 basic medicine, medicine.medical_specialty, business.industry, Gastroenterology, Inflammatory Bowel Diseases, General Medicine, Prospective evaluation, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, 030220 oncology & carcinogenesis, Internal medicine, Adalimumab, Medicine, Active smoking, business, medicine.drug
Published
2018
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11. Healthy Lifestyle Is a Protective Factor from Moderate and Severe Relapses and Steroid Use in Inflammatory Bowel Disease: A Prospective Cohort Study.

Author

García-Mateo S, Martínez-Domínguez SJ, Gargallo-Puyuelo CJ, Gallego B, Alfambra E, Escuin M, García-Mateo S, López J, and Gomollón F

Subjects
Humans, Prospective Studies, Male, Female, Adult, Middle Aged, Inflammatory Bowel Diseases drug therapy, Follow-Up Studies, Colitis, Ulcerative drug therapy, Colitis, Ulcerative therapy, Adrenal Cortex Hormones therapeutic use, Young Adult, Recurrence, Healthy Lifestyle, Exercise, Diet, Mediterranean, Severity of Illness Index, Protective Factors, Crohn Disease drug therapy
Abstract

Background: A healthy lifestyle, including good adherence to a Mediterranean diet (MD) and regular physical exercise, may be an important factor during the course of inflammatory bowel disease (IBD). Our aim is to determine whether adherence to MD, physical activity, and the combination of both can impact on IBD course., Methods: This prospective cohort study includes 693 IBD outpatients who were in remission with a median follow-up time of 27 months (interquartile range 22-29 months). Each patient completed a survey to assess their adherence to the MD and physical activity. Healthy lifestyle was considered to be a proper adherence to both MD and an active lifestyle. Relapse during follow-up, severity of relapses, need for systemic steroids, and therapy changes were recorded., Results: During the follow-up period, 188 patients (27.1%) experienced relapse, of which 56.1% were moderate or severe. Among patients with relapse, 85 (45%) required treatment with corticosteroids, and 15 (7.9%) were hospitalized. Patients with ulcerative colitis (CU) were more adherent to healthy lifestyle than patients with Crohn's disease (P = .011). Healthy lifestyle was associated with lower risk of moderate and severe relapses (adjusted Hazard ratio [aHR], 0.250; 95% confidence interval [CI], 0.093-0.670) and steroids use (aHR 0.292; 95% CI, 0.103-0.828) in IBD patients and with lower risk of moderate and severe relapses (aHR 0.270; 95% CI, 0.093-0.789) in UC patients., Conclusions: Healthy lifestyle has a favorable influence on promoting a milder disease course, and thus should be a crucial part of clinical management of patients with IBD., (© The Author(s) 2024. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Published
2025
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12. When metabolic comorbidities and risk of malnutrition coexist: The new era of inflammatory bowel disease.

Author

García-Mateo S, Martínez-Domínguez SJ, Gargallo-Puyuelo CJ, Villarino MTA, Laredo V, Gallego B, Alfambra E, Sanz B, and Gomollón F

Subjects
Humans, Male, Female, Adult, Middle Aged, Risk Factors, Comorbidity, Quality of Life, Risk Assessment, Malnutrition epidemiology, Inflammatory Bowel Diseases epidemiology, Inflammatory Bowel Diseases complications
Abstract

Background: Metabolic dysfunction-associated steatotic liver disease (MASLD) and risk of malnutrition can coexist in patients with inflammatory bowel disease (IBD). We performed a malnutrition risk assessment as part of the standard follow-up of IBD patients and studied the potential risk factors for being at risk of malnutrition based on the presence or absence of MASLD., Methods: The Malnutrition Universal Screening Tool (MUST) was used to screen malnutrition risk (MUST ≥1) and controlled attenuation parameter (CAP ≥248 dB/min) to assess MASLD. Adherence to a Mediterranean diet, physical activity, and quality of life were also assessed., Results: Of 686 evaluated IBD patients, 130 (18.9%) were identified as being at risk of malnutrition. Patients without MASLD (n = 89 [68.5%]) were more likely to be at risk than those with MASLD (n = 41 [31.5%], p = 0.005). However, among patients at risk of malnutrition, those with MASLD were more likely to have active IBD (82.9%) than patients without MASLD (39.3%, p < 0.001). Female sex (OR 1.984, p = 0.027) and young age (OR 1.014, p = 0.006) were associated with malnutrition risk only in patients with IBD without MASLD. Being at risk of malnutrition was associated with worse quality of life (p < 0.001), especially in IBD patients with MASLD., Conclusions: Malnutrition risk and quality of life are modified by the presence of MASLD in IBD patients., Competing Interests: Declaration of competing interest Professor Gomollón has received payments for lectures from Abbvie, Janssen, Takeda, MSD, and Pfizer. His research group has received unrestricted grants for research from Janssen, Abbvie, and GETECCU., (Copyright © 2024. Published by Elsevier Inc.)

Published
2025
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13. A booster dose of SARS-COV-2 vaccine improves suboptimal seroconversion rates in patients with inflammatory bowel disease. Results of a prospective multicenter study of GETECCU (VACOVEII study).

Author

Casas Deza D, Julián Gomara AB, Caudevilla Biota E, Beltrán B, Domènech E, Gutiérrez Casbas A, Mañosa M, Zabana Y, Roc Alfaro L, Valverde Romero E, García González E, Sicilia B, Laredo V, Alcalá Escriche MJ, Madero Velázquez L, Ferreiro-Iglesias R, Palmero Pérez A, Calafat M, Rubio Iturria S, Moraleja Yudego I, Ber Nieto Y, García Mateo S, Gisbert JP, Vicente Lidón R, Arias L, Alfambra E, Doñate Borao AB, Peña González E, Corsino Roche P, Vicuña Arregui M, Elorza A, Domínguez Cajal M, Chaparro M, Barreiro-de Acosta M, and García-López S

Subjects
Humans, Prospective Studies, Female, Male, Middle Aged, Adult, Aged, Antibodies, Viral blood, Immunosuppressive Agents therapeutic use, Seroconversion, Inflammatory Bowel Diseases drug therapy, Inflammatory Bowel Diseases immunology, Immunization, Secondary, COVID-19 Vaccines immunology, COVID-19 Vaccines administration & dosage, COVID-19 prevention & control, COVID-19 immunology
Abstract

Background: The response to SARS-CoV-2 vaccination decreases in inflammatory bowel disease (IBD) patients, specially under anti-TNF treatment. However, data on medium-term effectiveness are limited, specially using new recommended seroconversion rate (>260BAU/mL). Our aim was to evaluate the 6-month>260 BAU-seroconversion rate after full vaccination and after booster-dose., Methods: VACOVEII is a Spanish multicenter, prospective study promoted by GETECCU. IBD patients full vaccinated against SARS-CoV-2 and without previous COVID-19 infection, treated or not with immunosuppressants, were included. The booster dose was administered 6 months after the full vaccination. Seroconversion was set at 260BAU/mL, according to most recent recommendations and was assessed 6 months after the full vaccination and 6 months after booster-dose., Results: Between October 2021 and March 2022, 313 patients were included (124 no treatment or mesalazine; 55 immunomodulators; 87 anti-TNF; 19 anti-integrin; and 28 ustekinumab). Most patients received mRNA-vaccines (86%). Six months after full vaccination, overall seroconversion rate was 44.1%, being significantly lower among patients on anti-TNF (19.5%, p<0.001) and ustekinumab (35.7%, p=0.031). The seroconversion rate after booster was 92%. Again, anti-TNF patients had a significantly lower seroconversion rate (67%, p<0.001). mRNA-vaccine improved seroconversion rate (OR 11.720 [95% CI 2.26-60.512])., Conclusion: The full vaccination regimen achieves suboptimal response in IBD patients, specially among those anti-TNF or ustekinumab. The booster dose improves seroconversion rate in all patients, although it remains limited in those treated with anti-TNF. These results reinforce the need to prioritize future booster doses in patients on immunosuppressants therapy, specially under anti-TNF, and using mRNA-vaccines., (Copyright © 2023 Elsevier España, S.L.U. All rights reserved.)

Published
2024
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14. Impact of mesalazine on the response to COVID-19 vaccination in patients with inflammatory bowel disease: Results of a prospective multicentre study of GETECCU (VACOVEII study).

Author

Casas Deza D, Julián Gomara AB, Caudevilla Biota E, Beltrán B, Domènech E, Gutiérrez Casbas A, Mañosa M, Zabana Y, Roc Alfaro L, Valverde Romero E, García González E, Sicilia B, Laredo V, Alcalá Escriche MJ, Madero Velázquez L, Ferreiro-Iglesias R, Palmero Pérez A, Calafat M, Rubio Iturria S, Moraleja Yudego I, Ber Nieto Y, García Mateo S, Gisbert JP, Vicente Lidón R, Arias L, Alfambra E, Doñate Borao AB, Peña González E, Corsino Roche P, Vicuña Arregui M, Elorza A, Domínguez Cajal M, Chaparro M, Barreiro-de Acosta M, and García-López S

Subjects
Humans, Female, Prospective Studies, Male, Middle Aged, Adult, Antibodies, Viral blood, Vaccination, Aged, Seroconversion, Vaccine Efficacy, SARS-CoV-2 immunology, Mesalamine therapeutic use, COVID-19 Vaccines immunology, Inflammatory Bowel Diseases drug therapy, Anti-Inflammatory Agents, Non-Steroidal therapeutic use, COVID-19 prevention & control, COVID-19 immunology
Abstract

Objective: The recommendations of the Spanish Ministry of Health on vaccination in risk groups include mesalazine among the treatments with a possible negative effect on its effectiveness. However, this is not the recommendation of most experts. Our objective was to evaluate the effect of mesalazine on the humoral response to the SARS-CoV-2 vaccine in patients with inflammatory bowel disease (IBD)., Methods: VACOVEII is a Spanish, prospective, multicenter study promoted by GETECCU, which evaluates the effectiveness of the SARS-CoV-2 vaccine in patients with IBD. This study includes IBD patients who have recieved the full vaccination schedule and without previous COVID-19 infection. Seroconversion was set at 260BAU/mL (centralized determination) and was assessed 6 months after full vaccination. In this subanalysis of the study, we compare the effectiveness of the vaccine between patients treated with mesalazine and patients without treatment., Results: A total of 124 patients without immunosuppressive therapy were included, of which 32 did not receive any treatment and 92 received only mesalazine. Six months after full vaccination, no significant differences are observed in the mean concentrations of IgG anti-S between both groups. In the multivariate analysis, antibody titers were independently associated with the use of mRNA vaccines and with SARS-CoV-2 infection., Conclusion: Mesalazine does not have a negative effect on the response to SARS-CoV-2 vaccines in IBD patients., (Copyright © 2024 Elsevier España, S.L.U. All rights reserved.)

Published
2024
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15. Cardiovascular risk assessment in inflammatory bowel disease with metabolic dysfunction-associated steatotic liver disease.

Author

García-Mateo S, Martínez-Domínguez SJ, Gargallo-Puyuelo CJ, Gallego B, Alfambra E, Aso MC, Martinez-Micaelo N, Amigó N, Martínez-García J, Baptista PM, Sanz B, Ballesta S, Espinosa J, Tejero C, and Gomollón F

Subjects
Humans, Male, Female, Cross-Sectional Studies, Adult, Middle Aged, Risk Assessment, Cardiovascular Diseases etiology, Cardiovascular Diseases epidemiology, Heart Disease Risk Factors, Fatty Liver complications, Fatty Liver diagnosis, Fatty Liver diagnostic imaging, Magnetic Resonance Spectroscopy, Inflammatory Bowel Diseases complications, Carotid Intima-Media Thickness
Abstract

Background and Aims: Inflammatory bowel disease (IBD) has been reported to increase the risk of early atherosclerosis even in young patients. Moreover, metabolic dysfunction-associated steatotic liver disease (MASLD), which has been linked to IBD, is a well-recognized but underdiagnosis entity related to cardiovascular risk. We analyze the impact of MASLD in IBD patients' cardiovascular risk through both advanced lipoprotein profile sorted by nuclear magnetic resonance spectroscopy, and carotid artery intima-media thickness (CIMT)., Methods: Cross-sectional cohort study which involves 941 IBD adult outpatients. Of them, 50 patients with IBD who met criteria for MASLD and 50 with IBD without MASLD, matched by sex and age were included. Alterations in CIMT were evaluated considering abnormal measures above the 75th percentile adjusted for sex and age. Specific advanced lipoprotein profile was also carried out., Results: Most of the patients had an abnormal CIMT (58%). MASLD (OR=5.05, CI 95%=1.71-14.92) and female sex (OR=3.32, CI 95%=1.03-10) were significantly associated with CIMT alterations. Dense LDL particles (with high cholesterol composition in general cohort (OR=3.62, 95% CI=1.07-12.19) and high triglycerides density in young subgroup (OR=6.25, 95% CI=1.04-50) but not total LDL cholesterol were associated with CIMT alterations., Conclusions: MASLD and female sex are associated with early atherosclerosis in IBD patients. Dense LDL particle in combination with vascular imaging findings should be evaluated as non-invasive tools in the management of cardiovascular risk in IBD patients., (Copyright © 2024 Elsevier España, S.L.U. All rights reserved.)

Published
2024
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16. Crohn´s disease is an independent risk factor for liver fibrosis in patients with inflammatory bowel disease and non-alcoholic fatty liver disease.

Author

Martínez-Domínguez SJ, García-Mateo S, Gargallo-Puyuelo CJ, Gallego Llera B, Refaie E, Callau P, Mendi C, Baptista PM, Hernández Ainsa M, Arroyo-Villarino MT, López de la Cruz J, Martínez-García J, Alfambra E, Simón Marco MÁ, Ampuero J, and Gomollón F

Subjects
Humans, Case-Control Studies, Cross-Sectional Studies, Risk Factors, Liver Cirrhosis complications, Prevalence, Non-alcoholic Fatty Liver Disease epidemiology, Crohn Disease complications, Crohn Disease epidemiology, Inflammatory Bowel Diseases complications
Abstract

Background and Aims: Controversial data have been reported regarding the prevalence of Non-Alcoholic Fatty Liver Disease (NAFLD) in Inflammatory Bowel Disease (IBD) population and IBD-related risk factors. The aim of the study was to assess the prevalence and risk factors associated with NAFLD and liver fibrosis in IBD participants compared with non-IBD controls., Methods: Cross-sectional, case-control study including 741 IBD cases and 170 non-IBD controls, matched by sex and age. All participants underwent liver ultrasound, transient elastography and laboratory tests. A logistic regression multivariable analysis was performed adjusting for classic metabolic risk factors and history of systemic steroid use., Results: The prevalence of NAFLD and significant liver fibrosis was 45 % and 10 % in IBD group, and 40 % and 2.9 % in non-IBD group (p = 0.255 and 0.062, respectively). Longer IBD duration (aOR 1.02 95% CI (1.001-1.04)) and older age at IBD diagnosis (aOR 1.02 95 % CI (1.001-1.04)) were independent risk factors for NAFLD in IBD group. Crohn´s Disease was an independent risk factor for significant liver fibrosis in participants with IBD and NAFLD (aOR 3.97 95 % CI (1.78-8.96)). NAFLD occurred at lower BMI levels in IBD group with NAFLD compared to non-IBD group with NAFLD (aOR 0.92 95 % CI (0.87-0.98))., Conclusions: Although we found no differences in the prevalence of NAFLD and liver fibrosis between IBD group and non-IBD group, our findings suggest that liver fibrosis progression should be closely monitored in patients with concomitant CD and NAFLD, more in particular in those with long standing active disease., Competing Interests: Declaration of Competing Interest The authors declare that there is no conflict of interest regarding this project., (Copyright © 2023 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.)

Published
2024
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17. Evaluation of Genetic Variants Associated with the Risk of Thiopurine-Related Pancreatitis: A Case Control Study from ENEIDA Registry.

Author

Guerra I, Barros F, Chaparro M, Benítez JM, Martín-Arranz MD, de Francisco R, Piqueras M, de Castro L, Carbajo AY, Bermejo F, Mínguez M, Gutiérrez A, Mesonero F, Cañete F, González-Muñoza C, Calvo M, Sicilia B, Alfambra E, Rivero M, Lucendo AJ, Tardillo CA, Almela P, Bujanda L, van Domselaar M, Ramos L, Fernández Sánchez M, Hinojosa E, Verdejo C, Gimenez A, Rodríguez-Lago I, Manceñido N, Pérez Calle JL, Moreno MDP, Delgado-Guillena PG, Antolín B, Ramírez de la Piscina P, Casanova MJ, Soto Escribano P, Martín Arranz E, Pérez-Martínez I, Mena R, García Morales N, Granja A, Boscá Watts MM, Francés R, Fernández C, Calafat M, Roig-Ramos C, Vera MI, Carracedo Á, Domènech E, and Gisbert JP

Subjects
Humans, Female, Male, Adult, Case-Control Studies, Middle Aged, Genetic Predisposition to Disease, Risk Factors, Genetic Variation, Mercaptopurine adverse effects, Mercaptopurine therapeutic use, Pancreatitis chemically induced, Pancreatitis genetics, Inflammatory Bowel Diseases genetics, Inflammatory Bowel Diseases drug therapy, Registries
Abstract

Introduction: Risk factors for developing pancreatitis due to thiopurines in patients with inflammatory bowel disease (IBD) are not clearly identified. Our aim was to evaluate the predictive pharmacogenetic risk of pancreatitis in IBD patients treated with thiopurines., Methods: We conducted an observational pharmacogenetic study of acute pancreatitis events in a cohort study of IBD patients treated with thiopurines from the prospectively maintained ENEIDA registry biobank of GETECCU. Samples were obtained and the CASR, CEL, CFTR, CDLN2, CTRC, SPINK1, CPA1, and PRSS1 genes, selected based on their known association with pancreatitis, were fully sequenced., Results: Ninety-five cases and 105 controls were enrolled; a total of 57% were women. Median age at pancreatitis diagnosis was 39 years. We identified 81 benign variants (50 in cases and 67 in controls) and a total of 35 distinct rare pathogenic and unknown significance variants (10 in CEL, 21 in CFTR, 1 in CDLN2, and 3 in CPA1). None of the cases or controls carried pancreatitis-predisposing variants within the CASR, CPA1, PRSS1, and SPINK1 genes, nor a pathogenic CFTR mutation. Four different variants of unknown significance were detected in the CDLN and CPA1 genes; one of them was in the CDLN gene in a single patient with pancreatitis and 3 in the CPA1 gene in 5 controls. After the analysis of the variants detected, no significant differences were observed between cases and controls., Conclusion: In patients with IBD, genes known to cause pancreatitis seem not to be involved in thiopurine-related pancreatitis onset., (© 2024 S. Karger AG, Basel.)

Published
2024
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18. Lifestyle Can Exert a Significant Impact on the Development of Metabolic Complications and Quality Life in Patients with Inflammatory Bowel Disease.

Author

García-Mateo S, Martínez-Domínguez SJ, Gargallo-Puyuelo CJ, Arroyo Villarino MT, Laredo De La Torre V, Gallego B, Alfambra E, and Gomollón F

Subjects
Humans, Quality of Life, Overweight complications, Cross-Sectional Studies, Life Style, Obesity complications, Obesity epidemiology, Crohn Disease complications, Metabolic Syndrome epidemiology, Diabetes Mellitus, Type 2, Inflammatory Bowel Diseases complications
Abstract

Inflammatory bowel diseases (IBDs) are associated with an increased risk of metabolic comorbidities. There is a lack of data regarding the relationship between lifestyle and metabolic diseases in IBD patients. A cross-sectional study on consecutive IBD outpatients was conducted. Adherence to the Mediterranean diet (MD) was assessed using a 14-item questionnaire from the PREDIMED study, and physical activity was evaluated using the GODIN-Leisure score. Body composition was studied based on body mass index and waist-hip ratio (WHR), while quality of life was assessed using a nine-item short questionnaire. Among the 688 evaluated IBD patients, 66% were overweight or obese, 72.7% did not lead an active lifestyle and 70.1% did not adhere to the MD. Metabolic syndrome was associated with age (OR = 1.07, p = 0.019), overweight/obesity (OR = 12.987, p < 0.001) and the inflammatory behavior of Crohn's disease (OR = 6.172, p = 0.001). Type 2 diabetes mellitus or prediabetes was associated with age (OR = 1.063 p = 0.016), overweight/obesity (OR = 3.861, p < 0.001) and the inflammatory behavior of Crohn's disease (OR = 4.716, p = 0.001). Overweight /obesity (OR = 5.494, p < 0.001), a high WHR (OR = 2.564, p = 0.005) and a non-active lifestyle (OR = 2.202, p = 0.0003) were associated with metabolic dysfunction-associated steatotic liver disease. Lifestyle, body composition and not solely systemic inflammation might exert a significant influence on the emergence of metabolic comorbidities such as MASLD, type 2 diabetes mellitus and metabolic syndrome in patients with IBD.

Published
2023
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19. Benefits of Paediatric to Adult Transition Programme in Inflammatory Bowel Disease: The BUTTERFLY Study of GETECCU and SEGHNP.

Author

Rubín de Célix C, Martín-de-Carpi J, Pujol-Muncunill G, Palomino LM, Velasco Rodríguez-Belvís M, Martín-Masot R, Navas-López VM, Ricart E, Casanova MJ, Rodríguez-Martínez A, Leo-Carnerero E, Alcaraz A, Mañosa M, Hernández V, Cobelas Cobelas MC, Sánchez C, Menchén L, Mesonero F, Barreiro-De Acosta M, Martinón-Torres N, Tejido Sandoval C, Rendo Vázquez A, Corsino P, Vicente R, Hernández-Camba A, Alberto Alonso JR, Alonso-Abreu I, Castro Millán AM, Peries Reverter L, Castro B, Fernández-Salgado E, Busto Cuiñas MM, Benítez JM, Madero L, Clemente F, Riestra S, Jiménez-Treviño S, Boscá-Watts M, Crehuá-Gaudiza E, Calvo Moya M, Huguet JM, Largo-Blanco EM, González Vives L, Plaza R, Guerra I, Barrio J, Escartín L, Alfambra E, Cruz N, Muñoz MC, Muñoz Pino MG, Van Domselaar M, Botella B, Monfort Miquel D, Rodríguez Grau MC, De La Mano A, Ber Y, Calvo Iñiguez M, Martínez-Pérez TJ, Chaparro M, and Gisbert JP

Abstract

(1) Background: Transition is a planned movement of paediatric patients to adult healthcare systems, and its implementation is not yet established in all inflammatory bowel disease (IBD) units. The aim of the study was to evaluate the impact of transition on IBD outcomes. (2) Methods: Multicentre, retrospective and observational study of IBD paediatric patients transferred to an adult IBD unit between 2017-2020. Two groups were compared: transition (≥1 joint visit involving the gastroenterologist, the paediatrician, a programme coordinator, the parents and the patient) and no-transition. Outcomes within one year after transfer were analysed. The main variable was poor clinical outcome (IBD flare, hospitalisation, surgery or any change in the treatment because of a flare). Predictive factors of poor clinical outcome were identified with multivariable analysis. (3) Results: A total of 278 patients from 34 Spanish hospitals were included. One hundred eighty-five patients (67%) from twenty-two hospitals (65%) performed a structured transition. Eighty-nine patients had poor clinical outcome at one year after transfer: 27% in the transition and 43% in the no-transition group ( p = 0.005). One year after transfer, no-transition patients were more likely to have a flare (36% vs. 22%; p = 0.018) and reported more hospitalisations (10% vs. 3%; p = 0.025). The lack of transition, as well as parameters at transfer, including IBD activity, body mass index < 18.5 and corticosteroid treatment, were associated with poor clinical outcome. One patient in the transition group (0.4%) was lost to follow-up. (4) Conclusion: Transition care programmes improve patients' outcomes after the transfer from paediatric to adult IBD units. Active IBD at transfer impairs outcomes.

Published
2023
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20. Management and Long-term Outcomes of Crohn's Disease Complicated with Enterocutaneous Fistula: ECUFIT Study from GETECCU.

Author

Barreiro-de Acosta M, Riestra S, Calafat M, Soto MP, Calvo M, Sánchez Rodríguez E, Caballol B, Vela M, Rivero M, Muñoz F, de Castro L, Calvet X, García-Alonso FJ, Utrilla Fornals A, Ferreiro-Iglesias R, González-Muñoza C, Chaparro M, Bujanda L, Sicilia B, Alfambra E, Rodríguez A, Pérez Fernández R, Rodríguez C, Almela P, Argüelles F, Busquets D, Tamarit-Sebastián S, Reygosa Castro C, Jiménez L, Marín-Jiménez I, Alcaide N, Fernández-Salgado E, Iglesias Á, Ponferrada Á, Pajares R, Roncero Ó, Morales-Alvarado VJ, Ispízua-Madariaga N, Sáinz E, Merino O, Márquez-Mosquera L, García-Sepulcre M, Elorza A, Estrecha S, Surís G, Van Domselaar M, Brotons A, de Francisco R, Cañete F, Iglesias E, Vera MI, Mesonero F, Lorente R, Zabana Y, Cabriada JL, Domènech E, and Rodríguez-Lago I

Subjects
Adult, Humans, Quality of Life, Retrospective Studies, Treatment Outcome, Crohn Disease drug therapy, Intestinal Fistula etiology, Intestinal Fistula surgery, Rectal Fistula etiology, Rectal Fistula surgery
Abstract

Background and Aims: Crohn's disease [CD] can develop penetrating complications at any time during the disease course. Enterocutaneous fistulae [ECF] are disease-related complications with an important impact on quality of life. Our aim was to describe the outcomes of this complication, including its medical and/or surgical management and their temporal trends. The primary endpoint was fistula closure, defined as the absence of drainage, with no new abscess or surgery, over the preceding 6 months., Methods: Clinical information from all adult patients with CD and at least one ECF-excluding perianal fistulae-were identified from the prospectively-maintained ENEIDA registry. All additional information regarding treatment for this complication was retrospectively reviewed., Results: A total of 301 ECF in 286 patients [January 1970-September 2020] were analysed out of 30 088 records. These lesions were mostly located in the ileum [67%] and they had a median of one external opening [range 1-10]. After a median follow-up of 146 months (interquartile range [IQR], 69-233), 69% of patients underwent surgery. Fistula closure was achieved in 84%, mostly after surgery, and fistula recurrence was uncommon [13%]. Spontaneous and low-output fistulae were associated with higher closure rates (hazard ratio [HR] 1.51, 95% confidence interval [CI] 1.17-1.93, p = 0.001, and HR 1.49, 95% CI 1.07-2.06, p = 0.03, respectively); this was obtained more frequently with medical therapy since biologics have been available., Conclusions: ECF complicating CD are rare but entail a high burden of medical and surgical resources. Closure rates are high, usually after surgery, and fistula recurrence is uncommon. A significant proportion of patients receiving medical therapy can achieve fistula closure., (© The Author(s) 2022. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Published
2022
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21. Early treatment with anti-tumor necrosis factor agents improves long-term effectiveness in symptomatic stricturing Crohn's disease.

Author

Rodríguez-Lago I, Hoyo JD, Pérez-Girbés A, Garrido-Marín A, Casanova MJ, Chaparro M, Fernández-Clotet A, Castro-Poceiro J, García MJ, Sánchez S, Ferreiro-Iglesias R, Bastón I, Piqueras M, Careda LEIB, Mena R, Suárez C, Cordón JP, López-García A, Márquez L, Arroyo M, Alfambra E, Sierra M, Cano N, Delgado-Guillena P, Morales-Alvarado V, Aparicio JC, Guerra I, Aulló C, Merino O, Arranz L, Hidalgo MA, Llaó J, Plaza R, Molina G, Torres P, Pérez-Galindo P, Romero MG, Herrera-deGuise C, Armesto E, Mesonero F, Frago-Larramona S, Benítez JM, Calvo M, Martín MDCL, Elorza A, Larena A, Peña E, Rodríguez-Grau MDC, Miguel-Criado J, Botella B, Olmos JA, López L, Aguirre U, and Gisbert JP

Subjects
Adalimumab pharmacology, Adalimumab therapeutic use, Adult, Age Factors, Biological Factors pharmacology, Constriction, Pathologic diagnosis, Constriction, Pathologic immunology, Constriction, Pathologic therapy, Crohn Disease complications, Crohn Disease diagnosis, Crohn Disease immunology, Endoscopy, Gastrointestinal adverse effects, Female, Follow-Up Studies, Humans, Infliximab pharmacology, Infliximab therapeutic use, Intestines drug effects, Intestines immunology, Intestines surgery, Male, Middle Aged, Patient Admission statistics & numerical data, Postoperative Complications etiology, Retrospective Studies, Risk Factors, Treatment Outcome, Tumor Necrosis Factor-alpha antagonists & inhibitors, Young Adult, Biological Factors therapeutic use, Crohn Disease therapy, Endoscopy, Gastrointestinal statistics & numerical data, Postoperative Complications epidemiology, Time-to-Treatment
Abstract

Background: There is limited evidence on the effectiveness of biological therapy in stricturing complications in patients with Crohn's disease., Aim: The study aims to determine the effectiveness of anti-tumor necrosis factor (TNF) agents in Crohn's disease complicated with symptomatic strictures., Methods: In this multicentric and retrospective study, we included adult patients with symptomatic stricturing Crohn's disease receiving their first anti-TNF therapy, with no previous history of biological, endoscopic or surgical therapy. The effectiveness of the anti-TNF agent was defined as a composite outcome combining steroid-free drug persistence with no use of new biologics or immunomodulators, hospital admission, surgery or endoscopic therapy during follow-up., Results: Overall, 262 patients with Crohn's disease were included (53% male; median disease duration, 35 months, 15% active smokers), who received either infliximab ( N  = 141, 54%) or adalimumab ( N  = 121, 46%). The treatment was effective in 87% and 73% of patients after 6 and 12 months, respectively, and continued to be effective in 26% after a median follow-up of 40 months (IQR, 19-85). Nonetheless, 15% and 21% of individuals required surgery after 1 and 2 years, respectively, with an overall surgery rate of 32%. Postoperative complications were identified in 15% of patients, with surgical site infection as the most common. Starting anti-TNF therapy in the first 18 months after the diagnosis of Crohn's disease or the identification of stricturing complications was associated with a higher effectiveness (HR 1.62, 95% CI 1.18-2.22; and HR 1.55, 95% CI 1.1-2.23; respectively). Younger age, lower albumin levels, strictures located in the descending colon, concomitant aminosalicylates use or presence of lymphadenopathy were associated with lower effectiveness., Conclusions: Anti-TNF agents are effective in approximately a quarter of patients with Crohn's disease and symptomatic intestinal strictures, and 68% of patients are free of surgery after a median of 40 months of follow-up. Early treatment and some potential predictors of response were associated with treatment success in this setting.

Published
2020
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22. Young age and tobacco use are predictors of lower medication adherence in inflammatory bowel disease.

Author

Bruna-Barranco I, Lué A, Gargallo-Puyuelo CJ, Arroyo MT, Alfambra E, Montero J, and Gomollón F

Subjects
Age Factors, Cross-Sectional Studies, Female, Humans, Incidence, Inflammatory Bowel Diseases epidemiology, Inflammatory Bowel Diseases psychology, Male, Middle Aged, Prognosis, Retrospective Studies, Risk Factors, Spain epidemiology, Tobacco Use epidemiology, Inflammatory Bowel Diseases drug therapy, Quality of Life, Tobacco Use adverse effects, Assessment of Medication Adherence
Abstract

Background: Medication adherence is crucial in the management of patients with inflammatory bowel disease (IBD) because medication nonadherence in these patients is associated with an increased risk of flare-up, relapse, recurrence, loss of response to anti-tumour necrosis factor agents, morbidity and mortality, and poor quality of life. Data on risk factors are very controversial in the literature., Aim: To assess the prevalence of medication nonadherence and to identify predictors of low medication adherence in Spanish patients with IBD., Patients and Methods: We carried out a cross-sectional study that included consecutive outpatients with IBD attending in our adult tertiary clinic in a 3-month period. Morisky 8-Item Medication Adherence Scale questionnaire as well as a survey of sociodemographic data were used., Results: A total of 181 patients were evaluated. Almost half of the patients (46.4%) had high medication adherence, 30.9% had medium adherence, and 22.7% had low adherence. In relation to predictive factors of medication adherence, multivariate analysis showed that age was associated with high adherence [odds ratio (OR): 1.04; 95% confidence interval (CI): 1.01-1.06; P=0.002]. However, being a smoker and presence of Crohn's disease were associated with low adherence (OR: 3.47; 95% CI: 1.36-8.90; P<0.01 and OR: 2.54; 95% CI: 1.12-5.79; P<0.05, respectively)., Conclusion: Only half of patients were high medication adherers. Young age, active smoking, and Crohn's disease seems to be predictors of low medication adherence. On the basis of these data, efforts for reinforce medication adherence should be especially directed to young patients and smokers.

Published
2019
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23. Iron Treatment May Be Difficult in Inflammatory Diseases: Inflammatory Bowel Disease as a Paradigm.

Author

Gargallo-Puyuelo CJ, Alfambra E, García-Erce JA, and Gomollon F

Subjects
Administration, Intravenous, Administration, Oral, Anemia, Iron-Deficiency therapy, Humans, Iron Deficiencies, Inflammatory Bowel Diseases drug therapy, Inflammatory Bowel Diseases physiopathology, Iron administration & dosage, Iron blood, Iron therapeutic use
Abstract

Iron plays a key role in many physiological processes; cells need a very exact quantity of iron. In patients with inflammatory bowel disease, anaemia is a unique example of multifactorial origins, frequently being the result of a combination of iron deficiency and anaemia of chronic disease. The main cause of iron deficiency is the activity of the disease. Therefore, the first aim should be to reach complete clinical remission. The iron supplementation route should be determined according to symptoms, severity of anaemia and taking into account comorbidities and individual risks. Oral iron can only be used in patients with mild anaemia, whose disease is inactive and who have not been previously intolerant to oral iron. Intravenous iron should be the first line treatment in patients with moderate-severe anaemia, in patients with active disease, in patients with poor tolerance to oral iron and when erythropoietin agents or a fast response is needed. Erythropoietin is used in a few patients with anaemia to overcome functional iron deficiency, and blood transfusion is being restricted to refractory cases or acute life-threatening situations.

Published
2018
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