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No studies evaluating the rapidity of response to biological therapies are available for Crohn's disease (CD). The aim of this study was to evaluate rapidity of onset of clinical response and impact on quality of life (QoL) of adalimumab therapy in adult anti-TNF-naïve patients with moderately-to-severely active CD.RAPIDA was an open-label, single-arm, prospective, multicenter clinical trial. Adult patients with moderately-to-severely active luminal CD, anti-TNF-naïve, and unresponsive to conventional therapy were treated with adalimumab. Clinical disease activity, QoL and inflammatory biomarkers were measured at day 4, and weeks 1, 2, 4, and 12 after treatment initiation.Eighty-six patients were included in the intention-to-treat (ITT) analyses. Clinical disease activity was reduced from a median of 9.0 points to 6.0 points at day 4. Clinical response (≥ 3-point reduction in the Harvey-Bradshaw Index, HBI) was achieved by 61.6% (d4) and 75.6% (w1) of patients in the ITT population (median 2.5 days) and with non-responder imputation (NRI), by 55.8% and 53.4%, respectively. The proportion of patients in clinical remission (HBI5) at weeks 2 and 4 in the ITT population was 54.7% and 62.8%, respectively (median 7.0 days), and 38.4% and 45.3% in the NRI population. All QoL scores significantly improved and inflammatory biomarkers significantly decreased from day 4 onwards (p0.0001).Rapid clinical response and remission, improvement in QoL and fatigue, and a reduction of inflammatory biomarkers were achieved with adalimumab as early as day 4 in adult anti-TNF-naïve patients with moderately-to-severely active CD.

A new subcutaneous formulation of the infliximab biosimilar CT-P13 has recently been developed for the treatment of inflammatory bowel disease (IBD), providing response rates similar to intravenous treatment. The use of this new formulation was requested, in an effort to limit patient attendance at intravenous infusion centers and to maintain biological treatment during the COVID-19 pandemic. The objective of this observational, retrospective and descriptive study was to assess CT-P13 efficacy and safety after switching from intravenous to a subcutaneous formulation in patients with IBD receiving maintenance therapy. This article shows preliminary results after six months of follow-up.

INTRODUCTION The primary goal of this study was to compare gastrointestinal symptom reduction in patients on bismuth-containing quadruple eradication therapy supplemented with Lactobacillus reuteri strains (DSM 17938 and ATCC PTA 6475) or placebo. MATERIALS AND METHODS This was randomized, double-blind, parallel-arm, placebo-controlled clinical trial. Patients received first-line an eradication regimen based on bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride (three-in-one capsules), and omeprazole 40 mg twice a day for ten days, plus a probiotic or placebo tablet for 30 days. During follow-up gastrointestinal symptoms were assessed using an evaluation scale (GSRS), and adverse events were collected at 0, 14, 28, and 56 days. RESULTS A total of 80 patients were included from February 2018 to May 2019 at a single site. Eradication therapy was effective for 85% of patients, with no differences between treatment arms. In the group receiving the probiotic, abdominal pain decreased in 42% of patients, compared with 19% in the control group (OR: 0.27; CI, 0.13-0.58; p < 0.001), and abdominal distension decreased in 25% versus 17% in the control group (OR: 0.24; IC, 0.19-0.84; p < 0.001); Conclusions: Treatment with L. reuteri only reduced abdominal pain and distension. Further studies are needed to establish the role of probiotics as adjuvant therapy in H. pylori eradication.

Background Ustekinumab is a monoclonal antibody that inhibits interleukins (IL)- 12 and -23 and it is approved for the treatment of Crohn's disease (CD) and more recently also ulcerative colitis (UC). Our aim was to evaluate the effectiveness and safety of Ustekinumab, as well as to identify possible predictive factors of response in a real-life setting. Methods Observational, retrospective, and multicenter study carried out in 4 hospitals in Andalusia. Adult patients with a confirmed diagnosis of CD treated with Ustekinumab from 2017 to 2019 were included. Clinical response was analyzed at 3, 6, and 12 months of treatment. Clinical disease activity was assessed with the Harvey Bradshaw index (HBI) and the Crohn's Disease Activity Index (CDAI), and the biochemical response was assessed with analytical parameters such as CRP and ESR. One-year ustekinumab drug-survival was analyzed. Results 98 patients were analyzed (mean age 43 and 52% men). 56% had failed to ≥2 previous biologicals therapies. At 3 months, 69% of the patients were in response and 40.8% in remission. At 6 months, 56% were in clinical remission. At 12 months, 73.7% in clinical response and 60.5% in remission. Corticosteroid-free remission was 32.4%, 44%, 47.4% at 3, 6, and 12 months, respectively. The cumulative survival at one year of treatment with ustekinumab was 85.3%. Biochemical parameters, such as CRP and ESR showed a statistically significant decrease between baseline and control levels at 3, 6, and 12 months. A lower HBI at baseline and female sex were predictors of corticosteroid-free clinical remission in a univariate analysis. In the multivariate analysis, no variables were found as predictors of corticosteroid-free clinical remission Conclusion: Ustekinumab therapy is safe and useful inducing a clinical response in more than 50% of patients including patients who have failed other biological therapies.

Background and study aims: Endoscopy plays an essential role in managing patients with ulcerative colitis (UC), as it allows us to visualize and assess the severity of the disease. As such assessments are not always objective, different scores have been devised to standardize the findings. The main aim of this study was to assess the interobserver variability between the Mayo Endoscopy Score (MES), Ulcerative Colitis Endoscopy Index of Severity (UCEIS) and Ulcerative Colitis Colonoscopy Index of Severity (UCCIS) analyzing the severity of the endoscopic lesions in patients with ulcerative colitis. Patients and methods: This was a single-cohort observational study in which a colonoscopy was carried out on patients with UC, as normal clinical practice, and a video was recorded. The results from the video were classified according to the MES, UCEIS and UCCIS by three endoscopic specialists independently, and they were compared to each other. The Mayo Endoscopy Score (MES) was used to assess the clinical situation of the patient. The therapeutic impact was analyzed after colonoscopy was carried out. Results: Sixty-seven patients were included in the study. The average age was 51 (SD ± 16.7) and the average MES was 3.07 (SD ± 2.54). The weighted Kappa index between endoscopists A and B for the MES was 0.8; between A and C 0.52; and between B and C 0.49. The intraclass correlation coefficient for UCEIS was 0.92 among the three endoscopists (CI 95 %: 0.83–0.96) and 0.96 for UCCIS among the three endoscopists (CI 95 % 0.94–0.97). A change in treatment for 34.3 % of the patients was implemented on seeing the results of the colonoscopy. Conclusions: There was an adequate, but not perfect, correlation between the different endoscopists for MES, UCEIS, UCCIS. This was higher with the last two scores. Thus, there is still some subjectivity to be minimized through special training, on assessing the seriousness of the endoscopic lesions in patients with UC.

A new subcutaneous formulation of the infliximab biosimilar CT-P13 has recently been developed for the treatment of inflammatory bowel disease (IBD), providing response rates similar to intravenous treatment. In an effort to limit patient attendance at intravenous infusion centers and to maintain biological treatment during the COVID-19 pandemic, the use of this new formulation was requested. The objective of this observational, retrospective, and descriptive study was to assess CT-P13 efficacy and safety after switching from intravenous to subcutaneous formulation in patients with IBD receiving maintenance therapy. This article shows preliminary results after six months of follow-up.

Background Biological agents, such as infliximab, have transformed the outcomes of patients with immune-mediated inflammatory diseases. The advent of biosimilar treatment options such as CT-P13 promises to improve the availability of biological therapy, yet real-world switching data are currently limited. Here, we assess the effectiveness and safety of switching to CT-P13 from infliximab reference product (RP) in patients with inflammatory bowel disease. Materials and methods This was a prospective single-center observational study in patients with moderate to severe Crohn’s disease (CD) and ulcerative colitis (UC). All patients were switched from infliximab RP (Remicade) to CT-P13 treatment and followed up for up to 12 months. The efficacy endpoint was the change in clinical response assessed at 3-monthly intervals, according to the Harvey–Bradshaw score and partial Mayo score for patients with CD and UC, respectively. C-reactive protein (CRP) was also measured. Adverse events were monitored and recorded throughout the study. Results A total of 98 patients with inflammatory bowel disease (67 CD/31 UC) were included. A total of 83.6% (56/67) of patients with CD were in remission at the time of the switch and 62.7% were in remission at 12 months. The Harvey–Bradshaw score showed a significant change at 12 months (P=0.007) but no significant change was observed in median CRP at this timepoint (P=0.364). A total of 80.6% (25/31) of patients with UC were in remission at the time of the switch and 65.3% (18/28) were in remission at 12 months. No significant changes in the median partial Mayo score (P=0.058) or CRP (P=0.329) were observed at 12 months. Serious adverse events related to medication were reported in 11 (11.2%) patients. Conclusion Switching from infliximab RP to CT-P13 is efficacious and well tolerated in patients with CD or UC for up to 12 months.

Introduccion: la endoscopia tiene un papel fundamental en el manejo de los pacientes con colitis ulcerosa (CU), ya que permite la visualizacion y evaluacion de la gravedad de la enfermedad. No obstante, dicha evaluacion no es siempre algo objetivo, por lo que se han desarrollado diferentes escalas que pretenden homogeneizar los hallazgos. Objetico: el objetivo del estudio fue evaluar la variabilidad interobservador entre el Indice de Mayo Endoscopico (IME) y el Indice de Severidad Endoscopica de la Colitis Ulcerosa (UCEIS), al analizar la gravedad de las lesiones endoscopicas en pacientes con CU. El objetivo secundario fue analizar si la preparacion catartica afectaba al grado de concordancia entre los endoscopistas. Material y metodos: se trata de un estudio observacional comparativo de una unica cohorte a la cual se realiza una colonoscopia bajo guia de practica clinica habitual a pacientes con CU y se estadifica segun el IME y el UCEIS por tres endoscopistas expertos. Para valorar el grado de correlacion interobservador se utilizaron el indice de Kappa para el IME y el coeficiente de correlacion intraclase para el UCEIS. Se incluyeron 67 pacientes, con edad media de 51 anos (DE ± 16,7) e indice de Mayo clinico medio de 3,07 (DE ± 2,54). Resultados: el indice de Kappa ponderado entre los endoscopistas A y B para el IME fue de 0,8; entre el A y el C, de 0,52; y entre el B y el C, de 0,49. Para el UCEIS, el coeficiente de correlacion intraclase fue del 0,922 entre los tres endoscopistas (IC 95 %: 0,832-0,959). Se encontro una mejor correlacion interobservador cuando la preparacion catartica era ≥ 8 segun la escala de Boston. Conclusion: existe, por tanto, una superior correlacion entre los diferentes endoscopistas para el UCEIS que para el IME, por lo que deberia ser considerado como el mejor indice a utilizar en la practica clinica. Una buena preparacion catartica es importante para mejorar la correlacion interobservador.

In our case, we want to highlight the importance of screening for opportunistic infectious diseases in these immunosuppressed patients. We present the case of an erythema nodosum triggered by reactivation of Herpes Simplex Virus (HSV) in a patient with ulcerative colitis.

Introduction between 30 % and 40 % of patients treated with infliximab lose response during maintenance. Therapeutic drug monitoring could be used to optimize management in these situations. However, infliximab serum levels are not well defined. The aim of this study was to determine the cut-off range of infliximab serum levels in Crohn's disease patients in remission in the clinical practice. Methods an observational retrospective study was performed from 2016 to 2017. Patients were included with established Crohn's disease, who had been on a maintenance dose schedule of infliximab. Infliximab levels and antibodies to infliximab were measured at least twice in all patients, after induction and after six months of treatment. Clinical remission was defined as ≤ 4 using the Harvey-Bradshaw index. Cluster analysis was used to analyze the results. Results one hundred and five Crohn's disease patients were included in the study; 57.1 % were male with a mean age of 39 years (SD ± 12.9). The median (range) time of the disease was eleven years (7-15) and the median (range) time of follow-up was 32 months (22-38). Patients who achieved remission had infliximab serum levels between 4.26-8.26 ug/ml versus 0.06-1.43 ug/ml in patients who did not achieve remission after induction. Infliximab serum levels were 2.84-7.75 ug/ml and 0.05-2.69 ug/ml in patients who achieved remission versus those who did not achieve remission after six months of treatment. Overall, 4.26-8.26 ug/ml was found to be the best cut-off range for remission. Conclusions in our clinical practice, serum levels of infliximab in Crohn's disease patients should be higher than 4 ug/ml to achieve clinical remission.

Introduccion y objetivos: la pandemia por el SARS-COV2 ha obligado a un cambio sustancial en la atencion a los pacientes con patologias digestivas, en especial a los pacientes con enfermedad inflamatoria intestinal (EII), por estar tratados con farmacos inmunomoduladores. En este sentido, algunas guias nacionales e internacionales han indicado las normas a tener en cuenta. No obstante, pocos trabajos han evaluado como han afrontado los pacientes esta infeccion. Por ello, hemos realizado este estudio con el objetivo de conocer como ha afectado la pandemia por SARS-COV2 a nuestros pacientes con EII. Material y metodos: se realizo una encuesta on-line entre los 295 miembros de la Asociacion de Enfermos de Crohn y Colitis Ulcerosa (ACCU) que constaba de 19 preguntas. Resultados: participaron 168 pacientes de la ACCU, de los cuales un 58 % eran mujeres, el 63,7 % tenia una EC y el 53 % recibia tratamiento biologico. Un 5 % fueron infectados por el SARS-CoV2, todos ellos varones. La principal preocupacion de los pacientes era el miedo a adquirir la infeccion (80,9 %). Mas del 90 % continuo con su tratamiento inmunosupresor y biologico. La mitad de los pacientes teletrabajaron durante el periodo de pandemia. Conclusiones: la perspectiva de los pacientes es fundamental para conseguir un adecuado manejo y evolucion de la enfermedad. Son necesarios mas trabajos que evaluen el impacto que situaciones excepcionales como la pandemia COVID-19 puede ocasionar sobre los pacientes con EII para mejorar la adherencia y el control de la enfermedad.

Background: vedolizumab is an α4β7 integrin antagonist. The aim of this study was to evaluate the clinical response and remission rates with vedolizumab. Methods: this was a retrospective study of inflammatory bowel disease (IBD) patients who received vedolizumab between 2016 and 2019. Response and remission rates were analyzed at three, six, 12, 18 and 24 months after induction. Results: fifty-five patients were included. Clinical remission rates in CD and UC at three, six, 12, 18 and 24 months were 19.35 %, 26.67 %, 30.43 %, 30 %, 38.89 % and 29.17 %, 26.09 %, 19.05 %, 26.67 % and 20 %, respectively. Conclusions: vedolizumab is effective for induction and maintenance of clinical remission, both in Crohn’s disease and ulcerative colitis.

Background: Several studies have reported positive efficacy outcomes for patients with inflammatory bowel disease treated with CT-P13, an infliximab biosimilar. Data from follow-up periods longer than 1 year are still scarce. Here, we assessed the long-term efficacy data, loss of response and safety after switching from infliximab to CT-P13 in patients with inflammatory bowel disease. Methods: This was a prospective single-center observational study involving patients with moderate-to-severe Crohn’s disease and ulcerative colitis switched from infliximab to CT-P13 treatment and reviewed up to 24 months. Efficacy and loss of response were measured using the Harvey–Bradshaw (HB) index and partial Mayo score for patients with Crohn’s disease and ulcerative colitis respectively. C-reactive protein, infliximab drug levels, adverse events and antidrug antibodies were also monitored throughout the study. Results: A total of 64 patients with Crohn’s disease and 36 patients with ulcerative colitis were included. Most of them (72%) remained on CT-P13. Overall, 28% of patients discontinued the therapy due to loss of response, adverse events or long-lasting clinical remission. Remission at 18 and 24 months occurred in 69.9% and 68.5% of patients, respectively. Dose increase was performed in 22% of patients, with remission being reached in 60% of them. HB index, partial Mayo score, C-reactive protein and infliximab drug levels did not show significant changes. Serious adverse events were reported in 14% of patients. Overall, two patients developed low levels of antidrug antibodies. Conclusions: Most of the patients switching from original infliximab were maintained on CT-P13 at 2 years of follow up with a good profile of efficacy and safety.

Background The ideal length of treatment with thiopurines in patients with ulcerative colitis (UC) in sustained remission remains unknown. It is widely accepted that the drug withdrawal is associated with a worse outcome. The aim of this study was to analyze the outcome after this withdrawal and to identify predictors of relapse. Methods A multicenter and retrospective study was designed. A total of 102 patients with UC who discontinued thiopurines in a situation of sustained remission were included. All the patients were followed up until last revision or until relapse (understood as the occurrence of signs and symptoms of UC that required a rescue treatment). Results After thiopurines withdrawal, overall relapse was recorded in 32.35% of the patients: 18.88% in the first year, 36.48% in the third, and 43.04% in the fifth year after withdrawal. On multivariate analysis, predictors of relapse were the time from diagnosis of UC until the starting of thiopurines (hazard ratio [HR], 1.01; 95% confidence interval [CI], 1.01-1.02; P = 0.039), the number of relapses before the withdrawal (HR, 1.3; 95% CI, 1.01-1.66; P = 0.029), pancolitis (HR, 5.01; 95% CI, 1.95-26.43; P = 0.028), the duration of treatment with thiopurines (HR, 0.15; 95% CI, 0.03-0.66; P = 0.013) and the situation of biological remission at withdrawal (HR, 0.004; 95% CI, 0.0001-0.14; P = 0.002). Conclusions The withdrawal of thiopurines in patients with UC, although in sustained remission, is related to a high relapse rate. Clinical variables such as the extent of the disease, the duration of treatment or time from diagnosis to the start of thiopurines should be considered before stopping these drugs.

BACKGROUND Infliximab original has changed the natural history of inflammatory bowel diseases (IBD) over the past two decades. However, the recent expiration of its patent has allowed the entry of the first Infliximab biosimilar into the European and Spanish markets. Currently switching drugs data in IBD are limited. AIM To compare the efficacy of infliximab biosimilar, CT-P13, against infliximab original, analyzing the loss of response of both at the 12 mo follow-up in patients with IBD. METHODS An observational study of two cohorts has been conducted. One retrospective cohort that included patients with IBD treated with Infliximab original, and a prospective cohort of patients who were switching from infliximab original to infliximab biosimilar (CT-P13). We had analyzed the overall efficacy and loss of efficacy in patients in remission at the end of one year after treatment with the original drug compared to the results of the year of treatment with the biosimilar. RESULTS 98 patients (CD 67, CU 31) were included in both cohorts. The overall efficacy for infliximab original per year of treatment was 71% vs 68.2% for infliximab biosimilar (P = 0.80). The loss of overall efficacy at 12 mo for infliximab original was 6.6% vs 14.5% for infliximab biosimilar (P = 0.806). The loss of efficacy in patients who were in basal remission was 16.3% for infliximab original vs 27.1% for infliximab biosimilar. Adverse events were 9.2% for infliximab original vs 11.2% for infliximab biosimilar. CONCLUSION The overall efficacy and loss of treatment response with infliximab biosimilar (CT-P13) is similar to that observed with infliximab original in patients who were switching at the 12 mo follow-up. There is no difference in the rate of adverse events.

espanolObjetivo: evaluar la eficacia y seguridad de la terapia cuadruple con omeprazol mas “una capsula tres-en-uno” que contiene subcitrato de bismuto, metronidazol y tetraciclina (BMTO) en pacientes, naive y fracasos previos, diagnosticados de infeccion con Helicobacter pylori, en el area de Sevilla, en condiciones de practica clinica habitual. Metodos: estudio prospectivo realizado en pacientes consecutivos con infeccion confirmada por Helicobacter pylori y sintomas gastrointestinales del tracto superior. Los pacientes fueron tratados, tras firmar el consentimiento, con Pylera® (capsula tres-en-uno que contiene 140 mg de subcitrato de bismuto, 125 mg de metronidazol y 125 mg de tetraciclina) cuatro veces al dia, mas omeprazol (20 o 40 mg) dos veces al dia, durante diez dias. La erradicacion fue establecida mediante un test de urea en aliento negativo realizado, al menos, 28 dias despues de finalizar el tratamiento. Resultados: un total de 58 pacientes fueron incluidos consecutivamente, dos de ellos fueron retirados del estudio por vomitos al tercer y quinto dia, respectivamente. Diecisiete (29,3%) pacientes tenian historia previa de tratamiento de su infeccion por Helicobacter pylori. En la poblacion por intencion de tratar las tasas de erradicacion fueron del 97,6% (40/41) y del 82,4% (14/17) en los pacientes tratados con Pylera® como primera linea o como terapia de rescate, respectivamente. Veintiocho pacientes (48%) presentaron, al menos, un acontecimiento adverso, la mayoria (86%) leves. Conclusion: diez dias de tratamiento con BMTO es una estrategia eficaz y segura en pacientes con infeccion confirmada por Helicobacter pylori. EnglishObjective: To evaluate the efficacy and safety of a quadruple regimen (BMTO) of the “3-in-1 capsule” (containing bismuth subcitrate potassium, metronidazole and tetracycline) plus omeprazole in naive and previously treated patients diagnosed with Helicobacter pylori (H. pylori) infection in the clinical setting in Seville (Spain). Methods: This is a prospective study carried out on consecutive patients with a confirmed H. pylori infection and upper gastrointestinal symptoms. After providing their informed consent, the patients were treated for ten days with a 3-in-1 capsule containing bismuth subcitrate potassium (140 mg), metronidazole (125 mg) and tetracycline (125 mg: Pylera®), three capsules four times daily, plus omeprazole (20 or 40 mg) twice daily. Eradication of infection was determined by a negative urea breath test at least 28 days after the end of treatment. Results: A total of 58 consecutive patients were enrolled into this study, two of whom withdrew early due to vomiting on days three and five, respectively. In this cohort, 17 patients (29.3%) had a prior history of medication to treat H. pylori. In the intent-to-treat population, eradication was achieved in 97.6% (40/41) and 82.4% (14/17) of cases in patients treated with BMTO as a first-line or rescue therapy, respectively. At least one adverse event was reported by 28 (48%) patients, mostly mild effects (86%). Conclusion: A ten day treatment with BMTO is an effective and safe strategy to combat confirmed H. pylori infection in patients

Pyoderma gangrenosum is a serious cutaneous complication seen in approximately 1 % of patients with inflammatory bowel disease (IBD). Oral corticosteroids are the mainstay treatment, although the evidence supporting their use is weak. The purpose of this study was to investigate the characteristics of pyoderma gangrenosum associated with Crohn’s disease or ulcerative colitis and which treatments are prescribed in Spanish clinical practice. In this retrospective, observational study, the medical records from all patients with IBD and a diagnosis of pyoderma gangrenosum attended by the gastroenterology departments of 12 Spanish hospitals were reviewed. Data on patient demographics and characteristics, underlying IBD and treatment, and pyoderma gangrenosum characteristics, treatment, and outcome were collected and analyzed. The data from 67 patients were analyzed (41 [61.2 %] women, 41 [61.2 %] with Crohn’s disease, 25 [37.3 %] with ulcerative colitis, and 1 [1.5 %] with indeterminate disease). The underlying disease was in remission in approximately one-third of patients at the time of presentation of pyoderma gangrenosum. Healing was achieved in all patients (in 3 without any systemic therapy). Oral corticosteroids were taken by 51 patients (76.1 %), almost always as first-line treatment, although definitive healing was attained in 19 (28.4 %). Biologic agents such as infliximab and adalimumab were taken by 31 patients (46.3 %) at some point (first-line in 6 patients [9.0 %]), with definitive healing in 29 patients (93.5 %). Oral corticosteroid therapy remains the most common treatment for pyoderma gangrenosum associated with inflammatory bowel disease. Biologic therapies such as infliximab and adalimumab should also be considered.

BACKGROUND AND AIMS: This study sought to determine the prevalence of malnutrition in patients with inflammatory bowel disease, to analyse the dietary beliefs and behaviours of these patients, to study their body composition, to evaluate their muscular strength and to identify the factors associated with malnutrition in these patients. METHODS: This was a prospective, multicentre study. Crohn's disease and ulcerative colitis patients from 30 Spanish centres, from the outpatient clinics, were included. A questionnaire of 11 items was applied to obtain data from patients' dietary behaviour and beliefs. Patients who accepted were evaluated to assess their nutritional status using Subjective Global Assessment and body mass index. Body composition was evaluated through bioelectrical impedance. RESULTS: A total of 1271 patients were included [51% women, median age 45 years, 60% Crohn's disease]. Of these, 333 patients underwent the nutritional evaluation. A total of 77% of patients declared that they avoided some foods to prevent disease relapse. Eighty-six per cent of patients avoided some foods when they had disease activity because of fear of worsening the flare. Sixty-seven per cent of patients modified their dietary habits after disease diagnosis. The prevalence of malnutrition was 16% [95% confidence interval = 12-20%]. In the multivariate analysis, history of abdominal surgery, active disease and avoidance of some foods during flares were associated with higher risk of malnutrition. CONCLUSIONS: The prevalence of malnutrition in inflammatory bowel disease patients was high. We identified some predictive factors of malnutrition. Most of the patients had self-imposed food restrictions, based on their beliefs.

Background: The incidence of inflammatory bowel disease is increasing in Europe and in Spain. However, there is no recent data from Southern Spain. Objectives: To determine the evolution of the hospital incidence of inflammatory bowel disease in Southern Spain. Material and methods: A retrospective study was performed in two hospitals in Southern Spain. Data was collected from inflammatory bowel disease patients, divided into two periods (1995-2000 and 2001-2014) and compared. The reference population from both areas was 1,011,555 inhabitants. Results: A total of 430 patients were registered during the first period (1995-2000); 50% (215) had Crohn’s disease that resulted in a cumulative incidence rate of 7.08 cases/100,000 inhabitants per year. The overall inflammatory bowel disease incidence was 3.54 cases/100,000 inhabitants per year. During the second period (2001-2014), 2,089 patients were collected; 51.7% had ulcerative colitis (1,081). The rate of cumulative incidence of inflammatory bowel disease was 14.7 cases/100,000 inhabitants per year (7.6 cases of ulcerative colitis/100,000 inhabitants/year and 7.1 cases of Crohn´s disease/100,000 inhabitants/year). Conclusions: The incidence of inflammatory bowel disease in Southern Spain has doubled in the last decade and is similar to that of the rest of the country and Europe.

Background: in most cases, inflammatory bowel disease (IBD) debuts at reproductive age. The data available in the literature show infliximab (IFX) to be a safe drug during pregnancy but there is very little evidence about the activity of the disease following drug withdrawal during pregnancy. Aims: determine the drug´s safety in pregnant women in our setting and assess its effect on the foetus, drawing on the experience of several hospitals. Secondly, observe the effect of treatment withdrawal on disease activity during pregnancy. Material and methods: a retrospective study was conducted of women with IBD who had received IFX treatment during pregnancy in five hospitals in Spain. Disease activity was assessed using Crohn´s Disease Activity Index, while UC was assessed using the Truelove-Witts Index in each trimester of pregnancy. Gestational age, weight and diseases in the foetus were determined at birth. Results: the study included 12 women with a mean age of 29 years; 4 had ulcerative colitis and 8 Crohn´s disease, with mean disease duration of 7 years. All but one, who was diagnosed during pregnancy, was receiving IFX treatment at conception. Six patients received uninterrupted treatment throughout the pregnancy, 2 requested voluntary interruption and in 3 cases treatment was interrupted in the third trimester as a precaution. They received a mean IFX dose of 400 mg every 8 weeks. Of the 6 patients who received continuous treatment, in 50% disease was held in remission. The 6 remaining patients suspended treatment for different reasons, presenting disease recurrence in all but one case (83.3%). Eight deliveries were vaginal and 4 by caesarean section. Newborns presented no congenital anomalies, intrauterine growth retardation or low birth weight and there was only one premature delivery. Conclusions: although cases included in the stduy are not significant, in our experience, IFX during pregnancy is a safe treatment for the mother and the foetus. In fact, in our study and in some cases, its withdrawal may lead to a worsening of the disease. However, further control studies are required with larger samples to obtain more representative findings.Introducción: la enfermedad inflamatoria intestinal (EII) es un trastorno crónico que debuta en la mayoría de los casos durante la edad reproductiva. Existen pocos datos sobre la seguridad durante el embarazo de los tratamientos disponibles, entre ellos los denominados biológicos, y estos están basados en resultados de casos esporádicos. Objetivos: determinar la seguridad del tratamiento con infliximab (IFX) durante el embarazo en mujeres con EII. Un segundo objetivo es observar el efecto que sobre la actividad de la enfermedad tiene el abandono del tratamiento. Material y métodos: se trata de un estudio retrospectivo en el que se incluyeron mujeres con EII embarazadas y que estaban en tratamiento con IFX durante el embarazo. Se incluyeron en el estudio a 5 hospitales de España. La actividad de la enfermedad se midió según el CDAI en la enfermedad de Crohn (EC) y la de la colitis ulcerosa (CU) según el índice de Truelove-Witts en cada trimestre del embarazo. La edad gestacional, el peso y las enfermedades del feto se determinaron al nacimiento. Resultados: se incluyeron doce mujeres con una edad media de 29 años, 4 diagnosticadas de CU y 8 de EC, con una duración media de la enfermedad de 7 años. Todas salvo una, que se diagnosticó durante el embarazo estaban siendo tratadas con IFX en el momento de la concepción. Seis pacientes recibieron el tratamiento de forma ininterrumpida durante todo el embarazo, 2 suspendieron el tratamiento de forma voluntaria y a tres se les suspendió el tratamiento en el tercer trimestre. Recibieron una dosis media de IFX de 400 mg cada 8 semanas. De las 6 pacientes que recibieron tratamiento continuo, el 50% se mantuvo en remisión. De las pacientes que abandonaron el tratamiento, un 83,3% (todas menos una) presentaron un brote de su enfermedad. Ocho partos fueron por vía vaginal y cuatro por cesárea. Ningún recién nacido presentó malformaciones congénitas, retraso del crecimiento intrauterino ni bajo peso y sólo hubo un parto prematuro. Conclusiones: aunque los casos incluidos en el estudio son pocos, según nuestra experiencia IFX es un fármaco seguro durante el embarazo para la madre y el feto. De hecho, parece que su suspensión puede conducir a un empeoramiento de la enfermedad. No obstante, son necesarios más estudios y con más pacientes para obtener resultados con mayor evidencia científica.

New e-health technologies can improve patient-physician communication and contribute to optimal patient care. We compared the diagnostic performance of the Simple Clinical Colitis Activity Index (SCCAI) self-administered by patients with ulcerative colitis (UC) at home (through a website) with the in-clinic gastroenterologist-assessed SCCAI.Patients were followed-up over 6 months. At months 3 and 6, patients completed the SCCAI online at home; within 48 h, gastroenterologists (blinded to patients' scores) completed the in-clinic SCCAI (reference). SCCAI scores were dichotomized to remission or active disease, and SCCAI changes in disease activity from month 3 to 6 were classed as worsening, stability, or improvement.A total of 199 patients (median age: 38 years; 56% female) contributed with 340 pairs of questionnaires. Correlation of SCCAI scores by patients and physicians was good (Spearman's ρ=0.79), with 85% agreement for remission or activity (95% CI: 80.8-88.6, κ=0.66). The negative predictive value for active disease was 94.5% (91.4-96.6); the positive predictive value was 68.0% (58.8-69.2). Agreement between patient and physician was higher in the 168 month 6 pairs than in the 172 month 3 pairs of questionnaires (89.3% (83.6-93.1) vs. 80.8% (74.2-86.0), P=0.027).In patients with UC, SCCAI self-administration via an online tool resulted in a high percentage of agreement with evaluation by gastroenterologists, with a remarkably high negative predictive value for disease activity. Remote monitoring of UC patients is possible and might reduce hospital visits.

Objective Colon capsule endoscopy (CCE) is a new endoscopic technique that is minimally invasive and allows evaluation of the colon mucosa without pain, sedation, and gas insufflation. To date, few studies have investigated the use of CCE in patients with ulcerative colitis (UC). This study compares the ability of CCE and a conventional colonoscopy to assess mucosal disease activity and the extent of inflammatory mucosa in patients with UC. Methods Forty-two patients (27 men, mean age 48.5 years) with known UC and indication for colonoscopy were enrolled in this single-blind, prospective study. All patients underwent CCE, followed by a colonoscopy. The activity and extent of the disease was assessed using Mayo scores and Montreal scores, respectively. Results There was a good correlation between CCE and colonoscopy in disease severity (κ=0.79; 95% confidence interval: 0.62-0.96) and extent of inflammation (κ=0.71; 95% confidence interval: 0.52-0.90) observed. The ability of CCE to assess a broad segment of distal ileum led to a change in the diagnosis of UC to ileocolonic Crohn's disease in three patients. Bowel preparation was considered adequate in 80% of the patients and no serious adverse events related to the CCE procedure or bowel preparation were reported. Conclusion CCE is a safe and useful method for the evaluation of patients with UC. The ability of CCE to assess distal ileum provides an advantage to colonoscopy as CCE can identify patients who have been incorrectly diagnosed with UC, resulting in a change in their diagnosis to Crohn's disease.

CD is a chronic inflammatory disorder associated to mucosal and transmural inflammation of the bowel wall. It is well known that CD can affect the entire gastrointestinal. Therefore, ileocolonoscopy and biopsies of the terminal ileum as well as of each colonic segment to look for microscopic evidence of CD are the first-line procedures to establish the diagnosis. However, it has been observed that up to 30% of the patients have only small bowel involvement. Evaluation of the small bowel has been made with radiological procedures, barium radiography, and abdominal computed tomography or by ileocolonoscopy or enteroscopy, but they have many recognized limitations. CE is undoubtedly a very useful diagnostic tool proposed to observe small-bowel lesions undetectable by conventional endoscopy or radiologic studies. We review different studies that have been published reporting the use of CE in suspected and evaluation of the extension or the recurrence in CD and also its use in pediatric population and its complications.

Corrigendum: Diagnostic Performance of the Simple Clinical Colitis Activity Index Self-Administered Online at Home by Patients With Ulcerative Colitis: CRONICA-UC Study

Background: adalimumab, a human anti-TNF, is an effective induction and maintenance therapy for patients with moderate to severe Crohn s disease. It seems to be effective in patients with resistance to infliximab, too, though the experience is more limited. Aim: to evaluate the efficacy of adalimumab, in patients with Crohn s disease (CD) and failure to previous treatment with infliximab. Methods: twenty-five patients with CD and failure to previous treatment with infliximab were enrolled; they were treated with 160/80 (24 patients) and 80/40 (1 patient) induction doses. We analyze clinical response to treatment with adalimumab by the Crohn’s disease Activity Index (CDAI) and plasma concentration of C-reactive protein (CRP), steroid sparing and complete fistula closure at week 48. Results: eighteen out of twenty-five patients (72%) achieved clinical remission (CDAI score < 150) at week 24 and 15/25 (60%) patients at week 48. There was a statistically significant difference (p < 0.01) in CRP serum levels from 21 to 8 mg/dl at week 48. Nine out of fifteen patients (60%) treated with corticosteroids were able to discontinue steroids. Three out of eleven patients (27%) with fistulizing Crohn s disease had complete fistula closure after the treatment. Seventy two percent of the patients (18/25) needed to increase adalimumab to weekly dose, in order to maintain clinical response. Five out of twenty-five patients (20%) had adverse events; two of them (8%) with serious adverse events (tuberculous meningitis and abdominal abscess) that forced the withdrawal of treatment. Conclusions: according to these data, adalimumab provides a clinical and analytical improvement in patients with CD and failure to previous therapy with infliximab.

Background: in most cases, inflammatory bowel disease (IBD) debuts at reproductive age. The data available in the literature show infliximab (IFX) to be a safe drug during pregnancy but there is very little evidence about the activity of the disease following drug withdrawal during pregnancy. Aims: determine the drug’s safety in pregnant women in our setting and assess its effect on the foetus, drawing on the experience of several hospitals. Secondly, observe the effect of treatment withdrawal on disease activity during pregnancy. Material and methods: a retrospective study was conducted of women with IBD who had received IFX treatment during pregnancy in five hospitals in Spain. Disease activity was assessed using Crohn’s Disease Activity Index, while UC was assessed using the Truelove-Witts Index in each trimester of pregnancy. Gestational age, weight and diseases in the foetus were determined at birth. Results: the study included 12 women with a mean age of 29 years; 4 had ulcerative colitis and 8 Crohn’s disease, with mean disease duration of 7 years. All but one, who was diagnosed during pregnancy, was receiving IFX treatment at conception. Six patients received uninterrupted treatment throughout the pregnancy, 2 requested voluntary interruption and in 3 cases treatment was interrupted in the third trimester as a precaution. They received a mean IFX dose of 400 mg every 8 weeks. Of the 6 patients who received continuous treatment, in 50% disease was held in remission. The 6 remaining patients suspended treatment for different reasons, presenting disease recurrence in all but one case (83.3%). Eight deliveries were vaginal and 4 by caesarean section. Newborns presented no congenital anomalies, intrauterine growth retardation or low birth weight and there was only one premature delivery. Conclusions: although cases included in the stduy are not significant, in our experience, IFX during pregnancy is a safe treatment for the mother and the foetus. In fact, in our study and in some cases, its withdrawal may lead to a worsening of the disease. How ever, further control studies are required with larger samples to obtain more representative findings.

Background and Aims The aims of this study were to determine the prevalence of fatigue in patients with inflammatory bowel disease [IBD], to identify the factors associated with fatigue and its severity, to assess the impact of fatigue on quality of life [QoL], and to evaluate the relationship between fatigue and sleep disorders. Methods This was a prospective multicentre study conducted at 22 Spanish centres. Consecutive patients followed at IBD Units were included. Fatigue was evaluated with the Fatigue Severity Scale [FSS] and the Fatigue Impact Scale [FIS]. Quality of life and sleep quality were assessed using the IBD Questionnaire-Short Form [IBDQ-9] and the Pittsburgh Sleep Quality Index [PSQI], respectively. Results A total of 544 consecutive adult IBD patients were included [50% women, mean age 44 years, 61% Crohn’s disease]. The prevalence of fatigue was 41% (95% confidence interval [CI] = 37–45%). The variables associated with an increased risk of fatigue were: anxiety [OR = 2.5, 95% CI = 1.6–3.7], depression [OR = 2.4, 95% CI = 1.4–3.8], presence of extraintestinal manifestations [EIMs] [OR = 1.7, 95% CI = 1.1–2.6], and treatment with systemic steroids [OR = 2.8, 95% CI = 1.4–5.7]. The presence of EIMs [regression coefficient, RC = 8.2, 95% CI = 2.3–14.2], anxiety [RC = 25.8, 95% CI = 20.0–31.5], depression [RC = 30.6, 95% CI = 24.3–37.0], and sleep disturbances [RC = 15.0, 95% CI = 9.3–20.8] were associated with severity of fatigue. Patients with fatigue had a significantly decreased IBDQ-9 score [p < 0.001]. Conclusions The prevalence of fatigue in IBD patients is remarkably high and has a negative impact on QoL. Therapy with systemic steroids is associated with an increased risk of fatigue. The severity of fatigue is associated with anxiety, depression, sleep disorders, and the presence of EIMs. Fatigue was not associated with anaemia, disease activity or anti-TNF therapy.