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Hepatitis C virus (HCV) one-step diagnosis improves recovery in patients with active infection. However, patients with previous anti-HCV+ may be excluded. We aimed to identify and retrieve non-referred or lost-to-follow-up HCV-infected patients. All anti-HCV+ patients seen in our hospital between 2013 and 2018 were included. In the first phase, we identified anti-HCV+ patients who were not referred to the Gastroenterology Unit (GU) or lost-to-follow-up. In the second phase, recovered patients were invited for a one-step visit for liver evaluation. A total of 1330 anti-HCV+ patients were included: 21.7% had not been referred to GU, and 23.1% were lost-to-follow-up. In the second phase, 49.6% of patients were contacted, and 92.8% attended a medical consultation: 62.7% had active infection, 92.2% were treated, and 86.5% achieved SVR (ITT). We concluded that screening microbiological data and referring unidentified patients with active HCV infection directly to specialists is an effective tool in achieving HCV microelimination.

[Purpose] Stenting as a bridge to surgery (SBTS) can transform an emergency surgery (ES) into an elective surgery in patients with symptomatic left-sided malignant colonic obstruction. Concerns have been raised regarding short-term morbidity and long-term oncologic outcomes, with contrasting results reported in the literature. Our main aim is to evaluate not only long-term oncologic outcomes but also short-term postoperative outcomes of stented patients who underwent elective surgery compared to those who had ES., [Methods] From January 2006 to May 2012, we retrospectively identified patients with confirmed left-sided colorectal cancer obstruction. This was done in two centers of reference of colorectal diseases in southern Spain with patients who were treated with curative intent either with ES or SBTS. The short- and long-term results were compared between both groups., [Results] There were 71 patients in the stenting group and 66 in the emergency surgery group, with similar demographic data. Initial stoma creation rates were lower in the SBTS group (16.9% vs. 54.5%, p, [Conclusions] The use of SBTS reduces ostomy rates in patients with obstructive colon malignancies. Long-term survival results are similar. Patients in the SBTS group with stage III AJCC status showed a higher 5-year recurrence-free survival rate than those in the ES group.

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.

[Introduction] patients with advanced chronic liver disease (CLD) may be at an increased risk of a severe course due to cirrhosis-associated immune dysfunction. The aim of this study was to determine the prevalence of CLD in COVID-19 patients and to analyze the course of the infection, compared with patients with non-liver disease., [Materials and methods] this was a retrospective single center study of all patients with a positive SARS-CoV-2 polymerase chain reaction (PCR) test from March 23rd to April 30th, 2020. Clinical and biochemical data of patients with and without CLD and COVID-19 were collected from the medical records., [Result] four hundred and forty-seven patients with a SARS-CoV-2 positive PCR were included, 6.3 % had CLD; 69.7 % of patients with CLD were male, with a median age of 65.5 years and active alcohol consumption and smoking; 75 % had non-advanced liver fibrosis and most had non-alcoholic fatty liver disease (NAFLD). The hospital admission rate (92.9 % vs 47.7 %, p < 0.001), concomitant comorbidities (diabetes 38.5 vs 16.5 %, p = 0.011; obesity 30.8 vs 8.5 %, p = 0.033; cancer 23.1 vs 5 %, p = 0.027; and chronic obstructive pulmonary disease (COPD) 19.2 vs 9 %, p = 0.009) and concomitant antibiotics treatment (19.3 vs 5 %, p = 0.018) were higher in patients with CLD than in those without CLD. In-patient hospital mortality rates were similar in both groups (30.8 vs 19.6 %, p = 0.289). The presence of CLD was not associated with mortality (OR = 1.06; 95 % CI = 0.35-3.18; p = 0.924). However, patients with CLD and COVID-19 who were male, obese or under concomitant antibiotic treatment had the highest risk of mortality according to the univariate analysis., [Conclusion] patients with CLD had a higher risk of hospital admission, with worse outcomes during the COVID-19 infection associated to other concomitant comorbidities and a suspicion of bacterial co-infection., Financial support statement: this study was partly supported by Plan Nacional de I+D+i 2013-2016 and Instituto de Salud Carlos III, Subdirección General de Redes y Centros de Investigación Cooperativa, Spanish Ministry of Science and Innovation, Spanish Network for Research in Infectious Diseases (REIPI RD16/0016/0001), co-financed by the European Development Regional Fund “A way to achieve Europe”, Operative Program Intelligence Growth 2014-2020.

Primary follicular lymphomas (FL) of the gastrointestinal (GI) tract are very rare and constitute < 4 % of all non-Hodgkin's lymphomas at this location. We report our experience with primary FL of the GI tract.

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.

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.

several barriers remain in the hepatitis C care cascade, which need to be removed in order to eliminate chronic hepatitis C. These barriers include deficiencies in screening and confirmatory diagnosis as well as difficulties in accessing treatment.to identify factors associated with the non-referral of patients with positive hepatitis C virus (HCV) antibodies and to identify factors associated with loss of follow-up or non-attendance of these patients to specialist consultation after referral.observational and retrospective single-center-study, including all positive HCV serology tests performed between January 2013 and May 2018, in the Virgen Macarena health area (Seville, Spain) before implementing the one-step diagnosis. Non-referred patients and patients who were lost to follow-up after being referred were identified.a total of 54 (77.4 %) patients diagnosed in Primary Care (PC) and 54 (22.2 %) from hospital specialists were not referred (p0.001). Predictors for non-referral were: stay in prison/institutionalization (p = 0.04), suffering chronic obstructive pulmonary disease (COPD) (p = 0.07), a normal AST value (p = 0.034) or test requested by Primary Care physician (PCP) (p = 0.004). Patients referred from PC were more likely to be lost to follow-up than those referred from hospital specialists (p0.001). Predictors of follow-up loss included: opioid replacement therapy (p = 0.034), absence of high blood pressure (p = 0.039) and test requested by PCP (p = 0.049).a high percentage of patients with positive HCV serology were not referred or were lost to follow-up, mainly those belonging to high risk social groups or those with associated comorbidities. Patients with average values of transaminases or those diagnosed in PC were also less frequently referred.

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/Objective: Osteoporosis and osteoporotic fracture risk are extraintestinal manifestations of the inflammatory bowel disease, whose etiopathogenic mechanisms have not been determined yet. Anti-tumor necrosis factor (TNF)-α are used in treatment of inflammatory bowel disease (IBD), but it is unknown if they play a role in osteoporotic fracture prevention. The objective of this study was to know if anti-TNF decreases fracture risk or modifies bone mineral density. To determine the possible risk factors associated with fractures, and assess the incidence of vertebral fractures in IBD patients. Methods: Longitudinal prospective cohort study (7 yr of follow-up); which included 71 IBD patients, 23 received anti-TNF-α; the remaining 48 received conventional treatment, constituted the control group. Patients participated in a questionnaire which gathered risk factors associated with the development of osteoporosis and fractures. Radiographs of the dorsolumbar-spine were performed and also a bone density measurement. Their biochemical and bone remodeling parameters were determined. Results: Although patients who did not receive anti-TNF-α, suffered more fractures but biologic therapy did not reduce the risk of new vertebral fractures. The increase of bone mass was significantly higher the group treated with anti-TNF-α. The increase in the lumbar spine was of 8% and in the femoral neck was of 6.7%. The only determinant factor for the incidence of vertebral fractures was a history of previous fractures (odds ratio of 12.8; confidence interval 95% 2.37–69.9; p = 0.003). The incidence of vertebral fractures in IBD patients was considerably high: 26.7/700 patient-yr. Conclusions: Anti-TNF-α, although increased bone mass in these patients, did not reduce the risk of new vertebral fractures. In this study, patients with IBD have a considerably high incidence of fractures. Only the existence of previous vertebral fractures was a predictive factor for consistent fractures.

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License.-- et al., [Objectives]: Treatment for celiac disease (CD) is a lifelong strict gluten-free diet (GFD). Patients should be followed-up with dietary interviews and serology as CD markers to ensure adherence to the diet. However, none of these methods offer an accurate measure of dietary compliance. Our aim was to evaluate the measurement of gluten immunogenic peptides (GIP) in stools as a marker of GFD adherence in CD patients and compare it with traditional methods of GFD monitoring. [Methods]: We performed a prospective, nonrandomized, multicenter study including 188 CD patients on GFD and 84 healthy controls. Subjects were given a dietary questionnaire and fecal GIP quantified by enzyme-linked immunosorbent assay (ELISA). Serological anti-tissue transglutaminase (anti-tTG) IgA and anti-deamidated gliadin peptide (anti-DGP) IgA antibodies were measured simultaneously. [Results]: Of the 188 celiac patients, 56 (29.8%) had detectable GIP levels in stools. There was significant association between age and GIP in stools that revealed increasing dietary transgressions with advancing age (39.2% in subjects ≥13 years old) and with gender in certain age groups (60% in men ≥13 years old). No association was found between fecal GIP and dietary questionnaire or anti-tTG antibodies. However, association was detected between GIP and anti-DGP antibodies, although 46 of the 53 GIP stool-positive patients were negative for anti-DGP. [Conclusions]: Detection of gluten peptides in stools reveals limitations of traditional methods for monitoring GFD in celiac patients. The GIP ELISA enables direct and quantitative assessment of gluten exposure early after ingestion and could aid in the diagnosis and clinical management of nonresponsive CD and refractory CD. Trial registration number NCT02711397., This work was supported by grants from Ministerio de Ciencia e Innovación and FEDER funds (DELIAC, IPT-2011-0952-900000), and Corporación Tecnológica de Andalucía (SINGLUCHECK, 1737/0118).

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

The slow progression of chronic hepatitis C (CHC) infection requires long observation periods to detect clinical changes. We compare the incidence of clinical events, hepatocellular carcinoma (HCC), overall mortality, liver-related mortality, and fibrosis progression between patients with a sustained virological response (SVR) and nonresponders (NR) after a 13-year follow-up period.One hundred and eighty-two CHC patients, who received interferon and ribavirin treatment between 1996 and 2000, were included. Clinical events were evaluated during follow-up. At the end of follow-up, transient elastography was used to assess fibrosis progression.Of the 182 patients, 46.7% (n=85) achieved an SVR. Twenty-seven patients developed hepatic decompensation (one SVR) and 15 developed HCC (three SVR). Twenty-nine patients died (eight SVR). Twelve of the 29 deaths were liver related (two SVR). Independent factors associated with hepatic decompensation were NR to treatment [hazard ratio (HR)=23.35; 95% confidence interval (CI): 2.90-189.25; P=0.003], advanced fibrosis at baseline (HR=9.11; 95% CI: 4.13-20.09), and treatment delay after diagnosis (HR=1.02; 95% CI: 1.00-1.03; P=0.012). Only the latter two were associated with HCC development and liver-related mortality. An assessment of liver fibrosis was performed on 125 patients (66 SVR). Fibrosis values were significantly lower in SVR patients, showing less progression to advanced stages of fibrosis [SVR: 6.6 (2.8); 95% CI: 5.8-7.3] than NR [NR: 14.0 (11.1); 95% CI: 11.1-16.9; P0.001].In patients with CHC, SVR is durable and reduces clinical events. The risk of HCC development is lower, but not eliminated. Sustained responders showed fibrosis stabilization or improved fibrosis values.

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: 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.

CT-P13 is a biosimilar of Remicade®, an agent approved in some countries for use in inflammatory bowel disease (IBD). Controlled clinical trials have demonstrated the efficacy and safety of CT-P13 in rheumatic diseases, but not in IBD. To assess the effectiveness and safety of CT-P13 in IBD patients in real clinical practice. This is a prospective observational study in patients with moderate to severe Crohn’s disease or ulcerative colitis treated with CT-P13. The study was performed in one single center. Patients included were naive or switched to anti-TNF treatment from the reference infliximab (Remicade®) to CT-P13. Efficacy and safety were assessed in naive and switched patients who were in remission at the time of the switch at months 3 and 6 of therapy. 87.5 and 83.9% of switched CD patients who were in remission at the time of the switch continued in remission, and 66.7 and 50% of naive CD patients reached remission, at months 3 and 6. In UC switched cases, 92 and 91.3% of patients in remission at the time of the switch continued in remission, at 3 and 6 months. In naive UC patients, the remission rates were 44.4 and 66.7%, at months 3 and 6. Adverse events occurred in 7.5% of patients during 6 months of study. CT-P13 was efficacious and well tolerated in patients with CD or UC.

Background and study aims: Colon capsules display images from the moment they are ingested, making the study of other extracolonic areas possible. The aim of this study was to analyze the significance of these extracolonic findings. Patients and methods: In this single-center, prospective study, 165 patients underwent colon capsule endoscopy (CCE) between September 2009 and October 2012 to rule out colonic pathology. Images were recorded, without interruptions, from the moment the capsule was ingested until its battery ran out. The study was deemed complete when the capsule had traveled from the esophagus to excretion or until the hemorrhoidal plexus was observed. Results: CCE was used for colorectal cancer (CRC) screening (81.2 %), to investigate for chronic diarrhea (9.7 %) and chronic iron deficiency anemia (6.1 %), and for patients with incomplete colonoscopy (3.0 %). The capsule returned findings in the esophagus in 52.1 % of patients, in the stomach in 45.5 % of patients, and in the small bowel in 70.7 % of patients, with the findings being considered relevant in 4.9 %, 9.7 %, and 22.6 % of patients, respectively. The whole extent of the digestive tract was fully recorded in 86.1 % of patients and the Z line could be fully observed in 57.6 % of patients. There were no adverse events. Conclusions: CCE allows the recording of images from almost the whole extent of the digestive tract in most patients, enabling relevant pathologies to be identified in extracolonic areas, particularly the small bowel. Technical and procedural improvements are still necessary in order to achieve better observation of the stomach and esophagus.

Objective To assess the effect of a 2-week treatment with dexibuprofen, in comparison with ibuprofen and diclofenac, on pepsinogen plasma concentrations and gastrointestinal mucosa, as well as the correlation of these changes with gastrointestinal mucosal injury. Methods 60 patients with rheumatologic disease in chronic therapy with NSAID, were included. After a 7-day run-in period patients were randomly assigned to receive a 14-day treatment with dexibuprofen (Group A; Day 1 - 3 = 400 mg t.i.d; Day 4 - 14 = 400 mg b.i.d.), ibuprofen (Group B; Day 1 - 3 = 800 mg t.i.d; Day 4 -14 = 800 mg b.i.d.) or diclofenac (Group C; Day 1 - 3 = 50 mg t.i.d; Day 4 - 14 = 50 mg b.i.d.). Upper gastrointestinal endoscopy (Day 15), capsule-endoscopy (Day 16, 7 patients of each group) and determination of pepsinogen plasma concentrations were performed (basal and Day 15). A semiquantitative scale was designed for the assessment of the gastrointestinal mucosa. Results No differences in plasma pepsinogen were found between treatment groups or gastrointestinal injury grades or between basal and post-therapy determinations. Dexibuprofen showed gastroduodenal mucosal injury in fewer patients (42.1%) than was the case with ibuprofen (5%; p = 0.003) and diclofenac (30%; p = N.S.). Dexibuprofen administration was also associated with more patients having no intestinal mucosal damage (42.86% vs. 28.7% in the diclofenac group and 14.29% in the ibuprofen group; p = 0.0175). The rate of clinical adverse events was similar in Groups A, B and C (28%, 38% and 34%). Conclusions Dexibuprofen showed a lower rate of gastroduodenal and intestinal mucosal injury. This effect was not mediated by modifications of plasma pepsinogen levels.

Background and Study Aims: The aim of this study was to assess the safety and usefulness of capsule endoscopy (CE) in pediatric patients with a suspicion of Crohn's disease. Patients and Methods: CE was used in 12 patients (four girls, eight boys; age 12 - 16; weight range 43-87 kg). The indication was a clinical suspicion of Crohn's disease not confirmed with traditional methods. Gastroscopy, colonoscopy, and small-bowel follow-through examinations were carried out in all of the patients, without any diagnostic findings. Ileoscopy was possible in 50% of the patients, and the ileal mucosa and biopsies were normal in all cases. Results: The capsule was easily swallowed by all of the patients. They all excreted the capsule normally, and no complications were observed in any case. CE identified lesions suggestive of Crohn's disease in seven of the 12 (58.3%), and the majority of the lesions were in the ileum. Conclusions: CE is safe in pediatric patients over 12 years of age. The procedure appears to be a very useful diagnostic tool in children with Crohn's disease.

Introduction: Capsule endoscopy (CE) has become a first-line tool for small bowel (SB) examination. However, adverse events (AEs), such as CE retention or aspiration, may occur. The aims of this study were to evaluate incidence, clinical outcomes and therapeutic approaches of CE-related AEs in the largest series published to date. Methods: Data from 5428 procedures performed at 12 institutions between August 2001 and January 2012 were retrospectively analyzed. Baseline patient characteristics; procedure; type, localization and symptoms before/after AEs; previous patency tests performed; therapeutic management and patient´s outcome were recorded. Results: The overall incidence of CE-related AEs was 1.9%: 2.0% for SB, 0.9% for esophageal and 0.5% for colon CE. The incidence of capsule retention was significantly higher than capsule aspiration (1.87% vs. 0.003%; p < 0.05), in patients suffering from inflammatory bowel disease (IBD) than in obscure GI bleeding (OGIB) (3.3% vs. 1.5%; p < 0.05) and in patients with the combination of nausea/vomiting, abdominal pain and distension. The SB was the most frequent localization of retention (88.2%). The use of patency tests -except for Patency© capsule- before CE was not a good predictor for AEs. Most of the patients with AEs developed no or mild symptoms (97%) and were managed by non-surgical methods (64.4%). Conclusions: CE-related AEs are uncommon and difficult to predict by imagiological examinations. SB retention, that is usually asymptomatic, is the most frequent AE. In absence of symptoms, non-surgical management of CE-related AEs is recommended.

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.

Background: Prophylaxis with recombinant factor VIII (rFVIII) is considered the optimal treatment for severe or moderate haemophilia A (HA). Bleeding into joints determines a proportional chronic joint damage to its frequency and severity. Knowledge of the individual's pharmacokinetics (PK) using Bayesian analysis helps to individualize prophylaxis therapy with recombinant factor VIII (rFVIII) in severe or moderate haemophilia A (HA) and minimize the risk of bleeding, extracting only 2-3 samples. Methods Retrospective study in HA patients with rFVIII (Advate®) prophylaxis from January 2014 to May of 2016. Bayesian model (myPKFit®) was employed to perform an individual PK profile using the retrospective data of rFVIII levels. PK parameters analyzed were: clearance (Cl); steady state volume (Vss); plasma half-life (t1/2); and time to reach rFVIII levels Results Nineteen patients were analyzed, with a mean age of 32 years (SD: 11.3; range 11-46) and 86 PK monitoring (4.5 per patient). Two patients with p75 14.4 h), with average age of 19.5; 39.4 & 35.8 years, respectively. We detected significant differences between t1/2 and median values of joint state, but not in ABR and AJBR. The mean values of joint scores were: PS (5.5, 22.1; 17; p=0.028), GS (1, 25.9, 17.6; p= 0,008) and NMR (1.2, 2.6, 2.0; p=0.042) for short, normal and long t1/2, respectively. The limited number of patients only allows observe significant differences in patients with short t1/2, patients that also have significantly lower age (p=0.007). The younger age of these patients also justifies the lower joint damage observed. After excluding two patients Conclusion PK monitoring showed a low intraindividual variability in t1/2, but significant interindividual CV. Age could modify PK parameters, so it should be assessed in an integrated manner with other clinical variables. Bayesian estimate with MyPKFit® allows know the PK profile of each patient and could be a useful tool to individualize prophylaxis adjusting by the physical activity and the bleeding pattern. We are performing a personalized one-year program to identify and treat the specific causes of poor bleeding control in prophylaxis therapy, and these are our preliminary results. Acknowledgments: This study will be supported by Baxalta grant "H15-29403". Disclosures Cid: Baxalta Innovations GmbH, now part of Shire: Other: Investigator Clinical Studies.

Therapy of gastric varices (GV) is still challenging. Cyanoacrylate (CYA) injection is the recommended treatment for bleeding GV, but has a known adverse event rate, which could be reduced if EUS is used for guidance. Otherwise, EUS-guided coil application (ECA) may be an alternative.To compare CYA and ECA embolization of feeding GV for feasibility, safety, and applicability.Retrospective analysis of a prospectively maintained database.Multicenter study, tertiary referral centers.Thirty consecutive patients with localized GV who received either CYA injection or ECA were included with follow-up for 6 months after treatment.There were 11 patients in the coil group and 19 patients in the CYA group. The GV obliteration rate was 94.7% CYA versus 90.9% ECA; mean number of endoscopy sessions was 1.4 ± 0.1 (range 1-3). Adverse events occurred in 12 of 30 patients (40%) (CYA, 11/19 [57.9%]; ECA, 1/11 [9.1%]; P.01); only 3 were symptomatic, and an additional 9 (CYA group) had glue embolism on a CT scan but was asymptomatic. No further adverse events occurred during follow-up. Six patients (20%) died unrelated to the procedures or bleeding.Nonrandomized; EUS expertise necessary.EUS-guided therapy for GV by using CYA or ECA is effective in localized GV. ECA required fewer endoscopies and tended to have fewer adverse events compared with CYA injection. Larger comparative studies are needed to prove these data.

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.

OBJECTIVE To evaluate the type, frequency, and severity of macroscopic small bowel mucosal injury after chronic NSAID intake as assessed by capsule endoscopy (CE), as well as to correlate the severity of gastroduodenal and intestinal damage in these patients. MATERIAL AND METHODS A prospective, endoscopist-blind, controlled trial. Sixteen patients (14F/2M; age: 57.06 +/- 10.16 yrs) with osteoarthritis (OA) on chronic therapy with NSAIDs underwent CE and upper gastrointestinal endoscopy (UGE). Seventeen patients with OA (9F/2M; age: 57.47 +/- 9.82 yrs) who did not take NSAIDs were included as a control group. A scale ranging from 0 to 2 (0 = no lesions, 1-minor = red spots or petechiae, denuded areas and/or 1-5 mucosal breaks; 2-major = > 5 mucosal breaks and/or strictures, or hemorrhage) was designed to assess the severity of small bowel mucosal injuries. RESULTS CE found intestinal lesions in 75% (12/16) of patients in the study group and in 11.76% (2/17) of controls (p < 0.01). Seven out of 16 NSAID consumers (43.75%) and none in the control group (0%) had a major small bowel mucosal injury (p < 0.01). The percentages of patients with grade 1 and 2 gastroduodenopathy in the study group, as assessed by UGE, were 37.14 and 23.81%, respectively. There was no significant difference in the rate of major enteropathy between patients with none or minor gastroduodenal injury, and those with major gastroduodenopathy (43.75 vs. 40%; p = N.S.). CONCLUSIONS Chronic NSAID intake is associated with a high rate of small bowel mucosal injuries. Our data have failed to demonstrate a relationship between the severity of gastroduodenal and intestinal injury.

Background and objectives: the diagnostic yield of push enteroscopy (PE) varies widely from 13 to 78% of cases, according to the various series. The aim of this retrospective cohort study was to determine the endoscopic and histological yield of PE in our health area. Patients and methods: a total of 355 consecutive patients (190 males/165 females; mean age 45 years, range 15-89) underwent PE over a 6-year period, from 1997 to 2003. PE was performed under sedation and without overtube. Small-bowel mucosa biopsies were taken in 199 explorations (56%). Clinical indications for PE included: chronic diarrhea (35%), occult digestive bleeding (ODB) or iron-deficiency anemia (28%), suspected small-bowel malignancy (16%), chronic abdominal pain (28/355; 8%), follow-up of polyposis or malabsorption syndromes (7%), and abnormal radiographic findings (6%). Results: PE detected lesions in 122 cases (34%); in 6 cases (6%) lesions were within the reach of esophagogastroduodenoscopy. A normal macroscopic appearance of the small intestinal mucosa with an abnormal histological study was seen in 16 patients (6%). Major findings included: malabsorptive diseases (14%), nonspecific enteropathy (5%), angiodysplasia (3,5%), lymphangiectasia (3%); jejunal polyps (2%), Crohn's disease (2%), intestinal tumors (2%), extrinsic jejunal strictures (0.5%), and other (10/355; 3%). Abnormal radiographic findings (62%), chronic diarrhea (37%) and ODB (31%) were the indications with a higher diagnostic yield. No major complications were seen. Conclusions: according to our experience, PE is a safe and useful tool for the evaluation of small-bowel disease, especially in some indications (abnormal radiographic findings, chronic diarrhea, and ODB). Small-bowel biopsy increases PE's diagnostic yield in patients with chronic diarrhea.

Aim: to study the usefulness and safety of capsule endoscopy as a diagnostic tool in various small bowel disorders. Design: a retrospective analysis of a series of cases. Material and methods: between August 2001 and August 2002, 92 capsule endoscopy procedures were performed in 88 patients (53M/39F, age: 43.87 ± 16.78). Indications included: chronic diarrhea (n = 33); unknown abdominal pain (n = 29); occult gastrointestinal bleeding or iron-deficiency anemia (n = 13); abdominal discomfort in NSAID takers (n = 7); staging of gastrointestinal tumors (n = 4), and asymptomatic controls (n = 2). Previously performed gastroscopy, colonoscopy, and small-bowel follow-through were not conclusive in all patients. Results: most frequently relevant findings included: jejuno-ileal apthas and ulcerations (29 patients), vascular malformations (13 patients), and intestinal neoplasm (6 patients). The groups with a higher rate of findings related to this indication were occult gastrointestinal bleeding (76.92%) and chronic diarrhea (67.85%), with the lowest rate in the abdominal pain group (34.48%). Therapeutic strategy was directly changed in 36 of 88 patients (40.90%) because of capsule-endoscopic findings. The only observed complication was the failed excretion of one of the capsules because of an unknown ulcerated intestinal stricture. Conclusions: capsule endoscopy is a safe procedure which can study the entire small bowel, meaning a valuable tool for the management of patients with suggestive signs and symptoms of intestinal disorders.

Background and study aims The aim of the present study was to assess the value of capsule endoscopy in the diagnostic work-up of patients in whom there is a clinical suspicion of small bowel Crohn's disease that cannot be confirmed using traditional techniques. Patients and methods A total of 21 patients (14 men, seven women; mean age 43 +/- 8 years) with a clinical and biochemical suspicion of Crohn's disease were included in the study. Conventional imaging work-up, including upper and lower endoscopy, as well as a small-bowel follow-through, was carried out in all of the patients. Results Pathological findings were not observed in 12 of the 21 patients (57 %). In the other nine patients (43 %), lesions supporting the diagnosis of Crohn's disease were seen. The most frequent findings were located in the distal ileum and included aphthae, lineal and serpiginous ulcers, and fissures. Four patients had lesions in the jejunum. One patient showed erosions in the distal duodenum, jejunum, and ileum. No adverse effects of the technique were observed in any of the patients. Conclusions Capsule endoscopy is a valuable diagnostic tool in patients with suspected Crohn's disease that has not been confirmed using standard imaging techniques.