Real-world long-term effectiveness of ustekinumab in ulcerative colitis: results from a spanish open-label cohort.

OBJECTIVE: Ustekinumab was recently approved for the treatment of moderate-to-severe ulcerative colitis (UC). Although data from the UNIFI clinical trial are encouraging, real-world data assessing effectiveness and safety are scarce. The aim of this study was to assess the effectiveness, safety and pharmacokinetics of ustekinumab in a large cohort of refractory UC patients. METHODS: Multicenter observational study of UC patients who received ustekinumab for active disease. The Partial Mayo Score (PMS), endoscopic activity, C-reactive protein (CRP) and faecal calprotectin (FC) were recorded at baseline and at different time points. Demographic and clinical data, adverse events (AEs) and surgeries were documented. RESULTS: A total of 108 patients were analyzed from 4 referral Spanish hospitals. The clinical remission rates were 59%, 56.5%, 57% and 69% of patients at weeks 8, 16, 24 and 52, respectively. Normalization of FC was achieved in 39.6%, 41% and 51% at weeks 8, 24 and 52, respectively. CRP normalization was observed in 79%, 75% and 76.5% of patients at weeks 8, 24 and 52, respectively. Fewer previous anti-TNF agents and loss of response to anti-TNF were associated with clinical response and normalization of FC, respectively. AEs were observed in 5 patients, and 9 underwent colectomy. Ustekinumab persistence rates were 91%, 83% and 81% at 24, 48 and 96 weeks, respectively. CONCLUSIONS: Ustekinumab demonstrated, in the real-world setting, long-term effectiveness and a favorable safety profile in a cohort of refractory UC patients.

Gastrointestinal bleeding due to disseminated histoplasmosis in a patient under anti-TNF treatment.

A 62-year-old woman, originally from Peru, with rheumatoid arthritis under treatment with anti-tumor necrosis factor (anti-TNF) therapy, was admitted due to constitutional syndrome and suspicion of neoplasia. Computed tomography (CT) scan revealed involvement of three segments of the colon, ascites, and likely peritoneal implants. Ascitic fluid analysis showed elevated adenosine deaminase (ADA) levels and lymphocytosis. The patient presented with hematemesis and hematochezia with hemodynamic instability. Upper gastrointestinal endoscopy identified an extensive ulcer in the middle esophagus with a granular base, elevated and defined edges, indeterminate for malignancy and without blood residues. Colonoscopy also revealed multiple extensive ulcers in the transverse colon, with whitish bases and thickened and necrotic-looking surrounding mucosal edges. Histology showed granulomas and yeast-like fungal structures with methenamine silver staining in both tissues, consistent with disseminated histoplasmosis. Antifungal treatment was initiated with good clinical evolution.

Selective granulocyte-monocyte apheresis during induction with vedolizumab in moderate-severe ulcerative colitis: Experience in a tertiary hospital.

AIM: Granulocyte and monocyte apheresis (GMA) is a potential therapeutic option when combined with various drugs for treatment of ulcerative colitis (UC). In this study, we analyze the efficacy and safety of GMA combined with vedolizumab (VDZ) during induction in patients with moderate-severe UC and incomplete response to steroids. PATIENTS AND METHODS: Single-center retrospective review of patients receiving GMA+VDZ. Data on the disease and previous treatments were collected. Clinical response was classified as no response, response without remission, and remission. Available data on biochemical and endoscopic response were included. Adverse events (AEs) were recorded. RESULTS: The study population comprised 6 patients with UC who had received GMA+VDZ during induction after failure of an anti-TNF agent. The median number of GMA sessions was 5 (IQR 4-5; 3-10). All the patients received VDZ 300mg iv at 0, 2, and 6 weeks, and 5 (83%) received an additional dose at week 10. During maintenance, all the patients continued VDZ iv every 8 weeks. The median follow-up was 57.6 months (IQR: 39-74). Four of the 6 patients achieved clinical remission after GMA+VDZ and continued in deep remission until the end of follow-up. A median, non-significant decrease of 1378µg/g (IQR: 924-5778µg/g) was observed for calprotectin and 42.2mg/l (IQR: 15.3-113.5) for CRP vs. baseline. No patient underwent colectomy. No treatment-related AEs were observed. CONCLUSIONS: GMA+VDZ during induction can be effective and safe in selected patients with moderate-severe UC and partial response to steroids.

Evaluation of the transition from intravenous to subcutaneous vedolizumab in patients with inflammatory bowel disease. / Valoración de la transición de vedolizumab intravenoso a subcutáneo en pacientes con enfermedad inflamatoria intestinal.

AIMS: The aim of the study is to evaluate the clinical and biochemical response of inflammatory bowel disease patients treated with vedolizumab, 16 weeks after transitioning from intravenous (iv) to subcutaneous (sc). METHODS: An observational, prospective, single-center cohort study was performed. Patients with inflammatory bowel disease and maintenance treatment with vedolizumab, stable for at least 4 months, were offered to switch to sc formulation. At the same time of treatment administration a blood test was performed, with vedolizumab levels and fecal calprotectin. RESULTS: Forty-three patients were included, 12 of them (27.9%) chose to transition to sc formulation. All included patients remained in remission during follow-up. At week 16 no significant differences were found in terms of calprotectin levels in patients on iv treatment (mean 146.6±SD 45.9) vs. sc (159.26±53.9) (p=0.9). Vedolizumab serum levels at week 16 were higher in the sc group (22,364.3±5141.6) vs. iv (11,425.9±1514.2) (p=0.009). At week 16, 9 (75%) of the patients in the sc group were highly satisfied with the medication and 11 (91.7%) considered it easy to administer. Four patients (12.9%) in the iv group and 2 (16.6%) in the sc group presented mild adverse effects. The 2 cases (100%) of the sc group the adverse event was local inflammation at the injection site. CONCLUSION: In our experience, vedolizumab sc is a convenient alternative to iv administration. Vedolizumab serum levels in patients who transitioned to sc were higher than iv formulation.

Position statement of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis on sexuality and inflammatory bowel disease. / Documento de posicionamiento. Recomendaciones del Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa sobre sexualidad y enfermedad inflamatoria intestinal.

It is widely acknowledged that inflammatory bowel disease (IBD) is associated with a high prevalence of sexual dysfunction (SD). However, there is a notable paucity of specific literature in this field. This lack of information impacts various aspects, including the understanding and comprehensive care of SD in the context of IBD. Furthermore, patients themselves express a lack of necessary attention in this area within the treatment of their disease, thus creating an unmet need in terms of their well-being. The aim of this position statement by the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU) is to provide a review on the most relevant aspects and potential areas of improvement in the detection, assessment, and management of SD in patients with IBD and to integrate the approach to sexual health into our clinical practice. Recommendations are established based on available scientific evidence and expert opinion. The development of these recommendations by GETECCU has been carried out through a collaborative multidisciplinary approach involving gastroenterologists, gynecologists, urologists, surgeons, nurses, psychologists, sexologists, and, of course, patients with IBD.

Efficacy and safety of biological treatment for inflammatory bowel disease in elderly patients: Results from a GETECCU cohort.

INTRODUCTION: Biological therapies used for the treatment of inflammatory bowel disease (IBD) have shown to be effective and safe, although these results were obtained from studies involving mostly a young population, who are generally included in clinical trials. The aim of our study was to determine the efficacy and safety of the different biological treatments in the elderly population. METHODS: Multicenter study was carried out in the GETECCU group. Patients diagnosed with IBD and aged over 65 years at the time of initiating biological therapy (infliximab, adalimumab, golimumab, ustekinumab or vedolizumab) were retrospectively included. Among the patients included, clinical response was assessed after drug induction (12 weeks of treatment) and at 52 weeks. Patients' colonoscopy data in week 52 were assessment, where available. Regarding complications, development of oncological events during follow-up and infectious processes occurring during biological treatment were collected (excluding bowel infection by cytomegalovirus). RESULTS: A total of 1090 patients were included. After induction, at approximately 12-14 weeks of treatment, 419 patients (39.6%) were in clinical remission, 502 patients (47.4%) had responded without remission and 137 patients (12.9%) had no response. At 52 weeks of treatment 442 patients (57.1%) had achieved clinical remission, 249 patients had responded without remission (32.2%) and 53 patients had no response to the treatment (6.8%). Before 52 weeks, 129 patients (14.8%) had discontinued treatment due to inefficacy, this being significantly higher (p<0.0001) for Golimumab - 9 patients (37.5%) - compared to the other biological treatments analyzed. With respect to tumor development, an oncological event was observed in 74 patients (6.9%): 30 patients (8%) on infliximab, 23 (7.14%) on adalimumab, 3 (11.1%) on golimumab, 10 (6.4%) on ustekinumab, and 8 (3.8%) on vedolizumab. The incidence was significantly lower (p=0.04) for the vedolizumab group compared to other treatments. As regards infections, these occurred in 160 patients during treatment (14.9%), with no differences between the different biologicals used (p=0.61): 61 patients (19.4%) on infliximab, 39 (12.5%) on adalimumab, 5 (17.8%) on golimumab, 22 (14.1%) on ustekinumab, and 34 (16.5%) on vedolizumab. CONCLUSIONS: Biological drug therapies have response rates in elderly patients similar to those described in the general population, Golimumab was the drug that was discontinued most frequently due to inefficacy. In our experience, tumor development was more frequent in patients who used anti-TNF therapies compared to other targets, although its incidence was generally low and that this is in line with younger patients based on previous literature.

Randomized clinical trial evaluating three low-volume preparations for colonoscopy in outpatients with Inflammatory Bowel Disease: the EII-PREP trial.

BACKGROUND: Data regarding bowel preparation in patients with Inflammatory Bowel Disease (IBD) are scarce. AIM: To compare efficacy, safety, and tolerability of low-volume preparations in patients with IBD. METHODS: Single-center, randomized, prescriber, and colonoscopist-blinded clinical trial. IBD outpatients undergoing colonoscopy were randomized 1:1:1 to receive 1 Liter-polyethylene glycol-ascorbate (1L-PEG), 2 Liters-PEG, or sodium picosulfate (SP). The primary endpoint was percentage of quality cleansing assessed via the Boston Bowel Preparation Scale (BBPS ≥6, segments ≥2). Secondary endpoints were total high quality cleansing (BBPS 8 or 9), high-quality segmental BBPS (≥2), and patients' tolerability, symptoms, and satisfaction, assessed by questionnaires. Safety was monitored by adverse event reporting, laboratory evaluation at colonoscopy, and telephonic follow-up. RESULTS: Ninety-two patients were included (33 1L-PEG, 28 2L-PEG, and 31 SP). No significant differences between preparations were observed in quality or high-quality total BBPS or high-quality segmental BBPS. Complete intake of the solution was higher for SP (p = 0.006) and lower for 1L-PEG (p = 0.02) compared to 2L-PEG intake (p = 0.55). Clinically irrelevant hyponatremia was higher in the SP group (p < 0.0001). SP instructions were easier to understand from patient's point of view (p = 0.01). Willingness to retake was higher with SP (p < 0.0001) and less for 1L-PEG (p < 0.0001). No serious adverse events were reported. CONCLUSIONS: We observed no differences in efficacy between low-volume preparations in patients with IBD. Complete intake was higher for SP and lower for 1L-PEG. SP and 2L-PEG instructions were better understood and graded, and SP was more likely to be retaken. Willingness to retake was lower for 1L-PEG. No serious adverse events were reported. SUMMARY: No differences in terms of efficacy were regarded in this clinical trial comparing low-volume preparations for colonoscopy in patients with IBD: however, Sodium Pisoculfate is better tolerated and accepted from patient's point of view. No serious adverse events were reported.

Serologic response to COVID-19 vaccines in patients with inflammatory bowel disease: a prospective study.

BACKGROUND AND AIMS: response to the SARS-CoV-2 vaccine can be altered in patients with immune-mediated diseases, such as inflammatory bowel disease, and in patients under immunosuppressive treatment. The aims of this study were to evaluate the serologic response to the SARS-CoV-2 vaccine in patients with inflammatory bowel disease, to analyze the influence of immunosuppressive drugs on response, and to describe any adverse events in this population. METHODS: this was a prospective study that included adult patients with inflammatory bowel disease. Baseline characteristics, concomitant treatments and previous COVID-19 symptoms were collected. Patients underwent serological testing before the first and after the second vaccine dose. RESULTS: a total of 265 patients were consecutively included. Patients received one of the following vaccines: messenger RNA vaccines from Pfizer/BioNTech and Moderna; and adenovirus vaccines from AstraZeneca and Janssen. All adverse events were mild, and the most frequent was injection site pain in 141 (86 %) patients. The seroconversion rate according to the treatment that patients were receiving was: 100 % for those without treatment, 92.5 % for patients treated with mesalazine, 90.3 % for those receiving immunomodulators, 88.9 % for patients with biological monotherapy and 92.5 % for patients on combined treatment. The generation of antibodies according to the vaccine administered was: Pfizer 92.9 %, Moderna 93.3 %, AstraZeneca 98.4 %, and Janssen 12.5 %. CONCLUSION: the antibody response after vaccination against SARS-CoV-2 is high in patients with inflammatory bowel disease. However, patients treated with immunosuppressive or biologic drugs had a lower response. Adverse events were frequent, but not serious.

Influence of biologic therapy on cardiovascular risk factors in patients with inflammatory bowel disease. / Influencia del tratamiento biológico en los factores de riesgo cardiovascular de los pacientes con enfermedad inflamatoria intestinal.

INTRODUCTION: Chronic immune-mediated diseases, including inflammatory bowel disease (IBD), present an increased risk of developing early atherosclerosis and cardiovascular events (CVE) at early age. OBJECTIVE: To describe the baseline and 1-year cardiovascular profile of patients with IBD according to the biologic treatment received, taking into account the inflammatory activity. PATIENTS AND METHODS: It is a retrospective, observational study that included 374 patients. Cardiovascular risk factors (CVRF) and CVE were collected at the baseline visit and at one-year follow-up to describe the cardiovascular risk according to the biological treatment received, also assessing clinical and biological remission. RESULTS: A total of 374 patients were included: 146 (38.73%) were treated with Infliximab, 128 (33.95%) with adalimumab, 61 (16.18%) with ustekinumab and 42 (11.14%) with vedolizumab. The changes in blood glucose levels are [86.31mg/dL (84.57-88.06) vs. 89.25mg/dL (87.54-90.96), P=.001] for those treated with antiTNFα and [86.52mg/dL (83.48-89.55) vs. 89.44mg/dL (85.77-93.11), P=.11] in the other group. In the group treated with antiTNFα total cholesterol values at baseline visit are [169.40mg/dL (164.97-173.83) vs. 177.40mg/dL (172.75-182.05) at one year of treatment, P=<.001], those of HDL [50.22mg/dL (48.39-52.04) vs. 54.26mg/dL (52.46-56.07), P=<.001] and those of triglycerides [114.77mg/dL (106.36-123.18) vs. 121.83mg/dL (112.11-131.54), P=.054]. Regarding weight, an increase was observed, both in those patients treated with antiTNFα [71.39kg (69.53-73.25) vs. 72.87kg (71.05-74.70), P<.001], and in the group treated with ustekinumab and vedolizumab [67.59kg (64.10-71.08) vs. 69.43kg (65.65-73.04), P=.003]. Concerning CVE, no significant differences were observed neither according to the drug used (p=0.36), nor according to personal history of CVE (P=.23) nor according to inflammatory activity (P=.46). CONCLUSIONS: Our results on a real cohort of patients with IBD treated with biologic drugs show a better control of certain cardiovascular parameters such as CRP or HDL, but a worsening of others such as total cholesterol or triglycerides, regardless of the treatment. Therefore, it is possibly the disease control and not the therapeutic target used, the one that affect the cardiovascular risk of these patients.

Urgent endoscopy versus early endoscopy: Does urgent endoscopy play a role in acute non-variceal upper gastrointestinal bleeding? / Endoscopia urgente frente a endoscopia precoz: ¿tiene algún papel la endoscopia urgente en la hemorragia digestiva alta aguda no varicosa?

INTRODUCTION: The main clinical practice guidelines recommend endoscopy within 24hours after admission to the Emergency Department in patients with non-variceal upper gastrointestinal bleeding. However, it is a wide time frame and the role of urgent endoscopy (<6hours) is controversial. MATERIAL AND METHODS: Prospective observational study carried out at La Paz University Hospital, where all patients were selected, from January 1, 2015 to April 30, 2020, who attended the Emergency Room and underwent endoscopy for suspected upper gastrointestinal bleeding. Two groups of patients were established: urgent endoscopy (<6hours) and early endoscopy (6-24hours). The primary endpoint of the study was 30-day mortality. RESULTS: A total of 1096 were included, of whom 682 underwent urgent endoscopy. Mortality at 30days was 6% (5% vs 7.7%, P=.064) and rebleeding was 9.6%. There were no statistically significant differences in mortality, rebleeding, need for endoscopic treatment, surgery and/or embolization, but there were differences in the necessity for transfusion(57.5% vs 68.4%, P<.001) and the number of concentrates of transfused red blood cells (2.85±4.01 vs 3.51±4.09, P=.008). CONCLUSION: Urgent endoscopy, in patients with acute upper gastrointestinal bleeding, as well as the high-risk subgroup (GBS ≥12), was not associated with lower 30-day mortality than early endoscopy. However, urgent endoscopy in patients with high-risk endoscopic lesions (ForrestI-IIB), was a significant predictor of lower mortality. Therefore, more studies are required for the correct identification of patients who benefit from this medical approach (urgent endoscopy).

Current management of bowel failure due to Crohn's disease in Spain: Results of a GETECCU survey. / Manejo actual del fracaso intestinal por enfermedad de Crohn en nuestro medio: resultados de una encuesta GETECCU.

INTRODUCTION: Intestinal failure is a rare pathology which requires knowledge and highly specialized multidisciplinary management. Crohn's disease (CD) being one of the most frequent causes in adults. MATERIAL AND METHODS: Survey format study carried out within the GETECCU group, included closed format questions about the diagnosis, management and current knowledge of intestinal failure in CD. RESULTS: Forty-nine doctors participated, belonging to different Spanish centers (19 cities). It was considered that a patient suffered from intestinal failure, in 67.3% (33/49 surveyed) when there was a disorder malabsorptive associated regardless of the intestinal length resected, with surgeries resective ileal repeated (40.8%, 20/49), the most frequent cause. It highlights frequent ignorance about the pathology (24.5%) did not know if there were patients in their center and also 40% did not know the pharmacological treatment. A total of 228 patients were registered for follow-up due to intestinal failure of any aetiology, 89 patients (39.5%) were identified with CD. Regarding the therapeutic management of patients with CD and intestinal failure (72.5%) were receiving total parenteral nutrition (NTP) and 24 patients (27%) with teduglutide. Regarding the response to the drug: 37.5% had no response to teduglutide, 37.5% partial response (reduce NTP) and 25% good response (withdrawal of home NTP). In questions related to knowledge about intestinal failure, it was considered limited (53.1%) or very limited (12.2%) by the surveyed. CONCLUSION: It is necessary to carry out a combined management of intestinal failure and CD in the context of a multidisciplinary approach.

Intestinal disease secondary to tocilizumab.

It is presented a case study of intestinal affectation on a patient under tocilizumab treatment for giant cell arteritis.

Endoscopic imaging of pneumatosis intestinalis.

This is a case report on the colonoscopic finding of intestinal pneumatosis.

Correlation between endoscopy and intestinal ultrasound for the evaluation of postoperative recurrence of Crohn's disease. / Correlación entre la endoscopia y la ecografía intestinal para la evaluación de la recurrencia posquirúrgica de la enfermedad de Crohn.

OBJECTIVE: Intestinal ultrasound is considered to be a valid alternative for the evaluation of post-operative recurrence (POR) of Crohn's disease. The aim of this study is to assess the correlation between ultrasound and endoscopic findings. METHODS: Patients with Crohn's disease were retrospectively recruited who had undergone ileocecal resection, and for whom a colonoscopy and intestinal ultrasound had been performed for the detection of POR. Recurrence was assessed using the Rutgeerts score (RS). The ultrasound findings analysed were bowel wall thickness (BWT), parietal hyperaemia using power Doppler, loss of layer pattern and mesenteric fat hypertrophy. RESULTS: A total of 31 patients were included, of which 15 (48.4%) had no POR (RS<2b) and 16 (51.6%) had POR (RS≥2b). A statistically significant association was identified between BWT and the presence of endoscopic recurrence (a mean of 2.75mm vs. 5.68mm, P>0.001). There was also a statistically significant difference in hyperaemia between the 2groups (P=0.03). For wall thickness, an area under the ROC curve (AUC) of 92.9% was obtained, and with a cut-off point of 3.4mm, a sensitivity of 100% and specificity of 86.6%. When comparing with the most frequent biomarkers (fecal calprotectin and serum CRP), a higher AUC was obtained for wall thickness (72.3% and 72.3% vs. 92.9%). CONCLUSIONS: In our experience, ultrasound has high diagnostic efficacy in the detection of POR and can be considered a valid non-invasive alternative to endoscopy.

Doppler Activity and Ultrasonographic Detection of Intra-Abdominal Fistulas Are Predictors of Surgery in Crohn's Disease.

Bakground and Aim: Predictors of the need for surgery in sticturing Crohn's disease (SCD) are lacking. Bowel ultrasound (US) is a harmless, noninvasive, and inexpensive diagnostic procedure that has proven to be a valuable tool in the management of Crohn's disease (CD). Our aim was to identify ultrasonographic findings in SCD that may associate with a higher risk of surgery, allowing us to make early choices regarding treatment election in this specific group of patients. MATERIALS AND METHODS: This was a retrospective, case-control study. Twenty-four patients diagnosed with SCD between 2013 and 2017 with a past history of stricture-related surgery were included and then matched with 46 non-operated controls. Prior US from patients in both groups were analyzed. US features considered for analysis were as follows: bowel wall thickness, degree of parietal vascularization (measured by Doppler activity), prestenotic dilation, involvement of mesenteric fat, and newly detected concomitant fistulas or abscess. RESULTS: Doppler activity (p < 0.001), enteroenteric fistulas (p = 0.04), enteromesenteric fistulas (p = 0.003), and associated abscess (p = 0.004) were significantly associated with the need for surgery in the short-term period. Multivariate analysis showed strong association of these features with the risk of surgery but failed to reach statistical significance. CONCLUSION: US features may potentially be used as point-of-care tools to aid clinicians in the assessment of the surgical risk in patients with SCD.

Adherence to intravenous biological treatment in inflammatory bowel disease patients during the COVID-19 pandemic.

The objective of this study was to determine the adherence to biological treatment in inflammatory bowel disease (IBD) patients during the COVID-19 pandemic at Hospital Universitario La Paz, in Madrid. All patients from our IBD Unit were informed via e-mail, social networks and websites about the convenience of continuing with treatment. In addition, patients were contacted by telephone a few days before to remind them of their appointment and the importance of adherence.

Prognostic value of ultrasound activity and parietal healing in patients with Crohn's disease.

INTRODUCTION: the "treat to target" strategy for the management of patients with Crohn's disease (CD) requires simple, reliable and non-invasive tools for continuous monitoring of the disease. Intestinal ultrasound has been proposed as an emerging technique that could be very useful in this field. MATERIAL AND METHODS: patients who had undergone an intestinal ultrasound in the clinical practice between February 2013 and October 2018 at our hospital were retrospectively included. The evolution of the patients during follow-up was assessed based on the presence of ultrasound activity and the therapeutic changes based on the results. RESULTS: two hundred and seventy-seven CD patients were included and the median follow-up time was 24 months (range 5-73 months). Signs of ultrasound inflammatory activity were identified in 166 patients (60 %), and of them, treatment was escalated in 116 patients (70 %) based on the results of the ultrasound. Among patients with identified ultrasound activity, in 166 patients (60 %) the evolution was less favorable than in those without activity, with a shorter time until the next outbreak. Thus, the median disease-free survival (without outbreaks) after performing the ultrasound was 18 months when ultrasound activity was identified (although in most of the patients [70 %] the treatment had been escalated) vs 47 months in patients without ultrasound activity. However, these differences were not statistically significant (p < 0.0001). Among the 111 patients without ultrasound activity, those who achieved "parietal healing" (74 patients) had a better evolution with a 12 % subsequent outbreak vs 27 % during follow-up (p = 0.05). Thus, 15 % of patients with parietal healing had an outbreak vs 34 % of those who had not normalized the ultrasound findings after three years of follow-up. CONCLUSION: intestinal ultrasound is a technique capable of detecting inflammatory activity in patients with Crohn's disease and the presence of ultrasound activity is a risk factor for a new outbreak of activity and/or clinical relapse. Likewise, the presence of "parietal or transmural healing" (PH) is associated with a better evolution of patients during follow-up. Thus, it could be a more precise objective to consider deep remission in CD, with intestinal ultrasound being a useful technique for this purpose.

Is the degree of i2a recurrence in Crohn's disease secondary to ischemic phenomena?

INTRODUCTION: the Rutgeerts score is used to assess post-surgical recurrence of Crohn's disease (CD). The score initially consisted of four grades, with a subsequent sub-classification of grade 2, under which ulcers confined to the anastomosis (i2a) are considered to be of a probable ischemic origin. The aim of this study was to assess whether ulcers confined to the anastomosis appear at the same frequency in patients undergoing surgery for other causes and can therefore be attributed to post-surgical changes. MATERIAL AND METHODS: this was a retrospective cohort study with patients who had undergone colonoscopy as per clinical practice between 2017 and 2018. There were two cohorts, one cohort of patients to assess the post-surgical recurrence of CD and another cohort for follow-up after colorectal cancer (CRC) treated with ileocolonic anastomosis. RESULTS: a total of 185 patients were included; 33 % had undergone surgery for CD and 67 % had undergone surgery for CRC. Fifty-six percent of patients were male. Of the patients in the group with ulcers confined to the anastomosis, 75 % had CD and 25 % had been operated on for CRC; the difference was statistically significant (p < 0.0001). In turn, of the patients operated on for CRC, 95 % had no anastomotic lesions compared to 18 % of patients with CD. These differences reached statistical significance (p < 0.0001). CONCLUSIONS: In our experience, the occurrence of ulcers on the ileocolonic anastomosis is uncommon in patients that have undergone surgery for CRC, in comparison to patients operated on due to CD. It is possible that these alterations in CD cannot therefore be attributed to solely ischemic or post-surgical phenomena.

Retrieval and treatment of patients with primary biliary cholangitis who are lost in the health system.

INTRODUCTION: hepatitis C patients loss to follow-up in the health care system has been shown to have negative consequences. This study aimed to investigate this issue as regards primary biliary cholangitis. METHODS: the databases (immunology, biochemistry, clinical reports, drug dispensation, appointments) of 4 reference hospitals in Spain (serving a population of 1,450,000 inhabitants) were analyzed. The diagnosis of primary biliary cholangitis was based on an antimitochondrial antibody titer ≥ 1:80, chronically elevated alkaline phosphatase, and the absence of other liver disease. Patients were classified as lost in the absence of reports indicating a diagnosis, specific medical follow-up, and/or treatment with bile salts. RESULTS: a total of 1372 patients with antimitochondrial antibody titers ≥ 1:80 were included between January 2010 and June 2019. A total of 697 (50.8 %) were classified as having primary biliary cholangitis, and 100 patients (14.3 %; 95 % CI: 11.8-17.2) were identified as lost. Of these, 30 were contacted and retrieved. The median age was 70 years, 93 % were female, median alkaline phosphatase was 185 IU/L, 10 % had pruritus, and 27 % had a transient elastography value > 9.5 kPa. The disease was confirmed and ursodeoxycholic acid was started in all 30 patients. Death was liver-related in 6 of the 100 patients classified as lost. CONCLUSION: up to 14.3 % of patients (1 out of 7) with a definitive diagnosis of primary biliary cholangitis remain undiagnosed, thus preventing monitoring and treatment. More than a quarter are at risk of advanced liver disease and its complications. Patients lost in the system must be identified and retrieved, and searching hospital databases is a suitable approach to meet this goal.

Optimization of azathioprine dose in combined treatment with anti-TNF-alpha in inflammatory bowel disease.

INTRODUCTION: The dose of thiopurine drugs in combined treatments with anti-TNF in inflammatory bowel disease (IBD) has not been clearly established. The purpose of this study is to assess whether the dose of azathioprine influences clinical and biochemical response/remission rates, and anti-TNF drug levels/antibody formation. MATERIAL AND METHODS: Patients with IBD on combined maintenance treatment with azathioprine and infliximab or adalimumab were selected. Based on the dose of azathioprine, two groups were defined (standard: 2-2.5mg/kg/day; and decreased: less than 2mg/kg/day). RESULTS: In the IFX group, there were no statistically significant differences (p=0.204) in the rates of remission (39% vs 41.3%), response (10% vs 21.7%) or failure (51.5% vs 37%) depending on the dose of thiopurine drugs. No differences were found between AZA-dose dependent IFX levels (2.46 vs 3.21µg/mL; p=0.211). In the adalimumab group, there were no statistically significant differences (p=0.83) in the rates of remission (66% vs 56%), response without remission (15.38% vs 25%) or failure (18% vs 18%) depending on the dose of thiopurines. With respect to ADA-levels, no differences were found in both groups (7.69 vs 8.23µg/mL; p=0.37). CONCLUSION: In our experience, no statistically significant differences were found in either anti-TNF levels or clinical-biological response/remission rates based on doses of azathioprine.