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Background Adalimumab (ADA) dose escalation from 40 mg SC every other week (EOW) to 40 mg weekly is approved for IBD patients with loss of response. A recently registered device containing 80 mg of ADA will allow an alternative dose escalation regimen with SC doses of 80 mg EOW. The ADASCAL study aimed to evaluate the preferences and satisfaction of patients with modifying the ADA regimen from 40 mg weekly to 80 mg EOW. Methods This multicentre cross-sectional study included patients with IBD in whom the ADA regimen was changed from 40 mg weekly to 80 mg EOW according to clinical practice. Patients who have received at least 4 doses of 80 mg EOW completed a 4-item self-questionnaire (a Likert-like 5-point scale for preferences, 2 closed questions for convenience, and a 100-point visual analogue scale [VAS] to evaluate patient’s preference for weekly or EOW ADA) (Figure 1); and the 14-item Treatment Satisfaction Questionnaire for medication (TSQM 1.4) that covers 4 domains: effectiveness, side effects, convenience, and overall satisfaction. Results Seventy-seven patients (64 CD, 13 UC; 67.5% men; mean age 48 years, SD 14.1) were included. The overall mean duration of exposure to ADA was 66 months (SD 34), with mean exposure to ADA 40 mg weekly of 40 months (SD 25), and mean exposure to ADA 80 mg EOW of 12 months (SD 5). At the time of the survey, 87.1% of CD patients and all UC patients were in clinical remission (Harvey-Bradshaw index ≤4 for CD, Partial Mayo score ≤1 for UC). According to the results of the questionnaires, 74% of the patients preferred the 80 mg EOW ADA regimen (59.7% had a strong preference and 14.3% had a slight preference) (Figure 1). Patients referred that ADA EOW regimen interferes less with daily activity and with travel plans. Most patients wanted to continue with ADA 80 mg EOW, as reflected by a mean VAS score of 84.7 (SD 24.1), where 0 indicated a choice for weekly ADA, 100 for ADA EOW, and 50 indifferent. Overall, 77% of patients preferred to continue with ADA EOW, 4% with ADA weekly, and 17% were indifferent. Attending physicians also reported a greater preference for the EOW ADA regimen (mean VAS score 93, SD 7.8). The mean global satisfaction according to the TSQM was 84.3% (SD 13.5), where 0 indicated extremely dissatisfied and 100 extremely satisfied. Patients reported very high TSQM scores for individual components: effectiveness 77.6% (SD 16.9), convenience 83.7% (SD 14.5), and side effects 86.1% (SD 23.4). Conclusion IBD patients in whom the ADA regimen was changed from 40 mg weekly to 80 mg EOW reported a higher preference for the EOW regimen. TSQM results indicated that patients had a high level of satisfaction with the current EOW regimen. Therefore, most patients wanted to continue with ADA 80 mg EOW.

Background Post-marketing data are required to confirm the durability and the long-term benefit and safety of UST in CD in clinical practice. Our aims were: (1) to evaluate the retention rate of UST in CD patients and to identify predictive factors of UST discontinuation; (2) to assess UST short-term effectiveness; (3) to analyse the durability of the response to UST in the long-term; and (4) to evaluate the safety of UST in clinical practice. Methods Retrospective, multicentre study (>60 centres). Patients with active CD [(Harvey–Bradshaw (HBI) >4)] that received at least one dose of UST intravenously before July 2018 were included. Clinical activity plus biochemical parameters were assessed at every UST administration. Clinical remission was defined as HBI score ≤4, and clinical response as a decrease in HBI ≥3 points. Loss of efficacy was defined as reappearance of symptoms that led to intensify the treatment dose, add another medication to control CD, switching or surgery in patients with short-term remission. The retention rate of UST treatment and the cumulative incidence of loss of efficacy were evaluated by survival curves, and predictive factors were assessed by Cox-regression. The short-term response was evaluated at week 8 and after the induction (week 16). Factors associated with short-term remission were assessed by multivariate analysis. Adverse events were recorded. Data quality was assured by remote monitoring. Results 331 CD patients have been included up to date (Table 1). The incidence rate of UST discontinuation was 15% per patient-year of follow-up: 8%, 13% and 20% at 6, 12 and 18 months (Figure 1). Previous surgery was the only factor associated with a higher risk of UST discontinuation [Hazard ratio (HR) = 2.03, 95% confidence interval (CI) = 1.1–3.6]. Short-term efficacy is shown in Figure 2. Previous surgery (OR = 0.3, 95% CI = 0.2–0.6) and higher HBI score at baseline (OR = 0.8, 95% CI=0.8–0.9) were associated with an impaired response to UST at week 16. The cumulative incidence of loss of response was 32% per-patient-year of follow-up (Figure 3); A higher HBI score at baseline was associated with a higher risk of losing response (HR = 1.2, 95% CI = 1.1–1.3). Neither the concomitant treatment with immunosuppressants nor the number of previous biologics were associated with UST short- and long-term benefit. Thirty adverse events were reported in 25 (7%) patients (Table 2). Conclusion Sustain is the largest real clinical practice study of UST to treat CD patients with the longest follow-up reported to date. UST was demonstrated to be effective in real-world use in the short and long run. Safety was consistent with the known profile of UST.

Background The effectiveness of the switch to another anti–tumor necrosis factor (anti-TNF) agent is not known. The aim of this study was to analyze the effectiveness and safety of treatment with a second and third anti-TNF drug after intolerance to or failure of a previous anti-TNF agent in inflammatory bowel disease (IBD) patients. Methods We included patients diagnosed with IBD from the ENEIDA registry who received another anti-TNF after intolerance to or failure of a prior anti-TNF agent. Results A total of 1122 patients were included. In the short term, remission was achieved in 55% of the patients with the second anti-TNF. The incidence of loss of response was 19% per patient-year with the second anti-TNF. Combination therapy (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.8–3; P < 0.0001) and ulcerative colitis vs Crohn’s disease (HR, 1.6; 95% CI, 1.1–2.1; P = 0.005) were associated with a higher probability of loss of response. Fifteen percent of the patients had adverse events, and 10% had to discontinue the second anti-TNF. Of the 71 patients who received a third anti-TNF, 55% achieved remission. The incidence of loss of response was 22% per patient-year with a third anti-TNF. Adverse events occurred in 7 patients (11%), but only 1 stopped the drug. Conclusions Approximately half of the patients who received a second anti-TNF achieved remission; nevertheless, a significant proportion of them subsequently lost response. Combination therapy and type of IBD were associated with loss of response. Remission was achieved in almost 50% of patients who received a third anti-TNF; nevertheless, a significant proportion of them subsequently lost response.

Aim To assess the likelihood of detecting latent tuberculosis infection [LTBI] by the positive conversion of a serial tuberculin skin test [TST] at 1 year in inflammatory bowel disease [IBD] patients with negative baseline two-step TST. Methods In this multicentre prospective cohort study, we evaluated rate and predictors of conversion of TST at 1 year in patients with negative baseline TST. We also evaluated management of patients who had a positive TST at baseline or a conversion at 1 year. In all patients we assessed TB cases occurring during follow-up. Results Of the 192 IBD patients receiving anti-tumour necrosis factor [TNF] and 220 IBD controls not receiving anti-TNF, 35 [8.5%, 95% CI 5.7-11.3] had positive conversion (median TST induration 13 mm, interquartile range [IQR] 9-16). Ten anti-TNF cohort patients [5.2%, 95% CI 2.5-9.5] versus 25 controls [11.4%, 95% CI 7.5-16.3] had TST conversion [p = 0.029]. In multivariate analysis, conversion was associated with smoking habit (odds ratio [OR] 2.19, 95% CI 1.08-3.97; p = 0.028). Anti-TNF-treated patients had a lower conversion rate [OR 0.41, 95% CI 0.20-0.83; p = 0.013]. The likelihood of conversion correlates with fewer immunosuppressive therapies between baseline TST and TST at 1 year [p = 0.042]. One case of active TB [isoniazid-resistant strain] occurred in a patient with positive baseline TST receiving anti-TNF [0.05 events/100 patient-years]. Conclusions Serial TST at 1 year can detect LTBI in IBD patients receiving anti-TNF therapy with negative baseline TST. Serial TST seems to be advisable to reduce the risk of TB cases associated with inability to detect LTBI in pre-treatment screening.

Background The information regarding IBD patients with COVID-19 suggests that the factors related to bad outcome are older age and comorbidity whereas immunosuppressants do not have a significant impact worsening the disease evolution. To date, there is no information to assess if there are differences in epidemiological, demographical, and clinical characteristics between infected and non-infected IBD patients. Methods Case-control study in IBD patients with COVID-19 (cases) compared to IBD without COVID-19 (controls) in the period March-July/2020 within the ENEIDA registry (promoted by GETECCU and with more than 60.000 IBD patients included). Cases were matched 1:2 by age (±5y), type of disease (CD/UC), gender, and centre. All controls were selected from only one investigator blind to other clinical characteristics of the patients to avoid selection bias. Results 496 cases and 964 controls from 63 Spanish centres were included. No differences were found within the basal characteristics including CD location, CD behaviour, extraintestinal manifestations, family history of IBD or smoking habits. Cases had ≥ 1 comorbidities (cases:43%vs. controls:36%, p=0.01) and occupational risk (cases:27% vs. controls:10.6%, p Conclusion Comorbidities and epidemiological risk factors are the most relevant aspects for the risk of COVID-19 in IBD patients. This risk of COVID-19 seems to be increased by aminosalicylates but not by immunosuppressants or biologics. The attitude regarding treating IBD patients with aminosalicylates during the COVID-19 pandemic deserves a deeper analysis. Funded by the Carlos III Health Institute COV20/00227.

Background and Aims Primary sclerosing cholangitis [PSC] is usually associated with inflammatory bowel disease [IBD]. An increased risk of malignancies, mainly colorectal cancer [CRC] and cholangiocarcinoma [CCA], has been reported in PSC-IBD patients. Our aim was to determine the clinical characteristics and management of PSC in IBD patients, and the factors associated with malignancies. Methods PSC-IBD patients were identified from the Spanish ENEIDA registry of GETECCU. Additional data were collected using the AEG-REDCap electronic data capture tool. Results In total, 277 PSC-IBD patients were included, with an incidence rate of 61 PSC cases per 100 000 IBD patient-years, 69.7% men, 67.5% ulcerative colitis and mean age at PSC diagnosis of 40 ± 16 years. Most patients [85.2%] were treated with ursodeoxycholic acid. Liver transplantation was required in 35 patients [12.6%] after 79 months (interquartile range [IQR] 50–139). It was more common in intra- and extrahepatic PSC compared with small-duct PSC (16.3% vs 3.3%; odds ratio [OR] 5.7: 95% confidence interval [CI] = 1.7–19.3). The incidence rate of CRC since PSC diagnosis was 3.3 cases per 1000 patient-years [95% CI = 1.9–5.6]. Having symptoms of PSC at PSC diagnosis was the only factor related to an increased risk of CRC after IBD diagnosis [hazard ratio= 3.3: 95% CI = 1.1–9.9]. CCA was detected in seven patients [2.5%] with intra- and extrahepatic PSC, with median age of 42 years [IQR 39–53], and presented a lower life expectancy compared with patients without CCA and patients with or without CRC. Conclusions PSC-IBD patients with symptoms of PSC at PSC diagnosis have an increased risk of CRC. CCA was only diagnosed in patients with intra- and extrahepatic PSC and was associated with poor survival.

Aim: To evaluate outcomes of early dose optimization of golimumab in ulcerative colitis (UC) patients with inadequate response to golimumab induction treatment.Methods: This observational, multicenter, cohort study included patients with moderate-to-severe active UC and with inadequate response to subcutaneous golimumab induction doses, in whom weight-based golimumab maintenance dose (European labeling) of 50mg every 4weeks (q4wk) was optimized before week 14 to 100mg q4wk. At week 14, we assessed clinical response and remission using the partial Mayo score. In the long term we evaluate the cumulative probabilities of golimumab failure-free survival and colectomy-free survival.Results: A total of 209 patients who received golimumab induction doses were eligible. Of these, 151 patients (72.2%) weighing less than 80kg were assigned to a golimumab maintenance dose of 50mg q4wk. Twenty-four patients (15.9% [12.5% overall]), in whom scheduled doses of 50mg q4wk were optimized to 100mg q4wk before week 14, compose the study population. At week 14, 16 patients (66.7%, 95% CI 45.7-87.6) had clinical response, of these 12 were corticosteroid free. Four patients (16.7%) achieved corticosteroid-free remission. After a median follow-up of 12months (IQR 10-22), 13 patients (54.2%) maintained clinical benefit. Thirteen of 16 patients (81.2%) with clinical response at week 14 maintained clinical benefit at last follow-up. All patients avoided colectomy. In none of the patients was golimumab dose de-escalated. There were no adverse events leading to golimumab withdrawal.Conclusion: Early optimization of golimumab dose induces clinical response at week 14 in two thirds of UC patients and leads to long-term clinical benefit in over half of patients.

Background: In APPRECIA trial, Crohn's disease (CD) patients undergoing intestinal resection were randomized to postoperative adalimumab (ADA) or azathioprine (AZA). Aims: To evaluate health-related quality of life (HRQoL) in APPRECIA trial. Methods: HRQoL was evaluated using disease-specific shortened Spanish version of the IBDQ (SIBDQ-9) and generic European Quality of Life-5 Dimensions (EQ-5D) questionnaires, completed at baseline and at weeks 24 and 52. Results: Sixty-one patients (37 ADA and 24 AZA) had evaluable data for HRQoL. Patients treated with ADA or AZA had significant improvement from baseline to weeks 24 and 52 in SIBDQ-9 and EQ-5D (p < 0.001 and p = 0.006 for all comparisons, respectively). There were no differences between treatment arms in mean change in SIBDQ-9 and EQ-5D at weeks 24 and 52 vs baseline. Only patients without endoscopic recurrence had significant improvement in SIBDQ-9 (p < 0.001) and EQ-5D (p < 0.001) at week 52. At week 52, there was a high to moderate negative correlation between CDAI score with SIBDQ-9 score( Pearson's r: -0.768) and with EQ-5D index (r: -0.644). Conclusion: HRQoL improved after intestinal resection in CD, irrespective of the postoperative therapyused (ADA or AZA). Outcomes in HRQoL were associated with prevention of endoscopic recurrence, sinceimprovements in HRQoL were only significant in patients with endoscopic remission at 1 year. (c) 2019 Editrice Gastroenterologica Italiana S. r. l. Published by Elsevier Ltd. All rights reserved.

The administration of propofol by endoscopists is a source of permanent friction with the Societies of Anesthesiology, which is based more on a clear conflict of economic interest on the part of the anesthesiologists than supported by scientific evidence. Maestro Antolin et al. (1) presented a series of more than 33,000 sedations performed with propofol by endoscopists, observing a frequency of cardiorespiratory adverse events of 0.13%. Rather than confrontation between different specialties, where the corporatism of the Anesthesiology Societies and their interest in monopolizing the use of a safe drug such as propofol prevails with no scientific support, anesthesiologists, endoscopists and nurses should instead work together for the benefit of our patients.

Aliment Pharmacol Ther 2011; 33: 340–348 Summary Background The long-term efficacy of adalimumab in patients with ulcerative colitis is not well known. Aim To evaluate the short- and long-term outcomes of adalimumab in ulcerative colitis patients previously treated with infliximab. Methods Patients with active ulcerative colitis were treated with adalimumab after failure of other therapies including infliximab. Short-term clinical response and remission were assessed at weeks 4 and 12. The proportion of patients who continued on adalimumab and the proportion of patients who remained colectomy free were assessed over the long term. Results Clinical response at weeks 4 and 12 was achieved in 16 (53%) and 18 (60%) patients, respectively, and clinical remission was obtained in 3 (10%) and 8 (27%) patients, respectively. After a mean 48 weeks’ follow-up, 15 patients (50%) continued on adalimumab. Six patients (20%) required colectomy. All patients who achieved clinical response at week 12 were colectomy free at long term. Conclusions Adalimumab was well tolerated and induced durable clinical response in many patients with otherwise medically refractory ulcerative colitis. Patients achieving clinical response at week 12 avoided colectomy over the long term.

Efficacy of infliximab in Crohn's disease (CD) showed by randomized controlled trials must be confirmed in clinical practice. We aimed to evaluate efficacy and safety of infliximab in CD patients of the Madrid area, looking for clinical predictors of response.Multicenter retrospective survey of all CD patients treated with infliximab in 8 University hospitals of the Madrid area (Spain) with a minimum follow up of 14 wks.169 patients included (48%males, mean age 39 +/- 12 yrs). 64% of them had perianal disease. 82% were under immunosuppressants. 1,355 infliximab infusions administered (mean 8, range 1-30). 90% response rate and 48% remission rate were obtained with induction therapy. 73% followed maintenance treatment, and 78% of them maintained or improved the response after a mean follow up of 28 months (range 3.5-86). 24 patients lost response during the follow up, after a mean of 41 wks (range 6-248). Only the prescription of maintenance therapy was predictive factor for favourable response (p0.01). 17 infusion reactions were reported (10% of the patients, 1.2% of the infusions; only one case was severe) and were the cause of treatment withdrawal in 7 patients. Co-treatment with immunosuppressive drugs and maintenance infliximab therapy were protective factors for infusion reactions (p0.05). Other adverse events occurred in 26% of the patients, and were cause of treatment withdrawal in 7 patients.Infliximab is effective and safe for CD management but concomitant immunosuppressive drugs and maintenance treatment should be prescribed to obtain the best outcome. That confirms in a real life clinical setting the favourable results obtained in randomized clinical trials.

Aim Anti-tumor necrosis factor (TNF)-alpha agents are widely used for the treatment of both inflammatory bowel disease (IBD) and psoriasis. Psoriatic skin lesions induced by anti-TNF have been described in patients with IBD. We report a case series of psoriasis induced by anti-TNF agents in IBD patients. Methods Systematic analysis of cases of psoriasis induced by anti-TNF in an IBD patient cohort in tertiary hospitals of Madrid. Results A total of 21 of 1294 patients with IBD treated with anti-TNF-alpha agents developed drug-induced psoriasis (cumulative incidence 1.62%; 95% CI 1.06%–2.47%): 14 patients with infliximab and 7 with adalimumab; seventeen with Crohn's disease, 4 with ulcerative colitis. The onset of skin lesions varied in a wide range of time (after a mean 13 ± 8 doses). The most frequent site of skin lesions was the limbs (62%) followed by the trunk (48%) and the scalp (43%). The psoriasis phenotypes were plaque psoriasis (57%), scalp (14%), palmoplantar pustulosis (14%), pustular generalized psoriasis (5%), guttate (5%) and inverse (5%). Four patients interrupted the anti-TNF treatment, and that led to the complete regression of lesions in 1 of them. The other 17 patients were maintained on anti-TNF therapy and managed with topical steroids. Conclusion Psoriatic lesions can be induced by anti-TNF drugs. Plaque psoriasis on the extremities and trunk were the most frequent presentations in our series. Topical steroid treatment is effective in most patients. Anti-TNF discontinuance may be reserved for patients with severe psoriasis or patients without response to topical therapy.

Introduction The response of Crohn's disease (CD) to infliximab is initially good, although a loss of efficacy is observed over time. Dose escalation has been recommended in such cases. Aims To study the response to an intensified infliximab regimen in patients with CD; and to evaluate the adverse effects associated with intensification of therapy and identify predictors of loss of response. Methods We performed a retrospective multicenter survey of all patients with CD who had been treated with at least the 3 induction doses of standard infliximab therapy, and for whom treatment had to be intensified due to loss of response. We analyzed the efficacy of the intensified regimen. Results Thirty-three patients were included. After the first intensification dose, 79% of patients had a clinical response (33.5% complete response, 45.5% partial response). In the long term, 83%, 69%, 47%, and 29% of patients who had an initial response to the intensification maintained the response at 6, 12, 18, and 36months, respectively. The loss of efficacy after escalation was 43% per patient-year of follow-up. One patient had an infusion reaction after 36 doses. One patient developed a herpes zoster infection. Conclusions A high proportion of patients whose dose of infliximab is increased due to loss of efficacy respond initially. However, nearly half lose the response after one year. The safety profile of an intensified infliximab regimen is good.

To estimate the impact of infliximab (IFX) maintenance therapy on the use of hospital resources in patients with Crohn's disease (CD).Medical records of patients treated with IFX maintenance therapy (5 mg/kg body weight; intravenous infusion) for luminal (L) or fistulizing (F) CD at 13 hospitals were retrospectively reviewed. Patients were assessed as their own controls. Use of CD-related healthcare resources was recorded comparing 1-year periods before and after first IFX infusion (pre-IFX and post-IFX).One hundred fifty-three CD patients (n=84 L; 69 F) fulfilled the inclusion criteria. Mean number of IFX infusions was 7/y with an average of 335 mg/infusion dose/patient. During the pre-IFX period, 55% of patients needed hospitalization versus 31% in the post-IFX period (P0.001). Mean inpatient stay was 11.3 d/y [11.2 (L), 11.5 (F)] for the pre-IFX period, and 6.3 d/y [6.2 (L), 6.3 (F)] in the post-IFX period (P0.001). Surgery was required in 24% patients in the pre-IFX period and in 11% post-IFX (P0.001). There were no significant changes in the incidence of outpatient visits although emergency room visits fell significantly.Maintenance IFX in CD patients is associated with decreases in the use and length of hospitalizations and the need for surgery in clinical practice.

Inflammatory bowel diseases are inflammatory, chronic and progressive diseases of the intestinal tract for which no curative treatment is available. Research in other fields with stem cells of different sources and with immunoregulatory cells (regulatory T-lymphocytes and dendritic T-cells) opens up new expectations for their use in these diseases. The goal for stem cell-based therapy is to provide a permanent cure. To achieve this, it will be necessary to obtain a cellular product, original or genetically modified, that has a high migration capacity and homes into the intestine, has high survival after transplantation, regulates the immune reaction while not being visible to the patient's immune system, and repairs the injured tissue.

analyzed by gene array, immunofluorescence, flow cytometry and thymidine incorporation. Results Anti-TNF induced regulatory macrophages displayed increased numbers of autophagosomes as well as an increased expression of autophagy related transcripts including atg5, atg7, atg9 and atg16l2, suggesting induction of autophagy by IFX treatment. Of all donors, 7 were homozygously carrying the CD associated risk allele, 14 were heterozygous and 7 were homozygous for the WT allele. The number of CD14+ regulatory macrophages correlated significantly with the number of WT alleles present in each individual culture, with the largest number of macrophages found in cultures containing 3 or 4 WT alleles (2 WT donors or 1 WT and 1 heterozygous). Similarly, expression of CD206, which is associated with the immunosuppressive function of macrophages, positively correlated with the number of WT alleles present. To confirm the functional consequences of these findings, IFX mediated suppression of T cell proliferation was determined. Again, the level of suppression correlated significantly with the number of WT alleles present in the respective donor combinations. Conclusion Induction of regulatory macrophages by IFX is associated with induction of autophagy. In vitro, the number and function of IFX induced macrophages correlated with the number of WT alleles for the autophagy related gene ATG16L1. This suggests that an intact autophagy pathway is important for effectiveness of anti-TNF therapy.

Shortand Long-Term Outcomes of Infliximab Dose Intensification in Patients With Ulcerative Colitis Carlos Taxonera, Manuel Barreiro-de Acosta, Marta Calvo, Cristina Saro, Guillermo Bastida, Maria Dolores Martin Arranz, Javier P. Gisbert, Valle Garcia-Sanchez, Ignacio Marin-Jimenez, Fernando Bermejo, Maria Chaparro, Angel Ponferrada Diaz, Ignacio Fernandez-Blanco, Pilar Martinez-Montiel, R. Pajares, Celia de Gracia, David Olivares, Fermin Estremera Arevalo, Juan L. Mendoza

Antecedentes La respuesta al tratamiento con IFX es inicialmente elevada, aunque con el paso del tiempo se ha observado, con cierta frecuencia, una perdida de eficacia. En estos pacientes con perdida de respuesta se ha recomendado “intensificar” el tratamiento con IFX. No obstante, se desconoce si el efecto beneficioso de esta estrategia se mantiene en el tiempo o es solo transitorio. Objetivos 1) Estudiar la respuesta (tanto a corto como a largo plazo) de los pacientes que precisan intensificar el tratamiento con IFX (aumentando la dosis o disminuyendo el intervalo). 2) Evaluar los efectos adversos asociados a la intensificacion del tratamiento. Metodos Estudio multicentrico retrospectivo. Se incluyeron pacientes con enfermedad de Crohn que hubieran recibido al menos las 3 dosis de induccion del tratamiento estandar con IFX (5 mg/kg) y que despues precisaran intensificacion del tratamiento (10 mg/kg cada 8 semanas o 5 mg/kg cada 4 semanas) por perdida de respuesta. Se analizo la eficacia del tratamiento intensificado en el momento inicial (tras la 1a infusion de la dosis intensificada) y final (en la ultima revision). Se utilizo el indice de Harvey-Bradshaw en el caso de enfermedad de Crohn no fistulizante. En la enfermedad fistulizante, la respuesta completa se definio como el cese del drenaje de todas las fistulas y la respuesta parcial como la reduccion en al menos un 50% del numero o del debito fistuloso. Se valoro la seguridad del tratamiento con la dosis intensificada. Resultados Se incluyeron 34 pacientes (edad media, 43 anos; 50% varones; 31% fumadores; 64% con afectacion ileocolica; 47% con patron fistulizante; 60% con enfermedad perianal). La mayoria (72%) recibia tratamiento concomitante con inmunomoduladores. El tiempo medio de seguimiento con el tratamiento intensificado fue de 56 semanas (rango: 4–169 semanas). El tiempo medio de tratamiento con IFX antes de la intensificacion de la dosis fue de 15 meses (rango: 3–43 meses). Con la primera dosis de tratamiento intensificado respondio el 78% de los pacientes (32% respuesta completa y 46% parcial). Mientras que con la ultima dosis de tratamiento intensificado solo un 61% de los pacientes presentaban respuesta (22% respuesta completa y 39% respuesta parcial). Un paciente sufrio una reaccion infusional tras 36 dosis de tratamiento intensificado, que se soluciono con el enlentecimiento de la infusion. Otro paciente presento infeccion por virus del herpes zoster, no precisando suspension del tratamiento. Conclusiones En ocasiones se requiere la intensificacion del tratamiento con IFX, una media de 15 meses despues del inicio del tratamiento con este farmaco. Un alto porcentaje de pacientes responden inicialmente al tratamiento intensificado, aunque este pierde de nuevo su eficacia en mas de un 10% de los casos. La intensificacion del tratamiento presenta un buen perfil de seguridad, sin observarse reacciones adversas graves.

s of the 4th Congress of ECCO the European Crohn’s and Colitis Organisation S73 Conclusions: This study reveals discrepancy in psychosocial symptoms, and competence between reports of parents and adolescents with IBD. Chronically ill adolescents may deny their problems as part of coping strategy. Further, it is possible that the parents of chronically ill IBD patients observe their children more than the parents of healthy children, and thus report more concerns. Complementary methods should be used while assessing psychosocial well-being of adolescents with IBD. P157 Intensification of infliximab (IFX) therapy in Crohn’s disease: efficacy and safety M. Chaparro1, P. Martinez-Montiel2, M. Van Domselaar3, F. Bermejo4, J.L. Perez-Calle5, B. Casis2, A. Lopez-Sanroman3, A. Algaba4, J. Mate1, J.P. Gisbert1 *. 1La Princesa Hospital, Madrid, Spain, 212 de Octubre Hospital, Madrid, Spain, 3Ramon y Cajal Hospital, Madrid, Spain, 4Fuenlabrada Hospital, Madrid, Spain, 5Alcorcon Hospital, Madrid, Spain Introduction: The response of Crohn’s disease to IFX therapy is initially high. However, a loss of efficacy is observed in some cases over time. In such patients with loss of response, an IFX therapy “intensification” has been recommended. Nevertheless, it is still unknown whether the beneficial effect of this intensification is prolonged or just transient. Aims: (1) To study the shortand long-term response of Crohn’s disease patients treated with IFX intensification (e.g., higher doses or shortened intervals). (2) To evaluate the adverse effects associated to therapy intensification. Methods: Retrospective multicenter survey. We included Crohn’s disease patients who had been treated with at least the three induction doses of the standard IFX therapy (5mg/kg 0 2 6w), and who later on needed treatment intensification (10mg/kg/8w or 5mg/kg/4w), because of loss of response. Short-term (after the first intensification dose) and the longterm (at the end of follow-up) efficacy of the intensified therapy was analyzed. Harvey Bradshaw’s index was used in luminal Crohn’s disease. In fistulizing Crohn’s disease, complete response was defined as closure of all fistulas, and partial response as a 50% or more reduction in the number or the debit of fistulas. Safety was evaluated by collection of adverse effects. Results: We included 34 patients (mean age, 43 years; 50% male; 31% smokers; 64% with ileocolic (L3) disease; 47% with fistulizing (B3) phenotype; 60% with perianal (p) disease). The majority (72%) of the patiens was treated with immunomodulators. The mean follow-up for intensified treatment was 56 weeks (range: 4 169 w). Mean time of IFX exposure before intensification was 15 months (range: 3 43 m). On the short-term, after the first intensification dose, 78% responded (32% complete response, 46% partial response). On the long-term, after the last intensification dose, only 61% were still responding (22% complete response, 39% partial response). One patient suffered an infusion reaction after 36 doses of intensified treatment, which subsided with slower infusion. One patient suffered an episode of herpes zoster, that did not interrupt the treatment. Conclusions: The intensification of IFX therapy is sometimes necessary after a mean drug exposure of 15 months. A high proportion will initially respond, but >10% of all cases lose effect again. Safety profile of IFX therapy intensification is good, having no severe adverse effects. P158 Safety of once daily versus twice daily dosing with mesalazine (Pentasa®) sachets. Results from a 12 month randomised controlled trial in maintenance of remission of ulcerative colitis A. Dignass1 *, B. Bokemeyer2, T. Stijnen3, H. Veerman4. 1Markus-Krankenhaus, Frankfurt/ Main, Germany, 2Gastroenterologische Gemeinschaftspraxis, Minden, Germany, 3University Leiden, Leiden, Netherlands, 4Ferring Pharmaceuticals, Hoofddorp, Netherlands Aims: Patients with quiescent ulcerative colitis (UC) are often non-compliant with their treatment for maintenance of remission. Non-compliance can lead to relapse and the return of symptoms. This study investigated remission and relapse rates in patients with UC in remission receiving once (OD) or twice (BD) daily mesalazine sachets. The primary endpoint was non-inferiority of the OD treatment regime compared to BD dosing. Safety data were collected as a secondary endpoint. Materials and Methods: A 12-month, investigator-blinded, randomised controlled trial was conducted. Patients with mild to moderate UC in remission who had experienced a relapse within the past year were randomised to receive 2 g/day mesalazine sachets given either in a OD or BD regime. Results: 362 patients were randomised. The primary endpoint UC-DAI remission rate at 1 year as measured by the Kaplan Meier showed a statistically significant difference of 11.9% in favour of the OD treatment group. Overall, 42.9% of the patients in the OD group and 36.4% of the patients in the BD group reported one or more adverse events (AE) during the study. The difference in overall incidence was not statistically significant (P= 0.24) and there was no clear difference between the described AEs in the different treatment arms. Six patients from the OD group and four patients from the BD group experienced a serious AE (SAE). All SAEs were not, or unlikely, related to the study medication. The SAEs experienced by the OD group were metastatic prostate cancer, myocardial ischemia, pyrexia, postoperative wound infection, squamous cell carcinoma, coronary artery disease, gastrointestinal ulcer haemorrhage, and cerebral haemorrhage. The SAE experienced in the BD group were meningioma, migraine with aura, spondylolisthesis, chest pain, convulsion, and hypokalaemia. None were related to the study medication. Overall, the most frequently reported treatment emergent AEs (TEAE) were gastrointestinal disorders (abdominal pain, diarrhoea and flatulence) or infections and infestations (bronchitis, gastroenteritis, nasopharyngitis and sinusitis). The majority of the TEAEs were mild or moderate in intensity and considered by the investigator to be unrelated, or unlikely related, to the study medication. P159 Ulcerative colitis might prevent colonic diverticulosis O. Yonal *, S. Ilhan, O. Atug, H. Over Hamzaoglu. Marmara University Hospital Gastroenterology, Istanbul, Turkey Background: Diverticulosis coli is characterized by abnormal thickening of the large bowel wall, luminal overpressure and an increase in sigmoid contractility. The anatomic features intrinsic to the colon, alterations in colonic wall with aging, motor dysfunction, and increased intraluminal pressure, may all play role in the development of diverticulosis. In ulcerative colitis (UC) chronic inflammatory activity causes reduction in bowel wall muscle tone and contractility. Patients with UC often have liquid stools and might result in low intracolonic pressure Aim: To evaluate the frequency of colonic diverticulosis in patients with UC and compare with control group. Methods: Colonoscopy results of patients with ulcerative colitis older than 50 years were retrospectively evaluated and by gest on M arch 1, 2016 http://eccoxfordjournals.org/ D ow nladed from

Background and aims: While it is commonly accepted that Inflammatory bowel disease (IBD) Comprehensive Care Units (ICCUs) facilitate the delivery of quality care to Crohn's disease and ulcerative colitis patients, it remains unclear how an ICCU should be defined or evaluated. The aim of the present study was to develop a comprehensive set of Quality Indicators (QIs) of structure, process, and outcomes for defining and evaluating an ICCU. Methods: A Delphi consensus-based approach with a standardized three-step process was used to identify a core set of QIs. The process included an exhaustive search using complementary approaches to identify potential QIs, and two Delphi voting rounds to select the QIs defining the core requirements for an ICCU. Results: The consensus selected a core set of 56 QIs (12 structure, 20 process and 24 outcome). Structure and process QIs highlighted the need for multidisciplinary management and continuity of care. The minimal IBD team should include an IBD nurse, gastroenterologists, radiologists, surgeons, endoscopists and stoma management specialists. ICCUs should be able to provide both outpatient and inpatient care and admission should not break the continuity of care. Outcome QIs focused on the adequate prophylaxis of disease complication and drug adverse events, the need to monitor appropriateness of treatment and the need to reinforce patient autonomy by providing adequate information and facilitating the patients' participation in their own care. Conclusions: The present Delphi consensus identified a set of core QIs that may be useful for evaluating and certifying ICCUs. (C) 2013 The Authors. Published by Elsevier B.V. on behalf of European Crohn's and Colitis Organisation. All rights reserved.