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Background Pouchitis and other inflammatory disorders of the pouch (IDP), such as Crohn′s-like disease of the pouch (CDP), are frequent in patients operated for a previous diagnosis of ulcerative colitis. Many different therapies have been used, but the effectiveness of immunosupresants (IMM) has been poorly explored in this setting. Our aim was to evaluate the use, efficacy and safety of IMM in patients with pouchitis or another IDP. Methods Retrospective and multicentric study of a Spanish cohort of pouch-carrying patients with previous diagnosis of ulcerative colitis, and subsequent diagnosis of IDP, following ECCO diagnostic criteria. Patients who used IMM to treat these conditions were selected. Clinical effectiveness was evaluated at long-term. We defined clinical remission as returning to the previous stool frequency, no pain or defecatory urgency, clinical response as the improvement in these parameters without the achievement of remission, and non-response as no improvement or worsening symptoms. Endoscopic response was evaluated when possible using modified pouchitis disease activity index (PDAI) endoscopic subscore. Adverse events were collected. We used descriptive statistics. Results In the overall cohort of 338 patients with IDP, 93 (27%) were treated with IMM. Of those, 57% males, median age 40 (20-71) ys, and 72% non-smokers. Colectomy was performed at a median age of 31 (18-63) ys and IPD was diagnosed 25 (1-235) months after ileostomy closure. IMM used were thiopurines (n=86), methotrexate (n=4), cyclosporine (n=2) and tacrolimus (n=1). IMM were used as monotherapy in 66 (71%) cases and were indicated as treatment of pouchitis (n=60, 65%), CDP (n=32, 34.4%) and cuffitis (n=1, 1%). Effectiveness was evaluated only for thiopurine monotherapy (n=62). After a median follow-up of 23 (1-234) months, clinical remission was achieved in 31%, clinical response in 31% and non-response in 38% (Figure 1). There were no differences in effectiveness between pouchitis and CDP (63.9% vs 57.7%, p= 0.62). Endoscopic response was evaluated in 19 (30.6%) cases. After a median of 9 months of follow-up median PDAI endoscopic subscore dropped from 3 (range 2-4) to 1 (range 0-3), (Figure 2). Adverse events related with treatment appeared in 28 patients (45%). Thiopurines were discontinued in 39 cases (63%) due to failure (17), toxicity (16) and long remission (6 cases). Conclusion In our cohort, thiopurines were used in 27% of patients with IDP, with long-term benefit (remission or response) in around two-thirds of them. This therapy could be one more option to manage these disorders.

Background Pouchitis and Crohn′s-like disease of the pouch (CDP) can be refractory to conventional therapy. Evidence of biological therapy has been rarely reported in large patient cohorts. We explored the use and effectiveness of these therapies and compared the success of a second biologic after antiTNF failure. Methods This is a retrospective RESERVO study of the Spanish cohort of GETECCU, that included patients operated for ulcerative colitis, with pouch construction, and subsequent diagnosis of pouchitis, CDP or cuffitis second ECCO diagnostic criteria1. Patients treated with antiTNF, Vedolizumab and/or Ustekinumab were selected. Clinical effectiveness was evaluated at long-term. We defined clinical remission as returning to the previous stool frequency, no pain or defecatory urgency, clinical response as the improvement in these parameters without the achievement of remission and non-response as no change or worsening of these symptoms. We also compared the effectiveness of second biologic (antiTNF vs vedolizumab-ustekinumab) after antiTNF failure, using descriptive and comparative statistics. Results The cohort comprised 145 patients. Demographic and clinical characteristics are represented in Table 1. A total of 232 biologic therapies were indicated. Of the total cohort, 60 (41.3%), 21 (14.4%) and 6 (4.1%) used two, three and four lines, respectively. Biologics used were Infliximab (n=95), Adalimumab (n=69), Vedolizumab (n=35), Ustekinumab (n=26) and Golimumab (n=7). Therapy characteristics, clinical effectiveness, need for intensification, discontinuation, and therapy duration for each biological therapy are represented in Table 2. Global rates of clinical remission, response, non-response and loss of response to a first biologic were 21.8%, 27.5%, 21.1% and 29.6%. Female gender was the only factor associated with effectiveness to a first biologic in univariate analysis (OR 2.16, CI 1.08–4.32, p 0.027). There were no significant differences regarding efectiveness between type of pouch disorder (pouchitis vs CDP, 51.6 vs 47.6%, p 0.48) or biologic agents. Thirty-nine patients received a second biologic after prior antiTNF failure (28 a second antiTNF and 11 non-antiTNF: 6 Vedolizumab, 5 Ustekinumab). Basal characteristics in this subgroup showed no significant differences. Clinical response (21.4 vs 63.6%, p 0.02) and discontinuation therapy rates (82.2 vs 54.5 %, p 0.04) after 11 months showed a more favorable profile for non-antiTNF therapy. Conclusion Biologics represent an effective option in the management of pouchitis and Crohn′s like disease of the pouch. Despite our small sample size, non-antiTNF therapy could be the best option after antiTNF failure. 1Fernando Magro. J Crohns Colitis 2017; 11(6): 649–670.

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: A recently registered device containing 80 mg of adalimumab (ADA) allows an alternative dose escalation regimen with ADA 80 mg every other week (EOW) given as a single subcutaneous injection instead of 40 mg every week. The ADASCAL study evaluated the preferences and satisfaction of inflammatory bowel disease (IBD) patients after switching their ADA regimen from 40 mg weekly to 80 mg EOW given with a single-dose pen. Methods: In this multicentre cross-sectional study, patients in whom the ADA regimen was changed from 40 mg weekly to 80 mg EOW completed the Treatment Satisfaction Questionnaire for Medication (TSQM 1.4), a four-item questionnaire [a Likert-type 5-point scale for preferences, two closed questions for convenience and a 100-point visual analogue scale (VAS) to assess which escalated ADA regimen patients would prefer to continue] and two Health-Related Quality of Life (HRQoL) questionnaires: the generic European Quality of Life–5 Dimensions (EQ-5D) and disease-specific Spanish version of the Inflammatory Bowel Disease Questionnaire (SIBDQ-9). Results: In total, 77 patients (64 Crohn’s disease and 13 ulcerative colitis) were included. The TSQM score showed a notably high global satisfaction [83.4, standard deviation (SD) = 14.1] of patients with ADA 80 mg EOW given with a single-dose pen, with 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). Most of the patients (74%) preferred the ADA EOW regimen (59.7% had strong preference, 14.3% slight preference). ADA EOW interferes less with daily activity (59.7%) and with travel plans (81.8%). Most patients (77%) would prefer to continue with ADA EOW (mean VAS score of 84.7, SD = 24.1, where 100 indicates a preference for ADA EOW). Patients reported high HRQoL scores on both the EQ-5D (72.3, SD = 20.1) and SIBDQ-9 (75.1, SD = 14.7). 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 and therefore most decided to continue with a single self-injection EOW.

Background Pouchitis and other inflammatory pouch diseases (IPD) are frequent in pouch-carrying patients operated for a previous diagnosis of ulcerative colitis. We evaluated characteristics and differences in therapeutic requirements between pouchitis, Crohn′s-like disease of the pouch (CDP) and cuffitis. Methods This is a retrospective and multicentric Spanish cohort of GETECCU (RESERVO Study), including pouch-carrying patients (operated 1995 to 2016) with previous ulcerative colitis, ileostomy closure and subsequent diagnosis of IPD (pouchitis, CDP or cuffitis), following ECCO diagnostic criteria1. Follow up extended to June 2020. Pouchitis was categorized attending current classifications. Use of medical and surgical therapies was collected and differences between pouchitis and CDP were analyzed using descriptive and comparative statistics. Results A total of 338 patients were included. Demographic and clinical characteristics are presented in Table 1. The most frequent IPD was pouchitis (n=258, 76%), followed by CDP (n=55, 16%) and cuffitis (n=25, 7.4%). Pouchitis was diagnosed at a median time of 27 (range 1–342) months. Prevalence according to pouchitis classification is presented in Figure 1. CDP was diagnosed at a median time of 77 (range 5–324) months, around 75% with a previous pouchitis diagnosis. Location of CDP (not mutually excludent) was pouch CDP (91%), 87% pre-pouch ileitis, and 41% perianal disease. Regarding behavior: 26 (47%) were inflammatory, 12 (22%) stricturing and 17 (31%) penetrating (8 rectovaginal fistulas). Cuffitis was diagnosed at a median time of 18 (range 1–219) months. Medical and surgical therapies used are shown in Figure 2. Immunosuppressants (58.2 vs 22.4%, p 0.001), biologics (74.5 vs 34.8%, p 0.0001), and surgery (41.8 vs 21.3%, p 0.003) were more used in CDP than in pouchitis. Conclusion Pouchitis and CDP are heterogeneous inflammatory pouch complications with a wide and high therapeutic requirement. CDP presents a later diagnosis and has higher therapeutic needs than pouchitis. 1. Fernando Magro, Paolo Gionchetti, Rami Eliakim et al, for the European Crohn’s and Colitis Organisation [ECCO], Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 1: Definitions, Diagnosis, Extra-intestinal Manifestations, Pregnancy, Cancer Surveillance, Surgery, and Ileo-anal Pouch Disorders, J Crohns Colitis 2017; 11(6): 649–670.

Background Perianal Crohn’s disease (pCD) is difficult to treat. Although anti-TNF, are the medical mainstay in fistula treatment, many patients become refractory. Recent data suggested that ustekinumab (UST) might be effective in pCD. This study aims to assess the effectiveness of UST in refractory pCD in the real-world practice. Methods This is a retrospective cohort of patients with pCD treated with UST in our IBD Unit between march 2015 and october 2020. We analyze demographics, disease charactersistics, surgical for pCD and prior exposure including inmunomodulators and biologic agents. The success of UST was defined on the physician judgment (improvement or absence of drainage). In patients with inactive pCD we analyzed rate of relapse. To analyze predictive factors of treatment success we performed a univariate and multivariable analysis. Results Fifty three patients were included (54.72 % female). Twenty four of them were smokers. The median age was 54 years (45–62). The mean duration of CD was 19 years and 50.94% had an intestinal resection. Fifty one patients (96,22%) had been treated with at least 1 anti-TNF and 38 (71.7%) with at least 2 anti-TNF. Sixteen had failed to vedolizumab. The median follow-up was 26 months (15–36). Twenty two (22/53) had active pCD. Eleven (50%) had intensified UST out of technical sheet (8 with 90 mg sc every 4 to 6 w, and 3 had 130 mg iv every 4 w). Fifteen patients (68.18 %; p Two of 32 patients (6.45%) with inactive pCD relapsed during the follow-up. Eleven patients (20.75%) discontinued UST: 6/53 (11.3%) due to adverse events (infections and arthralgia), 4/53 (7,54) patient′s choice or physician judment. One patient who had been treated with four biologics before UST developed a pleomorphic cutaneous sarcoma Conclusion Ustekinumab might by an effective treatment in refractory pCD. More studies are needed to confirm our data

To evaluate effectiveness and safety of adalimumab in CD patients of the Madrid area and identify predictors of response.Multicenter retrospective survey of all CD patients treated with adalimumab in 9 hospitals of the Madrid area (Spain). Univariate and multivariate analysis of predictors of response was performed.174 patients included (50% males) with a median follow-up of 40 weeks. 30% had active perianal fistulizing disease at the beginning of the therapy with adalimumab. 59% had been previously treated with infliximab, being the lost of response (42.2%) the most frequent cause of withdrawal of the drug. 33% of patients needed dose escalation from every-other week to every week. The median time for this dose escalation was 33 weeks (range 2-120). The percentages of complete response at 4 weeks, 6 months and end of follow-up were 63, 70 and 63% in luminal disease and 49, 50 and 41% in perianal disease respectively. The prevalence of adverse events was 18% (most frequent was: 5 abscesses) causing the withdrawal of the drug in 21% of them.Adalimumab is effective and safe for the management of CD, even in refractory cases to infliximab.

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.

MP Martínez-Montiel, B Casis-Herce , GJ Gómez-Gómez, A Masedo-González, C Yela-San Bernardino, C Piedracoba, G Castellano-Tortajada Division of Gastroenterology, Hospital 12 de Octubre, Madrid, SpainAbstract: Although corticosteroids are an effective treatment for induction of remission in inflammatory bowel disease (IBD), many patients are dependent on or refractory to corticosteroids. This review is based on scrutinizing current literature with emphasis on randomized controlled trials, meta-analyses, and Cochrane reviews on the management of IBD refractory to corticosteroids. Based on this evidence, we propose algorithms and optimization strategies for use of immunomodulator and biologic therapy in IBD refractory to corticosteroids.Keywords: immunomodulators, anti-tumor necrosis factor alpha, Crohn's disease, ulcerative colitis, drug levels, treatment optimization

Background and aims: P atients with inflammatory bowel disease [IBD] are at increased risk for developing some types of neoplasia. Our aims were to determin the risk for cancer in patients with IBD and to describe the relationship with immunosuppressive therapies and clinical management after tumor diagnosis. Methods: R etrospective, multicenter, observational, 5-year follow-up, cohort study. Relative risk [RR] of cancer in the IBD cohort and the background population, therapeutic strategies, and cancer evolution were analyzed. Results: A total of 1 45 cancers were diagnosed in 133 of 9100 patients with IBD (global cumulative incidence 1.6% vs 2.4% in local population; RR = 0.67; 95% confidence interval [CI]: 0.57–0.78). Patients with IBD had a significantly increased RR of non-melanoma skin cancer [RR = 3.85; 2.53– 5.80] and small bowel cancer [RR = 3.70; 1.23–11.13]. After cancer diagnosis, IBD treatment was maintained in 13 of 27 [48.1%] patients on thiopurines, in 2 of 3 on methotrexate [66.6%], none on anti-TNF-α monotherapy [n = 6] and 4 of 12 [33.3%] patients on combined therapy. Rate of death and cancer remission during follow-up did not differ [p > 0.05] between patients who maintained the treatment compared with patients who withdrew [5% vs 8% and 95% vs 74%, respectively]. An association between thiopurines [p = 0.20] or anti-TNF-α drugs [p = 0.77] and cancer was not found. Conclusions: P atients with IBD have an increased risk for non-melanoma skin cancer and small bowel cancer. Immunosuppresive therapy is not related to a higher overall risk for cancer or worse tumor evolution in patients who maintain these drugs after cancer diagnosis.

A case is reported of collagenous gastrobulbitis on collagenous colitis in a 57-year-old woman with a 6-month history of watery diarrhea. Low serum levels of total proteins and albumin and increased fecal elimination of alpha1-antitrypsin were the only abnormal laboratory test results. Biopsy specimens from the colon, rectum, antrum, fundus, and duodenal bulb showed a thick subepithelial band composed of ultrastructurally normal collagen immunohistochemically negative for collagen IV and laminin. The diarrhea resolved with prednisone and responded to this treatment after a relapse 6 months later. One year later the patient developed severe alimentary intolerance and secondary weight loss. This symptom also responded to the same treatment. However, the collagen deposition did not disappear in the second biopsy samples of colonic and gastric mucosa. Only six cases have been previously reported with gastric and/or duodenal subepithelial collagenous deposition. Four were associated with collagenous colitis. One of these presented a subepithelial collagenous band in the terminal ileum. All these features suggest that this collagen deposition may affect the entire digestive tract with variable intensity, extension, and symptoms.

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.

Background: hyperhomocysteinemia has been recently described in patients with inflammatory bowel disease (IBD), that could be related to the increased risk for thrombosis that exists in this disease. The aim of this study was the assessment of hyperhomocysteinemia in patients with IBD and its relation among vitamin B12 and folate levels, and methylenetetrahydrofolate reductase (MTHFR) 677C→ T and 1298A→C mutations. Patients and methods: fifty two consecutive patients with IBD were studied (29 women and 23 men); age: mean (standard deviation 41.7 [11.9] years) and 186 controls with no difference in age and gender. Hyperhomocysteinemia was considered as homocysteine levels higher than mean plus two standard deviations of the control group (≥ 13 ∝mol/l). Results: patients had an elevated prevalence of hyperhomocysteinemia (17.3 vs. 3.7%; p = 0.002) and lower folate (7.6 [4.1] vs. 8.9 [3.7] ng/ml; p = 0.01) and B12 vitamin levels (499 [287] vs. 603 [231] pg/ml; p = 0.003). Homocysteinemia was higher (14.3 [5.8] vs. 9.1 [3.9] ∝mol/l; p = 0.006) in 6 patients (11.5%) that had suffered thromboembolism. Frequency of MTHFR 677C→T (13.5 vs. 11.3%; p = 0.66) and 1298A→C (7.8 vs. 7.0%; p = 0.76) mutations was not increased in patients. Odds ratio (OR) for IBD in hyperhomocysteinemic patient was 5.51, 95% confidence interval (CI), 1.81-16.76; p = 0.002). Hyperhomocysteinemia was negatively associated with feminine gender (OR 0.08, 95% CI 0.01-0.49; p = 0.006) and folate levels (OR 0.04, 95%CI: 0.007-0.20; p < 0.001). Conclusions: hyperhomocysteinemia is associated with IBD and low folate levels, and could be involved in development of thromboembolism. MTHFR 677C→T and 1298A→C mutations are not related with the disease.

Objective To evaluate the efficacy and toxicity of infliximab for the treatment of fistulizing Crohn's disease. Methods Consecutive patients with fistulizing Crohn's disease receiving infliximab were prospectively enrolled. Partial response was defined as a reduction of 50% or more from base-line in the number of draining fistulae. Complete response was defined as the closure of all fistulae. The influence of different variables on the efficacy of infliximab was evaluated. Results 108 patients were included. The disease was inflammatory plus fistulizing in 18% and only fistulizing in 82%. After the third infusion of infliximab the response was partial in 26% and complete in 57%. Response (%) rates (partial/complete) depending on fistula location were: enterocutaneous (25/68%), perianal (35/60%), rectovaginal (36/64%), and enterovesical (20/40%). None of the studied variables (including concomitant immunosuppressive therapy) correlated with efficacy of infliximab in the multivariate analysis. Incidence of adverse effects (21%) depending on the dose of infliximab was: first dose (5.6%), second (7.4%), and third (11.1%). Conclusions Infliximab is an efficacious treatment for fistulizing Crohn's disease. Partial response was achieved in approximately one third of the patients, and complete response in more than half. No studied variable was predictive of response. Adverse effects were relatively infrequent and mild.

DOP071 Inflammatory bowel diseases: a new cardiovascular risk factor? L. Caillo1 *, G. Danan1, V. Georgescu2, L. Papineau1, F. Gonzalez1, J.-F. Bourgaux3, F. Guillon4, G.-P. Pageaux1, R. Altwegg1 *. 1University Hospital of St Eloi, Departement of Hepatology and Gastroenterology, Montpellier, France, 2University Hospital, Department of Medical Information, Montpellier, France, 3University Hospital, Department of Hepatology and Gastroenterology, Nimes, France, 4University Hospital of St Eloi, Department of Digestive Surgery, Montpellier, France

Introduction: A significant proportion of Crohn's Disease (CD) patients have already been treated with two biologic therapies. Follow-up from current published retrospective or prospective open label studies on patients who have already received 2 biologics does not extend beyond 1 year (1-4) Methods: Our aim was to collect ‘real-life', long-term data on the tolerability and efficacy of the second biologic agent in (re)-capturing response, and to assess whether the reason for stopping the first agent impacted on the successful use of the second agent. We carried out secure data collection from 3 teaching IBD centres on CD patients currently on, or already failed a second biologic. We collected data on disease duration, distribution and behaviour, and report on the aetiology in the failure of the first biologic and the subsequent outcome of the second biologic agent. Response to biologics was assessed by Harvey Bradshaw Index or Physicians Global Assessment. Results: We collected data on 66 patients (F 46%, mean age at diagnosis: 25). The disease distribution was characterised as L1: 11%, L2:32% L3:56% L4:1% and the behaviour as B1: 41% B2: 35% B3: 24% . 17% of our cohort had perianal involvement. 36 patients have had a total of 41 resectional operations. 1st biologic: 64/66 patients had infliximab (IFX) first-line, followed by adalimumab (ADA), and 2/66 patients had ADA followed by IFX. Reasons for swapping were 1o failure in 23%, secondary-loss of response in 38%, intolerance to the first agent in 29%, and fear of hypersensitivity reaction due to previous episodic exposure to IFX in 10% (irrespective of efficacy or tolerance) 2nd biologic: 70% of patients remained on the second biologic after a median follow-up of 22 months. Reasons for discontinuing therapy were 1o failure in 35%, secondary loss of response in 25%, intolerance (or patient concerns regarding potential side-effects) in 25%, and achieving remission in 5%; no reason provided for the remainder 5%. Neither the demographics, disease characteristics nor the reason for failing the first biologic had a statistically significant bearing in predicting the initial response to and subsequent outcome of the second biologic. Conclusion: 1. We report an overall 70% retention on the second biologic at 22 months following all-cause failure of the first agent in CD patients from England and Ireland. 2. Patients responded equally well to the second biologic, irrespective of the reason for the failure of the first biologic. References: 1.Swaminath A et al, APT 2009 2. Seiderer J et al, APT 2007, Peyrin-Biroulet L et al, APT 2007, 4. Papadakis KA et al, AJG 2005.

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