Rita Monterubbianesi

Disease patterns in late-onset ulcerative colitis: Results from the IG-IBD “AGED study”

BACKGROUND Late-onset UC represents an important issue for the near future, but its outcomes and relative therapeutic strategies are yet poorly studied. AIM To better define the natural history of late-onset ulcerative colitis. METHODS In a multicenter retrospective study, we investigated the disease presentation and course in the first 3 years in 1091 UC patients divided into 3 age-groups: diagnosis ≥65years, 40-64 years, and <40years. Disease patterns, medical and surgical therapies, and risk factors for disease outcomes were analyzed. RESULTS Chronic active or relapsing disease accounts for 44% of patients with late-onset UC. Across all age-groups, these disease patterns require 3-6 times more steroids than remitting disease, but immunomodulators and, to a lesser extent, biologics are less frequently prescribed in the elderly. Advanced age, concomitant diseases and related therapies were found to be inversely associated with the use of immunomodulators or biologics, but not with surgery. CONCLUSIONS The conclusion that late-onset UC follows a mild course may apply only to a subset of patients. an important percentage of elderly patients present with more aggressive disease. Since steroid use and surgery rates did not differ in this subgroup, lower use of immunosuppressive therapy and biologics may reflect concerns in prescribing these therapies in the elderly.

Surgical and nonsurgical hospitalization rates and charges for patients with ulcerative colitis in Italy: A 10-year cohort study

BACKGROUND Today we are observing an increasing incidence of ulcerative colitis associated with an improved survival of patients. AIM To analyse current rates, outcomes, and costs of inpatient care for ulcerative colitis patients of central Italy. METHODS The cohort included 644 ulcerative colitis patients, living in the Lazio region, with diagnosis made or confirmed by the staff of a single tertiary referral centre in Rome (1997-2006). Follow-up data on hospitalization rates, costs, and colectomy rates were collected from the Regional Hospital Information System. RESULTS Overall hospitalization rates were 3 times higher than those of the regions general population, reflecting excess admissions for digestive or infectious diseases (standardized hospitalizations rates for digestive-tract: 15.9; for infectious diseases: 3.5). The overall cumulative risk for colectomy was 7.5%. On the average, hospitalizations for ulcerative colitis lasted 10 days. The mean reimbursement for a ulcerative colitis-related hospitalization was EUR 5120 (€4609 for nonsurgical admissions, €8655 for surgical hospitalizations). CONCLUSION Ulcerative colitis patients are 3 times more likely to be hospitalized than the general population. Colectomy rates in Italian ulcerative colitis patients resemble those of northern Europe, but most hospital admissions are for diagnostic procedures or medical therapy. Hospitalizations are almost twice as long as those reported in the United States although their mean cost is considerably lower.

P303 Ulcerative colitis (UC) in the elderly – Moderate at onset but then a milder course? An IG-IBD study

P302 Utility of “trough levels” determination and anti-infliximab antibodies in patients with inflammatory bowel disease. Estimation of individual pharmacokinetic parameters (PK) through population pharmacokinetic model G. Juan1,2 *, A. Alvarino3,4, L. Oltra4, N. Maroto4, N. Cano2, I. Ferrer2, J. Hinojosa2,4. 1Hospital de Manises, Farmacia Hospitalaria, Valencia, Spain, 2Hospital de Manises, Digestivo, Manises, Spain, 3Hospital de Manises, LABCO, Valencia, Spain, 4Hospital de Manises, Gastroenterology, Valencia, Spain

W1257 Infliximab for Severe Ulcerative Colitis: Short-Term and One Year Outcome of Three Dose Regimen. An Italian Multicentre Open-Label Study

and five negatives when the bridge ELISA assay was used. The three patients who were positive for HACA in the homogenous assay also had low levels of IFX in their serum. Conclusions: A novel non-radiolabeled liquid-phase homogeneous assay with high sensitivity, accuracy and reproducibility has been developed to measure the IFX and HACA levels in serum from patients treated with IFX. This automated assay provides an important tool for clinicians to monitor and relate the clinical status of patients with their HACA and drug levels at any time during the course of treatment.

The Time Course of Diagnostic Delay in Inflammatory Bowel Disease Over the Last Sixty Years: An Italian Multicentre Study

Background and Aims Inflammatory bowel disease [IBD] patients are still under-diagnosed or diagnosed with serious delay. We examined whether diagnostic delay [DD] in IBD has changed over the last 60 years, and explored the risk factors of longer DD. Methods In total, 3392 IBD patients recorded in the registry of four IBD Italian centres were divided according to the year of diagnosis into a historical cohort [HC: 1955-84] and modern cohort [MC: 1985-2014]. DD, i.e. time lapse between onset of symptoms indicative of IBD and definitive diagnosis, was divided into four sub-periods [0-6, 7-12, 13-24, >24 months], which were correlated with age and disease location/behaviour at diagnosis. Results Median DD in IBD was 3.0 months, it was significantly [P < 0.0001] higher in Crohns disease [CD] [7.1 months] than in ulcerative colitis [UC] [2.0 months], and did not differ either between the HC and the MC or over the last three decades. However, the proportion of patients with a DD>24 months was significantly [P < 0.0001] higher in the HC [26.0%] than in the MC [18.2%], and the same trend was evident over the last three decades [1985-94: 19.9%; 1995-2004: 16.4%; 2005-14: 13.9%; P = 0.04]. At logistic regression analysis, age at diagnosis >40 years (CD: odds ratio 1.73, 95% confidence interval [CI] 1.31-2.28, P < 0.0001; UC: 1.41, 95% CI 1.02-1.96, P = 0.04) and complicated disease at CD diagnosis [1.39, 95% CI 1.06-1.82, P = 0.02] were independently associated with a DD>24 months. Conclusions DD duration has not changed over the last 60 years in Italy, but the number of IBD patients with a longer DD significantly decreased. Older age at diagnosis and a complicated disease at CD diagnosis are risk factors for longer DD.

DOP093 Characterisation of incident cases of cancer in inflammatory bowel disease: A prospective multicenter matched-pair IG-IBD study

DOP093 Characterisation of incident cases of cancer in inflammatory bowel disease: A prospective multicenter matched-pair IG-IBD study L. Biancone1 *, C. Petruzziello1, A. Armuzzi2, M.L. Scribano3, R. D’Inca4, C. Papi5, L. Spina6, L. Guidi2, A. Kohn3, E. Calabrese1, G. Condino1, S. Onali1, F. Mocciaro7, R. Monterubbianesi3, P. Alvisi8, W. Fries9, G. Riegler10, F. Castiglione11, I. Frankovic4, G. Margagnoni5, R. Di Mitri7, G. Meucci12, F. Rogai13, S. Ardizzone14, A. Orlando15, F. Pallone1. 1Universita di Roma Tor Vergata, Medicina dei sistemi, cattedra di Gastroenterologia, Roma, Italy, 2Universita Cattolica, CIC, Roma, Italy, 3A.O.San Camillo Forlanini, Gastroenterology Unit, Rome, Italy, 4University of Padova, Gastroenterology Department, Padova, Italy, 5AO S. Filippo Neri, UOC GE/Hep, Roma, Italy, 6Universita S. Donato, Gastroenterologia, Milano, Italy, 7ARNAS Civico-Di Cristina-Benfratelli Hospital, Gastroenterology and Endoscopy Unit, Palermo, Italy, 8Ospedale Maggiore, Pediatria, Bologna, Italy, 9Universita di Messina, Medicina Interna, Messina, Italy, 10Seconda Universita Napoli, SUN, Napoli, Italy, 11Universita “Federico II” di Napoli, Gastroenterologia, Napoli, Italy, 12S. Giuseppe Hospital, Gastroenterology, Milano, Italy, 13AOU Careggi, Largo Brambilla, Gastroenterologia, Firenze, Italy, 14Luigi Sacco University Hospital, Gastroenterology Department, Milano, Italy, 15Ospedale Cervello, Medicina Interna, Palermo, Italy

Sustained Clinical Efficacy and Mucosal Healing of Thiopurine Maintenance Treatment in Ulcerative Colitis: A Real-Life Study

Background and Aims Thiopurines are commonly used for treating ulcerative colitis (UC), despite the fact that controlled evidence supporting their efficacy is limited. The aim of this study was to evaluate the long-term outcome of thiopurines as maintenance therapy in a large cohort of UC patients. Methods All UC patients receiving thiopurine monotherapy at three tertiary IBD centers from 1995 to 2015 were identified. The primary endpoint was steroid-free clinical remission. Secondary endpoints were mucosal healing (MH), defined as Mayo endoscopic subscore 0, long-term safety, and predictors of sustained clinical remission. Results We identified 192 patients, contributing a total of 747 person-years of follow-up (median follow-up 36 months, range 1–210 months). Steroid dependency was the most common indication for thiopurine treatment (58%). Steroid-free remission occurred in 45.3% of patients; 36.3% stopped thiopurines because of treatment failure and 18.2% for adverse events or intolerance. The cumulative probability of maintaining steroid-free remission while on thiopurine treatment was 87%, 76%, 67.6%, and 53.4% at 12, 24, 36, and 60 months, respectively. MH occurred in 57.9% of patients after a median of 18 months (range 5–96). No independent predictors of sustained clinical remission could be identified. Conclusions Thiopurines represent an effective and safe long-term maintenance therapy for UC patients.

Mo1264 Clinical Characteristics of Inflammatory Bowel Disease May Influence the Cancer Risk When Using Immunomodulators: Incident Cases of Cancer in a Multicenter Case-Control Study

anesthesia at the Surgical Department-San Camillo Forlanini Hospital from 1980 to 2012. Recto-vaginal and recto-urethral fistulas were excluded. The follow-up was calculated from diagnosis to the onset of a NO or to the end of observation. Patients were divided in 3 cohorts according to the time of diagnosis (A: 1980-’89, B: 1990-’99, C: 2000-’12). Results: 229 (47% females, median age 34 [range 9 74]) patients with perianal fistulas were analyzed; 19 with rectovaginal or recto-urethral fistulas were excluded. Out of 210 patients: 56 (27%) had ileal disease, 55 (26%) colonic, 98 (47%) ileocolonic involvement. Complex fistulas were diagnosed in 181 patients (160 transphincteric, 10 suprasphincteric, 11 extrasphincteric), 30 had simple fistulas (5 superficial, 25 intersphincteric), 103 rectal involvement. The follow up was 72 months, within this period 99% of patients underwent 1 surgical procedure, 58% underwent 2 or more procedures. The cumulative probability of disease free from NOs was 0.7, not influenced by the type of fistula, by the age at diagnosis or by the sex, and was not significantly different for the three cohorts. Conversely, the risk of NO was significantly related to localization of disease (colonic vs ileal disease, p = 0.001) and to rectal involvement (p = 0.002). Two or more surgical procedures were related to an increased risk of NO compared to a single one (p < 0.001). The risk was not significantly reduced by immunosuppressive or biological therapy. At multivariate analysis, the risk of NO was independently predicted by the number of surgical procedures (P= 0.009) and colic disease (P= 0.04). Conclusions: Our results suggest that in patients with perianal CD, the risk of NO is high, not influenced by the type of fistula but significantly related with disease localization, rectal involvement and need of more than one surgical procedure. Despite the introduction of biological and immunosuppressive treatments, the probability of negative outcomes did not change.

P.02.9 INCIDENT CASES OF CANCER IN IBD: CLINICAL CHARACTERISTICS OF IBD VS IMMUNOMODULATORS IN A PROSPECTIVE MULTICENTER CASE-CONTROL STUDY

effective non invasive monitoring could help clinicians in the management of Crohn’s disease (CD) patients treated with adalimumab. Aim of the study is to identify early predictors of long term clinical response during treatment with adalimumab. Material and methods: 68 patients with moderate to severe CD referred to a nurse-led outpatient clinic were prospectively enrolled from January 2009 to December 2011. All patients were treated with a 160–80 mg every other week (eow) induction protocol and maintained with 40 mg eow. Clinical activity (Harvey Bradshaw Index – HBI), faecal lactoferrin (LF), C reactive protein (CRP) were assessed at baseline, at the end of induction and 6 and 12 months after. Results: After induction, 42.3% of patients were in clinical remission and 37% responded showing at least a 2-points decrease in HBI. LF and CRP decreased significantly after the induction period (p<0.001 and p=0.02 respectively) and remained in the normal range throughout the maintenance period. 63% of patients in remission at the end of induction maintained remission at one year (p=0.02, OR=0.15), on the contrary only 36% of patients still active after induction were able to reach clinical remission at twelve months (p=0.009, OR=6.96). After twelve months 58.3% of patients were in remission according to HBI. 61% of patients achieving LF normalization at the end of induction were in clinical remission at one year (p=0.004, OR=0.06), while only 39% of patients with abnormal LF (p=0.004, OR=15.45). 95% patients with normal CRP after induction were in clinical remission at one year (p=0.003, OR=0.06), while only 4.5% of those showing abnormal CRP (p=0.003, OR=15.75). Linear regression models found that clinical remission combined with early CRP and LF normalization after induction is the best predictor of maintenance of clinical remission at one year. Conclusions: Clinical activity and biochemical markers performed at the end of induction proved to be reliable in predicting the course of CD in the long term maintenance treatment with adalimumab, therefore clinical and laboratory monitoring should be performed routinely in these patients.

P.80 INFLIXIMAB FOR SEVERE ULCERATIVE COLITIS: SHORT-TERM AND ONE YEAR OUTCOME OF THREE DOSE REGIMEN. AN ITALIAN MULTICENTRE OPEN-LABEL STUDY

and five negatives when the bridge ELISA assay was used. The three patients who were positive for HACA in the homogenous assay also had low levels of IFX in their serum. Conclusions: A novel non-radiolabeled liquid-phase homogeneous assay with high sensitivity, accuracy and reproducibility has been developed to measure the IFX and HACA levels in serum from patients treated with IFX. This automated assay provides an important tool for clinicians to monitor and relate the clinical status of patients with their HACA and drug levels at any time during the course of treatment.