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Ustekinumab is a monoclonal antibody used as treatment for various inflammatory conditions. We present a pediatric patient with Crohn’s disease who did not tolerate infliximab and was then changed to ustekinumab. He developed anaphylaxis to the medication after the second dose. A drug desensitization protocol was created by the allergy team leading to successful administration of both intravenous and then subcutaneous ustekinumab. As monoclonal agents become mainstays of therapy for inflammatory conditions, there are increased reports of allergic reactions. Prior reports and protocols of ustekinumab desensitization have not been reported. This case report highlights successful desensitization to ustekinumab as well as the importance of a multidisciplinary approach to addressing treatment needs of patients who develop life-threatening reactions to such medications.

Women and minorities are underrepresented in leadership positions in academic specialties. We investigated representation of women and minorities in selected leadership positions and in fellowships in North American academic pediatric gastroenterology programs (PGP) via voluntary surveys. We also assessed for factors influencing diversity. We found that 45.8% of Program Directors (PD), 75% of division chiefs (DC), and 71% of Pediatrics department chairs were men. Sixty-three percentage of the PG fellows were women. Most DCs were male professors. Most PDs, DCs, and department chairs were White (70%, 80%, and 88.3%), with Blacks being the least represented group in leadership and also among fellows. We found a higher likelihood of having a White PD if the department chair was White. We found gender and racial disparities in all PGP leadership positions. This data can serve as a guide in efforts to support diversity for both gender and race at all positions and academic ranks.

BACKGROUND: Racially disparate care has been shown to contribute to suboptimal health care outcomes for minorities. Using the ImproveCareNow network, we investigated differences in management and outcomes of pediatric patients with Crohn's disease at diagnosis and 1-year postdiagnosis. METHODS: ImproveCareNow is a learning health network for pediatric inflammatory bowel disease. It contains prospective, longitudinal data from outpatient encounters. This retrospective study included all patients with Crohn's disease ≤21 years, September 2006 to October 2014, with the first recorded encounter ≤90 days from date of diagnosis and an encounter 1 year ±60 days. We examined the effect of race on remission rate and treatment at diagnosis and 1 year from diagnosis using t-tests, Wilcoxon rank-sum tests, χ statistic, and Fisher's exact tests, where appropriate, followed by univariate regression models. RESULTS: Nine hundred seventy-six patients (Black = 118 (12%), White = 858 (88%), mean age = 13 years, 63% male) from 39 sites were included. Black children had a higher percentage of Medicaid insurance (44% versus 11%, P < 0.001). At diagnosis, Black children had more active disease according to physician global assessment (P = 0.027), but not by short Pediatric Crohn's Disease Activity Index (P = 0.67). Race differences in treatment were not identified. Black children had lower hematocrit (34.8 versus 36.7, P < 0.001) and albumin levels (3.6 versus 3.9, P = 0.001). At 1 year, Black children had more active disease according to physician global assessment (P = 0.016), but not by short Pediatric Crohn's Disease Activity Index (P = 0.06). CONCLUSIONS: Black children with Crohn's disease may have more severe disease than White children based on physician global assessment. Neither disease phenotype differences at diagnosis nor treatment differences at 1-year follow-up were identified.

Background. Maintenance of health leads to better outcomes in patients with chronic illness. ImproveCareNow, an international inflammatory bowel disease (IBD) quality improvement (QI) network, recommends maintenance-of-health visits twice a year. We identified a gap in care, with only 64% of IBD patients having documented visits within 200 days. Therefore, we sought to improve our follow-up rate to a goal of 80%. Methods. Using population management (PM) reports, we identified patient-, data-, and treatment-related reasons for no documented visit within 200 days. We used the Pareto chart, key drivers, and process flow mapping and implemented changes using Plan-Do-Study-Act (PDSA) cycles to improve follow-up visit rates. Outcomes were presented using a control run chart with pre- and post- intervention data. Results. The most common reasons for no visits were patient nonadherence with appointments (50%) and relocation/transition to an adult provider (25%). The median percentage of documented visits within 200 days increased from 64% to 83% (p<0.0001), and this increase has been sustained for one year. Conclusions. Using the PM tool and focused QI interventions improved data quality and the percentage of patients with a documented visit within 200 days. The process is simple and can be applied to patients with other chronic illnesses.

Background & Aims: Up to 30% of patients with Crohn's disease (CD) require surgery within the first 5 years from diagnosis. We investigated the recent risk of bowel surgery in an inception cohort of pediatric patients with CD and whether early use of biologics (tumor necrosis factor antagonists) alters later disease course. Methods: We collected data from the Pediatric Inflammatory Bowel Disease Collaborative Research Group registry on 1442 children (age, ó16 y) diagnosed with CD from January 2002 through December 2014. Data were collected at diagnosis, 30 days following diagnosis, and then quarterly and during hospitalizations for up to 12 years. Our primary aim was to determine the 10-year risk for surgery in children with CD. Our secondary aim was to determine whether early use of biologics (

BACKGROUND AND OBJECTIVE: Pediatric endoscopic procedures are essential in the evaluation and treatment of gastrointestinal diseases in children. Although pediatric endoscopists are greatly interested in increasing efficiency and through-put in pediatric endoscopy units, there is scarcely any literature on this critical process. The goal of this study was to improve the timeliness of pediatric endoscopy procedures at Children’s Hospital at Montefiore. METHODS: In June 2010, a pediatric endoscopy quality improvement initiative was formed at Children’s Hospital at Montefiore. We identified patient-, equipment-, and physician-related causes for case delays. Pareto charts, cause and effect diagrams, process flow mapping, and statistical process control charts were used for analysis. RESULTS: From June 2010 to December 2012, we were able to significantly decrease the first case endoscopy delay from an average of 17 to 10 minutes (P < .001), second case delay from 39 to 25 minutes (P = .01), third case delay from 61 to 45 minutes (P = .05), and fourth case delay from 79 to 51 minutes (P = .05). Total delay time decreased from 196 to 131 minutes, resulting in a reduction of 65 minutes (P = .02). From June 2010 to August 2011 (preintervention period), an average of 36% of first endoscopy cases started within 5 minutes, 51% within 10 minutes, and 61% within 15 minutes of the scheduled time. From September 2011 to December 2012 (postintervention period), the percentage of cases starting within 5 minutes, 10 minutes, and 15 minutes increased to 47% (P = .07), 61% (P = .04), and 79% (P = .01), respectively. CONCLUSIONS: Applying quality improvement methods and tools helped improve pediatric endoscopy timeliness and significantly decreased total delays.

OBJECTIVES To analyze the IBD5 locus in a homogenous cohort of Ashkenazi Jewish (AJ) children with Crohn disease (CD). PATIENTS AND METHODS A total of 83 AJ children with CD and 73 AJ healthy controls were studied. Genotyping for single nucleotide polymorphisms (SNPs) including OCTN1 (SLC22A4; 1672C-->T), OCTN2 (SLC22A5; 207G-->C), IGR2096, IGR2198, and IGR2230 genes was performed using the TaqMan system. NOD2/CARD15 variants also were typed using established methods. RESULTS All IBD5 SNPs tested were in linkage disequilibrium (D'>0.8), and showed significant association with CD in our cohort of AJ children. The IGR2096 SNP, which is not located within the same linkage disequilibrium block as the OCTN1 and 2 SNPs, showed an even stronger association with CD (P = 0.017; odds ratio = 1.7). Patients with CD who had the OCTN1 susceptibility allele were more likely to carry 1 of the 3 NOD2/CARD15 SNPs tested (P = 0.01; odds ratio = 4.8). CONCLUSIONS We have demonstrated a significant association between the IBD5 locus and CD in a homogenous cohort of pediatric AJ patients. Due to the tight linkage disequilibrium in the region, it is not possible to identify the causative IBD5 variant. Future functional studies will ultimately reveal the causative gene variant at this locus.

NOD2/CARD15 variants have recently been shown to be associated with Crohn's disease (CD). No analysis of NOD2/CARD15 gene variants has so far been reported in pediatric patients. Therefore, our aim was to analyze NOD2/CARD15 gene variants in children with CD and to perform genotype-phenotype analyses.We studied 101 children with CD and 136 healthy controls. Detailed phenotypic information was obtained from each patient. Patients were genotyped for the three NOD2/CARD15 variants R702W (single nucleotide polymorphism 8 [SNP8]), G908R (SNP12), and L1007fs (SNP13), and genotype-phenotype correlations were performed.We found 33 NOD2/CARD15 mutations in 29 of 101 patients (29%). The frequency of NOD2 variation was 31% in white (n=87) compared with 11% in controls (chi2=14; p=0.0001; OR=3.7; 95% CI=1.7-7.8). Four white patients but not control subjects were compound heterozygotes. NOD2/CARD15 variants were significantly associated with ileal disease (chi2=4.5; p=0.03; OR=5; 95% CI=0.9-35.9). Of the children with NOD2/CARD15 variants, 44% wereor =5th percentile for weight at diagnosis, whereas only 15% of children without mutations wereor =5th percentile (chi2=8.7; p=0.003; OR=4.5; 95% CI=1.4-14.4). Similar trends were observed for height but they did not reach statistical significance.Our results demonstrate that: 1) the three NOD2/CARD15 variants confer risk to CD in children; 2) NOD2/CARD15 variants are associated with ileal disease in children as in adults; and 3) NOD2/CARD15 variants are associated with lower weight percentiles at diagnosis in children and a tendency toward lower height percentile, suggesting an association between growth in children with CD.

A wide range of cholestatic liver diseases result from various primary defects in bile formation. Clinical features include jaundice, pruritus, failure to thrive, fat malabsorption, cholelithiasis, and variably progressive cirrhosis. Accurate diagnosis of these disorders is essential for determination of prognosis and selection of the most appropriate therapies. Severe genetic defects in canalicular bile acid and phospholipid excretion lead to progressive liver disease that often requires liver transplantation. Defects in bile acid biosynthesis and aminophospholipid transport may be responsive to medical or non-transplant surgical approaches.

OBJECTIVES Gender equality in the workplace has not been described in pediatric gastroenterology. METHODS An electronic survey that explored perceptions of career parity, work-life balance, and workplace harassment was sent to all members of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. Reponses were anonymous. RESULTS Of the 303 respondents (21%), there was an even distribution across geographic region, age, and gender (54% men). Gender affected perception of salary and promotion; 46% of men but only 9% of women feel that "women earn the same as men" (P

Variations in chronic illness care are common in our health care system and may lead to suboptimal outcomes. Specifically, inconsistent use and suboptimal medication dosing have been demonstrated in the care of patients with inflammatory bowel disease (IBD). Quality improvement (QI) efforts have improved outcomes in conditions such as asthma and diabetes mellitus, but have not been well studied in IBD. We hypothesized that QI efforts would lead to improved outcomes in our pediatric IBD population.A QI team was formed within our IBD center in 2005. By 2007, we began prospectively capturing physician global assessment (PGA) and patient-reported global assessment. Significant QI interventions included creating evidence-based medication guidelines, joining a national QI collaborative, initiation of preclinic planning, and monitoring serum 25-hydroxyvitamin D.From 2007 to 2010, 505 patients have been followed at our IBD center. During this time, the frequency of patients in clinical remission increased from 59% to 76% (P 0.05), the frequency of patients who report that their global assessment is7 increased from 69% to 80% (P 0.05), and the frequency of patients with a Short Pediatric Crohn's Disease Activity Index (sPCDAI)15 increased from 60% to 77% (P 0.05). The frequency of repeat steroid use decreased from 17% to 10% (P 0.05). We observed an association between the use of a vitamin D supplement (P = 0.02), serum 25-hydroxyvitamin D (P 0.05), and quiescent disease activity.Our results show that significant improvements in patient outcomes are associated with QI efforts that do not rely on new medication or therapies.

Although it is known that extraintestinal manifestations (EIMs) commonly occur in pediatric inflammatory bowel disease (IBD), little research has examined rates of EIMs and their relation to other disease-related factors in this population. The purpose of this study was to determine the rates of EIMs in pediatric IBD and examine correlations with age, sex, diagnosis, disease severity, and distribution.Data were prospectively collected as part of the Pediatric IBD Collaborative Research Group Registry, an observational database enrolling newly diagnosed IBD patients16 years old since 2002. Rates of EIM (occurring anytime during the period of enrollment) and the aforementioned variables (at baseline) were examined. Patients with indeterminate colitis were excluded from the analysis given the relatively small number of patients.One thousand nine patients were enrolled (mean age 11.6 +/- 3.1 years, 57.5% boys, mean follow-up 26.2 +/- 18.2 months). Two hundred eighty-five (28.2%) patients experienced 1 or more EIMs. Eighty-seven percent of EIM occurred within the first year. Increased disease severity at baseline (mild vs moderate/severe) was associated with the occurrence of any EIM (P0.001), arthralgia (P = 0.024), aphthous stomatitis (P = 0.001), and erythema nodosum (P = 0.009) for both Crohn disease (CD) and ulcerative colitis (UC) during the period of follow-up. Statistically significant differences in the rates of EIMs between CD and UC were seen for aphthous stomatitis, erythema nodosum, and sclerosing cholangitis.EIMs as defined in this study occur in approximately one quarter of pediatric patients with IBD. Disease type and disease severity were commonly associated with the occurrence of EIMs.

Infliximab is effective in treating moderate/severe ulcerative colitis (UC) in adults. The aim of this study was to determine the outcome after treatment with infliximab in pediatric UC.We performed a multicenter cohort study of 332 pediatric patients with UC enrolled in the Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry. Childrenor=16 years of age and newly diagnosed with UC are enrolled in the registry. Disease and medication information are collected prospectively from the treating physician at diagnosis, 30 days, and quarterly thereafter. No interventions were specified, per protocol.Of 332 patients, 52 (16%) received infliximab (23%3 months from diagnosis, 38% 3-12 months, 38%12 months). Mean age at infliximab initiation was 13.3+/-2.6 (range 6-17) years; 87% of patients had pancolitis. Median follow-up was 30 months. Continuous maintenance (CM) therapy was given in 65%, episodic in 21%, episodic converted to CM in 6%, and insufficient data in 8% of patients. Sixty-three percent of patients were corticosteroid refractory, and 35% were corticosteroid dependent. Concomitant medications at first infliximab infusion included corticosteroids (87%), thiopurines (63%), and 5-aminosalicylates (51%). Corticosteroid-free inactive disease by physician global assessment was noted in 12/44 (27%), 15/39 (38%), and 6/28 (21%) patients at 6, 12, and 24 months, respectively. Kaplan-Meier analysis showed that the likelihood of remaining colectomy free after treatment with infliximab was 75% at 6 months, 72% at 12 months, and 61% at 2 years.In this cohort of children with UC receiving infliximab, corticosteroid-free inactive disease was observed in 38 and 21% of patients at 12 and 24 months, respectively. By 24 months, 61% of patients had avoided colectomy.

To investigate the safety profile of acquiring additional intestinal biopsies for research purposes in children undergoing a medically indicated colonoscopy.A retrospective review of 122 pediatric patients who underwent colonoscopy over a 9 mo time period was completed. 38/122 participants consented to a research study in which 4 additional biopsies were obtained, in addition to routine biopsies. The outcomes after colonoscopy were measured in the research participants, and compared to 84 control participants who did not consent for the study. Groups were compared with regard to number of biopsies obtained, underlying diagnosis, and both serious and minor adverse outcomes. Data was collected including: age, gender, race, indication, diagnosis, number of biopsies obtained per case and post procedure adverse events. Medical records were reviewed and a questionnaire was completed by each of the ten gastroenterologists who performed procedures during the study. Physicians were asked about individual patient outcomes to ensure that all adverse events, such as perforation, excessive bleeding, infection, and minor gastrointestinal outcomes, were captured and included.The research group had more biopsies obtained (mean = 13.58 ± 4.21) compared to controls (mean = 9.33 ± 4.40), P ≤ 0.0001, however there was no difference in adverse events. Serious outcomes, defined as perforation, bleeding and infection, did not occur, in either group. As such, the relationship between serious adverse events and number of biopsies obtained was not determined. Minor gastrointestinal outcomes, such as abdominal pain, diarrhea or vomiting, were reported in 21 patients (8 research participants and 13 control participants) however the incidence of minor gastrointestinal outcomes between the two groups did not vary significantly, P = 0.45. Additionally, the mean number of biopsies obtained in patients who had a minor outcome (mean = 12.1 ± 0.77), compared to those with no adverse outcome (mean = 10.34 ± 0.5), revealed no statistical difference between the groups (P = 0.12), suggesting that number of biopsies is not associated with incidence of minor adverse events.Patients participating in research requiring acquisition of additional biopsies for research purposes alone, are not at an increased risk of adverse outcomes.

O-11 Real world outcomes of contemporary treatments in children with Crohn’s disease: observations from the pediatric IBD collaborative research group registry J. Markowitz1 *, T. Lerer2, J. Morganstern2, C. Deslandres2, G. Tomer2, M. Schaefer3, S. Kugathasan2, W. Faubion2, M. Kappelman2, B. Sudel2, M. Hitch2, D. Keljo2, A. Grossman2, R. Carvalho2, N. Leleiko2, S. Saeed2, M. Oliva-Hemker2, M. Kay2, J. Rosh2, M. Pfefferkorn2, A. Otley2, J. Rick2, D. Mack2, J. Cabrera2, A. Griffiths2, J. Hyams2. 1Cohen Children’s Medical Center of NY, Lake success, United States of America, 2The Pediatric IBD Collaborative Research Group, Hartford, United States of America, 3The Pediatric IBD Collaborative Group, Hartford, United States of America

Background & Aims We examined the incidence of Crohn's disease (CD)-related surgery in a multi-center, inception cohort of pediatric patients with CD. We also examined the effect of starting immunomodulator therapy within 30 days of diagnosis. Methods Data from 854 children with CD from the Pediatric Inflammatory Bowel Disease Collaborative Research Group who were diagnosed with CD between 2002 and 2008 were analyzed. Results Overall, 76 (9%) underwent a first CD-related surgery, 57 (7%) underwent a first bowel surgery (bowel resection, ostomy, strictureplasty, or appendectomy), and 19 (2%) underwent a first non-bowel surgery (abscess drainage or fistulotomy). The cumulative risks for bowel surgery, non-bowel surgery, and all CD-related surgeries were 3.4%, 1.4%, and 4.8%, respectively, at 1 year after diagnosis and 13.8%, 4.5%, and 17.7%, respectively, at 5 years after diagnosis. Older age at diagnosis, greater disease severity, and stricturing or penetrating disease increased the risk of bowel surgery. Disease between the transverse colon and rectum decreased the risk. Initiation of immunomodulator therapy within 30 days of diagnosis, sex, race, and family history of inflammatory bowel disease did not influence the risk of bowel surgery. Conclusions In an analysis of pediatric patients with CD, the 5-year cumulative risk of bowel surgery was lower than that reported in recent studies of adult and pediatric patients but similar to that of a recent retrospective pediatric study. Initiation of immunomodulator therapy at diagnosis did not alter the risk of surgery within 5 years of diagnosis.

Aim: 30% of patients hospitalized with severe UC prove steroid-refractory. We aimed to evaluate outcomes and predictors of response to infliximab as rescue therapy in severe pediatric UC. Methods: As part of a prospective multicenter study, we evaluated factors associated with immediate and 1-year response to infliximab in steroid-refractory severe pediatric UC. Data were recorded at admission, days 3 and 5, at introduction of infliximab, at discharge and 1-year thereafter, using standardized data collection forms. Disease activity was determined using the validated Pediatric UC Activity Index (PUCAI). Serum TNF alpha level was determined before infliximab treatment using a cytokine antibody panel (TransSignal, CA). Concurrently, fecal calprotectin and lactoferrin levels were ascertained using standard assays in a central laboratory. Results: Of 128 children admitted, 33 failed steroids and treated with infliximab within 10.5±6 days. Mean PUCAI score at introduction of infliximab was 66±13 points, indicating persistence of severe colitis. 25/33 children (76%) responded and were discharged within 5±4 days of infliximab therapy; 7 in complete clinical remission (PUCAI 0.2). CRP, ESR, albumin and hemoglobin were not predictive of response to infliximab. Neither fecal calprotectin nor lactoferrin values were predictive of response (area under ROC curve 0.61 and 0.63, respectively; P>0.2). Serum TNF-alpha level was similar between responders and non-responders (10.6pg/ml (IQR 4-30) vs. 8.3pg/ml (5.7-11); P=0.4). 8 of the 25 responders received only 3-dose induction, and the others continued maintenance therapy without concomitant immunomodulation. Cumulative 1-year sustained response rate was 55% (18/33). There were no deaths and only 1 patient stopped treatment due to infusion reaction. Conclusion: Infliximab is safe and effective in inducing and maintaining clinical remission in steroid-refractory pediatric UC. Serum TNF-alpha level and fecal biomarkers are not useful in predicting outcome, but higher disease severity, judged clinically, and new onset disease are associated with reduced response.

Background: Children with severe ulcerative colitis resistant to corticosteroids either need to undergo surgery or be treated with more intensive immunosuppression (e.g. cyclosporine, tacrolimus, infliximab). The short and long term efficacy of such therapies is not well described in children. Methods: From 1994 to 2008, 52 children (26M; mean age 13y, range 4-21 y) with steroid-refractory colitis were treated with tacrolimus at our institution. Medical record reviewwas performed on these patients. Data extracted allowed the calculation of the Pediatric Ulcerative Colitis Activity Index (PUCAI). In addition, other measures of disease activity, adverse events, and long-term outcomes were assessed. Statistical analysis of outcomes was performed using SAS statistical software. Results: Out of 52 patients, 46 were treated with tacrolimus with the intent to transition to maintenance medical therapy, while 6 were treated to allow corticosteroid weaning prior to elective colectomy. The median dose of tacrolimus utilized was 0.2 mg/kg/day (range 0.1-0.5 mg/kg/day) in two divided doses; the median trough level during induction therapy was 11 ng/ml. The median length of stay after the institution of tacrolimus was 10 days (range 3-37 days). The mean PUCAI score was 66.8 (±14.3 SD) prior to the initiation of tacrolimus therapy, and 21.9 (±14.8 SD) at time of hospital discharge. Of the 46 patients that were treated with the aim of postponing surgery, 43/46 (94%) were discharged without surgery. Patients were maintained on tacrolimus for 3 to 6 months (median 114 days), and transitioned to maintenance therapy (6MP, AZA, or infliximab). The probability of colectomy in this patient cohort was 7% at 1 month, 14% at 3 months, 30% at 12 months, and 57% at 25 months. No colectomies were performed in patients followed for longer than 25 months (longest follow-up 13 years). The most common adverse events noted in the first three months included tremor (32%), hypertension (21%), infections (9%), creatinine >1.5 x baseline (9%), and hyperglycemia (8%). These adverse effects resolved with weaning of steroids or transition to maintenance therapy. Conclusion: Tacrolimus is effective induction therapy in corticosteroid refractory colitis, and is generally well tolerated. However, many patients will develop exacerbations of colitis upon transition to maintenance therapies. The long term colectomy rate in this challenging population remains approximately 60% over time.

Azathioprine (AZA) and 6-mercaptopurine (6MP) are well established treatments for adults and children with inflammatory bowel disease (IBD). However, up to 40% of patients do not respond, at times because of an individual's preferential metabolism of the thiopurine to an inactive and potentially hepatotoxic metabolite, 6-methylmercaptopurine (6MMP), rather than the active 6-thioguanine nucleotides (6TGN) (Dubinsky et al., 2002). The use of allopurinol in AZA/6MP treated adults with preferential 6MMP production has improved levels of 6TGN, reduced 6MMP and been associated with clinical improvement (Sparrow et al., 2005, 2007). Parents of children with IBD and preferential 6MMP metabolism have been offered the opportunity to initiate similar therapy for their children when clinical circumstances warranted a change in therapy. We describe the clinical outcomes of children receiving allopurinol with low dose AZA/6MP versus alternative therapies. Methods: Retrospective chart review identified children who were poor responders to AZA/6MP and had preferential production of 6MMP (defined as 6MMP/6TGN ratio >11). Poor AZA/6MP response was defined as any of the following: 1) persistent IBD-related symptoms, 2) elevated transaminases 3) steroid dependence. Subjects were grouped according to therapeutic intervention (Grp1: allopurinol and reduced dose AZA/6MP; Grp2: other therapies). Clinical goals for each subject were defined at initiation of therapy and response defined as achieving the goals by 3-6 months after beginning treatment. Thiopurine metabolites pre and post therapy were also determined. Results: 27 children had 6MMP/6TGN >11 (mean age 12.4 yrs, 63% male, 20 Crohn, 7 UC). 14 received allopurinol (Grp1), and 13 (Grp2) alternative therapies (infliximab, methotrexate, surgery, adjusted 6MP/AZA dose, 5ASA). Clinical goals were achieved in 12/14 Grp1 subjects and only 4/13 Grp2 subjects (p

G A A b st ra ct s start time & polyp yield. Methods: We performed a controlled before & after study of patients receiving screening, surveillance, or diagnostic colonoscopies at a University-based VA medical Center. We compared the relationship between polyp yield and start time in our historical cohort (pre period) vs a 3-month intervention (post period) in which 3'x2' informational posters were placed in endoscopy rooms within view of operators & nurses. The poster depicted a bar graph of the previously documented hour-by-hour drops in polyp yield coupled with prominent text: “What time is it now?” The primary outcome was number of polyps reported by the endoscopist. We first measured the unadjusted relationship between colonoscopy start time and polyp yield for each period. We then performed logistic regression to measure the effect of start time on polyp yield while adjusting for period and other covariates. Finally, we created a time*polyp interaction term, and performed regression to evaluate whether period predicted the time-polyp relationship. Results: There were 494 & 108 patients in the pre & post periods, respectively. More polyps were found in the pre vs. post periods (2.1 vs 1.6 polyps per patient; p

Background: Children with severe ulcerative colitis resistant to corticosteroids either need to undergo surgery or be treated with more intensive immunosuppression (e.g. cyclosporine, tacrolimus, infliximab). The short and long term efficacy of such therapies is not well described in children. Methods: From 1994 to 2008, 52 children (26M; mean age 13y, range 4-21 y) with steroid-refractory colitis were treated with tacrolimus at our institution. Medical record reviewwas performed on these patients. Data extracted allowed the calculation of the Pediatric Ulcerative Colitis Activity Index (PUCAI). In addition, other measures of disease activity, adverse events, and long-term outcomes were assessed. Statistical analysis of outcomes was performed using SAS statistical software. Results: Out of 52 patients, 46 were treated with tacrolimus with the intent to transition to maintenance medical therapy, while 6 were treated to allow corticosteroid weaning prior to elective colectomy. The median dose of tacrolimus utilized was 0.2 mg/kg/day (range 0.1-0.5 mg/kg/day) in two divided doses; the median trough level during induction therapy was 11 ng/ml. The median length of stay after the institution of tacrolimus was 10 days (range 3-37 days). The mean PUCAI score was 66.8 (±14.3 SD) prior to the initiation of tacrolimus therapy, and 21.9 (±14.8 SD) at time of hospital discharge. Of the 46 patients that were treated with the aim of postponing surgery, 43/46 (94%) were discharged without surgery. Patients were maintained on tacrolimus for 3 to 6 months (median 114 days), and transitioned to maintenance therapy (6MP, AZA, or infliximab). The probability of colectomy in this patient cohort was 7% at 1 month, 14% at 3 months, 30% at 12 months, and 57% at 25 months. No colectomies were performed in patients followed for longer than 25 months (longest follow-up 13 years). The most common adverse events noted in the first three months included tremor (32%), hypertension (21%), infections (9%), creatinine >1.5 x baseline (9%), and hyperglycemia (8%). These adverse effects resolved with weaning of steroids or transition to maintenance therapy. Conclusion: Tacrolimus is effective induction therapy in corticosteroid refractory colitis, and is generally well tolerated. However, many patients will develop exacerbations of colitis upon transition to maintenance therapies. The long term colectomy rate in this challenging population remains approximately 60% over time.