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Odds ratios (95% confidence intervals) for multiple regression analysis for predictors of severe, moderate and mild disease relative to remission *p value <0.05 Tu1189 Effect of Anti-TNFα Therapy on Prevalence of Depression in Patients With Inflammatory Bowel Disease Dustin E. Loomes, Alexandra E. Dittrich, Karen Madsen, Levinus A. Dieleman, Brendan P. Halloran, Richard N. Fedorak, Karen I. Kroeker Background: Inflammatory bowel disease (IBD) is a chronic inflammatory condition associ- ated with significant morbidity, including psychiatric disease such as depression. The preva- lence of depression, and the effect of anti-tumor necrosis factor alpha (TNFα) therapy on cognitive and somatic symptoms is not yet fully understood. Objectives: To examine (1) the prevalence of depression, using the validated Beck Depression Inventory-II (BDI-II) in patients with IBD, and (2) the association between depression with anti-TNFα therapy, disease type, disease activity, CRP, anemia, fatigue, and health related quality of life (HRQoL). Methods: Using a cross-sectional design in adult outpatients with a confirmed diagnosis of IBD, participants completed questionnaires assessing depression (BDI-II), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)), and HRQoL (Short IBD Question- naire (SIBDQ)). The BDI-II is categorized into minimal (0-13), mild (14-19), moderate (20- 28) and severe (29-63) depression, and can be grouped into cognitive and somatic domains. Demographic characteristics were also obtained. Results: Two hundred and ninety-five patients (50.8% female) with IBD (69.8% CD), including 55.2% anti-TNFα were enrolled. The prevalence of mild (14.2%), moderate (11.5%), and severe (7.5%) depressive symptoms in IBD patients was higher than reported population prevalences (13.7%; 7.1%; 2.1%, respectively). The proportion of depressed female patients (37.3%) was not statistically different to that of depressed males (28.9%, p=0.13). There was a trend seen in mean BDI- II scores between CD (12.4±10.0) and UC (10.2±8.4, p=0.07) patients. Anti-depressant use (17.1±11.8, p=0.002), clinical assessment of active disease (15.0±10.0, p<0.001), and steroid use (14.1±11.0, p=0.043) were associated with a higher mean depression inventory, but anti-TNFα use (12.4±9.8, p=0.17), high CRP (13.5±9.3, p=0.29), and anemia (13.4±10.6, p=0.25) were not significantly different. In depressed patients, mean HRQoL scores (SIBDQ 3.7±1.4) were significantly lower than non-depressed patients (5.2±1.5, p<0.001). Somatic scores were significantly higher in IBD patients with features of active disease (7.7±4.2 vs 5.1±3.7, p=0.005) or high CRP (7.4±4.0 vs 5.8±4.3, p<0.001). Conversely, those with antiTNFα therapy had significantly more cognitive depressive symptoms (6.3±6.1 vs 4.9±5.7, p=0.047) than those not on biologics, but not somatic symptoms (6.2±4.1 vs 6.0±4.2, p= 0.69). Conclusions: Prevalence of depression in adult outpatient IBD practice is significantly higher compared with the general population, especially in those patients with active disease. AntiTNFα therapy was associated with increased cognitive, but not somatic depressive symp- toms. S-779 AGA Abstracts Tu1190 Clinical Outcome and Prediction of Final Diagnosis in Pediatric Inflammatory Bowel Disease Unclassified (IBD-U) Patients Tatyana Hofmekler, Cary Sauer, Scott Gillespie, Courtney McCracken, Madeline Bertha, Thomas D. Walters, Lee Denson, Anne M. Griffiths, Marla Dubinsky, James Markowitz, Robert Baldassano, Wallace Crandall, Joel R. Rosh, Marian D. Pfefferkorn, Anthony R. Otley, Melvin B. Heyman, Neal S. Leleiko, Susan S. Baker, Stephen L. Guthery, Jonathan Evans, David Ziring, Richard Kellermayer, Michael C. Stephens, David R. Mack, Maria Oliva-Hemker, Ashish S. Patel, Barbara S. Kirschner, Dedrick E. Moulton, Stanley A. Cohen, Michael Kappelman, Jeffrey S. Hyams, Subra Kugathasan Approximately 10% of patients with IBD are diagnosed with IBD-unclassified (IBD-U). Due to diagnostic ambivalence these patients may experience delayed standard treatment for UC and CD. A diagnosis of IBD-U often precludes enrollment in clinical trials specific to CD or UC. IBD-U may be associated with higher relapses, poor surgical outcomes and higher risk of cancer. Prospective studies examining pediatric IBD-U patients are lacking. Aim: To test the hypothesis that pediatric patients diagnosed with IBD-U comprise a distinct clinical entity compared with UC and CD. Data were obtained from the RISK study, an ongoing, prospective observational research program started in 2008 that includes 28 centers in North America. Children under 17 years with newly diagnosed IBD were enrolled from 2008 to 2011. A site investigator established a diagnosis of IBD-U in the setting of colon- only IBD, without small bowel involvement, and accompanied by endoscopic and histological features that did not allow a firm diagnosis of CD or UC. Of the 1400 patients enrolled, 134 (10%) were labeled IBD-U at baseline and followed for a mean of two years. Baseline characteristics are given in Table 1. During the follow up, patients either remained as IBD- U or were reclassified as CD or UC when the disease evolved. Baseline characteristics were compared to determine differences predictive of final diagnoses. Change in PGA scores was compared across the treatment types. Multiple logistic regressions were used to identify risk factors associated with a final diagnosis of UC or CD. Of the 134 IBD-U patients, 26 (24.1%) had a subsequent diagnosis of CD, 39 (36.1%) UC, and 69 (51.5%) remained IBD-U. Gender or age at diagnosis did not differ among the groups (Table 1). In children with IBD-U, PGA improved most with early therapy of steroids and immunomodulators/biologics. During follow up, patients that remained IBD-U or were diagnosed with CD had higher levels of ASCA compared with UC patients. Both CD and UC patients had higher ANCA levels compared with IBD-U patients. More CD and UC patients had NOD2 variants compared with IBD-U. Logistic regression models indicated elevated ANCA and CBir levels as risk factors associated with CD (AUC=0.743), whereas elevated ANCA and low ASCA levels were associated with UC (AUC=0.732). In a well-characterized cohort of 134 children with IBD-U at diagnosis, half remained IBD-U at 2 years. Those who remained IBD-U had mild to moderate PGA at diagnosis. Factors that predict change to CD include ASCA, ANCA, NOD2, CBir; factors that predict change to UC include ANCA and low ASCA. Those remaining IBD-U tend to be sero-negative and lack genetic markers suggesting a different pathogenesis plays a role in persistent IBD-U. Table 1: Baseline characteristics by Clinical Diagnosis (N=134) 1 Pairwise comparisons indicated significant differences between CD and UC (p = 0.015) and IBD-U and UC (p = 0.01). 2 Pairwise comparisons indicated significant differences between CD and IBD-U (p = 0.040) and UC and IBD-U (p = 0.001). * designates significant differences across the IBD groups Tu1191 There's an App for That—Measuring Disease-Specific Knowledge and Mood in Children With Inflammatory Bowel Disease Jeanne Tung, John Grunow, Noel J. Jacobs Background: Data suggests physicians poorly assess disease-specific literacy and transition readiness in pediatric patients with inflammatory bowel disease (IBD). Tools to test knowledge in a clinic setting are lacking. Aim: We piloted an electronic ipad game, with the aims of 1) measuring IBD and transition related knowledge in a pediatric IBD population, and 2) measure concomitant mood and quality of life (QOL), modifying it based on expert opinion as well as medical team and patient feedback. Methods: Two pediatric IBD clinics developed and tested 2 versions of Emma, an interactive iPad-based educational game. Patients between 10-18 years of age played Emma during an office visit, allowing clinicians to review results and provide teaching. Each patient answered 12 randomly selected disease-related questions AGA Abstracts

Tu1189 Effect of Anti-TNFα Therapy on Prevalence of Depression in Patients With Inflammatory Bowel Disease

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Odds ratios (95% confidence intervals) for multiple regression analysis for predictors ofsevere, moderate and mild disease relative to remission

*p value <0.05

Tu1189

Effect of Anti-TNFα Therapy on Prevalence of Depression in Patients WithInflammatory Bowel DiseaseDustin E. Loomes, Alexandra E. Dittrich, Karen Madsen, Levinus A. Dieleman, Brendan P.Halloran, Richard N. Fedorak, Karen I. Kroeker

Background: Inflammatory bowel disease (IBD) is a chronic inflammatory condition associ-ated with significant morbidity, including psychiatric disease such as depression. The preva-lence of depression, and the effect of anti-tumor necrosis factor alpha (TNFα) therapy oncognitive and somatic symptoms is not yet fully understood. Objectives: To examine (1)the prevalence of depression, using the validated Beck Depression Inventory-II (BDI-II) inpatients with IBD, and (2) the association between depression with anti-TNFα therapy,disease type, disease activity, CRP, anemia, fatigue, and health related quality of life (HRQoL).Methods: Using a cross-sectional design in adult outpatients with a confirmed diagnosis ofIBD, participants completed questionnaires assessing depression (BDI-II), fatigue (FunctionalAssessment of Chronic Illness Therapy-Fatigue (FACIT-F)), and HRQoL (Short IBD Question-naire (SIBDQ)). The BDI-II is categorized into minimal (0-13), mild (14-19), moderate (20-28) and severe (29-63) depression, and can be grouped into cognitive and somatic domains.Demographic characteristics were also obtained. Results: Two hundred and ninety-fivepatients (50.8% female) with IBD (69.8% CD), including 55.2% anti-TNFα were enrolled.The prevalence of mild (14.2%), moderate (11.5%), and severe (7.5%) depressive symptomsin IBD patients was higher than reported population prevalences (13.7%; 7.1%; 2.1%,respectively). The proportion of depressed female patients (37.3%) was not statisticallydifferent to that of depressed males (28.9%, p=0.13). There was a trend seen in mean BDI-II scores between CD (12.4±10.0) and UC (10.2±8.4, p=0.07) patients. Anti-depressant use(17.1±11.8, p=0.002), clinical assessment of active disease (15.0±10.0, p<0.001), and steroiduse (14.1±11.0, p=0.043) were associated with a higher mean depression inventory, butanti-TNFα use (12.4±9.8, p=0.17), high CRP (13.5±9.3, p=0.29), and anemia (13.4±10.6,p=0.25) were not significantly different. In depressed patients, mean HRQoL scores (SIBDQ3.7±1.4) were significantly lower than non-depressed patients (5.2±1.5, p<0.001). Somaticscores were significantly higher in IBD patients with features of active disease (7.7±4.2 vs5.1±3.7, p=0.005) or high CRP (7.4±4.0 vs 5.8±4.3, p<0.001). Conversely, those withantiTNFα therapy had significantly more cognitive depressive symptoms (6.3±6.1 vs 4.9±5.7,p=0.047) than those not on biologics, but not somatic symptoms (6.2±4.1 vs 6.0±4.2, p=0.69). Conclusions: Prevalence of depression in adult outpatient IBD practice is significantlyhigher compared with the general population, especially in those patients with active disease.AntiTNFα therapy was associated with increased cognitive, but not somatic depressive symp-toms.

S-779 AGA Abstracts

Tu1190

Clinical Outcome and Prediction of Final Diagnosis in Pediatric InflammatoryBowel Disease Unclassified (IBD-U) PatientsTatyana Hofmekler, Cary Sauer, Scott Gillespie, Courtney McCracken, Madeline Bertha,Thomas D. Walters, Lee Denson, Anne M. Griffiths, Marla Dubinsky, James Markowitz,Robert Baldassano, Wallace Crandall, Joel R. Rosh, Marian D. Pfefferkorn, Anthony R.Otley, Melvin B. Heyman, Neal S. Leleiko, Susan S. Baker, Stephen L. Guthery, JonathanEvans, David Ziring, Richard Kellermayer, Michael C. Stephens, David R. Mack, MariaOliva-Hemker, Ashish S. Patel, Barbara S. Kirschner, Dedrick E. Moulton, Stanley A.Cohen, Michael Kappelman, Jeffrey S. Hyams, Subra Kugathasan

Approximately 10% of patients with IBD are diagnosed with IBD-unclassified (IBD-U). Dueto diagnostic ambivalence these patients may experience delayed standard treatment for UCand CD. A diagnosis of IBD-U often precludes enrollment in clinical trials specific to CDor UC. IBD-U may be associated with higher relapses, poor surgical outcomes and higherrisk of cancer. Prospective studies examining pediatric IBD-U patients are lacking. Aim: Totest the hypothesis that pediatric patients diagnosed with IBD-U comprise a distinctclinical entity compared with UC and CD. Data were obtained from the RISK study, anongoing, prospective observational research program started in 2008 that includes 28 centersin North America. Children under 17 years with newly diagnosed IBD were enrolled from2008 to 2011. A site investigator established a diagnosis of IBD-U in the setting of colon-only IBD, without small bowel involvement, and accompanied by endoscopic and histologicalfeatures that did not allow a firm diagnosis of CD or UC. Of the 1400 patients enrolled,134 (10%) were labeled IBD-U at baseline and followed for a mean of two years. Baselinecharacteristics are given in Table 1. During the follow up, patients either remained as IBD-U or were reclassified as CD or UC when the disease evolved. Baseline characteristics werecompared to determine differences predictive of final diagnoses. Change in PGA scores wascompared across the treatment types. Multiple logistic regressions were used to identify riskfactors associated with a final diagnosis of UC or CD. Of the 134 IBD-U patients, 26 (24.1%)had a subsequent diagnosis of CD, 39 (36.1%) UC, and 69 (51.5%) remained IBD-U. Genderor age at diagnosis did not differ among the groups (Table 1). In children with IBD-U, PGAimproved most with early therapy of steroids and immunomodulators/biologics. Duringfollow up, patients that remained IBD-U or were diagnosed with CD had higher levels ofASCA compared with UC patients. Both CD and UC patients had higher ANCA levelscompared with IBD-U patients. More CD and UC patients had NOD2 variants comparedwith IBD-U. Logistic regression models indicated elevated ANCA and CBir levels as riskfactors associated with CD (AUC=0.743), whereas elevated ANCA and low ASCA levelswere associated with UC (AUC=0.732). In a well-characterized cohort of 134 children withIBD-U at diagnosis, half remained IBD-U at 2 years. Those who remained IBD-U had mildto moderate PGA at diagnosis. Factors that predict change to CD include ASCA, ANCA,NOD2, CBir; factors that predict change to UC include ANCA and low ASCA. Thoseremaining IBD-U tend to be sero-negative and lack genetic markers suggesting a differentpathogenesis plays a role in persistent IBD-U.Table 1: Baseline characteristics by Clinical Diagnosis (N=134)

1 Pairwise comparisons indicated significant differences between CD and UC (p = 0.015)and IBD-U and UC (p = 0.01). 2 Pairwise comparisons indicated significant differencesbetween CD and IBD-U (p = 0.040) and UC and IBD-U (p = 0.001). * designates significantdifferences across the IBD groups

Tu1191

There's an App for That—Measuring Disease-Specific Knowledge and Mood inChildren With Inflammatory Bowel DiseaseJeanne Tung, John Grunow, Noel J. Jacobs

Background: Data suggests physicians poorly assess disease-specific literacy and transitionreadiness in pediatric patients with inflammatory bowel disease (IBD). Tools to test knowledgein a clinic setting are lacking. Aim: We piloted an electronic ipad game, with the aims of1) measuring IBD and transition related knowledge in a pediatric IBD population, and 2)measure concomitant mood and quality of life (QOL), modifying it based on expert opinionas well as medical team and patient feedback. Methods: Two pediatric IBD clinics developedand tested 2 versions of Emma, an interactive iPad-based educational game. Patients between10-18 years of age played Emma during an office visit, allowing clinicians to review resultsand provide teaching. Each patient answered 12 randomly selected disease-related questions

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