Barbara Bancroft

Rates and Predictors of Oral Medication Adherence in Pediatric Patients with IBD

Background:Symptoms of inflammatory bowel disease (IBD) include bloody diarrhea, fatigue, abdominal pain, and weight loss. Long-term management of remission for most patients requires adherence to taking 1 or more oral medications daily, in the absence of symptoms. We investigated whether disease characteristics and behavioral characteristics predict adherence to prescribed medical regimens. Methods:Patients aged 8 to 17.5 years, newly diagnosed with IBD, and a matched cohort previously diagnosed were studied over a 6-month period. Adherence was assessed using medication electronic monitoring devices (Medication Event Monitoring Systems); participants and parents completed questionnaires regarding emotional and behavioral functioning, and biological parameters were monitored. Results:Adherence was monitored for 45 newly and 34 previously diagnosed patients. In total, 16,478 patient-days (including 12,066 discrete days) were electronically monitored. Overall, 70.6% of 5-aminosalicylic acid and 65.4% of 6-mercaptopurine doses were taken. Only 25% and 15% of older adolescents took at least 80% of their 5-aminosalicylic acid and 6-mercaptopurine, respectively, compared with about 83% and 64% of 8-year-olds to 11-year-olds. Only age and behavioral issues were statistically linked to rates of adherence. Conclusions:Adherence to commonly prescribed oral medications for IBD is challenging for patients. Screening for emotional and behavioral problems, especially among older adolescents, would be important in identifying patients at risk of poor adherence, who might benefit from interventions. Biological solutions, although critical, when applied without attention to behavioral issues, are not likely to provide the level of therapeutic benefit that can be provided in a combined biobehavioral approach.

Depressive symptoms in youth with inflammatory bowel disease compared with a community sample.

Background:Previous investigations have produced mixed findings on whether youth with inflammatory bowel disease (IBD) experience elevated rates of depressive symptoms. Our first aim was to compare self-report of depressive symptoms by youth with IBD with a community sample. The second aim was to examine the relationship between symptoms of depression and measures of disease activity. Methods:Item-level responses on the Childrens Depression Inventory among a sample of 78 youth diagnosed with IBD were compared with responses from a community sample using 1-sample t-tests. Particular attention was given to items assessing somatic symptoms of depression given the potential overlap with IBD disease symptoms. The relationship between depressive symptoms and IBD disease activity was evaluated using Spearmans rank correlation coefficients and linear regression. Results:Youth with IBD reported lower levels of depressive symptoms compared with the community sample on the Childrens Depression Inventory Total Score, and similar or lower levels of difficulty on items assessing somatic symptoms. Most of the sample had inactive or mild disease activity at the time of participation, with 14% experiencing moderate/severe disease activity. Higher ratings of disease activity were related to greater depressive symptoms. Responses on somatic items from the Childrens Depression Inventory were not differentially related to disease activity. Conclusions:As a group, pediatric patients with IBD did not experience the clinical levels of depressive symptoms or elevations in depressive symptoms when compared with a community sample. Somatic symptoms of depression do not differentiate youth with IBD experiencing elevations in disease activity from youth experiencing nonsomatic symptoms of depression.

6-Thioguanine levels in pediatric IBD patients: adherence is more important than dose.

Background:Thiopurine immunosuppressants such as 6-mercaptopurine (6-MP) are widely used to maintain remission in children with both Crohns disease and ulcerative colitis. Therapeutic efficacy is associated with higher red blood cell levels of the thiopurine metabolite 6-thioguanine (6-TGN). Studies in both children and adults have inexplicably failed to demonstrate a significant correlation between prescribed dose and level of 6-TGN. We aimed to quantify the relationship between 6-TGN levels and adherence. Methods:We used electronic monitoring devices to assess adherence in children and adolescents with inflammatory bowel diseases who were prescribed 6-MP. Results:During 3230 days of monitoring in 19 subjects, adherence to 6-MP was 74.2%. Due to the generally low adherence to the prescribed dose of 6-MP, the 6-TGN level was not correlated with the prescribed dose. The 6-TGN level was significantly correlated with the adherence-adjusted dose (R2 = 0.395). It was also significantly correlated to adherence alone (R2 = 0.478). Adherence to 5-aminosalicylic acid and 6-MP were significantly positively correlated (rs (9) = 0.82, P = 0.00), and a significant relationship was found between 5-aminosalicylic acid adherence and 6-TGN levels independent of 6-MP adherence. Furthermore, low adherence to 6-MP was associated with increased likelihood of escalation of medical therapy. Conclusions:Red blood cell 6-TGN levels are strongly correlated with the dose, when the dose is actually taken. Lack of efficacy of thiopurines may often be the result of poor adherence. Novel ways of assessing and improving adherence are necessary. Future trials should assess adherence in study participants. Intake of 5-aminosalicylic acid positively influences 6-TGN levels.

Incidence of Crohn's Disease and Ulcerative Colitis in Rhode Island: Report from the Ocean State Crohn's and Colitis Area Registry.

Background:Studies describing the incidence of Crohns disease (CD) and ulcerative colitis (UC) are uncommon in the United States. We sought to determine the incidence of CD and UC in the state of Rhode Island. Methods:The Ocean State Crohns and Colitis Area Registry is a state-based inception cohort of patients newly diagnosed with inflammatory bowel disease (IBD) in Rhode Island. To confirm a diagnosis of CD, UC, or IBD unclassified (IBDU), the National Institute of Diabetes and Digestive and Kidney Diseases IBD Genetics Consortium criteria were applied in a review of medical records from gastroenterology practices located in the state of Rhode Island and adjacent to the Rhode Island border in Massachusetts and Connecticut. Using population-based data, we determined the statewide incidence of IBD in Rhode Island from 2008 to 2010. Results:A total of 971 Rhode Island residents were diagnosed with IBD, including 444 with CD, 486 with UC, and 41 with IBD unclassified from 2008 to 2010. The overall age- and sex-adjusted IBD incidence was 30.2 (95% confidence interval, 28.3–32.1) per 100,000 persons in this time frame with 13.9, 15.1, and 1.3 per 100,000 diagnosed with CD, UC, and IBD unclassified, respectively. Of the total incident cases in Rhode Island, 30% (n = 291) were enrolled in Ocean State Crohns and Colitis Area Registry for follow-up. Conclusions:The incidence of IBD in Rhode Island is higher than that previously reported by other population-based cohorts in the United States. Prospective follow-up of individuals enrolled in the community-based Ocean State Crohns and Colitis Area Registry cohort is ongoing.

Dietary behaviors in newly diagnosed youth with inflammatory bowel disease

ABSTRACT The impact of dietary behaviors on health outcomes in youth with inflammatory bowel disease (IBD) is unclear. The present study examined dietary behaviors and their association with biomedical factors in youth with IBD. Eighty-six newly diagnosed youth (mean age = 12.6) were included in analyses. Biomedical factors included disease activity and inflammatory markers. Despite adequate total caloric intake, estimated nutrient and fruit and vegetable intakes were below recommended levels. There was a significant negative association between vegetable intake and C-Reactive Protein (p = 0.04). Results suggest that dietary behaviors play an important role in IBD health outcomes.

Stability of Emotional and Behavioral Functioning in Youth with Inflammatory Bowel Disease

This study prospectively examined stability of psychological and behavioral functioning in two matched cohorts of youth with inflammatory bowel disease (IBD): (1) newly diagnosed and (2) previously diagnosed patients. Youth and their parents completed measures of emotional and behavioral functioning at Time 1 and 6 months later. Mean-level analyses indicated that scores at Time 1 and Time 2 were within the nonclinical range. A significant decrease occurred in internalizing symptoms for previously diagnosed patients. Both groups demonstrated high levels of profile stability with no significant differences across groups. Results suggest that emotional and behavioral functioning is generally stable without targeted intervention.

6-TGN Levels in Pediatric IBD Patients: Adherence Is More Important Than Dose: P-159

BACKGROUND: The REACH study helped determine the efficacy and safety of infliximab in patients 6-17 years of age. The dosing, including induction, was found to be similar to adult dosing. This study also demonstrated an incidence of serious infections at 5.7%. The most prevalent adverse events were respiratory infections. In 2012, deBie et al. reviewed the literature on the use of anti-TNF medications in pediatric IBD and found adjustments in dosing between 27-49% of the time. The median time to dose adjustment was 6-9 months. After initiation of infliximab, intestinal surgery was performed in 25-35% of patients with Crohn’s disease. There are no reports on the use of infliximab in patients less than 6 years of age. METHODS: This was a descriptive, retrospective chart review of patients with IBD receiving infliximab as standard care for treatment of IBD from June 2002July 2012. RESULTS: Since 2002, our institution has diagnosed 790 patients with IBD; 50 patients (6%) were under 6 years of age at the time of diagnosis. 13 (26%) of these patients with IBD received infliximab when they were less than 6 years of age; 8 diagnosed with Crohn’s disease, 3 with UC, and 2 with indeterminant colitis. The age at diagnosis ranged from 11 months to 66 months with a mean of 37 months. 12 patients presented with bloody diarrhea. The age infliximab was initiated ranged from 15 months to 69 months with a mean of 46 months. 7 patients received monotherapy. Prior to 2008, infliximab was given in combination with mercaptopurine in one patient and azathioprine in 3 patients. Since 2008, methotrexate was given in combination with infliximab in two patients. The number of doses of infliximab given ranged from 2 to 38 with dosage ranges of 4.7 mg/kg to 13 mg/kg. The doses were adjusted in 6 patients, 4 with success. Two patients still on infliximab have not had dose adjustments due to high initial doses (9.3 mg/kg and 12.5 mg/kg). Seven patients had colectomies; two diagnosed with UC, two indeterminant colitis, two diagnosed with Crohn’s after an initial diagnosis of UC, and one patient with severe perianal Crohn’s disease. Six of the patients requiring colectomy were prior to 2008; only one out of 7 patients in the past 4 years required a colectomy. Two patients developed hives after 6-7 doses and one had an acute infusion reaction with facial swelling and desaturation. Other potential complications were limited to one patient with mycoplasma pneumonia, one with recurrent UTIs, and one with recurrent Clostridium difficile. The patient with severe perianal disease has since been diagnosed with IL10RA. CONCLUSION(S): Infliximab was used successfully in 6 out of 7 patients with IBD in the past 4 years. All six patients who received infliximab prior to 2008 went on to colectomy.

Physical Activity and Health Outcomes in Pediatric Inflammatory Bowel Disease: P-147

BACKGROUND: Recent studies suggest an increasing incidence of inflammatory bowel disease (IBD) in children. However, the impact of this increase on the secular trends of inpatient care and disease burden in hospitalized children with IBD is unknown. Therefore, the aims of this study were to evaluate the rate of hospitalization and disease behavior in hospitalized children with IBD in the United States from 2000 to 2009. METHODS: We used the U.S. Healthcare Cost and Utilization Project Kids’ Inpatient Database. Data were weighted to generate national-level estimates. RESULTS: We identified 61,779 cases of pediatric IBD during four triennial periods from 2000 to 2009. During the period of study, the rate of hospitalization of children with any diagnosis of IBD increased from 43.6 to 72.0 (cases per 10,000 total hospitalizations entered into the database per year; 2000 vs. 2009; P <0.001). Specifically, for Crohn’s disease (CD) the rate increased from 28.3 to 45.7 (P <0.001) and for ulcerative colitis (UC) 15.2 to 26.1 (P <0.001). There was an increasing trend in the rate of hospitalization in pediatric cases of IBD overall, and CD and UC individually (evaluation of entire time period, Cochran-Armitage test for trend, P <0.001 for each disease). The age distribution of hospitalized children with IBD did not change over the decade of study. Mortality (1 per 1,000 cases of IBD) and length of hospital stay (LOS; median, 4 days) remained constant. Hospitalization charges (adjusted for inflation) increased (median,

Nutrition and dietary behaviors in pediatric Inflammatory Bowel Disease: P-64.

11,614 to

Tu1270 Hygiene Factors in India and the US in Early Childhood Influence the Subsequent Development of Crohn's Disease but Not Ulcerative Colitis: A Large Case Controlled Study in Two Countries

20,724, P <0.001). Significant increasing trends were found for comorbid disease burden and systemic complications (including electrolyte disturbances and anemia), and the need for blood transfusion and parenteral nutrition (P <0.001 for each). There, also, was an increase in the number of cases with fistulae, obstruction, and perianal disease (P <0.001 for each). In comparison of IBD and non-IBD cases, those with IBD had lower mortality, longer LOS, and higher charges (P <0.001 for each). Case-control matching demonstrated a lower risk of death (adjusted odds ratio, aOR 0.25, 95% CI, 0.20-0.31), longer LOS (aOR 2.48, 95% CI, 2.40-2.50), and higher charges (aOR 1.92, 95% CI, 1.88-1.96) in those with IBD. CONCLUSION(S): These results demonstrate an increasing trend in the number of pediatric cases with IBD admitted to the hospital from 2000 to 2009. Moreover, we found an increasing trend in disease-specific and systemic complications in these children along with an increasing cost of the hospital stay. These findings are consistent with earlier studies demonstrating that the epidemiology of pediatric IBD is changing as demonstrated by an increase in hospitalized cases. Also, these data suggest there has been an increase in the severity and frequency of complicated disease.