1
Age at date of test was determined by subtracting the patient's date of birth from the date of test. Individuals younger than age 10 and older than age 80 were excluded. The patients were divided into age groups from 10-19, 20-29, 30-39, 40-49, 50-59, 60-69, and 70-79. Results: There were 26,450 patients who underwent HACA testing who met inclusion criteria. The rate of negative HACA was 81.9% of the10,155 patients aged 10-19; 80% of the 4004 patients aged 20-29; 78.9% of the 3831 patients aged 30-39; 79.9% of patients aged 40-49; 79.9% of the 2735 patients aged 50-59; 77.8% of the 1600 patients aged from 60-69; and 74.8% of the 616 patients aged 70-79 (see Figure 1). This reveals a statistically significant decrease in the rate of HACA negativity by decade of life (Chi square, p<.0001). Conclusion: Older patient age was associated with a significant increase of HACA in patients treated with infliximab in clinical practice. Figure 1: Rate of negative HACA by decade of life. Sa2041 Hematologic Monitoring After Immunomodulator Initiation in Veterans With Inflammatory Bowel Disease: A Practice Audit Jason K. Hou, Jennifer R. Kramer, Peter Richardson, Shubhada Sansgiry, Hashem El-Serag Background/Aims: Immunomodulator medications (IMM) play a vital role in the care of patients with inflammatory bowel disease (IBD) as steroid sparing agents. However, they are associated with hematologic suppression even in patients with normal thiopurine methyl- transferase activity. Practice guidelines recommend monitoring of hematologic parameters after the initiation of IMM in IBD patients. However, adherence to hematologic monitoring after IMM initiation has not been previously reported in large practice settings. The aim of this study was to evaluate the prevalence and determinants of hematologic monitoring after IMM initiation among a national cohort of veterans with IBD. Methods: We identified a cohort of VA users with IBD from fiscal years 2003-2009 using the national Veterans Affairs (VA) administrative datasets: Inpatient and Outpatient Medical SAS® Datasets and laboratory tests from Decision Support System. IBD patients were identified by a previously validated algorithm using International Classification of Diseases, 9th Revision diagnosis codes for Crohn's disease (555.x) or ulcerative colitis (556.x). Subjects with filled prescriptions for azathioprine, 6-mercaptopurine, and methotrexate were included, with the date of the first filled IMM prescription defined as the IMM index date. Based on the least stringent interpretation of practice guidelines, the primary endpoint was the proportion of subjects who had a white blood cell count (WBC) completed within 90 days of the IMM index date. Determinants of WBC monitoring were identified by univariate and multivariate analyses. Results: A total of 4,325 unique IBD patients were identified with filled IMM prescriptions, of whom 73% were Caucasian, 10% African American, 3% Hispanic, and 14% of other or unknown race; 93% were male. Overall, only 39% of subjects completed a WBC within 90 days of IMM index date. Monitoring rates increased over time, from 31% in 2003 to 52% in 2009. There was variability of monitoring frequency by facility, ranging from 0-77%. In multivariate analyses, older age at IMM index date was associated with a lower rate of monitoring (65+ vs. < 35 years of age, OR 0.79, 95%CI 0.64-0.98). In addition, increased frequency of VA encounters (13+ visits per year vs. < 3 visits year, OR 17.20, 95%CI 10.59- 27.94), and more recent year of IMM index date (OR 1.13, 95% CI 1.09-1.17) were associated with increased rates of hematologic monitoring. Race, region, concomitant biologic medication, comorbidity, and facility load of IBD patients on IMM were not significantly associated with hematologic monitoring. Conclusions: Hematologic monitoring among vet- erans with IBD after IMM initiation is low with wide variability based on facility. Provider and system wide interventions are needed to improve adherence and reduce variability of IMM monitoring across facilities. Sa2042 A Simple Test for Mesalamine Use: Random Urine Salicylate Levels Anne E. Gifford, Anders Berg, Conor Lahiff, Gary L. Horowitz, Alan C. Moss Background: Patients with IBD are frequently non-adherent with mesalamine therapy, but there are few reliable tools to assess non-adherence in the clinic setting. Ingested mesalamine is excreted in the urine as 5-ASA or N-acetyl-5-ASA, salicylates which should be readily detectable in urine by a standard salicylate test. We sought to determine the correlation between urinary salicylate levels, and urinary 5-ASA and N-Acetyl-5-ASA levels as measured by liquid chromatography-tandem massspectrometry (LC-MS/MS). Methods: Patients with ulcerative colitis (UC) prescribed mesalamine were prospectively enrolled to provide an unexpected spot urine sample at a clinic visit. Time since last reported dose, and dosing regimen were recorded. Urinary salicylate levels and creatinine were measured by standard colorimetric assay, and 5-ASA and N-acetyl-5-ASA determined by LC-MS/MS. The "total salicylate equivalents" were obtained by converting all salicylate metabolite results into mmol/ L units and summing their total, and these were then converted from mmol/L into μg/ml using the molecular weight of salicylate. In addition, samples of urine from individuals not taking mesalamine were also tested for salicylate levels by colorimetric assay. Statistical S-387 AGA Abstracts analysis was conducted using JMP. Results: 82 patients with UC and 20 controls were enrolled in the study. The majority of UC patients (93%) were prescribed mesalamine at total daily dose > 2.4 g/day. The mean time since last dose before urinalysis was 10 hours (range 1-31.5 hours). Median spot urinary salicylate level was 358 μg/mL [range 0-3580 μg/mL] in patients prescribed mesalamine, and 3 μg/mL [range 0-38 μg/mL] in controls. In the control group, 90% of spot urine salicylate levels were less than 10 μg/mL. In patients with UC, the median levels of total salicylate equivalents was 476 μg/mL [range 15-4920], 5-ASA 50 μg/mL [range 0-2303] and N-acetyl-5-ASA 607 μg/mL [range 1-3992] respectively by LC-MS/MS. Urinary salicylate levels by colorimetric assay were closely correlated with LC-MS/MS levels of total salicylate equivalents (R2 = 0.91 at P < 0.001) (Figure 1). When a receiver operating characteristic (ROC) curve was generated, a colorimetric urinary salicylate threshold of 45μg/mL had a sensitivity of 94% and specificity of 100% for the identification of mesalamine users (AUC 0.98). Conclusions: There is a high correlation between salicylate levels and 5-ASA metabolite levels in the urine of patients taking mesalamine. Urine salicylate levels above a threshold of 45ug/mL indicated mesalamine use in this cohort. Spot urinary salicylate levels may provide a simple, readily available, method to test mesalamine adherence. Sa2043 Adherence to Monthly Thiopurine Blood Work Monitoring Declines Over Time in Adults With Inflammatory Bowel Disease Jonathan Wong, Richard N. Fedorak, Karen Wong, Karen I. Kroeker BACKGROUND Patient adherence to medical therapy is usually studied in the context of medication use. Thiopurines, such as azathioprine (AZA) and 6-mercaptopurine (6-MP), are frequently used to maintain remission in inflammatory bowel disease (IBD) patients. Patients on thiopurines are recommended to complete routine surveillance blood testing as a consequence of thiopurine associated leukopenia and elevated liver enzymes. AIM The aim of this study is to determine the adherence of patients with IBD on thiopurines to monthly surveillance blood test monitoring and to determine if the adherence changed over time. METHODS A patient search was conducted in a university gastroenterology patient database to identify IBD patients currently on thiopurines. Patients were instructed on the monthly blood testing required and adherence was reinforced at each clinic visit and with yearly laboratory re-ordering of blood testing. Charts were reviewed for demographic informa- tion, diagnosis and blood test frequency and results, which include white blood cell (WBC) and liver enzymes. For the purpose of this study, only blood tests measured over 20 days apart were counted as monthly blood tests. Patients were grouped by the number of years on thiopurine therapy and cross-tabulated with number of venipunctures per year. Data was analyzed using Microsoft Excel and SPSS. RESULTS The initial patient search identified 348 IBD patients on thiopurines. 165 patients were included in this study. Reasons for exclusion include: did not live in the local area and so could not confirm if all blood tests were available (163); patients were in clinical trials (4); and incomplete patient records (16). Mean age was 36.5±1.1 years. 48% were male, and 76% had Crohn's disease and 24% ulcerative colitis. The average number of blood tests, per year (mean±SE), during the first year of thiopurine treatment was significantly higher (7.7±0.32) than for patients using thiopurines for more than one year (5.3±0.17), p=5.47x10 -11 . CONCLUSION IBD patients on thiopurines completed routine surveillance blood tests less frequently than the recommended monthly monitoring. Furthermore, adherence to blood test monitoring was significantly higher in the first year of thiopurine treatment and markedly declined in subsequent years. Table 1. Frequency of venipuncture per year varies by duration of thiopurine use (Data reported as number and % of patients in that year of thiopurine use; Chi-squared, p=0.000015) AGA Abstracts

Sa2043 Adherence to Monthly Thiopurine Blood Work Monitoring Declines Over Time in Adults With Inflammatory Bowel Disease

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Page 1: Sa2043 Adherence to Monthly Thiopurine Blood Work Monitoring Declines Over Time in Adults With Inflammatory Bowel Disease

Age at date of test was determined by subtracting the patient's date of birth from the dateof test. Individuals younger than age 10 and older than age 80 were excluded. The patientswere divided into age groups from 10-19, 20-29, 30-39, 40-49, 50-59, 60-69, and 70-79.Results: There were 26,450 patients who underwent HACA testing who met inclusioncriteria. The rate of negative HACA was 81.9% of the10,155 patients aged 10-19; 80% ofthe 4004 patients aged 20-29; 78.9% of the 3831 patients aged 30-39; 79.9% of patientsaged 40-49; 79.9% of the 2735 patients aged 50-59; 77.8% of the 1600 patients aged from60-69; and 74.8% of the 616 patients aged 70-79 (see Figure 1). This reveals a statisticallysignificant decrease in the rate of HACA negativity by decade of life (Chi square, p<.0001).Conclusion: Older patient age was associated with a significant increase of HACA in patientstreated with infliximab in clinical practice.

Figure 1: Rate of negative HACA by decade of life.

Sa2041

Hematologic Monitoring After Immunomodulator Initiation in Veterans WithInflammatory Bowel Disease: A Practice AuditJason K. Hou, Jennifer R. Kramer, Peter Richardson, Shubhada Sansgiry, Hashem El-Serag

Background/Aims: Immunomodulator medications (IMM) play a vital role in the care ofpatients with inflammatory bowel disease (IBD) as steroid sparing agents. However, theyare associated with hematologic suppression even in patients with normal thiopurine methyl-transferase activity. Practice guidelines recommend monitoring of hematologic parametersafter the initiation of IMM in IBD patients. However, adherence to hematologic monitoringafter IMM initiation has not been previously reported in large practice settings. The aim ofthis study was to evaluate the prevalence and determinants of hematologic monitoring afterIMM initiation among a national cohort of veterans with IBD. Methods: We identified acohort of VA users with IBD from fiscal years 2003-2009 using the national Veterans Affairs(VA) administrative datasets: Inpatient and Outpatient Medical SAS® Datasets and laboratorytests from Decision Support System. IBD patients were identified by a previously validatedalgorithm using International Classification of Diseases, 9th Revision diagnosis codes forCrohn's disease (555.x) or ulcerative colitis (556.x). Subjects with filled prescriptions forazathioprine, 6-mercaptopurine, and methotrexate were included, with the date of thefirst filled IMM prescription defined as the IMM index date. Based on the least stringentinterpretation of practice guidelines, the primary endpoint was the proportion of subjectswho had a white blood cell count (WBC) completed within 90 days of the IMM index date.Determinants of WBC monitoring were identified by univariate and multivariate analyses.Results: A total of 4,325 unique IBD patients were identified with filled IMM prescriptions,of whom 73% were Caucasian, 10% African American, 3% Hispanic, and 14% of other orunknown race; 93% were male. Overall, only 39% of subjects completed a WBC within 90days of IMM index date. Monitoring rates increased over time, from 31% in 2003 to 52%in 2009. There was variability of monitoring frequency by facility, ranging from 0-77%. Inmultivariate analyses, older age at IMM index date was associated with a lower rate ofmonitoring (65+ vs. < 35 years of age, OR 0.79, 95%CI 0.64-0.98). In addition, increasedfrequency of VA encounters (13+ visits per year vs. < 3 visits year, OR 17.20, 95%CI 10.59-27.94), and more recent year of IMM index date (OR 1.13, 95% CI 1.09-1.17) wereassociated with increased rates of hematologic monitoring. Race, region, concomitant biologicmedication, comorbidity, and facility load of IBD patients on IMM were not significantlyassociated with hematologic monitoring. Conclusions: Hematologic monitoring among vet-erans with IBD after IMM initiation is low with wide variability based on facility. Providerand system wide interventions are needed to improve adherence and reduce variability ofIMM monitoring across facilities.

Sa2042

A Simple Test for Mesalamine Use: Random Urine Salicylate LevelsAnne E. Gifford, Anders Berg, Conor Lahiff, Gary L. Horowitz, Alan C. Moss

Background: Patients with IBD are frequently non-adherent with mesalamine therapy, butthere are few reliable tools to assess non-adherence in the clinic setting. Ingested mesalamineis excreted in the urine as 5-ASA or N-acetyl-5-ASA, salicylates which should be readilydetectable in urine by a standard salicylate test. We sought to determine the correlationbetween urinary salicylate levels, and urinary 5-ASA and N-Acetyl-5-ASA levels as measuredby liquid chromatography-tandem massspectrometry (LC-MS/MS). Methods: Patients withulcerative colitis (UC) prescribed mesalamine were prospectively enrolled to provide anunexpected spot urine sample at a clinic visit. Time since last reported dose, and dosingregimen were recorded. Urinary salicylate levels and creatinine were measured by standardcolorimetric assay, and 5-ASA and N-acetyl-5-ASA determined by LC-MS/MS. The "totalsalicylate equivalents" were obtained by converting all salicylate metabolite results into mmol/L units and summing their total, and these were then converted from mmol/L into μg/mlusing the molecular weight of salicylate. In addition, samples of urine from individuals nottaking mesalamine were also tested for salicylate levels by colorimetric assay. Statistical

S-387 AGA Abstracts

analysis was conducted using JMP. Results: 82 patients with UC and 20 controls wereenrolled in the study. The majority of UC patients (93%) were prescribed mesalamine attotal daily dose > 2.4 g/day. The mean time since last dose before urinalysis was 10 hours(range 1-31.5 hours). Median spot urinary salicylate level was 358 μg/mL [range 0-3580μg/mL] in patients prescribed mesalamine, and 3 μg/mL [range 0-38 μg/mL] in controls.In the control group, 90% of spot urine salicylate levels were less than 10 μg/mL. In patientswith UC, the median levels of total salicylate equivalents was 476 μg/mL [range 15-4920],5-ASA 50 μg/mL [range 0-2303] and N-acetyl-5-ASA 607 μg/mL [range 1-3992] respectivelyby LC-MS/MS. Urinary salicylate levels by colorimetric assay were closely correlated withLC-MS/MS levels of total salicylate equivalents (R2 = 0.91 at P < 0.001) (Figure 1). Whena receiver operating characteristic (ROC) curve was generated, a colorimetric urinary salicylatethreshold of 45μg/mL had a sensitivity of 94% and specificity of 100% for the identificationof mesalamine users (AUC 0.98). Conclusions: There is a high correlation between salicylatelevels and 5-ASA metabolite levels in the urine of patients taking mesalamine. Urine salicylatelevels above a threshold of 45ug/mL indicated mesalamine use in this cohort. Spot urinarysalicylate levels may provide a simple, readily available, method to test mesalamine adherence.

Sa2043

Adherence to Monthly Thiopurine Blood Work Monitoring Declines OverTime in Adults With Inflammatory Bowel DiseaseJonathan Wong, Richard N. Fedorak, Karen Wong, Karen I. Kroeker

BACKGROUND Patient adherence to medical therapy is usually studied in the context ofmedication use. Thiopurines, such as azathioprine (AZA) and 6-mercaptopurine (6-MP),are frequently used to maintain remission in inflammatory bowel disease (IBD) patients.Patients on thiopurines are recommended to complete routine surveillance blood testing asa consequence of thiopurine associated leukopenia and elevated liver enzymes. AIM Theaim of this study is to determine the adherence of patients with IBD on thiopurines tomonthly surveillance blood test monitoring and to determine if the adherence changed overtime. METHODS A patient search was conducted in a university gastroenterology patientdatabase to identify IBD patients currently on thiopurines. Patients were instructed on themonthly blood testing required and adherence was reinforced at each clinic visit and withyearly laboratory re-ordering of blood testing. Charts were reviewed for demographic informa-tion, diagnosis and blood test frequency and results, which include white blood cell (WBC)and liver enzymes. For the purpose of this study, only blood tests measured over 20 daysapart were counted as monthly blood tests. Patients were grouped by the number of yearson thiopurine therapy and cross-tabulated with number of venipunctures per year. Datawas analyzed using Microsoft Excel and SPSS. RESULTS The initial patient search identified348 IBD patients on thiopurines. 165 patients were included in this study. Reasons forexclusion include: did not live in the local area and so could not confirm if all blood testswere available (163); patients were in clinical trials (4); and incomplete patient records (16).Mean age was 36.5±1.1 years. 48% were male, and 76% had Crohn's disease and 24%ulcerative colitis. The average number of blood tests, per year (mean±SE), during the firstyear of thiopurine treatment was significantly higher (7.7±0.32) than for patients usingthiopurines for more than one year (5.3±0.17), p=5.47x10-11. CONCLUSION IBD patients onthiopurines completed routine surveillance blood tests less frequently than the recommendedmonthly monitoring. Furthermore, adherence to blood test monitoring was significantlyhigher in the first year of thiopurine treatment and markedly declined in subsequent years.Table 1. Frequency of venipuncture per year varies by duration of thiopurine use

(Data reported as number and % of patients in that year of thiopurine use; Chi-squared,p=0.000015)

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