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Sa1187 Peripheral Blood Eosinophilia in Patients With Inflammatory Bowel Disease Is Associated With Worse Outcomes: A 5-Year Prospective Study
counts. Both PBE and RBE were associated with higher CD activity scores (p<0.01), but only PBE was associated with higher UC activity index (p=0.02). Neither PBE nor RBE predicted health related quality of life (p>0.05) in patients with IBD. Hypereosinophilia independently predicted more ED visits (p=0.02), but otherwise was not associated with the outcomes of interest. Conclusions: In IBD patients, PBE and RBE are biomarkers of more severe illness and a worse clinical course. Future studies are warranted to characterize the mechanisms underlying eosinophilia-associated IBD, in order to determine new therapeutic targets for this subset of patients. Demographic characteristics and univariate analysis of patients with PBE
Sa1186 Prognostic Significance of Anti-Saccharomyces Cerevisiae Antibody (ASCA) in Southwestern Ohio Veteran IBD Population Mustafa Musleh, Drew Triplett, Salma Akram BACKGROUND & AIMS: Inflammatory Bowel Disease (IBD) is a term that includes two heterogeneous intestinal disorders: Crohn's disease (CD) and ulcerative colitis (UC). CD and UC both are characterized with different serology markers, anti-Saccharomyces cerevisiae antibody (ASCA) is more common in CD and perinuclear anti-neutrophil cytoplasmic antibody (P-ANCA) is more prevalent in UC patients, with some overlap. Positivity of immune markers may be associated with different disease phenotype and different prognosis. The aim of the study is to describe characteristics of our cohort of veteran patients with IBD and to analyze the effect serology positivity and disease course, severity and prognosis. MATERIALS and METHODS: This is a retrospective study of veterans with inflammatory bowel disease seen at Dayton VA Medical Center between January 2004 and June 2011. Patients who underwent testing for ASCA and/or P-ANCA were included in the study. Relevant demographic and clinical data was obtained through electronic chart review. RESULTS: Ninety five IBD (60 CD and 35 UC) patients who had ASCA and/or P-ANCA serology results available were included in the study. Overall, 88 (57 CD and 31 UC) patients were tested for ASCA and 39% were positive. Total of 80 (49 CD and 31 UC) patients were tested for P-ANCA and 15% were positive. Among patients with CD, ASCA and pANCA were positive in 48% and 10%.of the patients respectively. Both ASCA and pANCA were positive in 23% each of the UC patients. Average age at IBD diagnosis in ASCA positive patients was 33 years (SD = 14 years), compared to 44 years (SD = 17 years) in those who were ASCA negative (P = 0.002). IBD patients with ASCA positive serology were less likely to have hypertension (21% vs. 54%, P= 0.03) and hyperlipidemia (29% vs. 53% P=0.02), compared to those who were ASCA negative. There was no difference in steroids use in IBD patients with ASCA positive serology compared to those who were ASCA negative (68% vs. 61% P=0.65). ASCA positive patients were more likely to require anti-TNF and/or immunosuppressive therapy compared to ASCA negative patients (65% vs. 39% P=0.03). CD patients with ASCA positive serology were more likely to have small bowel resection (48% vs. 21 % P=0.048). CONCLUSIONS: IBD Veteran patients in southwest Ohio with ASCA positive serology are more likely to have earlier disease onset, more aggressive disease course, requiring escalation of medical therapy and more frequent bowel surgeries. ASCA serology is widely available and can be used as a simple prognostic tool in veteran IBD patients.
Sa1188 Momentary Ratings Versus Recalled Ratings of Abdominal Pain in Patients With Crohn's Disease: Methodological Implications for Future Patient Reported Outcomes Measures Leighann Litcher-Kelly, Peter M. Black The FDA issued a guidance report in 2009 stating the importance of collecting information from patients, including symptoms, in clinical trials . The most widely used outcome measure in Crohn's disease clinical trials is the Crohn's Disease Activity Index (CDAI), which includes a 7 day prospective patient diary to assess daily abdominal pain. A key criticism of the CDAI is non-compliance with the prospective diary, including documentation of retrospective completion (Sandborn et al., 2002). While this may appear to be a minor methodological alteration, past research has shown that retrospective reports of a subjective construct such as pain may be reported as higher than if pain is reported without any recall (Gorin & Stone 2001). Furthermore, the "peak-end" (PE) effect, first described in Kahneman and Redelmeier's seminal work on colonoscopy pain (Kahneman et al., 1993; Redelmeier et al., 2003), states that a patient's report of recalled pain will be based disproportionately on the times they experience the most (Peak) pain, and the most proximal experiences of pain (End), while the duration of pain does not influence recall. The goal of the current study was to examine how Peak and End reports of pain are related to recalled reports in a sample of 25 patients with Crohn's disease. Method: This study compared momentary abdominal pain ratings assessed approximately 5 times per day over seven days using an electronic diary, and compared these data to recall of abdominal pain over the those same 7 days, completed on a paper questionnaire. Hypothesis: Based on the PE effect, the best predictors of recalled abdominal pain will be the Peak and End momentary assessments, with the duration of pain experienced over the recall period (the percentage of momentary assessments when patients reported having pain), will not being a significant predictor. Results: As expected the recalled reported of abdominal pain were higher than the average of the momentary assessments for the same time period. Step-wise regression was used to examine how Peak+End momentary reports of abdominal pain predicted recalled pain (step 1), and how Peak+End+Duration of pain predicted recalled pain. The data indicated that study hypothesis was supported; specifically the best predictors of recalled abdominal pain were the Peak and End momentary assessments (accounting for 48% of model variance, p<0.001). Including Duration into the model only accounted for an additional 7% of the variance, which was not significant (p>0.05). Conclusion: This information may inform appropriate recall periods for the assessment of patient symptoms, such as abdominal pain in patients with Crohn's disease. Given the FDA Patient-Reported Outcomes (PRO) guidance, this is essential information that can be used in development of assessments of Crohn's disease symptoms, to be used in future clinical trials.
Sa1187 Peripheral Blood Eosinophilia in Patients With Inflammatory Bowel Disease Is Associated With Worse Outcomes: A 5-Year Prospective Study Jorge D. Machicado, Toufic Kabbani, Claudia Ramos Rivers, Benjamin H. Click, Arthur Barrie, Douglas J. Hartman, Miguel Regueiro, Jason M. Swoger, Marc Schwartz, Leonard Baidoo, Jana G. Hashash, Michael A. Dunn, David G. Binion Background: Eosinophils are granulocyte lymphocytes with effector and antigen presenting functions, playing a central role in the immune response to parasitic infection, allergic phenomenon and chronic inflammatory disorders including asthma and inflammatory bowel disease (IBD). Peripheral blood eosinophilia (PBE) has been demonstrated in subgroups of patients with asthma and IBD, and it may function as a biomarker for this unique endotype of chronic inflammation. The clinical course of IBD patients with PBE is not well defined. We aimed to determine the role of PBE in the clinical course of patients with IBD. Methods: We used a prospective, longitudinal IBD registry of patients followed in a tertiary referral center between 2009-2013. PBE was defined by an absolute eosinophil count (AEC) greater than 500/uL at any time during the study period. Recurrent blood eosinophilia (RBE) was defined as PBE on at least four separate occasions, while hypereosinophilia was defined by AEC greater than 1500/uL. The clinical course of patients with IBD was measured with patterns of medication use, healthcare utilization, disease activity scores (Harvey-Bradshaw index, ulcerative colitis (UC) disease activity index) and health related quality of life (short inflammatory bowel disease questionnaire (SIBDQ)). We calculated associations of eosinophilia with outcomes of interest using multiple linear regression analysis with adjustment for demographic characteristics, IBD disease type, primary sclerosing cholangitis, and medication use. Results: Out of 1,734 IBD patients, 332 (19.1%) had PBE detected at any point in time during the 5-year observation period. PBE was more prevalent in UC than in Crohn's disease (CD) (25.8% vs 14.6%, p < 0.0001). Patients with UC had more RBE (5.1% vs 2.8%, p =0.014) and hypereosinophilia (1.6% vs 0.6%, p=0.04) than patients with CD. Table 1 shows demographics and results of bivariate analysis. On multivariate analysis, the presence of PBE or RBE in patients with IBD independently predicted more hospitalizations (p<0.001), surgical procedures (p<0.05), clinic visits (p<0.001), phone calls (p<0.001), ED visits (p<0.001), and narcotic use (p<0.01), compared to those with normal eosinophil
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AGA Abstracts
AGA Abstracts
215, 40%; median age 31 years old, IQR: 24 - 42). Indication for surgery was intractable inflammation in 7% (n = 37), fibrostenotic disease in 50 % (n = 270) and penetrating disease in 43% (231/538) of the cases. Laparoscopy was used in 383 (71%) patients, while 47 patients (12%) were converted. Median hospital stay was 7 days (IQR: 5 - 8). Overall postoperative morbidity was reported in 122 (23%) patients. 15 patients (3%) developed an anastomotic leak, despite a low ileostomy rate. Indeed, 7% (n = 38) had an ileostomy. All but one stomas were reversed after a median time lapse of 5 months (IQR: 4 - 7). Specimen length (p = 0.002) and preoperative anti-TNF use (p = 0.0353) increased the risk of anastomotic leakage significantly. Median follow up was 6 years (IQR : 2 - 9). Clinical recurrence after 5 and 10 years were 45% and 55% respectively. Postoperative smoking (p = 0.0047) and microscopic section margin positivity (p < 0.0001) significantly influenced clinical recurrence. Surgical recurrence after 5 and 10 years were 6.5% and 19.1% respectively. Surgical recurrence was significantly influenced by smoking (p = 0.012), postoperative treatment regimen (p = 0.0008) and microscopic resection margin positivity (p = 0.0119). Conclusion: Ileocecal resection for Crohn's disease is safe and is more effectively keeping the patient in surgical remission than previously reported. Overall surgical recurrence rate is low. The risk of surgical recurrence is not a valid argument to delay surgery in Crohn's patients.
Sa1186 Prognostic Significance of Anti-Saccharomyces Cerevisiae Antibody (ASCA) in Southwestern Ohio Veteran IBD Population Mustafa Musleh, Drew Triplett, Salma Akram BACKGROUND & AIMS: Inflammatory Bowel Disease (IBD) is a term that includes two heterogeneous intestinal disorders: Crohn's disease (CD) and ulcerative colitis (UC). CD and UC both are characterized with different serology markers, anti-Saccharomyces cerevisiae antibody (ASCA) is more common in CD and perinuclear anti-neutrophil cytoplasmic antibody (P-ANCA) is more prevalent in UC patients, with some overlap. Positivity of immune markers may be associated with different disease phenotype and different prognosis. The aim of the study is to describe characteristics of our cohort of veteran patients with IBD and to analyze the effect serology positivity and disease course, severity and prognosis. MATERIALS and METHODS: This is a retrospective study of veterans with inflammatory bowel disease seen at Dayton VA Medical Center between January 2004 and June 2011. Patients who underwent testing for ASCA and/or P-ANCA were included in the study. Relevant demographic and clinical data was obtained through electronic chart review. RESULTS: Ninety five IBD (60 CD and 35 UC) patients who had ASCA and/or P-ANCA serology results available were included in the study. Overall, 88 (57 CD and 31 UC) patients were tested for ASCA and 39% were positive. Total of 80 (49 CD and 31 UC) patients were tested for P-ANCA and 15% were positive. Among patients with CD, ASCA and pANCA were positive in 48% and 10%.of the patients respectively. Both ASCA and pANCA were positive in 23% each of the UC patients. Average age at IBD diagnosis in ASCA positive patients was 33 years (SD = 14 years), compared to 44 years (SD = 17 years) in those who were ASCA negative (P = 0.002). IBD patients with ASCA positive serology were less likely to have hypertension (21% vs. 54%, P= 0.03) and hyperlipidemia (29% vs. 53% P=0.02), compared to those who were ASCA negative. There was no difference in steroids use in IBD patients with ASCA positive serology compared to those who were ASCA negative (68% vs. 61% P=0.65). ASCA positive patients were more likely to require anti-TNF and/or immunosuppressive therapy compared to ASCA negative patients (65% vs. 39% P=0.03). CD patients with ASCA positive serology were more likely to have small bowel resection (48% vs. 21 % P=0.048). CONCLUSIONS: IBD Veteran patients in southwest Ohio with ASCA positive serology are more likely to have earlier disease onset, more aggressive disease course, requiring escalation of medical therapy and more frequent bowel surgeries. ASCA serology is widely available and can be used as a simple prognostic tool in veteran IBD patients.
Sa1188 Momentary Ratings Versus Recalled Ratings of Abdominal Pain in Patients With Crohn's Disease: Methodological Implications for Future Patient Reported Outcomes Measures Leighann Litcher-Kelly, Peter M. Black The FDA issued a guidance report in 2009 stating the importance of collecting information from patients, including symptoms, in clinical trials . The most widely used outcome measure in Crohn's disease clinical trials is the Crohn's Disease Activity Index (CDAI), which includes a 7 day prospective patient diary to assess daily abdominal pain. A key criticism of the CDAI is non-compliance with the prospective diary, including documentation of retrospective completion (Sandborn et al., 2002). While this may appear to be a minor methodological alteration, past research has shown that retrospective reports of a subjective construct such as pain may be reported as higher than if pain is reported without any recall (Gorin & Stone 2001). Furthermore, the "peak-end" (PE) effect, first described in Kahneman and Redelmeier's seminal work on colonoscopy pain (Kahneman et al., 1993; Redelmeier et al., 2003), states that a patient's report of recalled pain will be based disproportionately on the times they experience the most (Peak) pain, and the most proximal experiences of pain (End), while the duration of pain does not influence recall. The goal of the current study was to examine how Peak and End reports of pain are related to recalled reports in a sample of 25 patients with Crohn's disease. Method: This study compared momentary abdominal pain ratings assessed approximately 5 times per day over seven days using an electronic diary, and compared these data to recall of abdominal pain over the those same 7 days, completed on a paper questionnaire. Hypothesis: Based on the PE effect, the best predictors of recalled abdominal pain will be the Peak and End momentary assessments, with the duration of pain experienced over the recall period (the percentage of momentary assessments when patients reported having pain), will not being a significant predictor. Results: As expected the recalled reported of abdominal pain were higher than the average of the momentary assessments for the same time period. Step-wise regression was used to examine how Peak+End momentary reports of abdominal pain predicted recalled pain (step 1), and how Peak+End+Duration of pain predicted recalled pain. The data indicated that study hypothesis was supported; specifically the best predictors of recalled abdominal pain were the Peak and End momentary assessments (accounting for 48% of model variance, p<0.001). Including Duration into the model only accounted for an additional 7% of the variance, which was not significant (p>0.05). Conclusion: This information may inform appropriate recall periods for the assessment of patient symptoms, such as abdominal pain in patients with Crohn's disease. Given the FDA Patient-Reported Outcomes (PRO) guidance, this is essential information that can be used in development of assessments of Crohn's disease symptoms, to be used in future clinical trials.
Sa1187 Peripheral Blood Eosinophilia in Patients With Inflammatory Bowel Disease Is Associated With Worse Outcomes: A 5-Year Prospective Study Jorge D. Machicado, Toufic Kabbani, Claudia Ramos Rivers, Benjamin H. Click, Arthur Barrie, Douglas J. Hartman, Miguel Regueiro, Jason M. Swoger, Marc Schwartz, Leonard Baidoo, Jana G. Hashash, Michael A. Dunn, David G. Binion Background: Eosinophils are granulocyte lymphocytes with effector and antigen presenting functions, playing a central role in the immune response to parasitic infection, allergic phenomenon and chronic inflammatory disorders including asthma and inflammatory bowel disease (IBD). Peripheral blood eosinophilia (PBE) has been demonstrated in subgroups of patients with asthma and IBD, and it may function as a biomarker for this unique endotype of chronic inflammation. The clinical course of IBD patients with PBE is not well defined. We aimed to determine the role of PBE in the clinical course of patients with IBD. Methods: We used a prospective, longitudinal IBD registry of patients followed in a tertiary referral center between 2009-2013. PBE was defined by an absolute eosinophil count (AEC) greater than 500/uL at any time during the study period. Recurrent blood eosinophilia (RBE) was defined as PBE on at least four separate occasions, while hypereosinophilia was defined by AEC greater than 1500/uL. The clinical course of patients with IBD was measured with patterns of medication use, healthcare utilization, disease activity scores (Harvey-Bradshaw index, ulcerative colitis (UC) disease activity index) and health related quality of life (short inflammatory bowel disease questionnaire (SIBDQ)). We calculated associations of eosinophilia with outcomes of interest using multiple linear regression analysis with adjustment for demographic characteristics, IBD disease type, primary sclerosing cholangitis, and medication use. Results: Out of 1,734 IBD patients, 332 (19.1%) had PBE detected at any point in time during the 5-year observation period. PBE was more prevalent in UC than in Crohn's disease (CD) (25.8% vs 14.6%, p < 0.0001). Patients with UC had more RBE (5.1% vs 2.8%, p =0.014) and hypereosinophilia (1.6% vs 0.6%, p=0.04) than patients with CD. Table 1 shows demographics and results of bivariate analysis. On multivariate analysis, the presence of PBE or RBE in patients with IBD independently predicted more hospitalizations (p<0.001), surgical procedures (p<0.05), clinic visits (p<0.001), phone calls (p<0.001), ED visits (p<0.001), and narcotic use (p<0.01), compared to those with normal eosinophil
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AGA Abstracts
AGA Abstracts
215, 40%; median age 31 years old, IQR: 24 - 42). Indication for surgery was intractable inflammation in 7% (n = 37), fibrostenotic disease in 50 % (n = 270) and penetrating disease in 43% (231/538) of the cases. Laparoscopy was used in 383 (71%) patients, while 47 patients (12%) were converted. Median hospital stay was 7 days (IQR: 5 - 8). Overall postoperative morbidity was reported in 122 (23%) patients. 15 patients (3%) developed an anastomotic leak, despite a low ileostomy rate. Indeed, 7% (n = 38) had an ileostomy. All but one stomas were reversed after a median time lapse of 5 months (IQR: 4 - 7). Specimen length (p = 0.002) and preoperative anti-TNF use (p = 0.0353) increased the risk of anastomotic leakage significantly. Median follow up was 6 years (IQR : 2 - 9). Clinical recurrence after 5 and 10 years were 45% and 55% respectively. Postoperative smoking (p = 0.0047) and microscopic section margin positivity (p < 0.0001) significantly influenced clinical recurrence. Surgical recurrence after 5 and 10 years were 6.5% and 19.1% respectively. Surgical recurrence was significantly influenced by smoking (p = 0.012), postoperative treatment regimen (p = 0.0008) and microscopic resection margin positivity (p = 0.0119). Conclusion: Ileocecal resection for Crohn's disease is safe and is more effectively keeping the patient in surgical remission than previously reported. Overall surgical recurrence rate is low. The risk of surgical recurrence is not a valid argument to delay surgery in Crohn's patients.