- Email: [email protected]
Su1093 Is There Any Association of Diabetes With Individuals on a Gluten-Free Diet?
5.6%, 7.8% and 5.5% respectively. In adjusted analysis, there was no significant difference in the overall rate of major malformations among live births in the adalimumab exposed vs. disease-matched group (adjusted Relative Risk (RR) 1.14, 95% Confidence Interval (CI) 0.26, 4.93). A total of 234 infants (70% of live born infants) received the study-related physical examination. The proportion of children with three or more minor malformations in the three groups did not differ, and there was no specific pattern of minor malformations identified. Using Cox Proportional Hazards modeling, the adjusted hazard ratio (HR) for spontaneous abortion was 1.96 (95% CI 0.47, 8.26) comparing the adalimumab vs. diseasematched groups; the rate was elevated in comparison to the non-diseased group (adjusted HR 3.79, 95% CI 1.01, 14.23), however the number of events was small. The rate of preterm delivery did not differ significantly among groups, nor did the proportion of infants who were small for gestational age. Conclusion Pregnant women with rheumatoid arthritis who are treated with adalimumab during the first trimester compared to women with the same underlying condition do not appear to be at increased risk of any of the adverse pregnancy outcomes evaluated. Although the sample size is small, these results provide reassuring data to women with rheumatoid arthritis who require treatment with adalimumab. Su1092 Age of Onset Is Associated With Seasonality of Onset and Exacerbation in Inflammatory Bowel Disease: A Multi-Center Observational Study by the Osaka Gut Forum Manabu Araki, Shinichiro Shinzaki, Hideki Lijima, Satoshi Hiyama, Takuya Yamada, Shoko Arimitsu, Masato Komori, Mari Ito, Akira Mukai, Sachiko Nakajima, Fumitaka Terabe, Kazuo Kinoshita, Shinji Kitamura, Yoko Murayama, Hiroyuki Ogawa, Yuichi Yasunaga, Masahide Oshita, Eiji Masuda, Masahiko Tsujii, Tetsuo Takehara Background: Inflammatory bowel diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are caused by a complex interaction between genetic and environmental factors. Although many environmental factors are suggested to affect the pathogenesis of IBD, it is controversial whether onset and exacerbation of IBD are associated with seasonal deviation. We aimed to clarify the disease seasonality and investigate the underlying characteristics in IBD patients. Methods: This was a multi-center observational study conducted by Osaka Gut Forum (OGF) comprising 20 institutions in Japan. A total of 1,078 IBD patients (303 CD patients, 775 UC patients) were enrolled. All patients were Japanese and data were collected using survey forms from doctors and questionnaires from patients from November 2013 to August 2014. Association between disease seasonality and patient characteristics was investigated. Statistical analysis was performed using Pearson's chi-square test, and odds ratio (OR) and 95% confidence interval (CI) were analyzed. Results: Disease onset was significantly more frequent in spring-summer compared with autumn-winter in IBD, especially in CD (p = 0.037 and 0.030, respectively), while UC patients did not show seasonality of disease onset. When the patients were divided into two groups by age of onset (A1/2 and A3 in Montreal classification), the proportion of patients with spring-summer onset was larger than that with autumn-winter onset in A1/2 group of IBD, especially of CD (p = 0.014 and p = 0.019, respectively), whereas A3 group did not show onset seasonality. Disease exacerbation was significantly more frequent in autumn-winter than in springsummer in IBD, especially in UC (p = 0.006 and 0.016, respectively), but CD patients did not show seasonality of disease exacerbation. A1/2 group had significant dominance in autumn-winter exacerbation in IBD, especially in UC (p = 0.013 and p = 0.038, respectively), whereas A3 group did not show exacerbation seasonality in both CD and UC. Multivariate analysis showed that age onset of A1/2 was the independent factor of seasonality for disease onset and exacerbation in IBD (OR 1.33, 95% CI 1.01 - 1.75, p = 0.042 and OR 1.62, 95% CI 1.21 - 2.16, p = 0.001, respectively). Conclusion: Seasonality of disease onset and exacerbation was observed in young-onset IBD patients, suggesting that young and elderlyonset patients might have different pathophysiological triggers for disease initiation and exacerbation.
Su1090 Gastroesophageal Reflux Disease Prevalence and Its Association With Sleep Disorders in a Community Based Study Aurelio Lopez-Colombo, Max J. Schmulson, Larisa Y. Jesús-Mejenes, Stephany GallegosZavala, Aarón M. Granados Bautista, Hugo F. Ramón Acosta, Víctor Roberto Ortiz-Juárez, Eduardo R. Morales-Hernández, Alvaro Montiel-Jarquin, Juan C. Lopez-Alvarenga, Víctor A. Segura-Bonilla, William C. Orr Background: Gastroesophageal reflux disease (GERD) is a common disorder that affects 1025% of the world population. GERD has also been associated with sleep disorders. In Mexico there is no data on GERD prevalence and its association with sleep disorders.1 Aims: To describe GERD prevalence and its association with sleep disorders based on direct data obtained via in home visits. Methods: This was a cross-sectional community-based survey. A sample size of 938 subjects was calculated. The survey was conducted in home visits from 15 towns in the State of Puebla in central Mexico. The first available adult in each household was invited to participate. Those who agreed were asked to answer the CarlssonDent Questionnaire (CDQ) and the Pittsburgh Sleep Quality Index (PSQI). GERD was considered present when CDQ score was equal to or greater than 4.2 Those individuals that scored equal to or less than 5 in the PSQI were considered good sleepers, while those with scores greater than 5 were considered poor sleepers.3 Tobacco, alcohol, drug consumption, health status and body mass index (BMI) were also assessed. Results: 1012 individuals agreed to participate, but 28 questionnaires were excluded because of missing data. Therefore, 984 subjects were analyzed; 365 (37.1%) men and 619 (62.9%) women, 41.3±16.5 yearsold, BMI: 26.8±4.7 kg/m2. There were 96 (9.8%) PPI users, 26 (2.6%) NSAIDs users and 6 (0.6%) reported a previous diagnosis of Barrett's esophagus. GERD was present in 327 (33.2%), and 569 (57.8%) were poor sleepers. Subjects with GERD were more likely to be poor sleepers (OR 3.0, 95% CI 2.2, 4.0). Conclusions: To our knowledge this is the first study to report GERD prevalence in an open population study based on data obtained via direct subject interviews. GERD prevalence was high (33.2%). There was a significant association between GERD and sleeping disorders with a prevalence which is considerably higher than noted in previous data. 1Huerta-Iga F et al. Rev Gastroenterol Mex 2013;78:2319. 2Gomez-Escudero O et al. Rev Gastroenterol Mex 2004;69:16-23. 3Buysse DJ et al. Psychiatry Research 1989;28:193-213.
Su1093 Is There Any Association of Diabetes With Individuals on a Gluten-Free Diet? Khalid Bo-Subait, Rok Seon Choung, Eric Marietta, Joseph A. Murray Background: The use of a gluten-free diet in those who do not have celiac disease, appear to be very common. A significant amount of public attention has focused on this practice, even though few studies on its characteristics and association with other diseases have been performed. There is one study showing a lower prevalence of type 2 DM and metabolic syndrome in patients with celiac disease (CD); however no study of association between diabetes and people without CD avoiding gluten (PWAG) has yet been published. Aim: To evaluate the association between diabetes and PWAG or CD in the non-institutionalized civilian adult population of the US between 2009 and 2012. Methods: We used the National Health and Nutrition Examination Surveys (NHANES) from 2009 to 2012 for this study. We tested serum samples from participants for immunoglobulin A (IgA) tissue transglutaminase antibodies and, if findings were abnormal, for IgA endomysial antibodies. CD was defined as self-reported diagnosis by questionnaire, or being positive on both tests. Information about adherence to a gluten-free diet (GFD) was obtained by an interviewer administered questionnaire. Diabetes was defined as a self-reported diagnosis. The association of the CD or PWAG status with clinical features (age, gender, and BMI) and diabetes was assessed using multiple variable logistic regression. Results: Overall 11,523 adults 20 years and older with complete data were included in the study. The proportion of diabetes was higher in PWAG (27%, 33/122) than in the non-PWAG group (12%, 1395/11401). However, the proportion of diabetes in patients with CD (14%) was similar to subjects without CD (12 %). Diabetes was significantly associated with reporting PWAG. In the multivariate model, the odds ratio for PWAG comparing participants with diabetes to those without diabetes was 2.60 (95% CI: 1.56, 4.34), adjusted by age, gender, and BMI. However, diabetes was not significantly associated with CD (includes both undiagnosed and diagnosed) [OR 1.36, 95% CI (0.56, 3.20)]. Conclusions: While CD is associated with a lower prevalence of type 2 diabetes or metabolic syndrome in the literature, PWAG is strongly associated with a higher prevalence of diabetes in our study. Since association does not prove causality, more studies are needed to explore these relationships.
Su1091 Pregnancy Outcome in Women Treated With Adalimumab for the Treatment of Rheumatoid Arthritis: An Update on the OTIS Autoimmune Diseases in Pregnancy Project Christina D. Chambers, Diana Johnson, Yunjun Luo, Ronghui Xu, Kenneth L. Jones Background Adalimumab is a fully human monoclonal antibody to tumor necrosis factor alpha and is approved for several indications including rheumatoid arthritis. Methods The OTIS Collaborative Research Group conducted a prospective cohort study in the U.S. and Canada between 2004-2013 comparing pregnancy outcomes in women with rheumatoid arthritis treated with adalimumab to women with rheumatoid arthritis not treated with adalimumab. Participants may have been treated with another DMARD or steroid but not methotrexate. An additional comparison group included women without any autoimmune disease. Participants enrolled prior to 19 weeks' gestation and were followed by telephone interviews. Medical records were reviewed, and a subset of infants received a dysmorphological examination by a study physician. Outcomes were compared using logistic regression and survival methods as appropriate with adjustment for confounders. Results Seventyfour adalimumab-exposed, 80 disease-matched and 218 non-diseased women were enrolled. Women in the adalimumab-exposed group had at least one dose of the medication in the first trimester; approximately 43% used adalimumab in all three trimesters. The lost-tofollow up rate was 5.9%. Disease severity, as measured by the HAQ at the time of enrollment and at 32 weeks' gestation, was similar between the two disease-matched groups. The rate of major defects in the exposed, disease-matched, and non-diseased comparison groups was
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have concurrent obesity and obesity-related comorbidities. The impact of concurrent obesity, DM, and NAFLD on progression of disease among chronic HCV patients is not well understood. Aims: To perform a systematic review of the literature evaluating the impact of concurrent obesity, DM, and NAFLD on disease progression among chronic HCV patients. Methods: Two authors independently performed a structured keyword search of MEDLINE and EMBASE from January 1, 2001 to July 1, 2014 to identify original articles evaluating the association of obesity, DM, and NAFLD on progression to advanced fibrosis among adults with chronic HCV. Studies involving chronic HCV patients co-infected with human immunodeficiency virus, hepatitis B virus, hepatocellular carcinoma, or other chronic liver diseases with the exception of NAFLD were excluded. Studies that primarily included postliver transplantation patients were also excluded. Studies were stratified by predictors of progression to advanced fibrosis or cirrhosis (obesity, DM, NAFLD) and country of origin. Quality assessment was performed using the Newcastle-Ottawa scale. Results: Twenty articles (20 cohort studies) met inclusion criteria and were included in the final analysis. Six studies were from the U.S., three studies were from Asia-Pacific regions, and 11 studies were from Europe. Seven studies reported an increased risk of advanced fibrosis (METAVIR F3-4 or Ishak score > 4) associated with obesity among chronic HCV patients, with the magnitude of effect ranging from an odds ratio (OR) of 1.081 (95% CI, 1.00 - 1.17) to 7.69 (95% CI 1.82 - 32.57). However, four studies did not demonstrate a significant association between obesity and advanced fibrosis. When evaluating the impact of DM, an increased risk of advanced fibrosis was observed in six studies (OR, 2.251; 95% CI, 1.080 - 4.693 to OR, 9.24; 95% CI, 2.56 - 33.36). Concurrent NAFLD among patients with chronic HCV was also associated with an increased risk of advanced fibrosis in 12 studies (OR, 1.80; 95% CI, 1.20 - 2.90 to OR, 14.3, 95% CI, 2.1-111.1). Using the Newcastle-Ottawa scale, 13 studies were of good quality and 7 studies were of fair quality. Conclusions: The current systematic review demonstrates that concurrent obesity, DM, and NAFLD is associated with a significantly higher risk of progression to advanced fibrosis among adults with chronic HCV. Targeted interventions to optimize the management of obesity and obesity-related diseases among HCV patients are needed.
AGA Abstracts
preparations. The Begg's funnel plot indicated low probability of publication bias. Conclusions: SPMC before colonoscopy appears to be equally effective to PEG-ES bowel preparations but better tolerated
*Odds ratios for PWAG or CD (OR [95% CI]); adjusted by age, gender, and BMI. Su1094 A Systematic Review and Meta-Analysis of Non-Invasive Biomarkers for Assessing Disease Activity in Inflammatory Bowel Disease Mahmoud H. Mosli, Guangyong Zou, Sushil Kumar Garg, Sean Feagan, John K. MacDonald, William Sandborn, Nilesh Chande, Brian G. Feagan
Su1097 Acute Coronary Syndrome and Risk of Gastrointestinal Hemorrhage: When Is It Safe to Proceed? Joseph Yeh, Bechien U. Wu, Ngoc J. Ho
Background: Endoscopic disease activity in inflammatory bowel disease (IBD) is associated with poor outcomes. Endoscopic evaluation is the gold standard for the assessment of disease activity, but is invasive, expensive and potentially time consuming. Identification of noninvasive biomarkers of disease activity in IBD is a research priority. Methods: The primary objective was to evaluate the diagnostic accuracy of 3 non-invasive biomarkers (fecal calprotectin [FC], stool lactoferrin [SL] and C-reactive protein [CRP]) used for the evaluation of disease activity in IBD. MEDLINE, EMBASE, the Cochrane Library, the ISI Web of Knowledge and conference abstracts were searched from inception to November 2014 for relevant studies. Grey literature databases (e.g. SIGLE) were also searched to identify studies not indexed in traditional databases. All cohort and case-control studies that evaluated the diagnostic accuracy of FC, SL or CRP for assessment of disease activity in symptomatic patients with previously diagnosed IBD (ulcerative colitis and Crohn's disease) were included. True positive, true negative, false positive and false negative rates were extracted for each biomarker and used to construct 2X2 tables for each cutoff. Sensitivity, specificity and area under the curve (AUC) estimates for FC, SL and CRP were calculated for each study based on different cut-offs and pooled together into single estimates for each test. Receiver operator characteristics (ROC) curves were then used to identify the cut-off values for each biomarker that best predicted endoscopic disease activity. Results: Nineteen studies (2456 participants) met our inclusion criteria. Sensitivity, specificity, and AUC values for the 3 biomarkers are summarized in Table 1. The best cut-off values to detect endoscopically active disease in IBD determined by ROC analysis were 50 μg/g, 7.25 μg/mL and 10 mg/dL for FC, SL and CRP, respectively. Conclusions: FC and SL are highly accurate biomarkers that can be used to screen symptomatic IBD patients for endoscopic disease activity prior to colonoscopy. Table 1. Diagnostic Accuracy of Fecal Calprotectin, Stool Lactoferrin, and C-reactive Protein
Introduction: Gastrointestinal hemorrhage (GIB) has been shown to be a serious complication in acute coronary syndrome ACS) associated with high mortality.1 In this patient population, a history of gastrointestinal disease is an independent predictor of GIB.2,3 The aim of this study was to determine at what point the risk of hemorrhage from gastrointestinal disease becomes acceptable to proceed without prior endoscopic evaluation. Methods: We conducted a retrospective study using a community-based integrated health care system in Southern California from 2006 to 2011. Our database represented 15 hospitals and 202 medical offices. Study inclusion criteria included patients with a history of gastrointestinal disease prior to diagnosis of ACS. ACS was defined as ST-segment elevation myocardial infarction, non-ST segment elevation myocardial infarction and unstable angina. Table 1 lists the ICD9 codes used to identify gastrointestinal disease and GIB in our analysis. Descriptive statistics were calculated for patients who developed GIB up to 1 year after the ACS diagnosis versus those who did not. Logistic regression models were constructed to examine the association between the time interval of gastrointestinal disease diagnosis prior to ACS and GIB, adjusting for age, gender, BMI, alcohol and smoking. Results: A total of 9652 patients satisfied the inclusion criteria of history of gastrointestinal disease and ACS. Of this group, 818 patients (9%) developed post-ACS GIB. The majority of post-ACS GIB (47.8%) occurred within one year of gastrointestinal disease diagnosis. Predicted probabilities for post-ACS GIB are displayed in Figure 1. The greatest risk of GIB (10-11%) occurred in patients with gastrointestinal disease history diagnosed within 1 year of ACS. The risk of GIB subsequently decreases as the interval increases between gastrointestinal disease and ACS diagnosis: 8% at 5 years, 5.8% at 10 years, 4.5% at 15 years. Conclusions: Our findings showed an inverse association between time interval of gastrointestinal disease diagnosis prior to ACS and risk of GIB: the longer the duration, the lower the risk. Although the risk and benefits for ACS patients should be weighed individually, those with a remote history of gastrointestinal disease over 10 years prior to ACS may have a low enough GIB risk to consider deferring endoscopic evaluation. References: 1. Abbas et al. Am J Cardiology 2005;96:173-6. 2. Shivaraju et al. Am Heart Journal 2011;162:1062-1068. 3. Bhala et al. BMJ 2011;343:d4264. 4. Nikolsky et al. J Am Coll Cardiol 2009;54(14):1293-302. Gastrointestinal disease and hemorrhage ICD-9 codes
Su1096 Picosulphate/Magnesium Citrate vs Polyethylene Glycol Electolyte Solution for Bowel Preparation: A Meta-Analysis of Randomized Controlled Trials Mohammad F. Madhoun, Hassaan Zia, Salman Nusrat, William M. Tierney Background: Polyethylene glycol electrolyte solution (PEG-ES) based bowel preparation for colonoscopy is very common. However, the large volume and the taste may reduce patient compliance, resulting into suboptimal bowel preparation. Recently, sodium picosulphate/ magnesium citrate (SPMC) has been evaluated in multiple randomized clinical trials (RCT's) as a lower volume and more palatable bowel preparation. Aims: The aims of this metaanalysis were to compare SPMC vs. PEG based products with regards (i) satisfactory bowel preparation, (ii) excellent bowel preparation, (iii) tolerability Methods: Studies were identified by searching ten medical databases including PubMed, Ovid MEDLINE and Cochrane Library Database for reports published between 1990 and 2014, using a reproducible search strategy. References from retrieved articles were also manually reviewed. Only fully published RCT's compared SPMC and PEG based products with regard to overall satisfactory bowel preparation were included. 2 reviewers independently scored the identified studies for methodology and abstracted pertinent data. Pooling was conducted by both fixed-effects and randomeffects models; results are presented from the random effects model when heterogeneity was significant. Risk ratio (RR) estimates with 95% confidence interval (CI) were calculated. Heterogeneity was assessed by I-squared index (I2) statistics. Results: Nine studies (involving 2954 subjects; 1461 in SPMC arm and 1493 in PEG arm) met the inclusion criteria, with mean age ranging from 52.8 to 65 years. Four studies used low volume PEG based products (two used 2L of PEG plus bisacodyl; two used 2L of PEG plus ascorbic acid). SPMC demonstrated a similar rate of satisfactory bowel preparation and abdominal pain compared to PEG but much less nausea and vomiting. Furthermore, SPMC subjects were more willing to repeat bowel preparation compared to PEG-ES subjects (table). Only 2 studies reported the rate of excellent bowel preparation, an attempt was made to obtain this data directly from the authors of the other studies but was unsuccessful. Subgroup analysis revealed similar result for split dose SPMC vs. 4 L PEG-ES and for SPMC vs. low volume PEG
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Su1090 Gastroesophageal Reflux Disease Prevalence and Its Association With Sleep Disorders in a Community Based Study Aurelio Lopez-Colombo, Max J. Schmulson, Larisa Y. Jesús-Mejenes, Stephany GallegosZavala, Aarón M. Granados Bautista, Hugo F. Ramón Acosta, Víctor Roberto Ortiz-Juárez, Eduardo R. Morales-Hernández, Alvaro Montiel-Jarquin, Juan C. Lopez-Alvarenga, Víctor A. Segura-Bonilla, William C. Orr Background: Gastroesophageal reflux disease (GERD) is a common disorder that affects 1025% of the world population. GERD has also been associated with sleep disorders. In Mexico there is no data on GERD prevalence and its association with sleep disorders.1 Aims: To describe GERD prevalence and its association with sleep disorders based on direct data obtained via in home visits. Methods: This was a cross-sectional community-based survey. A sample size of 938 subjects was calculated. The survey was conducted in home visits from 15 towns in the State of Puebla in central Mexico. The first available adult in each household was invited to participate. Those who agreed were asked to answer the CarlssonDent Questionnaire (CDQ) and the Pittsburgh Sleep Quality Index (PSQI). GERD was considered present when CDQ score was equal to or greater than 4.2 Those individuals that scored equal to or less than 5 in the PSQI were considered good sleepers, while those with scores greater than 5 were considered poor sleepers.3 Tobacco, alcohol, drug consumption, health status and body mass index (BMI) were also assessed. Results: 1012 individuals agreed to participate, but 28 questionnaires were excluded because of missing data. Therefore, 984 subjects were analyzed; 365 (37.1%) men and 619 (62.9%) women, 41.3±16.5 yearsold, BMI: 26.8±4.7 kg/m2. There were 96 (9.8%) PPI users, 26 (2.6%) NSAIDs users and 6 (0.6%) reported a previous diagnosis of Barrett's esophagus. GERD was present in 327 (33.2%), and 569 (57.8%) were poor sleepers. Subjects with GERD were more likely to be poor sleepers (OR 3.0, 95% CI 2.2, 4.0). Conclusions: To our knowledge this is the first study to report GERD prevalence in an open population study based on data obtained via direct subject interviews. GERD prevalence was high (33.2%). There was a significant association between GERD and sleeping disorders with a prevalence which is considerably higher than noted in previous data. 1Huerta-Iga F et al. Rev Gastroenterol Mex 2013;78:2319. 2Gomez-Escudero O et al. Rev Gastroenterol Mex 2004;69:16-23. 3Buysse DJ et al. Psychiatry Research 1989;28:193-213.
Su1093 Is There Any Association of Diabetes With Individuals on a Gluten-Free Diet? Khalid Bo-Subait, Rok Seon Choung, Eric Marietta, Joseph A. Murray Background: The use of a gluten-free diet in those who do not have celiac disease, appear to be very common. A significant amount of public attention has focused on this practice, even though few studies on its characteristics and association with other diseases have been performed. There is one study showing a lower prevalence of type 2 DM and metabolic syndrome in patients with celiac disease (CD); however no study of association between diabetes and people without CD avoiding gluten (PWAG) has yet been published. Aim: To evaluate the association between diabetes and PWAG or CD in the non-institutionalized civilian adult population of the US between 2009 and 2012. Methods: We used the National Health and Nutrition Examination Surveys (NHANES) from 2009 to 2012 for this study. We tested serum samples from participants for immunoglobulin A (IgA) tissue transglutaminase antibodies and, if findings were abnormal, for IgA endomysial antibodies. CD was defined as self-reported diagnosis by questionnaire, or being positive on both tests. Information about adherence to a gluten-free diet (GFD) was obtained by an interviewer administered questionnaire. Diabetes was defined as a self-reported diagnosis. The association of the CD or PWAG status with clinical features (age, gender, and BMI) and diabetes was assessed using multiple variable logistic regression. Results: Overall 11,523 adults 20 years and older with complete data were included in the study. The proportion of diabetes was higher in PWAG (27%, 33/122) than in the non-PWAG group (12%, 1395/11401). However, the proportion of diabetes in patients with CD (14%) was similar to subjects without CD (12 %). Diabetes was significantly associated with reporting PWAG. In the multivariate model, the odds ratio for PWAG comparing participants with diabetes to those without diabetes was 2.60 (95% CI: 1.56, 4.34), adjusted by age, gender, and BMI. However, diabetes was not significantly associated with CD (includes both undiagnosed and diagnosed) [OR 1.36, 95% CI (0.56, 3.20)]. Conclusions: While CD is associated with a lower prevalence of type 2 diabetes or metabolic syndrome in the literature, PWAG is strongly associated with a higher prevalence of diabetes in our study. Since association does not prove causality, more studies are needed to explore these relationships.
Su1091 Pregnancy Outcome in Women Treated With Adalimumab for the Treatment of Rheumatoid Arthritis: An Update on the OTIS Autoimmune Diseases in Pregnancy Project Christina D. Chambers, Diana Johnson, Yunjun Luo, Ronghui Xu, Kenneth L. Jones Background Adalimumab is a fully human monoclonal antibody to tumor necrosis factor alpha and is approved for several indications including rheumatoid arthritis. Methods The OTIS Collaborative Research Group conducted a prospective cohort study in the U.S. and Canada between 2004-2013 comparing pregnancy outcomes in women with rheumatoid arthritis treated with adalimumab to women with rheumatoid arthritis not treated with adalimumab. Participants may have been treated with another DMARD or steroid but not methotrexate. An additional comparison group included women without any autoimmune disease. Participants enrolled prior to 19 weeks' gestation and were followed by telephone interviews. Medical records were reviewed, and a subset of infants received a dysmorphological examination by a study physician. Outcomes were compared using logistic regression and survival methods as appropriate with adjustment for confounders. Results Seventyfour adalimumab-exposed, 80 disease-matched and 218 non-diseased women were enrolled. Women in the adalimumab-exposed group had at least one dose of the medication in the first trimester; approximately 43% used adalimumab in all three trimesters. The lost-tofollow up rate was 5.9%. Disease severity, as measured by the HAQ at the time of enrollment and at 32 weeks' gestation, was similar between the two disease-matched groups. The rate of major defects in the exposed, disease-matched, and non-diseased comparison groups was
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have concurrent obesity and obesity-related comorbidities. The impact of concurrent obesity, DM, and NAFLD on progression of disease among chronic HCV patients is not well understood. Aims: To perform a systematic review of the literature evaluating the impact of concurrent obesity, DM, and NAFLD on disease progression among chronic HCV patients. Methods: Two authors independently performed a structured keyword search of MEDLINE and EMBASE from January 1, 2001 to July 1, 2014 to identify original articles evaluating the association of obesity, DM, and NAFLD on progression to advanced fibrosis among adults with chronic HCV. Studies involving chronic HCV patients co-infected with human immunodeficiency virus, hepatitis B virus, hepatocellular carcinoma, or other chronic liver diseases with the exception of NAFLD were excluded. Studies that primarily included postliver transplantation patients were also excluded. Studies were stratified by predictors of progression to advanced fibrosis or cirrhosis (obesity, DM, NAFLD) and country of origin. Quality assessment was performed using the Newcastle-Ottawa scale. Results: Twenty articles (20 cohort studies) met inclusion criteria and were included in the final analysis. Six studies were from the U.S., three studies were from Asia-Pacific regions, and 11 studies were from Europe. Seven studies reported an increased risk of advanced fibrosis (METAVIR F3-4 or Ishak score > 4) associated with obesity among chronic HCV patients, with the magnitude of effect ranging from an odds ratio (OR) of 1.081 (95% CI, 1.00 - 1.17) to 7.69 (95% CI 1.82 - 32.57). However, four studies did not demonstrate a significant association between obesity and advanced fibrosis. When evaluating the impact of DM, an increased risk of advanced fibrosis was observed in six studies (OR, 2.251; 95% CI, 1.080 - 4.693 to OR, 9.24; 95% CI, 2.56 - 33.36). Concurrent NAFLD among patients with chronic HCV was also associated with an increased risk of advanced fibrosis in 12 studies (OR, 1.80; 95% CI, 1.20 - 2.90 to OR, 14.3, 95% CI, 2.1-111.1). Using the Newcastle-Ottawa scale, 13 studies were of good quality and 7 studies were of fair quality. Conclusions: The current systematic review demonstrates that concurrent obesity, DM, and NAFLD is associated with a significantly higher risk of progression to advanced fibrosis among adults with chronic HCV. Targeted interventions to optimize the management of obesity and obesity-related diseases among HCV patients are needed.
AGA Abstracts
preparations. The Begg's funnel plot indicated low probability of publication bias. Conclusions: SPMC before colonoscopy appears to be equally effective to PEG-ES bowel preparations but better tolerated
*Odds ratios for PWAG or CD (OR [95% CI]); adjusted by age, gender, and BMI. Su1094 A Systematic Review and Meta-Analysis of Non-Invasive Biomarkers for Assessing Disease Activity in Inflammatory Bowel Disease Mahmoud H. Mosli, Guangyong Zou, Sushil Kumar Garg, Sean Feagan, John K. MacDonald, William Sandborn, Nilesh Chande, Brian G. Feagan
Su1097 Acute Coronary Syndrome and Risk of Gastrointestinal Hemorrhage: When Is It Safe to Proceed? Joseph Yeh, Bechien U. Wu, Ngoc J. Ho
Background: Endoscopic disease activity in inflammatory bowel disease (IBD) is associated with poor outcomes. Endoscopic evaluation is the gold standard for the assessment of disease activity, but is invasive, expensive and potentially time consuming. Identification of noninvasive biomarkers of disease activity in IBD is a research priority. Methods: The primary objective was to evaluate the diagnostic accuracy of 3 non-invasive biomarkers (fecal calprotectin [FC], stool lactoferrin [SL] and C-reactive protein [CRP]) used for the evaluation of disease activity in IBD. MEDLINE, EMBASE, the Cochrane Library, the ISI Web of Knowledge and conference abstracts were searched from inception to November 2014 for relevant studies. Grey literature databases (e.g. SIGLE) were also searched to identify studies not indexed in traditional databases. All cohort and case-control studies that evaluated the diagnostic accuracy of FC, SL or CRP for assessment of disease activity in symptomatic patients with previously diagnosed IBD (ulcerative colitis and Crohn's disease) were included. True positive, true negative, false positive and false negative rates were extracted for each biomarker and used to construct 2X2 tables for each cutoff. Sensitivity, specificity and area under the curve (AUC) estimates for FC, SL and CRP were calculated for each study based on different cut-offs and pooled together into single estimates for each test. Receiver operator characteristics (ROC) curves were then used to identify the cut-off values for each biomarker that best predicted endoscopic disease activity. Results: Nineteen studies (2456 participants) met our inclusion criteria. Sensitivity, specificity, and AUC values for the 3 biomarkers are summarized in Table 1. The best cut-off values to detect endoscopically active disease in IBD determined by ROC analysis were 50 μg/g, 7.25 μg/mL and 10 mg/dL for FC, SL and CRP, respectively. Conclusions: FC and SL are highly accurate biomarkers that can be used to screen symptomatic IBD patients for endoscopic disease activity prior to colonoscopy. Table 1. Diagnostic Accuracy of Fecal Calprotectin, Stool Lactoferrin, and C-reactive Protein
Introduction: Gastrointestinal hemorrhage (GIB) has been shown to be a serious complication in acute coronary syndrome ACS) associated with high mortality.1 In this patient population, a history of gastrointestinal disease is an independent predictor of GIB.2,3 The aim of this study was to determine at what point the risk of hemorrhage from gastrointestinal disease becomes acceptable to proceed without prior endoscopic evaluation. Methods: We conducted a retrospective study using a community-based integrated health care system in Southern California from 2006 to 2011. Our database represented 15 hospitals and 202 medical offices. Study inclusion criteria included patients with a history of gastrointestinal disease prior to diagnosis of ACS. ACS was defined as ST-segment elevation myocardial infarction, non-ST segment elevation myocardial infarction and unstable angina. Table 1 lists the ICD9 codes used to identify gastrointestinal disease and GIB in our analysis. Descriptive statistics were calculated for patients who developed GIB up to 1 year after the ACS diagnosis versus those who did not. Logistic regression models were constructed to examine the association between the time interval of gastrointestinal disease diagnosis prior to ACS and GIB, adjusting for age, gender, BMI, alcohol and smoking. Results: A total of 9652 patients satisfied the inclusion criteria of history of gastrointestinal disease and ACS. Of this group, 818 patients (9%) developed post-ACS GIB. The majority of post-ACS GIB (47.8%) occurred within one year of gastrointestinal disease diagnosis. Predicted probabilities for post-ACS GIB are displayed in Figure 1. The greatest risk of GIB (10-11%) occurred in patients with gastrointestinal disease history diagnosed within 1 year of ACS. The risk of GIB subsequently decreases as the interval increases between gastrointestinal disease and ACS diagnosis: 8% at 5 years, 5.8% at 10 years, 4.5% at 15 years. Conclusions: Our findings showed an inverse association between time interval of gastrointestinal disease diagnosis prior to ACS and risk of GIB: the longer the duration, the lower the risk. Although the risk and benefits for ACS patients should be weighed individually, those with a remote history of gastrointestinal disease over 10 years prior to ACS may have a low enough GIB risk to consider deferring endoscopic evaluation. References: 1. Abbas et al. Am J Cardiology 2005;96:173-6. 2. Shivaraju et al. Am Heart Journal 2011;162:1062-1068. 3. Bhala et al. BMJ 2011;343:d4264. 4. Nikolsky et al. J Am Coll Cardiol 2009;54(14):1293-302. Gastrointestinal disease and hemorrhage ICD-9 codes
Su1096 Picosulphate/Magnesium Citrate vs Polyethylene Glycol Electolyte Solution for Bowel Preparation: A Meta-Analysis of Randomized Controlled Trials Mohammad F. Madhoun, Hassaan Zia, Salman Nusrat, William M. Tierney Background: Polyethylene glycol electrolyte solution (PEG-ES) based bowel preparation for colonoscopy is very common. However, the large volume and the taste may reduce patient compliance, resulting into suboptimal bowel preparation. Recently, sodium picosulphate/ magnesium citrate (SPMC) has been evaluated in multiple randomized clinical trials (RCT's) as a lower volume and more palatable bowel preparation. Aims: The aims of this metaanalysis were to compare SPMC vs. PEG based products with regards (i) satisfactory bowel preparation, (ii) excellent bowel preparation, (iii) tolerability Methods: Studies were identified by searching ten medical databases including PubMed, Ovid MEDLINE and Cochrane Library Database for reports published between 1990 and 2014, using a reproducible search strategy. References from retrieved articles were also manually reviewed. Only fully published RCT's compared SPMC and PEG based products with regard to overall satisfactory bowel preparation were included. 2 reviewers independently scored the identified studies for methodology and abstracted pertinent data. Pooling was conducted by both fixed-effects and randomeffects models; results are presented from the random effects model when heterogeneity was significant. Risk ratio (RR) estimates with 95% confidence interval (CI) were calculated. Heterogeneity was assessed by I-squared index (I2) statistics. Results: Nine studies (involving 2954 subjects; 1461 in SPMC arm and 1493 in PEG arm) met the inclusion criteria, with mean age ranging from 52.8 to 65 years. Four studies used low volume PEG based products (two used 2L of PEG plus bisacodyl; two used 2L of PEG plus ascorbic acid). SPMC demonstrated a similar rate of satisfactory bowel preparation and abdominal pain compared to PEG but much less nausea and vomiting. Furthermore, SPMC subjects were more willing to repeat bowel preparation compared to PEG-ES subjects (table). Only 2 studies reported the rate of excellent bowel preparation, an attempt was made to obtain this data directly from the authors of the other studies but was unsuccessful. Subgroup analysis revealed similar result for split dose SPMC vs. 4 L PEG-ES and for SPMC vs. low volume PEG
AGA Abstracts
S-406