sa1105 international perceptions of ibs: survey of ibs investigators from the global multinational...

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Sa1104 Efficacy of Adalimumab in Refractory Ulcerative Colitis in Clinical Practice Marie Lequoy, Philippe Seksik, Yoram Bouhnik, Matthieu Allez, Franck Carbonnel, Anne Bourrier, Harry Sokol, Laurent Beaugerie, Jacques Cosnes Introduction Controlled trials have demonstrated the efficacy of anti-TNF in ulcerative colitis (UC). Unlike infliximab (IFX), there are limited data with regard to the efficacy of adalimumab (ADA) in clinical practice. The aim of this study was to evaluate the efficacy of ADA for inducing and maintaining remission in patients with refractory UC and to compare it with that of patients maintained under IFX. Patients and Methods This retrospective and multicentre study included 68 consecutive patients with refractory UC (n=62) or unclassified colitis (n=6) treated with ADA between 2006 and 2012 as rescue therapy. 36 of those had lost response to IFX, 14 had developed intolerance, 13 were primary failures, and 13 patients had refused IFX. Primary study endpoints were achievement of clinical remission (clinical Mayo score [without endoscopy] 2), time-to-clinical recurrence (Kaplan Meier) and time- to-colectomy (Kaplan Meier). Treatment was considered as efficacious if it obtained and/or maintained clinical remission along follow-up, partially efficacious in case of flares responding to intensification of therapy, and unsuccessful in all other cases. In addition, we compared time-to-clinical recurrence, time-to-colectomy, median values of hemoglobin and CRP, and need for additional medications through semesters between 56 patients treated with ADA and 56 patients treated with IFX matched for sex and duration of prior anti-TNF treatment. Results Among the 63 patients who were active when starting ADA, 40 (63%) achieved clinical remission after a median period of 1 month. Among the 45 patients in clinical remission after induction with ADA (n=40) or switched from IFX while inactive (n=5), 32 (71%) were still in remission at 1 year and 26 (58%) at 2 years. Among the total of 68 patients, 14 (21%) underwent colectomy (cumulative rate 19% at 2 years and 34% at 4 years). Predictive factors of colectomy were early disease (p ,0.05), deep ulcerations (p= 0.04), thrombocytosis (p,0.05) and anemia (p,0.02). No patient died during the survey. Six (9%) had non serious adverse events. Overall, ADA was efficacious in 31 patients (46%), partially efficacious in 15 patients (22%) and unsuccessful in 22 patients (32%). Comparison with patients maintained under IFX showed no significant differences regarding time-to- clinical recurrence, time-to-colectomy, and median values of clinical Mayo score, CRP and hemoglobin along the survey. However steroids were used more often in the ADA group (18 on 119 semesters (15%) versus 5 on 197 (3%) in the IFX group; p = 0.03). Conclusion In clinical practice, ADA is well tolerated and effective as it is able to achieve and maintain clinical remission in about half patients with refractory ulcerative colitis, in particular in those who had lost response or had developed intolerance to IFX. Sa1105 International Perceptions of IBS: Survey of IBS Investigators From the Global Multinational IBS Initiative Mark Pimentel, Nicholas J. Talley, Eamonn M. Quigley, Albis Hani, Ala I. Sharara, Varocha Mahachai In the absence of a validated biomarker, IBS study has been largely based on clinical impressions derived from the observation of sufferers in the West. These impressions served as the basis for diagnostic criteria, such as the Rome criteria. In the last decade, a broader more global understanding of IBS has begun to emerge. As a result, experts in the field now have more varied opinions of IBS diagnostic criteria and outcome measures. In this study, IBS experts from around the world were surveyed to determine their opinions on IBS diagnostic criteria, outcome measures and predominant complaints. Methods: The Multina- tional IBS Initiative, comprising a group of international clinician investigators in IBS, was convened in 2012. In preparation for this meeting, investigators were sent a questionnaire covering their perception of IBS symptoms, diagnostic criteria, outcome measures for trials, and the need for new IBS criteria. The credibility of the investigators as IBS experts was evaluated in two ways: the number of publications in IBS and the number of IBS subjects seen each month. The answers to the questionnaire were sub-stratified based on their participation in the Rome process. A total of 59 investigators were invited to attend a meeting representing 5 continents (Europe, Asia, Australia, North America and South America). Representatives from FDA and NIH also participated in the meeting but were not asked to complete the pre-meeting survey. Results: The 39 IBS clinician investigators completing the survey had a combined total of 966 publications and 51% saw more than 20 IBS subjects per month. Of these, 11 were, at some point, part of a Rome committee. While 51.4% and 82.9% of those surveyed used Rome III criteria in their clinic and as the basis for patient enrollment in clinical studies, respectively, 77.1% reported that Rome III criteria inadequately represented IBS in their clinical experience. In fact, 54.3% concluded that bloating was the most important symptom in IBS and only 28.6% endorsed that abdominal pain was most important. As a result, 80.0% of those surveyed felt new criteria were needed. Most (65.7%) agreed IBS could be diagnosed easily without need for diagnostic tests. In identifying healthy controls, IBS investigators felt this should be done through a negative symptom questionnaire and not simply through the use of the term "healthy". With regard to outcome measures for clinical trials, 77.1% concluded that, in contrast to current approaches, approximating normal bowel function was the most important outcome for IBS trials. Conclusions: In this survey of leading international investigators on IBS, the majority felt that new criteria for IBS were needed to encompass bloating, in particular. Furthermore, clinical trials in IBS need to incorporate normalization of bowel function as an important patient-relevant outcome. S-203 AGA Abstracts Sa1106 Risk Factors for a Positive Fecal Immunochemical Test in the Subsequent Screening for Colorectal Neoplasms Yi-Chia Lee, Han-Mo Chiu, Tsung-Hsien Chiang, Hsiu-Po Wang, Jaw-Town Lin, Ming- Shiang Wu Background: Although the fecal immunochemical test is effective in detecting colorectal neoplasms, participation to subsequent screening decreases with time. Following a negative test, it is important to identify subjects who are more likely to yield a positive fecal immuno- chemical test in the subsequent rounds. Methods: Our database consisted of 30117 partici- pants who underwent periodic fecal immunochemical tests during a 5-year period. We recruited those who were aged 50 years or more and had a negative fecal immunochemical test in the first round. We collected individual factors, including the demographic characteris- tics, body mass index, education level, social habits such as smoking, alcohol, and regular exercise, comorbidity, medications such as antiplatelet agents and nonsteroidal anti-inflam- matory drugs, family histories with cancer, biochemical studies such as fasting sugar, HbA1c, cholesterol, triglyceride, hemoglobin, platelet count, C-reactive protein, and uric acid, and the presence of metabolic syndrome or not, to identify risk factors associated with a positive fecal immunochemical test in the subsequent rounds. We used the Kaplan-Meier curves and Cox proportional hazards regression models for statistical analyses. Results: From the first round to fourth round, 14411, 3783, 1537, and 624 participants received the fecal tests, respectively, and 8.7%, 5.7%, 5.1%, and 3.9% were tested positive, respectively. A total of 3783 subjects (men: 63.6%; mean age ± standard deviation: 59.4 ± 7.2) with baseline negative tests were followed up (mean screening round: 2.62 ± 0.88, and mean screening interval: 2.43 ± 1.01 years). Our data was therefore composed of 9922 fecal tests, 9183 person-years, and 302 subjects with a positive test in the subsequent rounds. Regression analyses showed that elder age (hazard ratio: 1.03, 95% CI: 1.01-1.04, p ,0.001) and male gender (hazard ratio: 1.31, 95% CI: 1.02-1.69, p=0.035) were significantly associated with a positive test in the subsequent rounds, controlling for any colonic adenoma detected and removed during the follow-up period. Men had a higher risk than women when they were aged less than 60 years (log-rank test, p=0.002) while this difference was no longer observed when both of them were aged 60 years or more (p=0.74). Conclusions: Following a negative baseline fecal immunochemical test, subjects with elder age and male gender are more likely to show a positive result in the subsequent rounds; however, this gender difference diminished with increasing age. Resource allocation to subjects with a higher risk for a positive fecal test may improve the effectiveness of a periodic program of colorectal neoplasm screening. Sa1107 An Evaluation of Appropriate Proton Pump Inhibitor Use in Our Hospital Population Jennifer K. Slane, Jarred E. Marshak, Anik Patel, Jessica L. Widmer, Martin Feuerman, James H. Grendell BACKGROUND: Studies have shown that a high percentage of patients on proton pump inhibitors (PPIs) do not have an appropriate indication. In addition, their use may be associated with long term effects and a controversial drug-drug interaction with clopidogrel. AIM: To evaluate prescribing practices of PPIs in our hospital population before admission and during hospitalization in both a general population and in a subset of clopidogrel users. METHODS: The study was a retrospective review of charts of adult patients admitted to Winthrop University Hospital in 2010. In phase I, we reviewed data of 236 patients prescribed a PPI during hospitalization. In Phase II, we reviewed data of 131 patients prescribed both a PPI and clopidogrel during hospitalization. We looked for appropriate indications, according to FDA approval and commonly accepted standards, which included gastroesopha- geal reflux disease, erosive esophagitis, Zollinger Ellison Syndrome, gastritis, and peptic ulcer disease. High risk states such as use of mechanical ventilation, a history of peptic ulcer disease, and non-steroidal anti-inflammatory medications or aspirin use for at least two weeks were also included. RESULTS: Phase I: At home, 72% of patients were found to have at least one indication for a PPI, yet only 62.3% were taking a PPI which was statistically significant (p,0.005) (Figure 1). In the hospital, only 81.4% of patients had an appropriate indication, which was statistically significant (p ,0.001) (Figure 1). Using the population of patients that were new to a PPI in the hospital, only 66.3% had an indication which was significant (p,0.001). Phase II: At home, 72.0% of patients had an indication for PPI use compared to 56.6% actually on a PPI (p value of 0.002), which was statistically significant (Figure 2). For hospitalized patients, 85.1% had an indication compared to 85.1% on a PPI (p value of 0.99), which was not statistically significant (Figure 2). CONCLUSION: In phase I, patients at home were more likely to have an indication for PPI use and not be on it rather than being on a PPI with no indication. In contrast, inappropriate prescribing of PPIs occurs in the hospital. Furthermore, for patients new to a PPI in the hospital, we showed significant inappropriate prescribing. When comparing this to our data from 2006 however, there is less inappropriate prescribing in the hospital, likely from educational efforts. In phase II, patients at home were more likely to have an indication for PPI use and not be on it rather than being on a PPI with no indication. Given the lack of a significant difference in the hospital dataset, it can be concluded that in our hospital, PPI indications are appropriate in the setting of clopidogrel use. This differs from our phase I results, likely due to educational efforts in our hospital. AGA Abstracts

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Sa1104

Efficacy of Adalimumab in Refractory Ulcerative Colitis in Clinical PracticeMarie Lequoy, Philippe Seksik, Yoram Bouhnik, Matthieu Allez, Franck Carbonnel, AnneBourrier, Harry Sokol, Laurent Beaugerie, Jacques Cosnes

Introduction Controlled trials have demonstrated the efficacy of anti-TNF in ulcerative colitis(UC). Unlike infliximab (IFX), there are limited data with regard to the efficacy of adalimumab(ADA) in clinical practice. The aim of this study was to evaluate the efficacy of ADA forinducing and maintaining remission in patients with refractory UC and to compare itwith that of patients maintained under IFX. Patients and Methods This retrospective andmulticentre study included 68 consecutive patients with refractory UC (n=62) or unclassifiedcolitis (n=6) treated with ADA between 2006 and 2012 as rescue therapy. 36 of those hadlost response to IFX, 14 had developed intolerance, 13 were primary failures, and 13 patientshad refused IFX. Primary study endpoints were achievement of clinical remission (clinicalMayo score [without endoscopy] ≤ 2), time-to-clinical recurrence (Kaplan Meier) and time-to-colectomy (Kaplan Meier). Treatment was considered as efficacious if it obtained and/ormaintained clinical remission along follow-up, partially efficacious in case of flares respondingto intensification of therapy, and unsuccessful in all other cases. In addition, we comparedtime-to-clinical recurrence, time-to-colectomy, median values of hemoglobin and CRP, andneed for additional medications through semesters between 56 patients treated with ADAand 56 patients treated with IFX matched for sex and duration of prior anti-TNF treatment.Results Among the 63 patients who were active when starting ADA, 40 (63%) achievedclinical remission after a median period of 1 month. Among the 45 patients in clinicalremission after induction with ADA (n=40) or switched from IFX while inactive (n=5), 32(71%) were still in remission at 1 year and 26 (58%) at 2 years. Among the total of 68patients, 14 (21%) underwent colectomy (cumulative rate 19% at 2 years and 34% at 4years). Predictive factors of colectomy were early disease (p ,0.05), deep ulcerations (p=0.04), thrombocytosis (p,0.05) and anemia (p,0.02). No patient died during the survey.Six (9%) had non serious adverse events. Overall, ADA was efficacious in 31 patients (46%),partially efficacious in 15 patients (22%) and unsuccessful in 22 patients (32%). Comparisonwith patients maintained under IFX showed no significant differences regarding time-to-clinical recurrence, time-to-colectomy, and median values of clinical Mayo score, CRP andhemoglobin along the survey. However steroids were used more often in the ADA group(18 on 119 semesters (15%) versus 5 on 197 (3%) in the IFX group; p = 0.03). ConclusionIn clinical practice, ADA is well tolerated and effective as it is able to achieve and maintainclinical remission in about half patients with refractory ulcerative colitis, in particular inthose who had lost response or had developed intolerance to IFX.

Sa1105

International Perceptions of IBS: Survey of IBS Investigators From the GlobalMultinational IBS InitiativeMark Pimentel, Nicholas J. Talley, Eamonn M. Quigley, Albis Hani, Ala I. Sharara,Varocha Mahachai

In the absence of a validated biomarker, IBS study has been largely based on clinicalimpressions derived from the observation of sufferers in the West. These impressions servedas the basis for diagnostic criteria, such as the Rome criteria. In the last decade, a broadermore global understanding of IBS has begun to emerge. As a result, experts in the field nowhave more varied opinions of IBS diagnostic criteria and outcome measures. In this study,IBS experts from around the world were surveyed to determine their opinions on IBSdiagnostic criteria, outcome measures and predominant complaints. Methods: The Multina-tional IBS Initiative, comprising a group of international clinician investigators in IBS, wasconvened in 2012. In preparation for this meeting, investigators were sent a questionnairecovering their perception of IBS symptoms, diagnostic criteria, outcome measures for trials,and the need for new IBS criteria. The credibility of the investigators as IBS experts wasevaluated in two ways: the number of publications in IBS and the number of IBS subjectsseen each month. The answers to the questionnaire were sub-stratified based on theirparticipation in the Rome process. A total of 59 investigators were invited to attend a meetingrepresenting 5 continents (Europe, Asia, Australia, North America and South America).Representatives from FDA and NIH also participated in the meeting but were not asked tocomplete the pre-meeting survey. Results: The 39 IBS clinician investigators completing thesurvey had a combined total of 966 publications and 51% saw more than 20 IBS subjectsper month. Of these, 11 were, at some point, part of a Rome committee. While 51.4% and82.9% of those surveyed used Rome III criteria in their clinic and as the basis for patientenrollment in clinical studies, respectively, 77.1% reported that Rome III criteria inadequatelyrepresented IBS in their clinical experience. In fact, 54.3% concluded that bloating was themost important symptom in IBS and only 28.6% endorsed that abdominal pain was mostimportant. As a result, 80.0% of those surveyed felt new criteria were needed. Most (65.7%)agreed IBS could be diagnosed easily without need for diagnostic tests. In identifying healthycontrols, IBS investigators felt this should be done through a negative symptom questionnaireand not simply through the use of the term "healthy". With regard to outcome measuresfor clinical trials, 77.1% concluded that, in contrast to current approaches, approximatingnormal bowel function was the most important outcome for IBS trials. Conclusions: In thissurvey of leading international investigators on IBS, the majority felt that new criteria forIBS were needed to encompass bloating, in particular. Furthermore, clinical trials in IBS needto incorporate normalization of bowel function as an important patient-relevant outcome.

S-203 AGA Abstracts

Sa1106

Risk Factors for a Positive Fecal Immunochemical Test in the SubsequentScreening for Colorectal NeoplasmsYi-Chia Lee, Han-Mo Chiu, Tsung-Hsien Chiang, Hsiu-Po Wang, Jaw-Town Lin, Ming-Shiang Wu

Background: Although the fecal immunochemical test is effective in detecting colorectalneoplasms, participation to subsequent screening decreases with time. Following a negativetest, it is important to identify subjects who are more likely to yield a positive fecal immuno-chemical test in the subsequent rounds. Methods: Our database consisted of 30117 partici-pants who underwent periodic fecal immunochemical tests during a 5-year period. Werecruited those who were aged 50 years or more and had a negative fecal immunochemicaltest in the first round.We collected individual factors, including the demographic characteris-tics, body mass index, education level, social habits such as smoking, alcohol, and regularexercise, comorbidity, medications such as antiplatelet agents and nonsteroidal anti-inflam-matory drugs, family histories with cancer, biochemical studies such as fasting sugar, HbA1c,cholesterol, triglyceride, hemoglobin, platelet count, C-reactive protein, and uric acid, andthe presence of metabolic syndrome or not, to identify risk factors associated with a positivefecal immunochemical test in the subsequent rounds. We used the Kaplan-Meier curvesand Cox proportional hazards regression models for statistical analyses. Results: From thefirst round to fourth round, 14411, 3783, 1537, and 624 participants received the fecaltests, respectively, and 8.7%, 5.7%, 5.1%, and 3.9% were tested positive, respectively. Atotal of 3783 subjects (men: 63.6%; mean age ± standard deviation: 59.4 ± 7.2) with baselinenegative tests were followed up (mean screening round: 2.62 ± 0.88, and mean screeninginterval: 2.43 ± 1.01 years). Our data was therefore composed of 9922 fecal tests, 9183person-years, and 302 subjects with a positive test in the subsequent rounds. Regressionanalyses showed that elder age (hazard ratio: 1.03, 95% CI: 1.01-1.04, p ,0.001) and malegender (hazard ratio: 1.31, 95% CI: 1.02-1.69, p=0.035) were significantly associated witha positive test in the subsequent rounds, controlling for any colonic adenoma detected andremoved during the follow-up period. Men had a higher risk than women when they wereaged less than 60 years (log-rank test, p=0.002) while this difference was no longer observedwhen both of them were aged 60 years or more (p=0.74). Conclusions: Following a negativebaseline fecal immunochemical test, subjects with elder age and male gender are more likelyto show a positive result in the subsequent rounds; however, this gender difference diminishedwith increasing age. Resource allocation to subjects with a higher risk for a positive fecaltest may improve the effectiveness of a periodic program of colorectal neoplasm screening.

Sa1107

An Evaluation of Appropriate Proton Pump Inhibitor Use in Our HospitalPopulationJennifer K. Slane, Jarred E. Marshak, Anik Patel, Jessica L. Widmer, Martin Feuerman,James H. Grendell

BACKGROUND: Studies have shown that a high percentage of patients on proton pumpinhibitors (PPIs) do not have an appropriate indication. In addition, their use may beassociated with long term effects and a controversial drug-drug interaction with clopidogrel.AIM: To evaluate prescribing practices of PPIs in our hospital population before admissionand during hospitalization in both a general population and in a subset of clopidogrel users.METHODS: The study was a retrospective review of charts of adult patients admitted toWinthrop University Hospital in 2010. In phase I, we reviewed data of 236 patients prescribeda PPI during hospitalization. In Phase II, we reviewed data of 131 patients prescribedboth a PPI and clopidogrel during hospitalization. We looked for appropriate indications,according to FDA approval and commonly accepted standards, which included gastroesopha-geal reflux disease, erosive esophagitis, Zollinger Ellison Syndrome, gastritis, and pepticulcer disease. High risk states such as use of mechanical ventilation, a history of peptic ulcerdisease, and non-steroidal anti-inflammatory medications or aspirin use for at least twoweeks were also included. RESULTS: Phase I: At home, 72% of patients were found to haveat least one indication for a PPI, yet only 62.3% were taking a PPI which was statisticallysignificant (p,0.005) (Figure 1). In the hospital, only 81.4% of patients had an appropriateindication, which was statistically significant (p,0.001) (Figure 1). Using the populationof patients that were new to a PPI in the hospital, only 66.3% had an indication which wassignificant (p,0.001). Phase II: At home, 72.0% of patients had an indication for PPI usecompared to 56.6% actually on a PPI (p value of 0.002), which was statistically significant(Figure 2). For hospitalized patients, 85.1% had an indication compared to 85.1% on a PPI(p value of 0.99), which was not statistically significant (Figure 2). CONCLUSION: In phaseI, patients at home were more likely to have an indication for PPI use and not be on itrather than being on a PPI with no indication. In contrast, inappropriate prescribing of PPIsoccurs in the hospital. Furthermore, for patients new to a PPI in the hospital, we showedsignificant inappropriate prescribing. When comparing this to our data from 2006 however,there is less inappropriate prescribing in the hospital, likely from educational efforts. Inphase II, patients at home were more likely to have an indication for PPI use and not beon it rather than being on a PPI with no indication. Given the lack of a significant differencein the hospital dataset, it can be concluded that in our hospital, PPI indications are appropriatein the setting of clopidogrel use. This differs from our phase I results, likely due to educationalefforts in our hospital.

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