sa1119 indicators of inadequate response to biologic therapies in patients with crohn's disease...

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AGA Abstracts stricturing, penetrating or perianal disease, no treatment with immunomodulators and anti- TNF, no need for surgery in the course of the disease. NS UC was defined as no requirement for immunomodulators, anti-TNF and colectomy. Patients were assessed at 1 year, 5 years and at the maximum follow-up. Patients with less than 5 years of follow-up were excluded. RESULTS: Among 887 patients, a subgroup of 439 CD and 173 UC were included with a mean follow-up of 19 and 15 years respectively. One year after the diagnosis 147 CD patients had NS CD. At 5 years and at the maximum follow-up respectively, 83/147 (56%) and 15/ 147 (10%) patients still had NS CD. Complications were strictures (29%), fistulizing disease (18%), perianal disease (37%). Immunomodulators and anti-TNF were required in 79% and 54% of patients respectively. Prognostic factors for persistent NS CD were older age at diagnosis (38 vs 26 years, p=0.005), no corticosteroid during the first year (p=0.036). In UC, 142 patients had NS disease one year after the diagnosis. 102/142 (72%) and 62 patients (44%) had NS UC after 5 years and at the maximum follow-up respectively. Surgery occurred in 19 patients (13%) after a mean time à 164 months. Immunomodulators were needed in 66 patients (47%) and anti-TNF in 37 patients (26%). NS UC was associated with absence of hospitalization for active UC over the first 5 years (p=0.009) and during the total course of UC (p<0.0001), no intake of corticosteroid during the first year (p=0.03). CONCLUSION: In our cohort representing referral centre recruitment, nearly all CD patients and 2/3 of UC with NS disease at diagnosis became severe with time. Old age at diagnosis was associated with NS CD outcome while absence of hospitalisation during the first year was associated with NS UC outcome. Absence of steroid use during the first year was associated with NS outcome in both diseases. Sa1116 Co-Morbid Psychiatric Disease and Chronic Pain Highly Correlate With Repeat Hospitalization in Inflammatory Bowel Disease Patients Lawrence F. Borges, Mathew Lucci, Bonnie Cao, Emily Collins, Brian Vogel, Emily Arthur, Danielle Emmons, Joshua R. Korzenik Background: Inpatient care for inflammatory bowel disease (IBD) patients poses a significant burden to the healthcare system. Repeat hospitalization in subgroups of IBD patients consti- tutes a large component of this problem; however, the factors that lead to repeat hospitaliza- tion are poorly understood. We hypothesize that factors other than disease activity may be responsible for repeated hospitalizations. Aim: To compare IBD patients that required a single unplanned hospitalization during the study period to those that required repeat hospitalizations in order to identify factors associated with increased healthcare utilization. Methods: A retrospective review was performed of IBD patients admitted to the Brigham and Women's Hospital from 1/1/11 to 12/31/2012. Patients with at least one unplanned, IBD-related admission during the study period were included. Elective surgeries and admis- sions for post-operative complications were excluded. Data was then collected including disease phenotype and related clinical information. In addition, data was collected regarding socioeconomic status and psychological stressors such as substance abuse and co-morbid psychiatric diagnoses. Descriptive statistics were used to analyze our study population, and Fisher's exact test was used to assess for factors associated with more frequent admissions. Results: 595 total unplanned hospital admissions were included in our analysis, which represents 232 patients. Patients admitted five times or more represented 12.93% of the cohort (n=30), but 43% of the total admissions (n=256). 49.57% (n = 115) were admitted only once during the study period, while 37.5% (n = 87) were admitted between two and four times. Of the admissions for those patients admitted five or more times, 45.7% (n= 117) were unrelated to disease activity. Independent risk factors for requiring two or more admissions during the study period included a diagnosis of Crohn's disease (OR 1.817; CI 1.04 - 3.195), a history of smoking (OR 2.869; CI 1.206 - 7.412), chronic pain (OR 5.684; CI 1.818 - 23.66), and a diagnosis of depression (OR 1.949; CI 1.024 - 3.778). Factors unrelated to repeat admission included age and gender. Conclusion: A small subgroup of IBD patients in our large sample size accounts for a significant portion of IBD inpatient care needs. Many of these admissions are driven by reasons unrelated to disease activity. Co- morbid chronic pain disorder and depression are risk factors for repeat hospitalization. Addressing these problems in the outpatient setting may reduce hospitalizations in IBD patients. Sa1117 Increased Ultraviolet Light Exposure Protects Against Inpatient Mortality in Patients With a Primary Diagnosis of Clostridium difficile Infection Shail M. Govani, Akbar K. Waljee, Ryan W. Stidham, Peter D. Higgins Background: Clostridium difficile infection (CDI) is an increasingly common cause of inpatient mortality. Vitamin D deficiency has been associated with more aggressive CDI, and UV exposure is a predictor of vitamin D levels. We aimed to determine whether average annual UV exposure was associated with mortality in patients with CDI. Methods: We used the national inpatient sample (NIS) from 2007 to 2011 to assess the mortality risk in patients with a primary diagnosis of CDI. Annual state average UV exposure and Charlson-Deyo comorbidity scores were assigned to each hospitalization. Student's t-test and Rao-Scott chi- square test were used to compare patients who died using SURVEY commands in SAS 9.3. Logistic regression modeling controlled for age, gender, race, coexisting bacterial infection, and other comorbidities. Sensitivity analyses were performed (1) using 3 digit zipcode level UV data, and (2) by excluding states with high UV exposure standard deviations (SD) and Hawaii (extreme UV exposure). This study assumes that individual patient UV exposures reflect the average UV exposure in their state or 3 digit zip code. Results: From 2007 to 2011, there were 563,495 hospitalizations with a primary diagnosis of CDI. The mortality rate was 3.4%. Patients who died from CDI were significantly more likely to be male, Caucasian, and of older age. In univariate analysis, the OR of inpatient mortality for UV index was 0.91 (95%CI: 0.88-0.95, p<0.0001) per unit of UV exposure. In a multivariable model adjusting for age, gender, race, Charlson-Deyo index, ulcerative colitis, and bacterial infection, UV index remained a protective factor with an OR of 0.93 (95%CI 0.89-0.97, p= 0.0006). UV exposure was not a nonspecific predictor of inpatient mortality across all hospitalizations in multivariate analysis (OR 1.01, 95%CI: 0.99-1.03, p=0.22). Sensitivity analyses re-demonstrated the protective effect of UV exposure on mortality. The OR for S-204 AGA Abstracts inpatient mortality in hospitalizations with any diagnosis of CDI controlling for the same covariates also demonstrates reduced risk (OR 0.96, 95%CI 0.93-0.98, p=0.0009). Conclu- sions: Increased UV exposure is associated with a reduced risk of inpatient mortality in patients with CDI in this ecological study. While there is likely substantial variation in individual UV exposure, local UV exposure averages are predictive of mortality. This could be due to a direct protective effect, or this may be mediated by vitamin D levels or other covariates of UV exposure. Further studies examining the relationship between UV exposure, vitamin D deficiency, and CDI are necessary. Sa1118 Gender Differences of IBD Care in the Healthcare Region of Stockholm Mikael Lördal, Thomas Cars, Bjorn Wettermark Background: The prevalence of inflammatory bowel disease (IBD) is similar in men and women. There is a lack of knowledge about gender differences in IBD health care utilization and treatment. The aim was therefore to study gender differences in a cohort of IBD-patients in the county of Stockholm, Sweden. Methods: Patients with a registered diagnosis of Crohns disease, ICD10 codes K50X, or ulcerative colitis, ICD10 codes K51X, with any contact with the health care system between 1 July 2010 and 31 December 2012 were identified in the Stockholm regional health care data warehouse (VAL). Data regarding outpatient visits in primary and specialist care, hospitalizations, dispensed prescriptions as well as anti-TNFα- antibodies administered at hospital were retrieved from the data warehouse. Results: A total number of 11 631 patients with IBD were identified, 8398 of those had at least one consultation in ambulatory care at any healthcare level or were hospitalized at least once during 2012. Ulcerative colitis was diagnosed in 4595 (males 52% and females 48%) patients and Crohns disease in 4126 (males 50% and females 50%) patients. The age distribution was the same in the two diseases. The costs for ambulatory care were almost similar between men and women while inpatient costs for Crohns disease and ulcerative colitis were 20 % and 44 % higher in men respectively. Expenditures on medicines were also higher for men with 25 % higher costs for Crohns disease and 35 % for ulcerative colitis. In the age group 20-40 years, 33 % more men received anti-TNFα-antibodies. Conclusion: In this population- based study including patients with IBD in a large Swedish region substantial gender differ- ences in healthcare care consumption and drug expenditure were identified. The major gender difference in anti-TNFα-antibodies observed in the age group of 20-40 years may be related fertility/pregnancy. However, the larger proportion of healthcare consumption in men needs to be further analyzed. Sa1119 Indicators of Inadequate Response to Biologic Therapies in Patients With Crohn's Disease From Real-World Practice Settings Hind T. Hatoum, Haridarshan Patel, Swu-Jane Lin, Reema Mody Introduction: The study objective was to determine the incidence of inadequate response to induction (I-phase) and maintenance (M-phase) therapies with biologic agents in Crohn's Disease (CD) patients in the real-world clinical setting. Methods: A retrospective cohort study was performed using the US Clinformatics administrative health claims database (2005- 2012). Patients with CD were identified as having the following: 2 claims for CD (ICD- 9-555.xx); 1 claim for a biologic [adalimumab (ADA), certolizumab (CER), infliximab (INF), or natalizumab (NAT)]; 6 months of plan enrollment prior to the first diagnosis of CD (index date); and 1 year follow-up from the first biologic (index drug). Non-biologic CD treatments included 5-ASA, oral or injectable corticosteroids, enteral budesonide, or immunomodulators. Indicators used as a proxy to assess inadequate response during the I- phase were switching to another biologic or augmentation with any new non-biologics. Additional indicators of dose escalation, flares, CD-related surgery, and urgent care (hospitali- zation or emergency room visit) were included in the M-phase. Patients who received labeled doses of biologics without any encounters of CD-related urgent care (during the I-phase), and with 2 claims for biologics were included in the M-phase. Bivariate statistical analyses were performed using chi-square test. Median time to and rates of inadequate response were estimated using the Kaplan-Meier Method. Results: Of 1417 CD patients who met the study inclusion criteria, 45.1% were males, and the mean (SD) age of patients was 39.4±13.4 years. As the index biologic, 39.8% received ADA, 11.2% CER, 48.7% INF, and 0.2% NAT. Mean duration from the initial CD diagnosis to first biologic was 388±440 days. After diagnosis, 80.5% (n=1140) of patients received 1 non-biologic CD treatment within 6 months prior to index drug. During I-phase, 8.0% (n=113) of patients had 1 indicator of inadequate response. Of 906 patients in the M-phase, 75.9% had 1 indicator of inadequate response (Table 1). There were no significant differences between the three biologics on the indicators of inadequate response, except for dose escalation. Estimated cumulative rates of inadequate response were 58.7% and 75.3% in first and second year, respectively, with a median time of 271 days and no significant differences between biologics. Conclusions: This

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Page 1: Sa1119 Indicators of Inadequate Response to Biologic Therapies in Patients With Crohn's Disease From Real-World Practice Settings

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sstricturing, penetrating or perianal disease, no treatment with immunomodulators and anti-TNF, no need for surgery in the course of the disease. NS UC was defined as no requirementfor immunomodulators, anti-TNF and colectomy. Patients were assessed at 1 year, 5 yearsand at the maximum follow-up. Patients with less than 5 years of follow-up were excluded.RESULTS: Among 887 patients, a subgroup of 439 CD and 173 UC were included with amean follow-up of 19 and 15 years respectively. One year after the diagnosis 147 CD patientshad NS CD. At 5 years and at the maximum follow-up respectively, 83/147 (56%) and 15/147 (10%) patients still had NS CD. Complications were strictures (29%), fistulizing disease(18%), perianal disease (37%). Immunomodulators and anti-TNF were required in 79%and 54% of patients respectively. Prognostic factors for persistent NS CD were older age atdiagnosis (38 vs 26 years, p=0.005), no corticosteroid during the first year (p=0.036). InUC, 142 patients had NS disease one year after the diagnosis. 102/142 (72%) and 62 patients(44%) had NS UC after 5 years and at the maximum follow-up respectively. Surgery occurredin 19 patients (13%) after a mean time à 164 months. Immunomodulators were needed in66 patients (47%) and anti-TNF in 37 patients (26%). NS UC was associated with absenceof hospitalization for active UC over the first 5 years (p=0.009) and during the total courseof UC (p<0.0001), no intake of corticosteroid during the first year (p=0.03). CONCLUSION:In our cohort representing referral centre recruitment, nearly all CD patients and 2/3 of UCwith NS disease at diagnosis became severe with time. Old age at diagnosis was associatedwith NS CD outcome while absence of hospitalisation during the first year was associatedwith NS UC outcome. Absence of steroid use during the first year was associated with NSoutcome in both diseases.

Sa1116

Co-Morbid Psychiatric Disease and Chronic Pain Highly Correlate WithRepeat Hospitalization in Inflammatory Bowel Disease PatientsLawrence F. Borges, Mathew Lucci, Bonnie Cao, Emily Collins, Brian Vogel, Emily Arthur,Danielle Emmons, Joshua R. Korzenik

Background: Inpatient care for inflammatory bowel disease (IBD) patients poses a significantburden to the healthcare system. Repeat hospitalization in subgroups of IBD patients consti-tutes a large component of this problem; however, the factors that lead to repeat hospitaliza-tion are poorly understood. We hypothesize that factors other than disease activity may beresponsible for repeated hospitalizations. Aim: To compare IBD patients that required asingle unplanned hospitalization during the study period to those that required repeathospitalizations in order to identify factors associated with increased healthcare utilization.Methods: A retrospective review was performed of IBD patients admitted to the Brighamand Women's Hospital from 1/1/11 to 12/31/2012. Patients with at least one unplanned,IBD-related admission during the study period were included. Elective surgeries and admis-sions for post-operative complications were excluded. Data was then collected includingdisease phenotype and related clinical information. In addition, data was collected regardingsocioeconomic status and psychological stressors such as substance abuse and co-morbidpsychiatric diagnoses. Descriptive statistics were used to analyze our study population, andFisher's exact test was used to assess for factors associated with more frequent admissions.Results: 595 total unplanned hospital admissions were included in our analysis, whichrepresents 232 patients. Patients admitted five times or more represented 12.93% of thecohort (n=30), but 43% of the total admissions (n=256). 49.57% (n = 115) were admittedonly once during the study period, while 37.5% (n = 87) were admitted between two andfour times. Of the admissions for those patients admitted five or more times, 45.7% (n=117) were unrelated to disease activity. Independent risk factors for requiring two or moreadmissions during the study period included a diagnosis of Crohn's disease (OR 1.817; CI1.04 - 3.195), a history of smoking (OR 2.869; CI 1.206 - 7.412), chronic pain (OR 5.684;CI 1.818 - 23.66), and a diagnosis of depression (OR 1.949; CI 1.024 - 3.778). Factorsunrelated to repeat admission included age and gender. Conclusion: A small subgroup ofIBD patients in our large sample size accounts for a significant portion of IBD inpatient careneeds. Many of these admissions are driven by reasons unrelated to disease activity. Co-morbid chronic pain disorder and depression are risk factors for repeat hospitalization.Addressing these problems in the outpatient setting may reduce hospitalizations in IBDpatients.

Sa1117

Increased Ultraviolet Light Exposure Protects Against Inpatient Mortality inPatients With a Primary Diagnosis of Clostridium difficile InfectionShail M. Govani, Akbar K. Waljee, Ryan W. Stidham, Peter D. Higgins

Background: Clostridium difficile infection (CDI) is an increasingly common cause of inpatientmortality. Vitamin D deficiency has been associated with more aggressive CDI, and UVexposure is a predictor of vitamin D levels. We aimed to determine whether average annualUV exposure was associated with mortality in patients with CDI. Methods: We used thenational inpatient sample (NIS) from 2007 to 2011 to assess the mortality risk in patientswith a primary diagnosis of CDI. Annual state average UV exposure and Charlson-Deyocomorbidity scores were assigned to each hospitalization. Student's t-test and Rao-Scott chi-square test were used to compare patients who died using SURVEY commands in SAS 9.3.Logistic regression modeling controlled for age, gender, race, coexisting bacterial infection,and other comorbidities. Sensitivity analyses were performed (1) using 3 digit zipcode levelUV data, and (2) by excluding states with high UV exposure standard deviations (SD) andHawaii (extreme UV exposure). This study assumes that individual patient UV exposuresreflect the average UV exposure in their state or 3 digit zip code. Results: From 2007 to2011, there were 563,495 hospitalizations with a primary diagnosis of CDI. The mortalityrate was 3.4%. Patients who died from CDI were significantly more likely to be male,Caucasian, and of older age. In univariate analysis, the OR of inpatient mortality for UVindex was 0.91 (95%CI: 0.88-0.95, p<0.0001) per unit of UV exposure. In a multivariablemodel adjusting for age, gender, race, Charlson-Deyo index, ulcerative colitis, and bacterialinfection, UV index remained a protective factor with an OR of 0.93 (95%CI 0.89-0.97, p=0.0006). UV exposure was not a nonspecific predictor of inpatient mortality across allhospitalizations in multivariate analysis (OR 1.01, 95%CI: 0.99-1.03, p=0.22). Sensitivityanalyses re-demonstrated the protective effect of UV exposure on mortality. The OR for

S-204AGA Abstracts

inpatient mortality in hospitalizations with any diagnosis of CDI controlling for the samecovariates also demonstrates reduced risk (OR 0.96, 95%CI 0.93-0.98, p=0.0009). Conclu-sions: Increased UV exposure is associated with a reduced risk of inpatient mortality inpatients with CDI in this ecological study. While there is likely substantial variation inindividual UV exposure, local UV exposure averages are predictive of mortality. This couldbe due to a direct protective effect, or this may be mediated by vitamin D levels or othercovariates of UV exposure. Further studies examining the relationship between UV exposure,vitamin D deficiency, and CDI are necessary.

Sa1118

Gender Differences of IBD Care in the Healthcare Region of StockholmMikael Lördal, Thomas Cars, Bjorn Wettermark

Background: The prevalence of inflammatory bowel disease (IBD) is similar in men andwomen. There is a lack of knowledge about gender differences in IBD health care utilizationand treatment. The aim was therefore to study gender differences in a cohort of IBD-patientsin the county of Stockholm, Sweden. Methods: Patients with a registered diagnosis of Crohnsdisease, ICD10 codes K50X, or ulcerative colitis, ICD10 codes K51X, with any contact withthe health care system between 1 July 2010 and 31 December 2012 were identified in theStockholm regional health care data warehouse (VAL). Data regarding outpatient visits inprimary and specialist care, hospitalizations, dispensed prescriptions as well as anti-TNFα-antibodies administered at hospital were retrieved from the data warehouse. Results: A totalnumber of 11 631 patients with IBD were identified, 8398 of those had at least oneconsultation in ambulatory care at any healthcare level or were hospitalized at least onceduring 2012. Ulcerative colitis was diagnosed in 4595 (males 52% and females 48%) patientsand Crohns disease in 4126 (males 50% and females 50%) patients. The age distributionwas the same in the two diseases. The costs for ambulatory care were almost similar betweenmen and women while inpatient costs for Crohns disease and ulcerative colitis were 20 %and 44 % higher in men respectively. Expenditures on medicines were also higher for menwith 25 % higher costs for Crohns disease and 35 % for ulcerative colitis. In the age group20-40 years, 33 % more men received anti-TNFα-antibodies. Conclusion: In this population-based study including patients with IBD in a large Swedish region substantial gender differ-ences in healthcare care consumption and drug expenditure were identified. The majorgender difference in anti-TNFα-antibodies observed in the age group of 20-40 years maybe related fertility/pregnancy. However, the larger proportion of healthcare consumption inmen needs to be further analyzed.

Sa1119

Indicators of Inadequate Response to Biologic Therapies in Patients WithCrohn's Disease From Real-World Practice SettingsHind T. Hatoum, Haridarshan Patel, Swu-Jane Lin, Reema Mody

Introduction: The study objective was to determine the incidence of inadequate responseto induction (I-phase) and maintenance (M-phase) therapies with biologic agents in Crohn'sDisease (CD) patients in the real-world clinical setting. Methods: A retrospective cohortstudy was performed using the US Clinformatics administrative health claims database (2005-2012). Patients with CD were identified as having the following: ≥2 claims for CD (ICD-9-555.xx); ≥1 claim for a biologic [adalimumab (ADA), certolizumab (CER), infliximab(INF), or natalizumab (NAT)]; ≥ 6 months of plan enrollment prior to the first diagnosisof CD (index date); and ≥1 year follow-up from the first biologic (index drug). Non-biologicCD treatments included 5-ASA, oral or injectable corticosteroids, enteral budesonide, orimmunomodulators. Indicators used as a proxy to assess inadequate response during the I-phase were switching to another biologic or augmentation with any new non-biologics.Additional indicators of dose escalation, flares, CD-related surgery, and urgent care (hospitali-zation or emergency room visit) were included in the M-phase. Patients who received labeleddoses of biologics without any encounters of CD-related urgent care (during the I-phase),and with ≥2 claims for biologics were included in the M-phase. Bivariate statistical analyseswere performed using chi-square test. Median time to and rates of inadequate response wereestimated using the Kaplan-Meier Method. Results: Of 1417 CD patients who met the studyinclusion criteria, 45.1% were males, and the mean (SD) age of patients was 39.4±13.4years. As the index biologic, 39.8% received ADA, 11.2% CER, 48.7% INF, and 0.2% NAT.Mean duration from the initial CD diagnosis to first biologic was 388±440 days. Afterdiagnosis, 80.5% (n=1140) of patients received ≥1 non-biologic CD treatment within 6months prior to index drug. During I-phase, 8.0% (n=113) of patients had ≥1 indicator ofinadequate response. Of 906 patients in the M-phase, 75.9% had ≥1 indicator of inadequateresponse (Table 1). There were no significant differences between the three biologics on theindicators of inadequate response, except for dose escalation. Estimated cumulative rates ofinadequate response were 58.7% and 75.3% in first and second year, respectively, with amedian time of 271 days and no significant differences between biologics. Conclusions: This

Page 2: Sa1119 Indicators of Inadequate Response to Biologic Therapies in Patients With Crohn's Disease From Real-World Practice Settings

real-world database study showed that within two years over 75% of CD patients had atleast one indicator of inadequate response during maintenance therapy with biologics. Doseescalation, flares, CD-related urgent care, and augmentation with non-biologic treatmentwere the major indicators of inadequate response.Table 1. Indicators of Inadequate Response to Biologics During the Maintenance PhaseAmong Patients With CD

Note: Natalizumab was not included in the analyses due to low sample size. *Comparisonsbetween adalimumab, certolizumab and infliximab treated groups with chi-square test.

Sa1120

Indicators of Inadequate Response to Anti-Tumor Necrosis Factor Therapies inPatients With Ulcerative Colitis From Real-World Practice SettingsHind T. Hatoum, Haridarshan Patel, Swu-Jane Lin, Reema Mody

Background: The study objective was to determine the incidence of inadequate response toinduction (I-phase) and maintenance (M-phase) treatment with anti-tumor necrosis factortherapies (anti-TNFs) in ulcerative colitis (UC) patients in real-world practice settings.Methods: A retrospective cohort study was performed using the US Clinformatics administra-tive health claims database (2005-2012). Patients with UC were identified as having thefollowing: ≥2 claims for UC (ICD-9-556.xx); ≥1 claim for an anti-TNF [adalimumab (ADA)or infliximab (INF)]; ≥6 months of plan enrollment prior to the first diagnosis of UC (indexdate); and ≥1 year follow-up from the first anti-TNF (index drug). Non anti-TNF UCtreatments included 5-ASA, oral or injectable corticosteroids, enteral budesonide, or immuno-modulators. The indicators used as a proxy for assessing inadequate response during the I-phase were switching to another anti-TNF or augmentation with any new non anti-TNFtreatment. Additional indicators of dose escalation, flares, UC-related surgery, and UC-related urgent care (hospitalization or emergency room visit) were included in the M-phase.Patients who received labeled doses of anti-TNFs without any encounters of UC-relatedurgent care (during the I-phase) and with ≥2 claims for anti-TNF were included in the M-phase. Bivariate statistical analyses were performed using chi-square test. Median time toand rates of inadequate response were estimated using the Kaplan-Meier Method. Results:A total of 587 UC patients met the study inclusion criteria, 51.8% of whom were male; themean (SD) age of patients was 42.8± 13.4 years and follow-up was 2.75±1.45 years. A totalof 22.3% (n=131) and 74.5% (n=437) of patients had received ADA and INF, respectively,as index drug. Mean (SD) duration from the initial UC diagnosis to first anti-TNF was471±476 days. After diagnosis, 89.8% (n=527) of patients received ≥1 new non anti-TNFtreatment within 6 months prior to index drug. During the I-phase, 5.3% (n=31) of patientshad at least one indicator of inadequate response. Of 338 patients included in the M-phase,77.8% (n=263) had at least one indicator of inadequate response (Table 1). The overallinadequate response rates did not differ significantly between ADA and INF. Estimatedcumulative rates of inadequate response in the M-phase were 66.2% and 77.7% in first andsecond year, respectively, with a median time to inadequate response of 197 days and nosignificant difference between the two anti-TNFs. Conclusion: This large-scale real-worldassessment of index anti-TNFs for the treatment of UC demonstrated that over three-quartersof patients on maintenance therapy had at least one indicator of inadequate response withintwo years, with dose escalation being the most commonly observed indicator.Table 1. Indicators of Inadequate Response to Anti-TNFs during the Maintenance PhaseAmong Patients with Ulcerative Colitis

*Comparisons between adalimumab and infliximab using Chi-square test.

S-205 AGA Abstracts

Sa1121

Predictive Factors of the Course of Crohn's Disease - Can We Treat inAnticipation?Francisca Dias de Castro, Joana Magalhães, Pedro Carvalho, Maria J. Moreira, José Cotter

Background and Aim: the course of Crohn's disease (CD) is highly variable and difficult topredict on the basis of information at the time of diagnosis. However it would be useful tocategorize patients at the onset of disease in low and high risk on the basis that treatingsevere CD with "top-down" strategy might change the natural history of CD. The aim ofthis study was to evaluate factors at first presentation that might predict the severity ofCD. Methods: retrospective, single-center study including 146 patients with CD diagnosedbetween June 1983 and December 2011. We defined aggressive CD as need for more than2 steroids courses required after diagnosis, need for surgery after diagnosis (except surgeryfor perianal disease or ileocecal resection as first choice of treatment) and need of admissionfor flare after diagnosis. The variables studied at diagnosis were smoking status, familyhistory of inflammatory bowel disease, extraintestinal manifestations, Montreal Classification(age, location of CD, involvement of the upper gastrointestinal tract, phenotype, perianaldisease), need for corticosteroids, admission and surgery on the first flare. Statistical analysiswas performed with SPSS vs 18.0 and a p value of less than 0,05 was considered statisticallysignificant. Results: 146 patients with CD were included, 55,5% female, with mean age37,6±11,9 years and mean follow-up of 86±60 months. 80 patients presented at follow-upwith non aggressive CD (55%) and 66 (45%) with aggressive CD. Independent factorspresent at diagnosis and significantly associated with aggressive CD were smoking status(p=0,022), stenotic and penetrating phenotype (p<0,001) and corticosteroids and admissionon the first flare (p<0,001). Given the results of the univariate analysis, in our cohort, thepresence at diagnosis in an individual patient of 2 or more out of the 4 factors was associatedwith a high risk of aggressive disease with a accuracy of 0,73 (sensitivity of 88%, a specificityof 61%, a positive predictive value of 65% and a negative predictive value of 86%). Conclu-sions: at diagnosis of Crohn's disease predictors of subsequent aggressive course are theinitial requirement for corticosteroids and admission, smoking status and penetrating andstenotic disease. The combination of 2 or more variables is highly associated with aggressivedisease and may be a useful way to make therapeutic decisions at diagnosis.

Sa1122

Patients With Ulcerative Colitis Are More Concerned About Complications ofTheir Disease Than Side Effects of MedicationsCorey A. Siegel, Kimberly D. Thompson, Danielle Walls, Susan J. Connor, Sabrina K.Stewart, Meenakshi Bewtra, David T. Rubin, Geri L. Baumblatt, Stefan D. Holubar, Astrid-Jane Greenup, Alexandra Sechi, Afaf Girgis, Jan Gollins

Background and aim: Patients with ulcerative colitis (UC) are often fearful and uncertainabout how their disease will affect their future. Better understanding these fears can helpproviders communicate more effectively with patients and facilitate more informed sharedmedical decisions. The aim of our study was to learn which aspects of UC care are mostconcerning to patients. Methods: Two patient focus groups were conducted at Dartmouth-Hitchcock to obtain qualitative data about patients' fears regarding UC treatment options.These focus groups (1) informed the development of a patient survey and (2) providedaudio to be used with affect trace technology. Next, a web-based survey was sent to UCpatients throughout the United States (US) and Australia (AUS). Within the survey, audioclips were played and respondents showed their strength of agreement or disagreement withrecorded statements in real-time using their computer mouse (affect trace). Qualitativemethods were used to analyze the focus group transcripts, standard quantitative analysisfor the survey results, and cluster analysis was performed on the affect trace response tothe audio clips. Results: 460 patients with ulcerative colitis (370 US, 90 AUS) respondedto the online survey. 53% of the respondents were women, mean age 49 (range 19 to 81).Patients represented 45 US states, and a single AUS state. US and AUS results were similar,and therefore presented together. The majority of patients (95%) rated their current healthas moderate or good. Most (92%) had UC for more than 2 years. Overall, the most concerningaspects of UC were the risk of colon cancer (CRC) (37%) and possible need for an ostomy(29%). When stratified by exposure to immunomodulators or biologics, those with prioror current exposure were most worried about needing an ostomy. In contrast, those whohad not received these therapies were most worried about CRC. Only 14% of patientsindicated that possible side effects from medications was their biggest concern. When askedwhat treatments they were very concerned about, 84% included surgery, followed by biologics(65%), steroids (63%), methotrexate (58%) and immunomodulators (45%). On clusteranalysis of the moment-to-moment affect trace, the most divergence in opinion centered onthe appropriate timing for colectomy and fear and uncertainty about their future with UC.Conclusion: Patients with UC are more fearful of developing CRC or having an ostomy thanthey are of side effects from medications. Of the medications, they are equally fearful ofsteroids and biologics, and less so of immunomodulators. To facilitate informed treatmentdecisions for patients with UC, in addition to discussing the benefits and risks of medications,it is also important to discuss the best strategies for decreasing the risk of colectomy and CRC.

Sa1123

What Patients Want to Know When Making Decisions About Their Treatmentfor Ulcerative Colitis: A Mixed Methods Approach Using Affect TraceTechnologyKimberly D. Thompson, Susan J. Connor, Danielle Walls, Jan Gollins, Sabrina K. Stewart,Meenakshi Bewtra, Geri L. Baumblatt, Stefan D. Holubar, Astrid-Jane Greenup, AlexandraSechi, Afaf Girgis, David T. Rubin, Corey A. Siegel

Background and Aim: Decision making for patients with ulcerative colitis (UC) involvesweighing tradeoffs of benefits and risks of medical and surgical interventions. To improveprovider communication, we aimed to understand what aspects of UC and its treatment aremost important to patients and how they would like to be informed. Methods: Two patientfocus groups were conducted to learn about patients' information needs regarding UC

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