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Optimal Dosing of Mesalamine for Maintenance of Clinical Remission inPatients With Distal Ulcerative Colitis and Residual Endoscopic Activity: ASubgroup Analysis of a Double-Blind, Double-Dummy, Randomized,Controlled, Dose-Ranging StudyWolfgang Kruis, Roland Greinwald, Ralph Mueller

Introduction: Proctosigmoiditis is the most frequent phenotype of ulcerative colitis (UC).Recently, it has been shown that 3 g oral mesalamine (Salofalk® granules) once daily (OD)showed higher rates for maintaining remission compared to lower doses of mesalamine,especially in patients with residual signs of endoscopic inflammatory activity at the startof the treatment.1 But, whether patients with proctosigmoiditis and residual endoscopicinflammation might profit from a higher dose is unclear. Aims: To study optimal dosingof mesalamine for maintenance of remission in proctosigmoiditis with residual endoscopicactivity at the start of treatment. Methods: This was a stratified subgroup analysis of adouble-blind, double-dummy, randomized, multicenter, comparative phase III study, inwhich the clinical outcome (i.e., clinical remission at wk 52) was analyzed in patients withproctosigmoiditis according to the presence of residual endoscopic inflammation at the startof maintenance treatment. Patients with active UCwho had recently achieved clinical (ClinicalActivity Index [CAI] ,= 4) and an endoscopic index (EI) ,= 3 were randomized tomesalamine (Salofalk® granules) 3g OD, 1.5g OD, or 0.5g TID for 12 months. Remissionat study end was defined as a CAI of ,= 4 with no increase of .=3 points from baseline.Results: A total of 647 patients who came into remission within the last 12 weeks prior tobaseline were randomized and treated; 217 patients with 3g OD, 212 with 1.5g OD, and218 with 0.5g TID mesalamine. All three treatment regimens were efficacious in maintainingclinical remission of UC over 1 year. A subgroup analysis in patients with vs. withoutresidual mucosal damage showed that 3g OD performed best in the subgroup with residualinflammation at start of treatment. A further subgroup analysis of patients with residualmucosal damage according to extent of UC revealed that 3g OD performed best independentlyfrom the extent (see table below). Conclusions: A dosage of 3g mesalamine (Salofalk®

granules) once daily showed the best efficacy for prevention of relapse in UC compared toa daily dose of 1.5g mesalamine, especially in patients with residual signs of inflammation,even in the distal colon. Reference: (1) Kruis W, Jonaitis L, Pokrotnieks J, Mikhailova TL,Horynski M, Batovsky M, et al. Aliment Pharmacol Ther. 2011;33(3):313-22. Support: Dr.Falk Pharma GmbH, Freiburg, GermanyClinical remission by mucosal damage and extent of mucosal damage (ITT):

OD, once daily; TID, three-times daily * 3g OD vs 1.5g OD; ** 3g OD vs 0.5g TID; ***1.5OD vs 0.5g TID; all tests 2-sided χ2

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Development of the Ulcerative Colitis Patient-Reported Outcomes (UC-PRO)QuestionnairePeter D. Higgins, Gale Harding, Donald L. Patrick, Dennis A. Revicki, Gary Globe, HemaN. Viswanathan, Sarah Trease, Kristina Fitzgerald, Dominique C. Borie, Nancy K. Leidy

Well-defined and reliable patient-reported outcome (PRO) measures are needed to providedirect evidence of treatment benefit in clinical trials evaluating new therapeutic agents forthe treatment of ulcerative colitis (UC). Aim: To develop a new instrument covering thesigns, symptoms and impacts of UC important to patients with this condition. Methods: Todetermine instrument content and structure, concept elicitation from 6 focus groups (n=38) and 1:1 interviews (n=10) were conducted with moderate to severe UC patients. Contentanalyses were performed by independent coders, with data organized in NVivo or ATLAS.ti.Based on these findings and input from clinical experts, a draft instrument was created.Two subsequent rounds of 1:1 interviews were conducted with UC patients (n=16) usingcognitive interview methodology, examining readability and comprehensiveness. Saturationwas reached in both rounds of data collection Results: Of the 64 participants, 24 (38%)were male; mean age ranged from 39.8 (SD=9.2) to 49.1 (SD=14.8) for the different interviewrounds. The most important and relevant UC symptoms were: bowel movement (BM)frequency, stool consistency, blood in stool, abdominal pain, joint pain, fatigue, weakness,urgency, mucus in stool, gas, bloating, loss of appetite, and feeling dehydrated. Importantimpacts included the use of daily coping strategies and effects on emotional well-being anddaily life. The UC-PRO is a 39-item measure covering these aspects of UC important to thepatients themselves. Given the day-to-day variability described by the patients, daily recall

S-768AGA Abstracts

is used for recording signs and symptoms (14 items) and coping strategies (8 items); one-week recall is used for assessing UC impact on emotion (8 items) and activities of daily life(9 items). During cognitive interviews, patients found items in the instrument clear, easyto understand, and relevant. Conclusion: The UC-PRO was developed based on patient andclinician input and addresses signs and symptoms of UC, coping strategies, daily life impact,and emotional impact. Research examining the quantitative performance properties includingreliability, validity, and ability to detect change, is underway.

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Development of the Crohn's Disease Patient-Reported Outcomes (CD-PRO)QuestionnairePeter D. Higgins, Gale Harding, Donald L. Patrick, Dennis A. Revicki, Gary Globe, HemaN. Viswanathan, Sarah Trease, Kristina Fitzgerald, Dominique C. Borie, Nancy K. Leidy

Well-defined and reliable patient-reported outcome (PRO) measures are needed to provideevidence of treatment benefits in clinical trials evaluating new therapeutic agents for thetreatment of Crohn's disease (CD). Aim: To develop a new instrument covering the signs,symptoms and impacts of CD that are important to patients. Methods: To determine instru-ment content and structure, concept elicitation from 5 focus groups (n=42) and 1:1 interviews(n=10) were conducted with moderate to severe CD patients. Content analyses were per-formed by independent coders, with data organized in NVivo or ATLAS.ti. Based on thesefindings and input from clinical experts, a draft instrument was created. Two subsequentrounds of 1:1 interviews were conducted with CD patients (n=22) using cognitive interviewmethodology, examining readability and comprehensiveness. Saturation was reached in bothrounds of data collection. Results: Of the 74 participants, 31 (42%) were male; mean ageranged from 36.3(SD=16.4) to 46.8 (SD=17.7) for the different interview rounds. The mostimportant and relevant CD signs and symptoms were pain (abdominal and joint pain),frequency of bowel movements (BMs), consistency of BMs, blood in stool, nausea, vomiting,fatigue, weakness, loss of appetite, urgency, gas, bloating, and feeling dehydrated. Importantimpacts included the use of daily coping strategies and effects on emotional well-being anddaily life. The CD-PRO is a 39-item measure covering these aspects of CD important to thepatients themselves. Given the day-to-day variability described by the patients, daily recallis used for recording signs and symptoms (14 items) and coping strategies (8 items); one-week recall is used for assessing CD impact on emotion (8 items) and activities of daily life(9 items). During cognitive interviews, patients found items in the instrument clear, easyto understand, and relevant. Conclusion: The CD-PRO was developed based on patient andclinician input and addresses signs and symptoms of CD, coping strategies, daily life impact,and emotional impact. Research examining the quantitative performance properties includingreliability, validity, and ability to detect change, is underway.

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Are Health Maintenance Screening and Prevention Practices Lower in HispanicPatients With Inflammatory Bowel Disease?Oriana M. Damas, Amar Mandalia, Hannah Mathew, Amar R. Deshpande, Daniel A.Sussman

Inflammatory bowel disease (IBD) patients receive fewer preventive services compared toother patients (1). No studies examining health maintenance in the Hispanic (Hisp) IBDpatient exist, and no existing studies look at the Physician Quality and Reporting Systemmeasures in IBD. The aim of our study was to compare the delivery of health maintenancebetween Hisp and Non-Hispanic Whites (NHW) IBD patients. A retrospective review ofIBD patients seen in the Gastroenterology clinic at a university-based tertiary care clinic wasperformed. Included patients were adults ≥18 y/o with a known diagnosis of IBD and self-reported Hisp or NHW ethnicity, seen in the clinic. Health maintenance tests includedPhysician Quality and Reporting Systemmeasures and recommendations from Gastroenterol-ogy societies, including those related to immunization, smoking cessation; and screeningfor osteoporosis and depression. Student's t-test and Chi-square were used to compareoutcomes. 150 IBD patients were included (Hisp 42%). Baseline characteristics between Hispand NHWs were similar. Physician Quality Compliance measures did not differ significantlybetween Hisp and NHW; Table 1. Among non-Physician Quality and Reporting Systemmeasures, there was no difference in completion of Dual Energy X-ray Absorptiometry scans,Pap smears, or skin cancer screening between the two groups; Table 2. Hisp had moremammograms than NHW despite similar ages (33% vs 7.0% and 47 vs 42 years, p=0.212for Hisp and NHW, respectively). No difference in influenza vaccination or pneumococcalimmunization was noted. Zoster vaccinations were low among both groups, but no differencebetween Hisp and NHW were seen (3.2% and 4.5% respectively, p=0.6). No varicella orMeasles Mumps Rubella vaccines were given in either group. Tetanus administration wasalso low, given in 6.3% of Hisp and 6.8% of NHWs. A similar percentage of patients inboth groups were screened for depression (14.3% and 15.9% in Hisp andNHW, respectively).Smoking cessation counseling was low. All patients who were hospitalized more than 4times during follow-up were less likely to receive any of the above mentioned preventivemeasures (Odd ratio 0.8) No difference in screening prescription or patient adherence wasobserved when accounting for provider Spanish-speaking proficiency. Prescription of healthmaintenance and prevention measures does not differ between Hispanic and NHW patientswith IBD. Low rates of preventive care were seen for varicella, zoster, and Tetanus vaccinesas well as smoking cessation counseling, though in a retrospective chart review of a partlyreferral population, some of these numbers may be underestimates. Nonetheless, theseareas require targeting for future quality of care improvement. 1. Sinclair JA, et al. HealthMaintenance in the IBD Patient. GastroclinNAmerica. 2012. 41:325-337.Table 1. Physician Quality Reporting System (PQRS) in Hispanics and Non-Hispanic Whiteswith Inflammatory Bowel Disease