S280 Poster presentations

P509Do you overlook the Clostridium difficile infection afterTB medication?K.C. Huh1 *, Y.m. Lee1, H.S. Koo1, S.M. Yoon2, Y. Jung3,J.E. Shin4, B.I. Jang5, S.H. Kim6, H.S. Moon7, S.W. Lee8.1Konyang University College of Medicine, Departmentof Internal Medicine, Daejeon, Korea, Department ofInternal Medicine, Daejeon, Korea, Republic of, 2ChungbukNational University College of Medicine, Department ofInternal Medicine, cheongju, Korea, Department of InternalMedicine, Cheongju, Korea, Republic of, 3SoonchunhyangUniversity College of Medicine, Department of InternalMedicine, Cheonan, Korea, Department of Internal Medicine,Cheonan, Korea, Republic of, 4Dankook University College ofMedicine, Department of Internal Medicine, Cheonan, Korea,Department of Internal Medicine, Cheonan, Korea, Republicof, 5Yeungnam University College of Medicine, Departmentof Internal Medicine, Daegu, Korea, Department of InternalMedicine, Daegu, Korea, Republic of, 6Eulji Universityhospital, Department of Internal Medicine, Daejeon, Korea,Department of Internal Medicine, Daejeon, Korea, Republicof, 7Chungnam National University Hospital, Department ofInternal Medicine, Daejeon, Korea, Department of InternalMedicine, Daejeon, Korea, Republic of, 8Catholic Universityof Korea, Daejeon St. Mary’s Hospital, Korea, Department ofInternal Medicine, Daejeon, Korea, Republic of

Background: Clostridium difficile is now the most commoninfectious cause of nosocomial diarrhea. There has been aprogressive rise in the incidence, severity, and complicationsglobally over the recent years.In a nationwide CDI study in Korea, 11 patients, among a totalof 1367 patients who had taken anti-TB medication, such asrifampin, developed CDI. Because of its low incidence, CDIafter TB medication can be considered unimportant. However,tuberculosis is still prevalent in Korea, and many patients areprescribed anti-TB therapy for at least 4 months.We aimed to determine which TB medications-associated CDIincidence from 2008 to 2013, and to analyze the clinicalfeatures that differ from other antibiotics-associated CDI.Methods: This multi-center study included patients from 8tertiary hospitals. The cases that met the criteria for CDIwere enrolled from 2008 to 2013. A retrospective analysis wasconducted to identify the clinical features of CDI patientsto whom TB medications were administrated. We excludedpatients without recorded variables and patients to whom anyantibiotics had been administered within a month from thestart of CDI.Results: The total incidence of CDI after TB medication was2.83 cases/1000 adults. When analyzing the clinical featuresof 54 CDI patients treated with TB medication, the medianage of patients was 68.3±16 years (range 25 to 93 years).Most patients had been diagnosed with pulmonary tuberculosis,and most patients had been treated with anti-TB medications,including rifampin (94.4%). The latency period to develop CDIafter the initiation of TB medication has a wide range; 3 daysto 167 days (mean, 41.8±35.0 days). The leukocytosis wasobserved in 22 (40.7%) patients, and creatinin elevation in3 (5.6%) patients. Severe complications of CDI were shown in 2patients; death secondary to CDI. The anatomic distributionof CDI included only the rectum in 4 cases, sigmoid in 11cases, descending colon in 5 cases, and up to the cecum in5 cases. Patients were usually treated with oral metronidazole(48 patients, 88.9%) with the 1st treatment, and there wereimprovements by the 1st regimen (47 patients, 87%). Therewere 21 improved patients, and they had received rifampincontinuously during CDI treatment. There were no significantdifferent improvements between the continued group and thediscontinued group. (44.7% vs. 55.3%).

Conclusions: The incidences of CDI after TB medication werenot low considering the relatively low TB medication usecompared with antibiotics use. Thus, for patients who havecomplained of abdominal pain or diarrhea while taking TBmedications, the possibility of TB medication-associated CDIshould be considered.

P510Do patients enrolled in pivotal trials represent allinflammatory bowel disease population? EFIFECT study

D. Ginard1 *, S. Khorrami1 *, L. Perez-Carazo1, E. Tavío2,A. Lopez-Sanroman2, M. García-Alvaredo3, F. Munoz3,L. Ibanez4, I. Marín-Jimenez4, J. Guevara5, F. Casellas5.1Hospital Universitario Son Espases, Gastroenterology, Palmade Mallorca, Spain, 2Hospital Universitario Ramon y Cajal,Gastroenterology, Madrid, Spain, 3Complejo Hospitalariode Leon, Gastroenterology Unit, Leon, Spain, 4HospitalUniversitario Gregorio Maranon, Gastroenterology, Madrid,Spain, 5Hospital Universitari Vall d’Hebron, Unitat AtencioCrohn-Colitis, Barcelona, Spain

Background: Randomized controlled trials (RCTs) provide thebest scientific evidence for the efficacy of biological drugin the treatment of inflammatory bowel disease (IBD). RCTsuse strict selection criteria and defined protocol study inorder to eliminate potential bias. Therefore, findings obtainedfrom these trials might not be assumed in general clinicalpractice (CP). The aim of this study was to estimate thepercentage of IBD patients treated with biologic drugs in CPwho would have been eligible for RCTs and to compare one-year outcomes between eligible and non-eligible patients.Methods: We performed a retrospective multicenter cohortstudy of adult patients with Crohn’s disease (CD) and ulcerativecolitis (UC) treated with anti-TNF agents and followed-up forat least 1 year, randomly selected from five Spanish tertiarycenters. The inclusion and exclusion criteria for RCTs wereextracted from ACCENT 1, ACCENT 2 and SONIC trials forinfliximab in CD, CLASSIC 1 and CHARM trials for adalimumabin CD, ACT 1 and ACT 2 trials for infliximab in UC.Results: Three hundred and seventy-eight IBD patients (276 CDand 99 UC) were included. Only 45.2% of patients (47.1%with CD and 41.4% with UC) would have been eligible forpivotal RCTs. The most common reasons for non-eligibility wereindications other than moderate severe IBD flare or perianaldisease (36.2%), the presence of symptomatic stenosis (17.9%)and the use of topical drugs (12.1%). One-year outcomes weresimilar for both eligible and non-eligible CD (67.1% vs. 70.1%,p = 0.608) and UC patients (72.4% vs. 63.4%, p = 0.342).Conclusions: More than half of IBD patients treated withbiologic drugs would not be represented in RCTs. Anti-TNFagents might have similar effectiveness in non-eligible IBDpatients than in those eligible for RCTs.