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Through-the-Scope Dilation in Stenotic Crohn's Disease: Results of a LargeCohort of Consecutive PatientsVera Kessler Brondolo, Janek Binek, Christian Felley, Christina A. Knellwolf, JanBorovicka, Paul H. Wiesel, Gian Dorta, Christa Meyenberger, Pierre F. Michetti

BACKGROUND: Sub-occlusions are frequent complications of Crohn's disease (CD). Theyare usually caused by stenosis, which can be due to recurrent CD or ischemic anastomosis.Through-the-scope balloon dilation (TTS) is the only alternative to intestinal resection orstricturoplasty for the treatment of intestinal strictures. Previous studies have reported along-term symptomatic benefit of TTS balloon dilation in CD ranging from 48% and 66%.The aim of this study is to evaluate safety and efficacy of repeated TTS balloon dilationsin CD strictures. PATIENTS AND METHODS: We retrospectively analyzed consecutiveendoscopy protocols of all CD patients who underwent colonoscopy or rectosigmoidoscopywith TTS balloon dilation between 2000 and 2007, in the hospital databases of UniversityHospital of Lausanne and Kantonspital St Gallen, Switzerland. All patients had histologicallyproven CD that did not improve under medical CD treatment, including 5-amino salicylicacid, azathioprine, 6-mercaptopurine, methotrexate, budesonide, prednisone or anti-TNFα.Hydrostatic TTS balloon dilation was performed using Wilson Cook/Boston Scientific bal-loons progressively inflated to maximal pressure for 60 seconds. RESULTS: Sixty-one consec-utive patients (33 females, 28 males), mean age 37±11 years, underwent dilation for a totalof 237 dilations. Mean balloon diameter was 18mm (range 10-25mm). An inflammatoryactivity was observed in 75% of strictures, 129 dilations were performed on anastomoticstrictures (54%), the other dilations were performed on surgically naïve bowel (21 in terminalileum, 11 at the ileo-cecal valve,4 in the right colon, 21 in the left colon, 51 in the recto-anal region). Mean number of dilations was 2.25 (interval range 1 to 21) per stricture. Allpatients had symptoms relief post dilation, mean time before repeated dilation was 132 days(range: 3-1495 days). One perforation occured, which required surgery. CONCLUSION:TTS balloon dilation is a safe and effective treatment of CD strictures. It can be used totreat anastomotic as well as disease-induced stenosis, independently of inflammatory status.Multiple TTS balloon dilations of the same stenosis is often required to improve symptoms.Repeated TTS dilations did not increase the risk of complications.

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Practice Patterns of 5-ASA Use in Ulcerative Colitis (UC): Results of aNational Vignette Survey Comparing Experts vs. Community ProvidersBrennan M. Spiegel, Wayne Ho, Eric Esrailian, Gil Y. Melmed, Peter D. Higgins, Corey A.Siegel, Marla C. Dubinsky, Stephan R. Targan

Background: Although 5-ASA is the mainstay of therapy for most outpatients with UC,there remains uncertainty about the optimal dose, timing, & indication for 5-ASA products.Three areas, in particular, have been debated: (1) use of low vs high-dose 5-ASA for inductionof remission in mild-to-moderate UC; (2) appropriateness of continuing indefinite 5-ASAafter induction of remission; & (3) role of 5-ASA for cancer chemoprevention. We conduceda national survey to measure current practice in these areas in a group of experts & “non-expert” community providers. Methods: We developed an online survey that included aclinical vignette of an outpatient UC patient with a moderate flare. The vignette was developedwith a panel of content experts to ensure face validity. Respondents viewed a standardizedpatient presentation (summary: 32 yo with 3mo of 3-5 loose bloody BM/day & moderatelower abd pain, now 2 wks low grade fever, no alarm features on exam) & then receivedmanagement questions guided by branching logic. Upon colonoscopy, respondents viewedan image of moderate diffuse inflammation to the mid-transverse colon. The survey elicitedprovider beliefs about various aspects of UC care, including use of 5-ASA. We surveyed arandom sample of 500 GIs from the AMA Masterfile & 40 international UC experts. Results:The response rate was 32% (N=169; 25 experts). 94% endorsed using 5-ASA in the vignette(54% mesalamine, 17% delayed-release mesalamine, 11% azulfidine, 9% balsalazide, 3%micronized mesalamine). 56% endorsed high-dose 5-ASA (4.8g mesalamine equivalent) toinduce remission. There was a trend towards more experts vs non-experts endorsing high-dose 5-ASA (71% vs 53%; p=0.1). 21% endorsed indefinite 5-ASA following remission.However, if the patient subsequently required 6-MP to induce remission, then 66% endorsedlong-term 5-ASA. Of those endorsing indefinite 5-ASA, 33% believed 5-ASA is indicatedfor cancer chemoprevention. In logistic regression adjusting for provider demographics,practice setting, & experience, experts remained over 5x more likely to endorse indefinite5-ASA in remission (OR=5.3; 95% CI=1.5-18.5) & over 4x more likely to use 5-ASA forchemoprevention (4.5; 1.3-15.5). Conclusions: Compared to non-experts, UC experts aremore likely to endorse indefinite 5-ASA after induction of remission, to believe 5-ASA hascancer chemopreventive properties, & to use high-dose 5-ASA to induce remission inmoderate UC (p=0.1). These variations between experts & non-experts indicate that furtherdevelopment & dissemination of evidence-based 5-ASA guidelines is warranted to assistdecision-making in these controversial areas.

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High Level of Adherence to Therapy in Dutch Patients with InflammatoryBowel DiseaseJudith E. Baars, Zuzana Zelinkova, Peter B. Mensink, Tineke Markus, E. J. Kuipers,Christien J. van der Woude

Background and aim: Previous studies of adherence to therapy demonstrated high prevalenceof non-compliance in patients (pts) with inflammatory bowel disease (IBD). However, thesestudies were all conducted by treating physicians and no data are available on pts' perspective.Aim of this study was to assess medication-taking behavior of IBD pts in The Netherlands.Methods: Adult pts with IBD were asked to complete anonymously an online survey ontheir experience concerning disease and treatment. This study was initiated by the Dutchpts' association of Crohn's disease and Ulcerative Colitis (CCUVN). Differences betweencompliant and non-compliant pts regarding age, gender, type of disease, disease duration,quality of life, relationship with treating physicians and medication were analyzed statistically

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using chi-square tests. Therapy adherence was defined as taking medication as per doctors'prescription. A randomly selected group of pts of our outpatient IBD clinic was used ascontrolgroup. Results: 1067 pts completed the survey at the CCUVN website (617 (57.8%)Crohn's Disease (CD), 450 (42.2%) ulcerative colitis (UC), 65.9% females, mean age 43 yrsold (SD 13.7)) Of 920 pts using medication at the moment of the survey, 123 (13.4%)admitted to be nonadherent to therapy. 797 pts (86.6%) were completely adherent totreatment. In total 582 pts were treated with 5-ASA of which 90.55% was compliant to thismedication. CD pts were more compliant in this group (p=0.005) as well as pts with worsequality of life (p=0.035). In the different therapy groups compliance was as follows: 330pts (30.9%) using corticosteroids 95.5% was adherent. Compliance rate was significantlyhigher (p=0.043) among pts with shorter duration of disease (≤ 8 yrs) and lower qualityof life (p=0.028). In the group using immunosuppressants (azathioprine, methotrexate) 414of 423 pts (97.87%) were adherent to therapy and only 1 of 111 anti-TNF users claimednot to be compliant. Of 144 pts treated with anti-diarrheal medication 70.14 % was therapycompliant. Gender and relationship with treating physicians were not significant in anygroup. Of 130 pts in the controlgroup (95 CD (73.1%), 32 UC (24.6%), 68 females (52.3%),70 pts (55.8%) > 8 yrs duration of disease), 114 pts (87.7%) used medication, of which92 (80.7%) were adherent to therapy. Conclusion: In contrast to previous studies, thispatient empowerment study shows high overall therapy adherence in Dutch IBD patients,even in non-active disease. CD diagnosis and lower quality of life were associated withhigher compliance rates. The only predisposing factor for non-compliance in this study waslong duration of disease.

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Mucosal Healing in Ulcerative Colitis Patients in Long-Term Therapy withInfliximabAlfredo Papa, Italo De Vitis, Luisa Guidi, Fabio Aiello, Giovanni Brandimarte, WalterElisei, Simona Guglielmo, Giammarco Mocci, Italia Roberto, Michele Bonizzi, Sara Ennas,Carla Felice, Gianluca Andrisani, Antonio Gasbarrini, Giuseppe Fedeli

Background and aims: Infliximab, an anti-tumor necrosis factor (TNF) chimeric monoclonalantibody, has shown clinical and endoscopic efficacy in short-term therapy in patients withmoderate-to-severe steroid-resistant or steroid dependent ulcerative colitis (UC). However,data on mucosal healing in UC patients with long-term scheduled maintenance therapy arescarce. Aim of this study was to assess the long-term efficacy of infliximab on endoscopicactivity in UC patients. Patients and Methods: seventeen patients with moderate-to-severeactive UC (l5 steroid dependent and 2 steroid-resistant) were included in this study. Allpatients were clinical responder to the infliximab induction course (5mg/Kg at 0, 2, and 6weeks) and underwent to a scheduled (every 8 weeks) maintenance therapy at the samedosage. Colonoscopy was performed at baseline and at week 54 (±8) or in case of clinicalrelapse. In 3 patients colonoscopy was performed also after 110 (±8) weeks. Clinical activitywas assessed by Mayo score (scores can range from 0 to 12, with higher scores indicatingmore severe disease) and endoscopic activity was measured by means of Mayo subscore forendoscopy (0= normal or inactive disease, 1= mild disease, 2= moderate disease, 3= severedisease). Mucosal healing was defined as an absolute subscore for endoscopy of 0 or 1.Results: the total number of infusions was 176, the mean number of infusions for patientswas 10.3±3.9. The mean duration of follow-up was 77.3±43.6 weeks. Four patients (23.5%)withdrew from scheduled treatment before one-year follow-up: three underwent to colectomyfor loss of response and one had a severe adverse reaction. At enrolment, 15 patients werein treatment with steroids that were gradually tapered and discontinuated, 11 patients werein concomitant treatment with azathioprine, 3 with methotrexate and 3 with 5-ASA. Thirteenpatients had a pancolitis and 4 a left-sided colitis. Mean Mayo score was 8.2±1.9 at baselineand 4.2±1.8 at week 54 (±8), with a statistically significant reduction (p=0.04). At enrolment,10 patients had moderate disease and 7 severe disease at endoscopy, at week 54 (±8) 10/13 (76%) of the remaining patients showed mucosal healing and 3/13 moderate endoscopicactivity. The 3 patients that underwent to a second follow-up endoscopy showed persistentclinical and endoscopic remission. Conclusions: the results of this study demonstrate thatlong-term scheduled maintenance therapy with infliximab in steroid-resistant and steroiddependent UC patients results in a decreased endoscopic evidence of inflammation with ahigh rate of persistent mucosal healing.

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Long Term Safety and Efficacy of Allopurinol and Azathioprine or 6-Mercaptopurine in Patients with Inflammatory Bowel DiseaseYvette Leung, Miles Sparrow, Stephen B. Hanauer

Background: We previously reported that IBD patients who are non-responders to thiopurinesdue to high thiopurine s-methyltransferase activity with preferential shunting of metabolites tohepatotoxic 6-methylmercaptopurine ribonucleotides (6-MMP) compared to 6-thioguaninenucleotides (6-TGN) can reverse the ratio of 6-MMP/6-TGN and respond to thiopurineswith the addition of allopurinol. The objective of this study is to report longer-term efficacyand safety, along with results for an additional 10 patients. Methods: Retrospective chartreview of patients at the University of Chicago IBD Center treated with allopurinol in additionto AZA/6-MP. Metabolite levels, medications, clinical efficacy and adverse events wereextracted. Results: 14 subjects were initially enrolled & reported (Group A). Since the initialprotocol 10 additional subjects have received combination therapy (Group B). In Group A,12/14 subjects had follow-up. 9 pts are continuing on allopurinol after a mean of 34 months(range 21-50). The reasons for discontinuation were: surgery (2), pancytopenia (1). At lastfollow-up the mean Simple Colitis Activity index for 5 UC pts was 0.75 ± 0.75 (SE). Themean Harvey Bradshaw index for the 4 CD pts was 2 ± 2. Aside from one patient whoincreased her dose of 6-MP while traveling and developed pancytopenia, there have beenno adverse events. No patients have had evidence of nodular regenerative hyperplasia orvenoocclusive disease. In Group B follow-up data were available for 8 pts after a mean of11.8 mos (range 2-33). After allopurinol was started mean 6-TGN levels increased from149.6 ± 23.1 to 252.4 ± 41.4 pmol/8 x 108 RBCs (p=0.025). In contrast 6-MMP levelsdecreased from a mean of 6603.7 ± 1759.9 to 1050.9 ± 756 pmol/8 x 10 8 RBCs (p=0.025).3/7 steroid-dependent pts in Group B have been weaned thus far. Mean treatment duration

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