Efficacy of 6-MP in prevention of endoscopic recurrence at anastomotic site after ileo-colic...

tertiary referral centers. To examine this issue, ACCENT I data wasanalyzed.Methods: In ACCENT I, 573 patients received a single infusion of 5 mg/kgIFX. At Week (Wk) 2, pts were randomized to 1 of 3 maintenanceregimens: 1) placebo at Wks 2, 6 and then placebo q8 wks (Group I), 2) 5mg/kg IFX at Wks 2, 6 and then 5 mg/kg q8 wks (Group II), and 3) 5 mg/kgIFX at Wks 2, 6 and then 10 mg/kg IFX q8 wks (Group III). Starting at Wk14, pts who lost response could crossover to episodic treatment with IFXat a dose 5mg/kg higher than their assigned maintenance dose. Inclusioncriteria excluded patients with symptomatic strictures. The total number ofpts developing new symptomatic intestinal strictures, stenosis or obstruc-tion during the 54 wk study period was analyzed for each of the treatmentgroups.Results: Average total dose of IFX received was significantly higher for ptsin Groups II and III than in Group I (40 mg/kg, 64.9 mg/kg vs. 9.7 mg/kg,respectively). The incidence of new presentations of intestinal stricture,stenosis or obstruction during the study period was lower in Groups II andIII, which received higher aggregate doses of IFX (Group I: 19/188, 10%;Group II: 11/192, 5.7%; Group III: 13/193, 6.7%)(p�.02 for Group II vs.Group I; p�.03 for Group III vs. Group I). This result was consistent forboth patients who demonstrated a clinical response to the initial IFX dose,and those who did not. (Responders: Group I: 10/110, 9%; Group II: 6/113,5.3%; Group III, 8/112, 7.1%)(p�.05 for Group II vs. Group I; p�.16 forGroup III vs. Group I). (Non–Responders: Group I 9/78, 11.5%; Group II5/79, 6.3%; Group III 5/81, 6.2%)(p�.05 for Group II vs. Group I andGroup III vs. Group I).Conclusions: These data from a large prospective trial of IFX in thetreatment of Crohn’s disease provide strong evidence that the use of IFXdoes not lead to an increase in the development of intestinal strictures,stenosis or obstruction, and strongly suggest that IFX may actually helpprevent these complications.

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STRICTURES AND RESPONSE TO INFLIXIMAB IN CROHN’SDISEASEAndrew M. Weinberg, Sushil Rattan, James D. Lewis, Chinyu Su, DavidA. Katzka, Julius Deren and Gary R. Lichtenstein*. Department ofMedicine Division of Gastroenterology, Hospital of the University ofPennsylvania, Philadelphia, PA and Department of Medicine, LankenauHospital, Wynnewood, PA.

Purpose: In a preliminary report we found that a poorer response toinfliximab therapy for Crohn’s disease (CD) occurs in pts with intestinalstrictures (Lichtenstein GR, et al. AJG 1999). We now report on a signif-icantly larger cohort of patients. Aim: to determine if Crohn’s Diseasepatients with strictures respond to infliximab as well as those withoutstrictures.Methods: 127 patient’s who received infliximab between January 1999 toJanuary 2002 for active CD were analyzed. Smoking status on all patientswas available. Clinical outcome improvement definitions: complete (pre-vious baseline), partial (�50% improvement), and none as assessed bypatients and physicians. Smoking definition: more than 7 cigarettes perweek within 6 months of Infliximab treatment. Association of the followingfactors and response to infliximab therapy was analyzed by univariate andmultivariate ordered logistic regression: intestinal or colonic stricture,proximal bowel dilation, male sex, smoking, fistula, previous surgicalresection, and disease duration.Results: Complete response in 68 (54%), parial and none 59 (46%) wereidentified. 19 of 127 patients (15%) were smokers. Stricture data wasavailable for 127 patients. Of these, 57 (45%) had strictures. In univariateanalysis, strictures had a statistically significant decreased rate of completeresponse (OR� 0.21, 95% CI 0.1–0.45). In multivariate analysis, afteradjusting for male sex, colonic disease, prior resection, and fistula, thepressence of a stricture also remained significantly associated with adecreased rate of complete response (adjusted OR�0.19, 95% CI 0.07–0.56). In univariate and multivariate analyses, no significant difference of

complete response among smokers versus non–smokers was seen (multi-variate analysis for smokers and complete response, adjusted OR�1.11,95% CI 0.25–4.99).Conclusions: Although we cannot predict with absolute certainty if anindividual patient will respond to infliximab, fewer patients with CD whohave intestinal strictures responded to infliximab that those individuals whodid not have strictures. Smoking was not found to be a predictor ofnon–response for patients with CD who were treated infliximab.

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EFFICACY OF 6–MP IN PREVENTION OF ENDOSCOPICRECURRENCE AT ANASTOMOTIC SITE AFTER ILEO–COLICRESECTION FOR CROHN’S DISEASEAndrew Blank, M.D., Burton I. Korelitz, M.D.* and GeorgiaPanagopoulos, Ph.D. Section of Gastroenterology, Lenox Hill Hospitaland New York University School of Medicine, New York, NY.

Purpose: The efficacy of 6–MP in maintaining remission of Crohn’sdisease has been well established. The objective of this study is to deter-mine the efficacy of 6–MP in maintaining endoscopic remission based onthe Rutgeerts’ scale in patients who have undergone ileo–colic resectionfor Crohn’s disease.Methods: This is a retrospective study of 55 patients with Crohn’s diseasewho had an ileo–colic resection. Patients were seen in one large metro-politan IBD practice during a period of 20 years. The groups were dividedinto those patients who received 6–MP immediately after surgery for atleast 6 months (group 1) vs. those who did not (group 2). Any endoscopicrecurrence was recorded at 6 months and annually thereafter and given aRutgeerts’ score of 1–4. A Kaplan–Meier survival analysis was employedand differences between the two groups were analyzed using the long–ranktest. The t–test, Chi–square, and Mann–Whitney U test were used toexamine baseline differences and disease characteristics between the twogroups.Results: There was no significant difference between the two groups in ageor gender (p�.5). No significant differences were observed between thetwo groups on time to relapse (p�.5). Median time to relapse in group 1was 52 months (range 5–168) and median time to relapse in group 2 wasalso 52 months (range 0–224). There was a significant difference, however,between the two groups on the Rutgeert’s score (p�.032). Group 2 ob-tained a higher median Rutgeerts’ score (median�3) than group 1 (medi-an�1).Conclusions: Postoperative administration of 6–MP did not result inlonger sustained endoscopic remission. However, the disease activity mea-sured endoscopically using the Rutgeerts’ score and thereby clinical recur-rence was significantly lower in patients who were started on 6–MPpostoperatively. Therefore, we favor the postoperative use of 6–MP inpatients who have undergone ileo–colic resection for Crohn’s disease.

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INTESTINAL MAST CELL ACTIVATION ANDDEGRANULATION FOLLOWING PHYSIOLOGICAL STRESSIN IBD: ELECTRON MICROSCOPY STUDYAaron Domm, Ashkan Farhadi, Megan Bakaitis, Shriram Jakate, AliBanan and Ali Keshavarzian*. Department of Internal Medicine,Section of Gastroenterology and Nutrition, Rush Medical College,Chicago, IL.

Purpose: The role of stress in the pathogenesis of Inflammatory BowelDisease (IBD) is not fully known. Stress–induced gastrointestinal dysfunc-tion may involve activation of mucosal mast cells (MC) through brain–gutaxis (BGA). We assessed the effect of physiologic stress on colonicmucosal MC activation & degranulation in healthy controls & those diag-nosed with IBD using Electron Microscopy (EM) technique.Methods: 12 individuals (4 controls, 3 inactive UC & 5 inactive CD) wereselected for stress test. Physiological stress was modeled using 5 consec-utive days of Cold Pressor Test (CPT). Mucosal biopsies were performed

S255AJG – September, Suppl., 2002 Abstracts