- Email: [email protected]
324 Quantification of Inflammation in Small Bowel Crohn's Disease Patients by Videocapsule Endoscopy and Magnetic Resonance Enterography
AGA Abstracts
children were more likely to receive treatment with anti-TNF atherapy than White children. This difference does not appear to be explained by differences in age, growth, nutrition, perianal disease or standardized disease severity scores, but rather by subjective assessment of disease severity and/or consideration of additional information such as endoscopic appearance that is not accounted for by the sPCDAI. (for the ImproveCareNow Pediatric IBD Learning Health System)
with 4 (67%) successfully tapered by the first maintenance dose. Clinical improvement based on PGA from baseline to 14 weeks was seen in 3 (50%) of the patients. While not statistically significant, PCDAI improved to 20.8 (+7.7) at 14 weeks (p=0.31). There were no infusion reactions. However, new extra-intestinal manifestations of bowel-associated dermatosis-arthritis syndrome occurred in one patient during induction, and a second patient developed a pelvic abscess and osteomyelitis concurrent with the first induction dose. Conclusion: This is the first experience of vedolizumab therapy in pediatric IBD. While this study is limited by the small number of patients, there appears to be modest improvement in disease activity measured by PGA and steroid reduction in the majority of patients. Steroid-free remission was not achieved in this cohort. Further prospective follow-up of a larger cohort treated with vedolizumab at this center is underway to provide additional data regarding efficacy and safety in pediatric IBD.
321 Vedolizumab Use in Pediatric Patients With Inflammatory Bowel Disease Namita Singh, Minesh Patel, Shervin Rabizadeh, Marla Dubinsky Background: Off-label use of vedolizumab in pediatric inflammatory bowel disease (IBD) is limited following its approval for adult patients with Crohn's disease (CD) and Ulcerative colitis (UC). We aimed to describe the experience of vedolizumab in pediatric IBD patients at a tertiary IBD center and to examine predictors of remission. Methods: A prospective database identified pediatric IBD patients (age < 18 years) receiving vedolizumab for either CD or UC. Data on demographics, surgical history, disease behavior, location, disease activity and previous treatments were collected. Disease activity was assessed using the pediatric Crohn's disease activity index (PCDAI) or pediatric UC activity index (PUCAI). Remission was defined as PUCAI £ 10 or PCDAI £ 10. Descriptive statistics and univariate analyses were performed to examine associations of clinical characteristics with therapeutic efficacy. Results: Eighteen pediatric patients, 13 CD and 5 UC, initiated vedolizumab between June 2014 and October 2014. Vedolizumab dose was 6mg/kg/dose, with maximum of 300mg/ dose, and infused at 0, 2, 6 weeks then every 8 weeks. Median age at diagnosis was 11.2 (range 1-16) years, median disease duration was 2.8 (range 0.5-15.2) years, and median age at vedolizumab initiation was 15.8 (range 11.4-17.9). Five (28%) patients had prior bowel surgery. All but one patient (94%) had failed at least one anti-TNF agent, and median time from last anti-TNF agent was 11.1 months (range 0-34.3 months). Three patients (17%), 1 UC and 2 CD, were switched from natalizumab. Seventeen patients have received the 6 week induction dose and 10/18 have received a week 14 dose. Week 6 and week 14 remission rates were 46.6% and 54.5%, respectively. Two of 3 UC patients were in remission at week 6, and all 3 UC patients were in remission at week 14, while only 4/12 (33%) CD patients were in remission at week 6 and 4/9 (44%) in remission at week 14. CD patients with small bowel involvement were less likely to be in remission than those with isolated colonic involvement (p=0.06). The presence of remission at week 6 was associated with remission at week 14 (p<0.05). One patient who was in remission with natalizumab relapsed once switched to vedolizumab. Baseline CRP, immunomodulator use, prior anti-TNF or natalizumab exposure, were not associated with efficacy outcomes. There were no serious infections, hospitalizations or infusion reactions. All patients remain on vedolizumab. Conclusion: In our experience, vedolizumab is safe in pediatric IBD patients, with efficacy similar to that reported in the adult phase 3 trials. The efficacy of vedolizumab was higher in UC patients, and in CD patients with colonic involvement. The phase 3 pediatric trial will provide further insight into the safety and efficacy of Vedolizumab in pediatric IBD patients.
323 Steroids No More! Exclusive Enteral Nutrition Therapy in Pediatric Patients With Crohn's Disease Results in Long-Term Avoidance of Corticosteroid Therapy Anthony R. Otley, Amy Grant, Nicholas Giffin, Mohsin Rashid, Gamal Mahdi, Johan Van Limbergen Intro: Exclusive Enteral nutrition (EEN) has been used as a primary therapy for the treatment of pediatric Crohn's Disease (CD). However, it has yet to be widely endorsed as a primary therapy by North American gastroenterologists despite evidence of its efficacy. Aim: To compare the long-term outcomes of CD patients initially managed with EN versus corticosteroids in a large retrospective cohort. Methods: A single centre, retrospective analysis (1985 to present) of 229 pediatric patients with CD receiving either EEN (n=153) or steroid induction therapy (n=76). EEN was used for a 12 week induction, followed by EN (50% total daily calories) + regular diet as maintenance. Clinical remission was defined as PCDAI £7.5 without height at baseline and at the 4-8 week follow-up, and £10 at the 6-, 12-, 24, and 36-month follow-up visits. A propensity analysis with nearest-neighbour matching, using a 1:2 replacement, and small caliper (.15; allowable standard deviation of estimated propensity score) was carried out. Matched baseline characteristics included gender, age, weight, height, PCDAI and Paris disease locations. Results: The propensity analysis reduced the sample size of each group, EEN (N=69) and corticosteroid (N = 70), yet reduced bias in initial assignment to therapy. EEN and Steroid patients (33% female in each group) were very similar in age (11.9±3.0, 12.0±2.5 years respectively), height (146.6±19.6, 147.4±14.5 cm), weight (36.5±13.7, 37.9±12.3 kg), and disease activity measured by PCDAI (31.1±10.9, 31.8±10.4) at baseline. Initial EEN therapy significantly decreased the risk of exposure to corticosteroids, as 76% and 66% of EEN matched patients remained steroid free over 1 and 3 years, respectively. EEN patients had a quicker induction of remission (4-8 weeks) with 80% of patients achieving clinical remission versus 63% of steroid patients (p < .05). There was a significant growth x group interaction over time, showing that EEN patients height z-score trajectory (-.14 at baseline to .11 at 36 months) was larger than Steroid group patients (p = .02) whose growth remained relatively unchanged from baseline to 36 months (z = -.14 to -.13). Conclusion: EEN therapy showed more positive effects over time via quicker induction of remission, significant changes in linear growth, and avoidance of corticosteroids over a 3-year follow-up period.
324 Quantification of Inflammation in Small Bowel Crohn's Disease Patients by Videocapsule Endoscopy and Magnetic Resonance Enterography Uri Kopylov, Eyal Klang, Shomron Ben-Horin, Doron Yablecovitch, Adi Lahat, Sandra Neuman, Noa Rozendorn, Nina Levhar, Abraham R. Eliakim, Michal Marianne Amitai Background: Video capsule endoscopy (VCE) and magnetic resonance enterograpgy (MRE) are the prime modalities for the evaluation of SBCD.. Mucosal inflammation on VCE can be quantified using the Lewis score (LS) or the Capsule Endoscopy Crohn's Disease Activity Index (CECDAI), incorporating mucosal edema, ulceration and strictures. Magnetic Resonance Index of Activity (MaRIA) is a novel MRE-based score that incorporates wall thickness, relative contrast enhancement, mucosal edema and ulceration in the distal SB and colon The aim of this study was to compare the quantification of distal SB inflammation using VCE and MRE-based diagnostic indices. Methods: Patients with known SBCD in steroid free clinical remission or with mild symptoms (CDAI<220) for at least 3 months were prospectively recruited and underwent MRE, followed by Agile patency capsule. If patency was proven, VCE was performed. LS, CECDAI and MaRIA score were calculated for the distal SB. C-reactive protein (CRP) and fecal calprotectin (FC) levels were obtained and evaluated for their association with the clinical scores. Results: Fifty patients underwent both VCE and MRE. Active disease was demonstrated in the distal SB in 62% of the patients by VCE and 72% by MRE (p=0.4). There was a strong correlation between MaRIA score and both VCE indices (LS-r=0.53, p=0.001; CECDAI- r=0.49, p=0.001), as well as between the CECDAI and LS (r=0.677, p=0.001). LS associated with mucosal healing (<135) correlated with a mean MaRIA score of 13.3 and a mean CECDAI of 4.9 by linear regression. CRP had moderate correlation with MaRIA (r=0.38, p=0.01) but not with VCE scores (LS- r= 0.1 p=0.5 CECDAI-r=0.24, p=0.1). FC was significantly correlated with all scores, however the association was somewhat stronger for the VCE scores (MaRIA- r=0.44 p=0.02; LS - r= 0.54 p=0.001; CECDAI- r=0.49, p=0.001). Summary: Significant correlation between the quantitative MRE and CE-based indices of inflammation in the distal SB was observed. A significant correlation was also demonstrated between LS and CECDAI. FC levels better correlated with VCE then with MRE score, while CRP had a good correlation with the MaRIA score only. The utility of these indices for prediction of future clinical relapse will be prospectively evaluated in future studies. Uri Kopylov and Eyal Klang have equally contributed to the study Marianne M Amitai and Rami Eliakin have equally contributed to the study
Figure 1: Disease activity Scores during Vedolizumab therapy
322 The Use of Vedolizumab for Treatment of Severe Pediatric Inflammatory Bowel Disease Maire A. Conrad, Ronen Stein, Elizabeth C. Maxwell, Lindsey Albenberg, Robert Baldassano, Andrew B. Grossman, Petar Mamula, David Piccoli, Judith R. Kelsen Background: Vedolizumab, a humanized IgG1 monoclonal antibody against a4b7integrin that inhibits T-lymphocyte migration into intestinal tissue, has recently been approved for adults with inflammatory bowel disease (IBD). There are no published data on vedolizumab use in pediatrics, but it may be a therapeutic option in children with disease refractory to current standard therapy. Aims: To evaluate use of vedolizumab in pediatric patients with refractory IBD and determine clinical response measured by disease activity. Secondary aim was to describe adverse effects associated with vedolizumab use in this population. Methods: Children between the ages of 13-19 with severe IBD refractory to biologic therapy and initiating vedolizumab at The Children's Hospital of Philadelphia from June 2014 were included. Indications for initiation of vedolizumab therapy were determined by the primary gastroenterologist and followed prospectively at each visit where clinical activity indices and outcomes were recorded. Dosing was the standard adult regimen of 300 mg at week 0, 2 and 6 followed by maintenance phase at 8 week intervals. Outcome measures following induction included disease activity, measured by Pediatric Crohn Disease Activity Index (PCDAI), Physician Global Assessment (PGA), and steroid exposure. Results: Twelve patients with Crohn disease and 1 patient with indeterminate colitis have initiated the induction regimen. The mean age (+SD) was 17.2(+1.9) years. The mean PCDAI at initiation of therapy was 31.0 (+ 14.5). In addition to failing biologic therapy, indications for vedolizumab included steroid dependence (7/13) and new stricturing disease (2/13). Six patients completed at least 14 weeks of therapy. Prior to induction, all 6 patients were on systemic steroids
AGA Abstracts
X : 55624$1AGA 03-28-15 04:55:56 PDFd : 55624B : e
S-72
Page 72
CTE to evaluate CD will undergo a standard exam and a low dose CTE exam in a random sequence on the same day. The standard exam was used to obtain FBP and adaptive statistical IR (ASIR) images and the low dose scans - the Model based IR (MBIR) images. Demographics, historic data and a stool sample for fecal calprotectin were collected from each patient. The Harvey Bradshaw Index (HBI) was used to determine clinical disease activity. De-identified, randomly ordered images were reviewed by 2 experienced radiologists, independently for signs of small bowel CD and an overall assessment of "active" or "inactive" was made. All available clinical data including fecal calprotectin was reviewed by an experienced Gastroenterologist to determine the presence or absence of disease activity which served as the gold standard for comparison with the CT findings. RESULTS: As of Nov. 2014, a total of 124 patients had been enrolled and underwent CTE scanning. 46% of the subjects were male with a mean age of 43.6 (SD15.7 yrs). The mean HBI was 4.5, 48.4% were clinically assessed to have active disease by the gastroenterologist. The Generalized estimating equations (GEE) method was used to compare the validity of the reconstruction algorithms (Table 1). These values all suggest non-inferiority, 95% confidence intervals cross the pre-specified non-inferiority margin of 0.1. Completion of enrolment are expected to produce narrower confidence intervals demonstrating no significant difference between the 3 techniques. Standard dose radiation exposure was 6.7 ± 3.8 mSv and low dose exposure was 2.9 ± 2.4 mSv (p<0.001). More frequently, image noise was rated moderate or higher (28.4 - 84.7%) for MBIR compared to only 2.6 - 4.5% for ASIR and FBP. CONCLUSION: Iterative reconstruction techniques for CTE have similar validity to traditional CTE techniques, at much lower radiation doses, for the identification of active small bowel inflammation in patients with Crohn's disease. Table 1
Abnormal Regional Homogeneity in Patients With Crohn's Disease and Its Relationship With Abdominal Pain Chunhui Bao, Peng Liu, Huirong Liu, Luyi Wu, Yin Shi, Jianye Zhang, Xiaoming Jin, Huangan Wu Background & aims: Increasing evidence indicates abnormal pain processing in the central nervous system in patients with Crohn's disease (CD). The purpose of this study was to understand changes in resting-state brain activity in CD patients in remission and its relationship with abdominal pain. Methods: Twenty-five CD patients with abdominal pain, 24 CD patients without abdominal pain, and 33 healthy control subjects were scanned using a 3.0 T functional magnetic resonance imaging (fMRI) scanner. Regional Homogeneity (ReHo) was used to assess resting-state brain activity among the three groups. Daily pain scores were collected 1 week before fMRI scanning. Results: Patients with abdominal pain exhibited lower ReHo values in the insula, middle cingulate cortex (MCC), supplementary motor area, and higher ReHo value in the temporal pole, whereas patients without abdominal pain exhibited lower ReHo value in the hippocampal/parahippocampal cortex and higher ReHo value in the dorsomedial prefrontal cortex (dmPFC) (all P<0.05). The ReHo values of the insula and MCC were significantly negatively correlated with abdominal pain scores (r=0.53, P=0.008, and r=-0.61, P=0.002, respectively) (Figure 1). Conclusion: We suggest that there exist different changes in resting-state brain activity between CD patients in remission with and without abdominal pain. The negative correlations between pain severity and ReHo values of the insula and MCC in the painful CD patients suggest the involvement of these brain regions in visceral pain processing.
Comparison of the validity of the 3 different reconstruction algorithms
327 A Randomized Comparison of High Definition Colonoscopy Alone With High Definition Dye Spraying and Electronic Virtual Chromoendoscopy Using iSCAN for Detection of Colonic Dysplastic Lesions During IBD Surveillance Colonoscopy Marietta Iacucci, Miriam Fort Gasia, Stefan J. Urbanski, Minoo Parham, Gilaad Kaplan, Remo Panaccione, Subrata Ghosh Background: Dye spraying chromoendoscopy (DSC) is considered the standard of practice for IBD surveillance colonoscopy. However, the resolution of high definition (HD) colonoscopy has increased considerably compared with standard definition colonoscopes and electronic filter techniques now allow detailed inspection of mucosal and vascular patterns. With changing technologies it is important to determine the optimum technique for detection of dysplastic lesions in IBD. Aim: To compare the following three different techniques for performing surveillance colonoscopy to detect colonic dysplastic lesions in IBD patients: HD, DSC (0.2% indigocarmine) and electronic virtual chromoendoscopy i-SCAN (EVC). Patients & Methods: A randomized study (NCT02098798) was conducted to determine the detection rates of neoplasia with HD alone, DSC or EVC in patients with long standing colitis, UC and CD. Consecutive patients with inactive disease were enrolled in 1:1:1 ratio into three arms of the study. Colonoscopy was performed using a Pentax EPKi processor and high-resolution video colonoscope (Pentax Tokyo). Endoscopic colonic lesions were classified by the Kudo pit pattern and Paris classification. Histopathologic assessment of the inflammatory activity was graded as no, mild to moderate, or severe inflammation. Neoplastic changes were classified by the new Vienna classification.The lesions of dysplasia-associated lesion or masses and adenoma-like masses (DALMs/ALMs), sessile serrated adenomas (SSAs), adenoma-like polyps (ALPs), hyperplastic polyps (HPs), and inflammatory polyps (IPs) were identified. The three arms were compared by Chi squared test. Results: 95 patients (46 female, median age 52 years, range 22-77 years) were assessed by HD (n=32, 33.7%), VEC (n=33, 34.7%) or DSC (n=30, 31.6%). Fifteen SSAs were found in 7 patients (15.6%); twenty-seven ALPs were found in 16 patients (28.1%); five DALMs were found in 4 patients (5.2%); thirty-eight HPs were found in 28 patients (39.6%) and eleven IPs were found in 10 patients (11.5%).The distribution of lesions for serrated adenoma (chi sq 7.07; p<0.05) and for tubular adenoma (chi sq 13.06; p<0.01) or comparing overall between dysplastic and non-dysplastic detection rate (chi sq 10.84; p<0.01) favoured HD or VEC but not DSC. HD had a sensitivity of 86.67%, specificity of 89.29%, PPV 89.66% and NPV 86.21% in detecting dysplastic lesions. DSC had a sensitivity of 66.67%, specificity of 88.57%, PPV 50%, NPV 93.94% and EVC had a sensitivity of 100%, specificity of 83.3%, PPV 64.71% and NPV 100%. Conclusion: Our results indicate that DSC, the currently accepted IBD surveillance standard of practice, is not more sensitive than either HD or VEC in detecting dysplastic lesions. In fact, the majority of dysplastic lesions were detected in the HD group. Number of colonic lesions and patients in each surveillance group
Figure.1. The significant differences in ReHo among the pain CD, non-pain CD, and HC groups with age, gender and weight as covariates. ( A) The main effectanalysis revealed significant differences inReHo values of the insula, HIPP/paraHIPP,dmPFC, MCC, SMA and temporal pole among the 3 groups. ( B) The post-hoc analysis showed that theReHo values of the insula, MCC and SMA in the pain CD group were lower and temporal pole was higher than the ReHo values of the othertwo groups. The ReHo values of the HIPP/paraHIPP in the non-pain group werelower and that of the dmPFC was higher than the ReHo values of the othertwo groups. (C) The ReHo values of the insula and MCC in the pain CD group were negatively correlated with the abdominal pain scores.HCs, healthy controls;HIPP/ paraHIPP, hippocampal/parahippocampal cortex;SMA, supplementary motor area; TP, temporal pole; VAS, visual analogue scale;* P<0.05, **P<0.01.
326 Effects of CT Reconstruction Algorithm on the Quantitative Assessment of Crohn's Disease: A Comparison of Standard and Low Dose CT Enterography Greg Rosenfeld, Jacqueline Brown, Patrick M. Vos, Jonathon Leipsic, Robert A. Enns, Brian Bressler BACKGROUND Traditional Computed tomography (CT) imaging relies on filtered back projection (FBP) for image reconstruction. Newer iterative reconstruction (IR) techniques use computer modeling to generate CT images with lower radiation exposure while retaining sufficient quality for accurate interpretation. CT Enterography (CTE) is the preferred imaging modality for assessing small bowel Crohn's Disease (CD). We report here preliminary findings comparing the validity of 2 low dose CTE techniques for evaluating inflammatory changes in patients suspected of having CD. METHODS: A total of 163 patients referred for diagnostic
S-73
X : 55624$1AGA 03-28-15 04:55:56 PDFd : 55624B : o
Page 73
AGA Abstracts
AGA Abstracts
325
children were more likely to receive treatment with anti-TNF atherapy than White children. This difference does not appear to be explained by differences in age, growth, nutrition, perianal disease or standardized disease severity scores, but rather by subjective assessment of disease severity and/or consideration of additional information such as endoscopic appearance that is not accounted for by the sPCDAI. (for the ImproveCareNow Pediatric IBD Learning Health System)
with 4 (67%) successfully tapered by the first maintenance dose. Clinical improvement based on PGA from baseline to 14 weeks was seen in 3 (50%) of the patients. While not statistically significant, PCDAI improved to 20.8 (+7.7) at 14 weeks (p=0.31). There were no infusion reactions. However, new extra-intestinal manifestations of bowel-associated dermatosis-arthritis syndrome occurred in one patient during induction, and a second patient developed a pelvic abscess and osteomyelitis concurrent with the first induction dose. Conclusion: This is the first experience of vedolizumab therapy in pediatric IBD. While this study is limited by the small number of patients, there appears to be modest improvement in disease activity measured by PGA and steroid reduction in the majority of patients. Steroid-free remission was not achieved in this cohort. Further prospective follow-up of a larger cohort treated with vedolizumab at this center is underway to provide additional data regarding efficacy and safety in pediatric IBD.
321 Vedolizumab Use in Pediatric Patients With Inflammatory Bowel Disease Namita Singh, Minesh Patel, Shervin Rabizadeh, Marla Dubinsky Background: Off-label use of vedolizumab in pediatric inflammatory bowel disease (IBD) is limited following its approval for adult patients with Crohn's disease (CD) and Ulcerative colitis (UC). We aimed to describe the experience of vedolizumab in pediatric IBD patients at a tertiary IBD center and to examine predictors of remission. Methods: A prospective database identified pediatric IBD patients (age < 18 years) receiving vedolizumab for either CD or UC. Data on demographics, surgical history, disease behavior, location, disease activity and previous treatments were collected. Disease activity was assessed using the pediatric Crohn's disease activity index (PCDAI) or pediatric UC activity index (PUCAI). Remission was defined as PUCAI £ 10 or PCDAI £ 10. Descriptive statistics and univariate analyses were performed to examine associations of clinical characteristics with therapeutic efficacy. Results: Eighteen pediatric patients, 13 CD and 5 UC, initiated vedolizumab between June 2014 and October 2014. Vedolizumab dose was 6mg/kg/dose, with maximum of 300mg/ dose, and infused at 0, 2, 6 weeks then every 8 weeks. Median age at diagnosis was 11.2 (range 1-16) years, median disease duration was 2.8 (range 0.5-15.2) years, and median age at vedolizumab initiation was 15.8 (range 11.4-17.9). Five (28%) patients had prior bowel surgery. All but one patient (94%) had failed at least one anti-TNF agent, and median time from last anti-TNF agent was 11.1 months (range 0-34.3 months). Three patients (17%), 1 UC and 2 CD, were switched from natalizumab. Seventeen patients have received the 6 week induction dose and 10/18 have received a week 14 dose. Week 6 and week 14 remission rates were 46.6% and 54.5%, respectively. Two of 3 UC patients were in remission at week 6, and all 3 UC patients were in remission at week 14, while only 4/12 (33%) CD patients were in remission at week 6 and 4/9 (44%) in remission at week 14. CD patients with small bowel involvement were less likely to be in remission than those with isolated colonic involvement (p=0.06). The presence of remission at week 6 was associated with remission at week 14 (p<0.05). One patient who was in remission with natalizumab relapsed once switched to vedolizumab. Baseline CRP, immunomodulator use, prior anti-TNF or natalizumab exposure, were not associated with efficacy outcomes. There were no serious infections, hospitalizations or infusion reactions. All patients remain on vedolizumab. Conclusion: In our experience, vedolizumab is safe in pediatric IBD patients, with efficacy similar to that reported in the adult phase 3 trials. The efficacy of vedolizumab was higher in UC patients, and in CD patients with colonic involvement. The phase 3 pediatric trial will provide further insight into the safety and efficacy of Vedolizumab in pediatric IBD patients.
323 Steroids No More! Exclusive Enteral Nutrition Therapy in Pediatric Patients With Crohn's Disease Results in Long-Term Avoidance of Corticosteroid Therapy Anthony R. Otley, Amy Grant, Nicholas Giffin, Mohsin Rashid, Gamal Mahdi, Johan Van Limbergen Intro: Exclusive Enteral nutrition (EEN) has been used as a primary therapy for the treatment of pediatric Crohn's Disease (CD). However, it has yet to be widely endorsed as a primary therapy by North American gastroenterologists despite evidence of its efficacy. Aim: To compare the long-term outcomes of CD patients initially managed with EN versus corticosteroids in a large retrospective cohort. Methods: A single centre, retrospective analysis (1985 to present) of 229 pediatric patients with CD receiving either EEN (n=153) or steroid induction therapy (n=76). EEN was used for a 12 week induction, followed by EN (50% total daily calories) + regular diet as maintenance. Clinical remission was defined as PCDAI £7.5 without height at baseline and at the 4-8 week follow-up, and £10 at the 6-, 12-, 24, and 36-month follow-up visits. A propensity analysis with nearest-neighbour matching, using a 1:2 replacement, and small caliper (.15; allowable standard deviation of estimated propensity score) was carried out. Matched baseline characteristics included gender, age, weight, height, PCDAI and Paris disease locations. Results: The propensity analysis reduced the sample size of each group, EEN (N=69) and corticosteroid (N = 70), yet reduced bias in initial assignment to therapy. EEN and Steroid patients (33% female in each group) were very similar in age (11.9±3.0, 12.0±2.5 years respectively), height (146.6±19.6, 147.4±14.5 cm), weight (36.5±13.7, 37.9±12.3 kg), and disease activity measured by PCDAI (31.1±10.9, 31.8±10.4) at baseline. Initial EEN therapy significantly decreased the risk of exposure to corticosteroids, as 76% and 66% of EEN matched patients remained steroid free over 1 and 3 years, respectively. EEN patients had a quicker induction of remission (4-8 weeks) with 80% of patients achieving clinical remission versus 63% of steroid patients (p < .05). There was a significant growth x group interaction over time, showing that EEN patients height z-score trajectory (-.14 at baseline to .11 at 36 months) was larger than Steroid group patients (p = .02) whose growth remained relatively unchanged from baseline to 36 months (z = -.14 to -.13). Conclusion: EEN therapy showed more positive effects over time via quicker induction of remission, significant changes in linear growth, and avoidance of corticosteroids over a 3-year follow-up period.
324 Quantification of Inflammation in Small Bowel Crohn's Disease Patients by Videocapsule Endoscopy and Magnetic Resonance Enterography Uri Kopylov, Eyal Klang, Shomron Ben-Horin, Doron Yablecovitch, Adi Lahat, Sandra Neuman, Noa Rozendorn, Nina Levhar, Abraham R. Eliakim, Michal Marianne Amitai Background: Video capsule endoscopy (VCE) and magnetic resonance enterograpgy (MRE) are the prime modalities for the evaluation of SBCD.. Mucosal inflammation on VCE can be quantified using the Lewis score (LS) or the Capsule Endoscopy Crohn's Disease Activity Index (CECDAI), incorporating mucosal edema, ulceration and strictures. Magnetic Resonance Index of Activity (MaRIA) is a novel MRE-based score that incorporates wall thickness, relative contrast enhancement, mucosal edema and ulceration in the distal SB and colon The aim of this study was to compare the quantification of distal SB inflammation using VCE and MRE-based diagnostic indices. Methods: Patients with known SBCD in steroid free clinical remission or with mild symptoms (CDAI<220) for at least 3 months were prospectively recruited and underwent MRE, followed by Agile patency capsule. If patency was proven, VCE was performed. LS, CECDAI and MaRIA score were calculated for the distal SB. C-reactive protein (CRP) and fecal calprotectin (FC) levels were obtained and evaluated for their association with the clinical scores. Results: Fifty patients underwent both VCE and MRE. Active disease was demonstrated in the distal SB in 62% of the patients by VCE and 72% by MRE (p=0.4). There was a strong correlation between MaRIA score and both VCE indices (LS-r=0.53, p=0.001; CECDAI- r=0.49, p=0.001), as well as between the CECDAI and LS (r=0.677, p=0.001). LS associated with mucosal healing (<135) correlated with a mean MaRIA score of 13.3 and a mean CECDAI of 4.9 by linear regression. CRP had moderate correlation with MaRIA (r=0.38, p=0.01) but not with VCE scores (LS- r= 0.1 p=0.5 CECDAI-r=0.24, p=0.1). FC was significantly correlated with all scores, however the association was somewhat stronger for the VCE scores (MaRIA- r=0.44 p=0.02; LS - r= 0.54 p=0.001; CECDAI- r=0.49, p=0.001). Summary: Significant correlation between the quantitative MRE and CE-based indices of inflammation in the distal SB was observed. A significant correlation was also demonstrated between LS and CECDAI. FC levels better correlated with VCE then with MRE score, while CRP had a good correlation with the MaRIA score only. The utility of these indices for prediction of future clinical relapse will be prospectively evaluated in future studies. Uri Kopylov and Eyal Klang have equally contributed to the study Marianne M Amitai and Rami Eliakin have equally contributed to the study
Figure 1: Disease activity Scores during Vedolizumab therapy
322 The Use of Vedolizumab for Treatment of Severe Pediatric Inflammatory Bowel Disease Maire A. Conrad, Ronen Stein, Elizabeth C. Maxwell, Lindsey Albenberg, Robert Baldassano, Andrew B. Grossman, Petar Mamula, David Piccoli, Judith R. Kelsen Background: Vedolizumab, a humanized IgG1 monoclonal antibody against a4b7integrin that inhibits T-lymphocyte migration into intestinal tissue, has recently been approved for adults with inflammatory bowel disease (IBD). There are no published data on vedolizumab use in pediatrics, but it may be a therapeutic option in children with disease refractory to current standard therapy. Aims: To evaluate use of vedolizumab in pediatric patients with refractory IBD and determine clinical response measured by disease activity. Secondary aim was to describe adverse effects associated with vedolizumab use in this population. Methods: Children between the ages of 13-19 with severe IBD refractory to biologic therapy and initiating vedolizumab at The Children's Hospital of Philadelphia from June 2014 were included. Indications for initiation of vedolizumab therapy were determined by the primary gastroenterologist and followed prospectively at each visit where clinical activity indices and outcomes were recorded. Dosing was the standard adult regimen of 300 mg at week 0, 2 and 6 followed by maintenance phase at 8 week intervals. Outcome measures following induction included disease activity, measured by Pediatric Crohn Disease Activity Index (PCDAI), Physician Global Assessment (PGA), and steroid exposure. Results: Twelve patients with Crohn disease and 1 patient with indeterminate colitis have initiated the induction regimen. The mean age (+SD) was 17.2(+1.9) years. The mean PCDAI at initiation of therapy was 31.0 (+ 14.5). In addition to failing biologic therapy, indications for vedolizumab included steroid dependence (7/13) and new stricturing disease (2/13). Six patients completed at least 14 weeks of therapy. Prior to induction, all 6 patients were on systemic steroids
AGA Abstracts
X : 55624$1AGA 03-28-15 04:55:56 PDFd : 55624B : e
S-72
Page 72
CTE to evaluate CD will undergo a standard exam and a low dose CTE exam in a random sequence on the same day. The standard exam was used to obtain FBP and adaptive statistical IR (ASIR) images and the low dose scans - the Model based IR (MBIR) images. Demographics, historic data and a stool sample for fecal calprotectin were collected from each patient. The Harvey Bradshaw Index (HBI) was used to determine clinical disease activity. De-identified, randomly ordered images were reviewed by 2 experienced radiologists, independently for signs of small bowel CD and an overall assessment of "active" or "inactive" was made. All available clinical data including fecal calprotectin was reviewed by an experienced Gastroenterologist to determine the presence or absence of disease activity which served as the gold standard for comparison with the CT findings. RESULTS: As of Nov. 2014, a total of 124 patients had been enrolled and underwent CTE scanning. 46% of the subjects were male with a mean age of 43.6 (SD15.7 yrs). The mean HBI was 4.5, 48.4% were clinically assessed to have active disease by the gastroenterologist. The Generalized estimating equations (GEE) method was used to compare the validity of the reconstruction algorithms (Table 1). These values all suggest non-inferiority, 95% confidence intervals cross the pre-specified non-inferiority margin of 0.1. Completion of enrolment are expected to produce narrower confidence intervals demonstrating no significant difference between the 3 techniques. Standard dose radiation exposure was 6.7 ± 3.8 mSv and low dose exposure was 2.9 ± 2.4 mSv (p<0.001). More frequently, image noise was rated moderate or higher (28.4 - 84.7%) for MBIR compared to only 2.6 - 4.5% for ASIR and FBP. CONCLUSION: Iterative reconstruction techniques for CTE have similar validity to traditional CTE techniques, at much lower radiation doses, for the identification of active small bowel inflammation in patients with Crohn's disease. Table 1
Abnormal Regional Homogeneity in Patients With Crohn's Disease and Its Relationship With Abdominal Pain Chunhui Bao, Peng Liu, Huirong Liu, Luyi Wu, Yin Shi, Jianye Zhang, Xiaoming Jin, Huangan Wu Background & aims: Increasing evidence indicates abnormal pain processing in the central nervous system in patients with Crohn's disease (CD). The purpose of this study was to understand changes in resting-state brain activity in CD patients in remission and its relationship with abdominal pain. Methods: Twenty-five CD patients with abdominal pain, 24 CD patients without abdominal pain, and 33 healthy control subjects were scanned using a 3.0 T functional magnetic resonance imaging (fMRI) scanner. Regional Homogeneity (ReHo) was used to assess resting-state brain activity among the three groups. Daily pain scores were collected 1 week before fMRI scanning. Results: Patients with abdominal pain exhibited lower ReHo values in the insula, middle cingulate cortex (MCC), supplementary motor area, and higher ReHo value in the temporal pole, whereas patients without abdominal pain exhibited lower ReHo value in the hippocampal/parahippocampal cortex and higher ReHo value in the dorsomedial prefrontal cortex (dmPFC) (all P<0.05). The ReHo values of the insula and MCC were significantly negatively correlated with abdominal pain scores (r=0.53, P=0.008, and r=-0.61, P=0.002, respectively) (Figure 1). Conclusion: We suggest that there exist different changes in resting-state brain activity between CD patients in remission with and without abdominal pain. The negative correlations between pain severity and ReHo values of the insula and MCC in the painful CD patients suggest the involvement of these brain regions in visceral pain processing.
Comparison of the validity of the 3 different reconstruction algorithms
327 A Randomized Comparison of High Definition Colonoscopy Alone With High Definition Dye Spraying and Electronic Virtual Chromoendoscopy Using iSCAN for Detection of Colonic Dysplastic Lesions During IBD Surveillance Colonoscopy Marietta Iacucci, Miriam Fort Gasia, Stefan J. Urbanski, Minoo Parham, Gilaad Kaplan, Remo Panaccione, Subrata Ghosh Background: Dye spraying chromoendoscopy (DSC) is considered the standard of practice for IBD surveillance colonoscopy. However, the resolution of high definition (HD) colonoscopy has increased considerably compared with standard definition colonoscopes and electronic filter techniques now allow detailed inspection of mucosal and vascular patterns. With changing technologies it is important to determine the optimum technique for detection of dysplastic lesions in IBD. Aim: To compare the following three different techniques for performing surveillance colonoscopy to detect colonic dysplastic lesions in IBD patients: HD, DSC (0.2% indigocarmine) and electronic virtual chromoendoscopy i-SCAN (EVC). Patients & Methods: A randomized study (NCT02098798) was conducted to determine the detection rates of neoplasia with HD alone, DSC or EVC in patients with long standing colitis, UC and CD. Consecutive patients with inactive disease were enrolled in 1:1:1 ratio into three arms of the study. Colonoscopy was performed using a Pentax EPKi processor and high-resolution video colonoscope (Pentax Tokyo). Endoscopic colonic lesions were classified by the Kudo pit pattern and Paris classification. Histopathologic assessment of the inflammatory activity was graded as no, mild to moderate, or severe inflammation. Neoplastic changes were classified by the new Vienna classification.The lesions of dysplasia-associated lesion or masses and adenoma-like masses (DALMs/ALMs), sessile serrated adenomas (SSAs), adenoma-like polyps (ALPs), hyperplastic polyps (HPs), and inflammatory polyps (IPs) were identified. The three arms were compared by Chi squared test. Results: 95 patients (46 female, median age 52 years, range 22-77 years) were assessed by HD (n=32, 33.7%), VEC (n=33, 34.7%) or DSC (n=30, 31.6%). Fifteen SSAs were found in 7 patients (15.6%); twenty-seven ALPs were found in 16 patients (28.1%); five DALMs were found in 4 patients (5.2%); thirty-eight HPs were found in 28 patients (39.6%) and eleven IPs were found in 10 patients (11.5%).The distribution of lesions for serrated adenoma (chi sq 7.07; p<0.05) and for tubular adenoma (chi sq 13.06; p<0.01) or comparing overall between dysplastic and non-dysplastic detection rate (chi sq 10.84; p<0.01) favoured HD or VEC but not DSC. HD had a sensitivity of 86.67%, specificity of 89.29%, PPV 89.66% and NPV 86.21% in detecting dysplastic lesions. DSC had a sensitivity of 66.67%, specificity of 88.57%, PPV 50%, NPV 93.94% and EVC had a sensitivity of 100%, specificity of 83.3%, PPV 64.71% and NPV 100%. Conclusion: Our results indicate that DSC, the currently accepted IBD surveillance standard of practice, is not more sensitive than either HD or VEC in detecting dysplastic lesions. In fact, the majority of dysplastic lesions were detected in the HD group. Number of colonic lesions and patients in each surveillance group
Figure.1. The significant differences in ReHo among the pain CD, non-pain CD, and HC groups with age, gender and weight as covariates. ( A) The main effectanalysis revealed significant differences inReHo values of the insula, HIPP/paraHIPP,dmPFC, MCC, SMA and temporal pole among the 3 groups. ( B) The post-hoc analysis showed that theReHo values of the insula, MCC and SMA in the pain CD group were lower and temporal pole was higher than the ReHo values of the othertwo groups. The ReHo values of the HIPP/paraHIPP in the non-pain group werelower and that of the dmPFC was higher than the ReHo values of the othertwo groups. (C) The ReHo values of the insula and MCC in the pain CD group were negatively correlated with the abdominal pain scores.HCs, healthy controls;HIPP/ paraHIPP, hippocampal/parahippocampal cortex;SMA, supplementary motor area; TP, temporal pole; VAS, visual analogue scale;* P<0.05, **P<0.01.
326 Effects of CT Reconstruction Algorithm on the Quantitative Assessment of Crohn's Disease: A Comparison of Standard and Low Dose CT Enterography Greg Rosenfeld, Jacqueline Brown, Patrick M. Vos, Jonathon Leipsic, Robert A. Enns, Brian Bressler BACKGROUND Traditional Computed tomography (CT) imaging relies on filtered back projection (FBP) for image reconstruction. Newer iterative reconstruction (IR) techniques use computer modeling to generate CT images with lower radiation exposure while retaining sufficient quality for accurate interpretation. CT Enterography (CTE) is the preferred imaging modality for assessing small bowel Crohn's Disease (CD). We report here preliminary findings comparing the validity of 2 low dose CTE techniques for evaluating inflammatory changes in patients suspected of having CD. METHODS: A total of 163 patients referred for diagnostic
S-73
X : 55624$1AGA 03-28-15 04:55:56 PDFd : 55624B : o
Page 73
AGA Abstracts
AGA Abstracts
325