Inflammatory Bowel Disease Registry Research Articles

Iranian Registry of Crohn's and Colitis: study profile of first nation-wide inflammatory bowel disease registry in Middle East.

Background/AimsA recent study revealed increasing incidence and prevalence of inflammatory bowel disease (IBD) in Iran. The Iranian Registry of Crohn’s and Colitis (IRCC) was designed recently to answer the needs. We reported the design, methods of data collection, and aims of IRCC in this paper.MethodsIRCC is a multicenter prospective registry, which is established with collaboration of more than 100 gastroenterologists from different provinces of Iran. Minimum data set for IRCC was defined according to an international consensus on standard set of outcomes for IBD. A pilot feasibility study was performed on 553 IBD patients with a web-based questionnaire. The reliability of questionnaire evaluated by Cronbach’s α.ResultsAll sections of questionnaire had Cronbach’s α of more than 0.6. In pilot study, 312 of participants (56.4%) were male and mean age was 38 years (standard deviation=12.8) and 378 patients (68.35%) had ulcerative colitis, 303 subjects (54,7%) had college education and 358 patients (64.74%) were of Fars ethnicity. We found that 68 (12.3%), 44 (7.9%), and 13 (2.3%) of participants were smokers, hookah and opium users, respectively. History of appendectomy was reported in 58 of patients (10.48%). The most common medication was 5-aminosalicylate (94.39%).ConclusionsTo the best of our knowledge, IRCC is the first national IBD registry in the Middle East and could become a reliable infrastructure for national and international research on IBD. IRCC will improve the quality of care of IBD patients and provide national information for policy makers to better plan for controlling IBD in Iran.

An integrated approach to e-health, data collection and patient-reported outcomes in inflammatory bowel disease

Medical management of inflammatory bowel disease (IBD) is expensive and has a considerable side-effect profile. Nurse-led care must follow quality standards and relies on patient input and consistent monitoring. There are a variety of novel e-health solutions to assist with this. Data collection and audit participation can be streamlined with the implementation of a patient-management system linked with the IBD Registry national data-collection initiative. However, this can carry a burden of input for clinicians. Patient-reported outcome measures (PROMs) allow for patient self-efficacy and remote review, potentially increasing outpatient capacity and adding value to IBD services. PROMs need to be validated and easy to use, such as IBD-Control. An ecosystem approach is effective in a fractured e-health landscape, and PROMS should be integrated with accessible patient portals. It is hoped that these developments will increase monitoring opportunities and outpatient capacity, as well as help nurses manage the increasingly complex care prescribed for IBD patients.

P082 PREOPERATIVE ANTI-TNFS ARE ASSOCIATED WITH A SHORTER INTERVAL TO DE NOVO CROHN’S DISEASE AFTER ILEAL POUCH-ANAL ANASTOMOSIS FOR ULCERATIVE COLITIS

Anti-tumor necrosis factor (anti-TNF) agents are widely used in the treatment of moderate to severe ulcerative colitis (UC) since commercial approval in 1998. Many patients however ultimately require surgery with ileal pouch-anal anastomosis (IPAA). Conversion of UC to Crohn’s disease (CD) following IPAA is a devastating complication termed de novo Crohn’s disease (DNCD). Despite increasing adoption, few prior studies have evaluated the effect of preoperative anti-TNFs on DNCD development. As we have noticed an increasing incidence of DNCD, we hypothesized that preoperative utilization of anti-TNFs may be associated with the development of DNCD after IPAA. A prospective inflammatory bowel disease (IBD) registry was queried for consecutive UC patients undergoing IPAA during the 25-year period ending 2018. Patients with preoperative CD or IBD unclassified were excluded. De novo CD after IPAA was diagnosed when 5 or more ulcers involving the small-bowel proximal to the ileal pouch or a pouch fistula or other perianal complication developed >3 months after ileostomy closure. Preoperative anti-TNF therapy and development of DNCD was compared between 3 chronologic periods throughout the study: period 1: 1993-1998 (pre-approval of anti-TNFs for UC), period 2: 1999-2008, and period 3: 2009-2018. Cox proportional-hazards model was used to identify predictors of DNCD development. The study cohort consisted of 400 patients (38.5 ± 16 years; males n=205, 51%; Table 1). Sixty-two patients (16%), 31 (50%) of whom were male, developed DNCD after IPAA during a mean follow-up period of 98 ± 67 months. The incidence of DNCD was similar between periods (n=8 [15%] during period 1; n=37 [20%] during period 2; n=17 [11%] during period 3; p=0.07). Usage of anti-TNFs increased during each successive period (n=0 [0%] during period 1, n=40 [22%] during period 2, n=125 [79%] during period 3; p<0.001) while time to DNCD decreased (mean time 87 ± 104 months during period 1; 53 ± 52 months during period 2; 18 ± 22 months during period 3; p=0.01). Incidence of DNCD was similar in anti-TNF treated (45%) compared to anti-TNF naïve patients (41%; p=0.58) but the time to de novo CD was significantly shorter in anti-TNF treated (27 ± 39 months) versus anti-TNF naïve patients (64 ± 66 months; p=0.008). Cox proportional hazards model identified preoperative anti-TNF therapy as an independent risk factor for development of DNCD after IPAA (HR 2.82; 95% CI 1.65 – 4.83; p<0.001). A Kaplan-Meier survival curve illustrates the significant difference in CD-free survival between anti-TNF treated compared to anti-TNF naïve patients (Figure 1; Log rank p=0.007). Preoperative utilization of anti-TNFs may play a significant role in the earlier development of DCND following IPAA. Figure 2. De novo Crohn’s Disease-Free Survival Based on Treatment with Anti-TNF

P082 PREOPERATIVE ANTI-TNFS ARE ASSOCIATED WITH A SHORTER INTERVAL TO DE NOVO CROHN’S DISEASE AFTER ILEAL POUCH-ANAL ANASTOMOSIS FOR ULCERATIVE COLITIS

Anti-tumor necrosis factor (anti-TNF) agents are widely used in the treatment of moderate to severe ulcerative colitis (UC) since commercial approval in 1998. Many patients however ultimately require surgery with ileal pouch-anal anastomosis (IPAA). Conversion of UC to Crohn’s disease (CD) following IPAA is a devastating complication termed de novo Crohn’s disease (DNCD). Despite increasing adoption, few prior studies have evaluated the effect of preoperative anti-TNFs on DNCD development. As we have noticed an increasing incidence of DNCD, we hypothesized that preoperative utilization of anti-TNFs may be associated with the development of DNCD after IPAA. A prospective inflammatory bowel disease (IBD) registry was queried for consecutive UC patients undergoing IPAA during the 25-year period ending 2018. Patients with preoperative CD or IBD unclassified were excluded. De novo CD after IPAA was diagnosed when 5 or more ulcers involving the small-bowel proximal to the ileal pouch or a pouch fistula or other perianal complication developed >3 months after ileostomy closure. Preoperative anti-TNF therapy and development of DNCD was compared between 3 chronologic periods throughout the study: period 1: 1993-1998 (pre-approval of anti-TNFs for UC), period 2: 1999-2008, and period 3: 2009-2018. Cox proportional-hazards model was used to identify predictors of DNCD development. The study cohort consisted of 400 patients (38.5 ± 16 years; males n=205, 51%; Table 1). Sixty-two patients (16%), 31 (50%) of whom were male, developed DNCD after IPAA during a mean follow-up period of 98 ± 67 months. The incidence of DNCD was similar between periods (n=8 [15%] during period 1; n=37 [20%] during period 2; n=17 [11%] during period 3; p=0.07). Usage of anti-TNFs increased during each successive period (n=0 [0%] during period 1, n=40 [22%] during period 2, n=125 [79%] during period 3; p<0.001) while time to DNCD decreased (mean time 87 ± 104 months during period 1; 53 ± 52 months during period 2; 18 ± 22 months during period 3; p=0.01). Incidence of DNCD was similar in anti-TNF treated (45%) compared to anti-TNF naïve patients (41%; p=0.58) but the time to de novo CD was significantly shorter in anti-TNF treated (27 ± 39 months) versus anti-TNF naïve patients (64 ± 66 months; p=0.008). Cox proportional hazards model identified preoperative anti-TNF therapy as an independent risk factor for development of DNCD after IPAA (HR 2.82; 95% CI 1.65 – 4.83; p<0.001). A Kaplan-Meier survival curve illustrates the significant difference in CD-free survival between anti-TNF treated compared to anti-TNF naïve patients (Figure 1; Log rank p=0.007). Preoperative utilization of anti-TNFs may play a significant role in the earlier development of DCND following IPAA.Figure 2De novo Crohn’s Disease-Free Survival Based on Treatment with Anti-TNF.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Inflammatory Bowel Disease Registry and Monitoring: Feasibility Study and Application (Isfahan Inflammatory Bowel Disease Surveillance Project).

Background:Inflammatory bowel disease (IBD) incidence has been increased in Iran as a developing country. Surveillance is a standard method for accessing valid data about disease epidemiology to make relevant decisions for disease control, prevention, and management. We designed Isfahan IBD Surveillance Project (IISP) to make a surveillance system in this area.Methods:The project is designed in 3 phases. At the first phase, a model of step-wise approach (core, expanded core, and optional variables) for IBD surveillance was designed and implemented among IBD patients registered at a major referral gastrointestinal diseases clinic in Isfahan. Data bank program and its software were designed with suitable and multifunctional features. A total of 352 IBD cases were registered to data bank and analyzed as a pilot study of IISP.Results:A total of 352 IBD patients, including 245 ulcerative colitis (UC), 80 Crohn's disease (CD), and 27 indeterminate colitis, were registered to the data bank. Bloody stool and abdominal cramp were the most common presentation symptom among UC and CD, respectively. Extensive pancolitis was the most prevalent phenotype (40%) of UC. Over two-thirds of our IBD patients were in remission states. Biologic agents had been prescribed in about 10% of patients during disease. Primary sclerosing cholangitis was detected in about 7% and 10% of CD and UC patients, respectively.Conclusions:Valid data from a standard surveillance system are a relevant, trustworthy tool for making decision by health policy-makers. Integrated comprehensive interventional programs for disease control and management is the second phase of IISP.

Small Bowel Cancer Complicating Inflammatory Bowel Disease: A Tertiary Referral Center Experience

Introduction: The incidence of small bowel cancer is rising in the U.S. While the association between inflammatory bowel disease (IBD) and colorectal cancer has been demonstrated, recent studies have suggested that IBD, specifically Crohn's disease (CD), may be associated with an increased risk of small bowel cancer (SBC). This association carries an especially poor prognosis, possibly explained by delayed diagnosis prior to the development of devastating complications. Data on the relationship between CD and small bowel cancer is limited. Methods: We performed an 8-year longitudinal analysis (2009-2016) of demographic, clinical, laboratory, and treatment data from an IBD registry at the University of Pittsburgh Medical Center to investigate the period prevalence of SBC in this referral population. Patients were identified using computer searches of comprehensive pathology and treatment data, with manual confirmation. Results: A total of 2,259 IBD patients were included (mean age 46, 52.5% women) of whom 848 had ulcerative colitis (UC) and 1,411 had CD. There were no cases of SBC in patients with UC. There were 8 cases (0.57%) of SBC in patients with CD. Five of these patients had adenocarcinoma, 2 had carcinoid tumors, and 1 had lymphoma. Of the 5 patients with small bowel adenocarcinoma, the mean age was 63.8, 3 (60%) were women, 3 (60%) had a history of smoking, and all were Caucasian. The average duration of CD to time of diagnosis of adenocarcinoma was 30 years. While 4 patients (80%) had exposure to immunosuppressive therapy, only 1 patient (20%) had exposure to anti-TNF biologic therapy. Two of the 5 patients (40%) with adenocarcinoma died from this complication during the observation period. Conclusion: Small bowel adenocarcinoma is a rare, albeit significant, complication of CD. Development of adenocarcinoma may be associated with longstanding disease and low rates of anti-TNF biologic use. In CD patients with longstanding disease and limited therapy, clinical suspicion for this complication is warranted. Future studies incorporating multiple clinical sites are necessary to better define the incidence and clinical characteristics of SBC in this population and to investigate the feasibility of screening patients with higher susceptibilities.670_A Figure 1. Small bowel adenocarcinoma detected on esophagogastroduodenoscopy (EGD)670_B Figure 2. Small bowel carcinoid detected on colonoscopy

Biological therapy and surgery rates in inflammatory bowel diseases - Data analysis of almost 1000 patients from a Hungarian tertiary IBD center.

Inflammatory bowel diseases (IBD) [Crohn’s disease (CD) and ulcerative colitis (UC)], are chronic relapsing disorders of unknown etiology. The aim of this study was to determine demographic features, disease phenotypes, medical and surgical therapies in our IBD patients and to identify which parameters are in association with the need of surgery and/or biologic therapy. Data on demographic and clinical characteristics of the patients were analyzed from the IBD registry of the 1st Department of Medicine, University of Szeged. The study period was between January 2007 and March 2015. Data of 911 IBD patients (428 CD, 483 UC) were analyzed. The median lag time between onset of symptoms and diagnosis proved to be significantly longer in UC than in CD (4.6 years vs. 2.1 years, p = 0.01). 40% of the patients received biological therapy, 301 patients underwent surgery required more frequently for CD than UC. Surgery was more common in CD patients with ileal location and penetrating behaviour. In UC, more severe disease onset predicted to unfavourable disease course. Higher proportion of surgery was shown in patient aged above 40 years in both CD and UC. Diagnostic delay of more than 1 year and appendectomy predicted to unfavourable disease outcome of both CD and UC. This analysis revealed that more than 1 year of diagnostic delay, disease activity at diagnosis in UC, CD, ileal location and penetrating behaviour are factors that may influence disease outcome. Use of thiopurines seemed to be protective in UC.

Anxiety, depression, and inflammation after restorative proctocolectomy.

Anxiety and depression (A&D) are more common in inflammatory bowel disease (IBD) and in IBD patients who undergo proctocolectomy with ileal pouch-anal anastomosis (IPAA). Our aim was to test the hypothesis that chronic inflammatory conditions in IPAA are associated with increased incidence of A&D. Retrospective cohort study at a single tertiary care referral center using a consented IBD and colon cancer natural history registry. Demographic and clinical factors, including surgical and psychiatric history, were abstracted. We compared A&D rate in three cohorts: (1) ulcerative proctocolitis with IPAA (UC) (n = 353), (2) Crohn's disease/indeterminate proctocolitis with IPAA (CDIC) (n = 49), and (3) familial adenomatous polyposis with IPAA (FAP) (n = 33). Forty-six CDIC patients (93.9%) demonstrated pouch-related inflammation, while 126 UC patients (35.7%) and 2 FAP patients (6.1%) developed pouchitis. CDIC had a higher rate of A&D co-diagnosis compared to UC and FAP (20.4 vs.12.7 vs.12.1% respectively; p< 0.05). UC patients with pouchitis also exhibited a higher rate of A&D than UC without pouchitis (19.8 vs.8.8%; p< 0.05). Multivariable analysis demonstrated that pre-operative corticosteroid use (OR = 4.46, CI = 1.34-14.87, p < 0.05), female gender (OR = 2.19, CI = 1.22-3.95, p < 0.01), tobacco use (OR = 2.92, CI = 1.57 = 5.41, p < 0.001), and pouch inflammation (OR = 2.37, CI = 1.28-4.39, p < 0.05) were each independently associated with A&D in these patients. Anxiety and depression were more common in patients experiencing inflammatory conditions of the pouch. UC without pouchitis and FAP patients demonstrated lower rates of A&D (that were comparable to the general population), implying that having an IPAA alone was not enough to increase risk for A&D. Factors independently associated with A&D in IPAA included an inflamed pouch, corticosteroid use, smoking, and female gender.

Predictors and Management of Loss of Response to Vedolizumab in Inflammatory Bowel Disease.

We quantified loss of response (LOR) to vedolizumab (VDZ) in clinical practice and assessed the effectiveness of VDZ dose intensification for managing LOR. Retrospective review (May 2014-December 2016) of a prospectively maintained inflammatory bowel disease (IBD) registry. Kaplan-Meier estimates were used to determine rates of LOR to VDZ . Independent predictors of LOR were identified using univariate and multivariable Cox proportional hazard regression. Success of recapturing response (>50% reduction in symptoms from baseline) and remission (complete resolution of symptoms) after dose intensification was quantified. Cumulative rates for VDZ LOR were 20% at 6 months and 35% at 12 months, with slightly lower rates in Crohn's disease than in ulcerative colitis (6 months 15% vs 18% and 12 months 30% vs 39%, P = 0.03). On multivariable analysis, LOR to a tumor necrosis factor (TNF) antagonist before VDZ use was associated with an increased risk for LOR to VDZ [hazard ratio (HR) 1.93; 95% confidence interval (CI) 1.25-2.97] in all patients. For Crohn's disease patients specifically, higher baseline C-reactive protein concentration was associated with increased risk for LOR to VDZ (HR 1.01 per mg/dL increase, 95% CI 1.01-1.02). Shortening of VDZ infusion interval from 8 to every 4 or 6 weeks recaptured response in 49% and remission in 18% of patients. LOR to a TNF antagonist before VDZ use and higher baseline C-reactive protein are important predictors of VDZ LOR. Treatment response can be recaptured in almost half of these patients with VDZ infusion interval shortening.

Risk factors for diagnostic delay in Crohn's disease and their impact on long-term complications: how do they differ in a tuberculosis endemic region?

The diagnosis of Crohn's disease (CD) can be delayed in clinical practice. In tuberculosis endemic areas, empirical anti-tubercular therapy further delays treatment. To assess risk factors for diagnostic delay and its impact on the long-term complications of Crohn's disease in India where tuberculosis is endemic. Data from a large prospectively established inflammatory bowel disease registry were analysed retrospectively. The time from onset of symptoms to diagnosis (diagnostic delay) was calculated and categorised into two groups based on median diagnostic delay. The risk factors for delay including anti-tubercular therapy were analysed. Logistic regression analysis was done to assess impact of diagnostic delay on development of stenotic and fistular complications including need for surgery. Seven hundred and twenty Crohn's disease patients (60.3% male, median: 28years) were included. Main outcome measures were stenosis, fistula and need for surgery. Subjects with diagnostic delay >18months (median) developed significantly higher stenotic complications and surgery (OR 4.12; 95% CI: 2.74-6.33, P<0.001 and OR 2.41, 95% CI: 1.68-3.42, P<0.001), respectively, compared to those ≤18months. There was no difference in the development of fistulous complications. 193/720 (27%) received anti-tubercular therapy which significantly contributed to diagnostic delay (OR: 2.47; 95% CI: 1.76-3.47, P<0.001) with 47% showing initial clinical response (Crohn's disease activity index- CDAI decrease >100). Moreover, the incidence of stenotic complications was significantly higher in patients who had received prior anti-tubercular therapy (55/193 (28.49%) vs 78/527 (14.8%), P<0.001, OR: 2.60, 95% CI: 1.64-4.12). Diagnostic delay in Crohn's disease is associated with significantly higher stenotic complications and need for surgery. Empirical anti-tubercular therapy is the single largest contributor to diagnostic delay in tuberculosis endemic areas. Despite initial clinical response to anti-tubercular therapy, long-term stenotic complications are higher.

Inflammatory bowel disease registries for collection of patient iron parameters in Europe.

Iron deficiency without anemia and iron deficiency anemia are common and frequently overlooked complications of inflammatory bowel disease. Despite the frequency and impact of iron deficiency in inflammatory bowel disease, there are gaps in our understanding about its incidence, prevalence and natural history and, consequently, patients may be undertreated. Medical registries have a key role in collecting data on the disease’s natural history, the safety and effectiveness of drugs in routine clinical practice, and the quality of care delivered by healthcare services. Even though iron deficiency impacts inflammatory bowel disease patients and healthcare systems substantially, none of the established European inflammatory bowel disease registries systematically collects information on iron parameters and related outcomes. Collection of robust iron parameter data from patient registries is one way to heighten awareness about the importance of iron deficiency in this disease and to generate data to improve the quality of patient care, patient outcomes, and thus quality of life. This objective could be achieved through collection of specific laboratory, clinical, and patient-reported measurements that could be incorporated into existing registries. This review describes the status of current European inflammatory bowel disease registries and the data they generate, in order to highlight their potential role in collecting iron data, to discuss how such information gathering could contribute to our understanding of iron deficiency anemia, and to provide practical information in regard to the incorporation of accumulated iron parameter data into registries.

Clinical characteristics and long-term prognosis of elderly-onset Crohn’s disease

Objectives: This study aimed to evaluate the clinical characteristics and clinical course of Asian elderly-onset Crohn’s disease (EOCD) patients in a large well-defined cohort of South Korean IBD patients.Materials and methods: From the Asan inflammatory bowel disease registry, we identified 29 EOCD patients (diagnosed with CD in age of 60 years or over) out of 2989 CD patients (1.0%). After excluding two patients with unclear data, 27 EOCD were matched with 108 young-onset CD (YOCD) and 108 middle age-onset CD (MOCD) for the interval from symptom onset to diagnosis (±3 years) and follow-up duration (±3 years).Results: Females were predominant in the EOCD group (59.3%) compared to MOCD (31.5%) and YOCD (29.6%) groups (p = .012). In EOCD group, terminal ileal location was the most common (63.0%) at diagnosis, whereas ileocolonic location in other groups (57.4% in MOCD and 78.7% in YOCD, respectively) (p < .001). Patients with perianal fistula at CD diagnosis were less common (14.8% in EOCD vs. 28.7% in MOCD vs. 49.1% in YOCD, p < .001). During follow-up, thiopurines were used less frequently in the EOCD group (48.1% in EOCD vs. 87.0% in MOCD vs. 89.8% in YOCD, p < .001), but the risk for intestinal resection was comparable among three groups (p = .583).Conclusions: EOCD may have a better clinical course than MOCD and YOCD, as demonstrated by the similar risk for intestinal resection despite the less frequent use of thiopurines.

P451 Long-term surgical outcome of ileal pouch-anal anastomosis when used for well-defined Crohn’s disease

Crohn’s disease (CD) is considered a contraindication to ileal pouch-anal anastomosis (IPAA). A preliminary study from our group in 17 patients showed the intentional use of IPAA in CD compared with ulcerative colitis patients was associated with a higher incidence of postoperative recurrent disease but no significant difference in pouch failure (Le Q et al., Inflamm Bowel Dis 2013;19:30–6). Using a larger sample size, this study sought to extend these findings in a larger patient cohort followed over a longer postoperative time. A prospective inflammatory bowel disease registry was queried for patients with pre-operative CD undergoing IPAA. Patients were considered to have CD before surgery based on a history of perianal disease, small-bowel disease, perianal disease, pre-treatment skip lesions or non-crypt associated granuloma. Patients were prospectively assessed for pouchitis or CD. Pouchitis (acute and chronic), postoperative CD (pouch inflammation into the afferent limb or pouch fistula) or pouch failure (need for permanent diversion) were assessed. Forty patients with pre-operative CD were identified. CD was diagnosed based on perianal disease (n = 13; 32%), small-bowel disease (n = 10; 25%), pre-treatment skip lesions (n = 10; 25%) and noncaseating granuloma (n = 7; 18%). Indications for surgery were medically unresponsive disease (n = 37;93%) or cancer/dysplasia (n = 3; 8%). After a median follow-up time of 61 (range 2–196) months, pouchitis developed in 11 (28%) patients (acute pouchitis (n = 9), chronic pouchitis (n = 2)). Seventeen (43%) patients developed postoperative recurrent CD in the afferent limb (n = 9), pouch fistulising disease (n = 4) or perianal disease (n = 4). Only one patient (3%) required faecal diversion. The incidence of recurrent CD over time is shown in the figure. This largest-ever report examining the intentional use of IPAA in well-defined CD has shown a high (43%) incidence of postoperative disease. However, there is a low (3%) incidence of ultimate pouch failure. Highly motivated patients with colorectal CD involving the more proximal and/or distal gastrointestinal tract may wish to undergo IPAA and avoid a definitive end ileostomy. Incidence of recurrent Crohns disease after IPAA.

Epidemiology and care structures for children and adolescents and young adults up to the 26th year of life with inflammatory bowel diseases (IBD) in Leipzig/Saxony/Germany

Valid data on the incidence of inflammatory bowel disease (IBD) in children and adolescents in Germany have not yet been published. Unpublished data of the Pediatric IBD Registry of Saxony (primary data source) have shown a decrease in age-specific incidence rates after the 14th year of age; therefore, a second data source was collected from adult gastroenterologists in Leipzig. All patients up to 25 years of age with a newly diagnosed IBD from adult gastroenterologists in Leipzig between 2005 and 2009 were included in the second data source: a total of 150 young patients with only two patients before age of 16 and 11 patients before age of 18 years. Using a second data source, the incidence of IBD in children and adolescents up to the completion of the 18th year, as determined by IBD Registry, was corrected from 6.6/100,000 (95%-CI 5.4–8.4) to an actual incidence of 11.0/100,000 (95%-CI 9.1–12.9). Age-specific incidence of IBD was also corrected, increasing continuously until the 18th year was completed. Nearly all patients up to 15 years (completeness 87.5%) were recorded by pediatricians to the IBD Registry. The actual incidence up to the age of 18 years for IBD in Leipzig is one of the highest worldwide. To obtain valid epidemiologic data up to the age of 18, the inclusion of adult gastroenterologists are necessary.

Direct health-care cost utilization in Hong Kong inflammatory bowel disease patients in the initial 2years following diagnosis.

There are scanty data on the health-care utilization from Asia where the incidence of inflammatory bowel disease (IBD) is rising rapidly. We aim to determine the direct health-care costs in the first 2years of diagnosis in an IBD cohort from Hong Kong and the factors associated with high cost outliers. This is a retrospective cohort study that included patients newly diagnosed with IBD in a territory-wide IBD registry. Patients' clinical information, hospitalization records, investigations, and IBD treatments were retrieved for up to 2years following diagnosis of IBD. Four hundred and thirty-five newly diagnosed IBD patients were included: 198 with Crohn's disease and 237 with ulcerative colitis. Total direct medical expenditure for this cohort 2years after the IBD diagnosis was $7072710: hospitalizations (33%), 5-aminosalicylic acid (23%), imaging and endoscopy (17%), outpatient visits (10%), surgery (8%), and biologics (6%). Mean direct medical costs per patient-year were significantly higher for Crohn's disease ($9918) than ulcerative colitis ($6634; P, 0.001). The total direct health-care cost decreased significantly after transition to the second year (P<0.01). High cost (>90th percentile) outliers were associated with surgery (OR 7.1, 95% CI 2.9-17.2) and low hemoglobin on presentation (OR 0.83, 95% CI 0.70-0.96). Hospitalization and 5-aminosalicylic acid usage accounted for 56% of total direct medical costs in the first 2years of our newly diagnosed IBD patients. Direct health-care costs were higher in the first year compared with the second year of diagnosis. Surgery and low hemoglobin on presentation were associated with high cost outliers.

Implementing IBD Registry audit tools in a nurse-led inflammatory bowel disease service at a district general hospital

Inflammatory bowel disease (IBD) is a chronic condition with no known cure. Continual auditing of patients is an important part of developing and refining therapies, including biologics, for inducing and maintaining remission. Between 2006 and 2016, the IBD National Audit gathered data that showed how services should improve standards to meet patient needs. This was followed by the IBD Registry, a multi-agency initiative to enable local teams to electronically record clinical data at the point of care to benefit patients, clinicians, commissioners and managers. The service integrates with existing hospital systems and uses a patient management system (PMS), a web tool for real-time data collection and a data visualisation tool for biologics. As of 2017, there were 99 participating sites, with data from 31 614 patients. A district general hospital successfully implemented the registry auditing tools, despite initial administrative challenges; the IBD team have used the data to demonstrate the value of the specialist nursing service, expanding it by recruiting another 0.6 whole-time equivalent nurse. The PMS offered more robust tools for monitoring complex, high-cost treatments, such as biologics.

Cancer Risk in 2621 Chinese Patients with Inflammatory Bowel Disease: A Population-based Cohort Study.

Studies on cancer risk in inflammatory bowel disease (IBD) have yielded inconsistent results. We conducted a population-based study to determine the risk of cancer in patients with Crohn's disease (CD) and ulcerative colitis (UC). Using a territory-wide IBD registry in Hong Kong, we identified 2621 patients with IBD and no history of cancer from 1990 to 2016. We followed them from diagnosis until either September 2016, cancer development, proctocolectomy, or death. Standardized incidence ratios (SIRs) of overall cancer and site-specific cancers were calculated. Of 2621 patients with IBD (1108 CD; 1603 UC; median age, 49 yr; 59.5% men) followed for 26,234 person-years, 88 patients developed cancer after IBD diagnosis. Patients with CD had an increased risk of anorectal cancers (SIR 4.11; 95% confidence interval (CI), 1.84-9.14) and hematological cancers (SIR 3.86, 95% CI, 1.61-9.27) including leukemia (SIR 5.98; 95% CI, 1.93-18.54). Nonmelanoma skin cancer was significantly increased in both CD and UC (CD: SIR 13.88; 95% CI, 1.95-98.51; UC: SIR 9.05; 95% CI, 2.26-36.19). Patients with CD had a higher risk of renal-cell carcinoma (SIR 6.89; 95% CI, 2.22-21.37), and patients with UC had a higher risk of prostate cancer (SIR 2.47; 95% CI, 1.24-4.95). In a population-based study, Chinese patients with CD are at an increased risk of anorectal cancers and hematological cancers compared with the general population. A higher risk of nonmelanoma skin cancer was also observed in CD and UC. Cancer surveillance should be considered.

Use of Biologic Therapy by Pregnant Women With Inflammatory Bowel Disease Does Not Affect Infant Response to Vaccines

In women with inflammatory bowel diseases (IBDs), exposure to immunomodulator or biologic therapy has not been associated with adverse events during pregnancy or outcomes of newborns. We investigated whether exposure of patients to these agents during pregnancy affects serologic responses to vaccines in newborns. We collected data from the Pregnancy in IBD and Neonatal Outcomes registry, which records outcomes of pregnant women with diagnosis of IBD receiving care at multiple centers in the United States, from 2007 through 2016. Serum samples collected from infants at least 7 months old were analyzed for titers of antibodies to Haemophilus influenzae B (HiB) or tetanus toxin; mothers completed a survey of vaccine practices and outcomes from July 2013 through October 2016. Umbilical cord blood samples from 33 infants were assayed for concentration of biologic agents. Vaccination response was compared between infants born to mothers exposed to biologic therapy (infliximab, adalimumab, certolizumab pegol, golimumab, natalizumab, vedolizumab, or ustekinumab-either as a single agent or in combination with an immunomodulator, at any time between conception and delivery) and infants born to unexposed mothers. A total of 179 women completed the vaccine survey (26 biologic unexposed, 153 exposed to a biologic agent). We found no significant difference in proportions of infants with protective antibody titers against HiB born to exposed mothers (n= 42, 71%) vs unexposed mothers (n= 8, 50%) (P= .41). We also found no difference in the proportion of infants with protective antibody titers to tetanus toxoid born to exposed mothers (80%) vs unexposed mothers (75%) (P= .66). The median concentration of infliximab in cord blood did not differ significantly between infants with vs without protective antibody titers to HiB (P= .30) or tetanus toxoid (P= .93). Mild reactions were observed in 7/40 infants who received rotavirus vaccine and whose mothers had been exposed to biologic therapies. Vaccination of infants against HiB and tetanus toxin, based on antibody titers measured when infants were at least 7 months old, does not appear to be affected by in utero exposure to biologic therapy.

The prevalence of bacterial overgrowth syndrome and its associated factors in patients with inflammatory bowel diseases (according to the data of the Novosibirsk registry)

To assess the prevalence of bacterial overgrowth syndrome (BOS) and its risk factors in patients with inflammatory bowel diseases (IBD). The patients from the Novosibirsk IBD registry, who had undergone a hydrogen breath test (HBT) using a Gastro+ device, were examined. In 93 IBD patients who had undergone a HBD, the prevalence of BOS was 48% (46.2% for ulcerative colitis and 51.2% for Crohn's disease). There was a strong correlation between abdominal bloating, abdominal rumbling, and positive HBT results in both patient groups. During the HBT, the patients with BOS frequently complained of diarrhea, borborygmi, belching, and anxiety. The findings suggest that BOS is highly prevalent among patients with IBD. BOS is associated with clinical symptoms, such as abdominal bloating, abdominal rumbling, tearfulness, and irritability.

Clinical course of ulcerative colitis patients who develop acute pancreatitis.

AIMTo investigate the clinical course of ulcerative colitis (UC) patients who develop acute pancreatitis.METHODSWe analyzed 3307 UC patients from the inflammatory bowel disease registry at Asan Medical Center from June 1989 to May 2015. The clinical course of UC patients who developed acute pancreatitis was compared with that of non-pancreatitis UC patients.RESULTSAmong 51 patients who developed acute pancreatitis, 13 (0.40%) had autoimmune, 10 (0.30%) had aminosalicylate-induced, and 13 (1.73%) had thiopurine-induced pancreatitis. All 13 patients with autoimmune pancreatitis (AIP) had type 2 AIP. Two (15.4%) patients had pre-existing AIP, and three (23.1%) patients developed AIP and UC simultaneously. Compared to non-pancreatitis patients, AIP patients had UC diagnosed at a significantly younger age (median, 22.9 years vs 36.4 years; P = 0.001). AIP and aminosalicylate-induced pancreatitis patients had more extensive UC compared to non-pancreatitis patients. All patients with pancreatitis recovered uneventfully, and there were no recurrences. Biologics were used more frequently in aminosalicylate- and thiopurine-induced pancreatitis patients compared to non-pancreatitis patients [adjusted OR (95%CI), 5.16 (1.42-18.67) and 6.90 (1.83-25.98), respectively]. Biologic utilization rate was similar among AIP and non-pancreatitis patients [OR (95%CI), 0.84 (0.11-6.66)]. Colectomy rates for autoimmune, aminosalicylate-induced, and thiopurine-induced pancreatitis, and for non-pancreatitis patients were 15.4% (2/13), 20% (2/10), 15.4% (2/13), and 7.3% (239/3256), respectively; the rates were not significantly different after adjusting for baseline disease extent.CONCLUSIONPancreatitis patients show a non-significant increase in colectomy, after adjusting for baseline disease extent.